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NCT Number: NCT06145308

Precision Treatment of Recurrent/Metastatic Salivary Gland Carcinoma Guided by Molecular Typing

Patients with salivary gland carcinoma were divided into groups according to HER2, NTRK, AR, TROP-2, etc. Patients in different groups were given precision targeted therapy or chemotherapy to evaluate the efficacy (ORR rate) and safety of precision therapy.

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Key information

Conditions

Salivary Gland Carcinoma Head and Neck Neoplasms Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Site Precision Therapy Salivary Gland Diseases Salivary Gland Neoplasms Stomatognathic Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fei Ma, Beijing, Beijing Municipality, China

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About this study

Patients with locally advanced/recurrent or oligometastatic salivary gland carcinoma will be stratified by HER2, NTRK, AR, TROP-2, etc., and receive precision-targeted or chemotherapy regimens, with efficacy (objective response rate, etc.) and safety of neoadjuvant/conversion therapy evaluated.

To assess the efficacy of post-operative adjuvant therapy guided by minimal residual disease (MRD) testing in locally advanced salivary gland carcinoma.

Patients with locally advanced/recurrent or symptomatic, rapidly progressive metastatic salivary gland carcinoma who are intolerant of or refuse surgery and radiotherapy will be molecularly stratified and treated with precision regimens, with efficacy (objective response rate, etc.) and safety of salvage therapy evaluated.

To evaluate efficacy (objective response rate, etc.) and safety of later-line therapy for locally advanced/recurrent or distant metastatic salivary gland carcinoma.

Using multi-omic approaches to explore salivary gland carcinoma heterogeneity and biomarkers associated with recurrence, metastasis, treatment response and prognosis.

To investigate concordance between drug-sensitivity testing using ex-vivo 3D tumour models and actual clinical outcomes, and to guide later-line treatment selection based on drug-sensitivity results.

The diagnostic and prognostic value of fibroblast activation protein inhibitor (FAPI) PET/CT for salivary gland cancer: All patients undergo routine standard examinations (FDG PET/CT) and FAPI PET/CT before and after treatment. Two independent blinded reading teams separately evaluate the two sets of images to provide diagnosis, staging, and follow-up on patient prognosis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with histopathologic diagnosis of salivary gland carcinoma
  • The tumor tissues were subjected to HER2/NTRK/AR/TROP-2 immunohistochemical staining.
  • ECOG physical status 0 or 1 score in the 3 days before the first medication of the study treatment;
  • Age 18 or older - no upper limit;
  • Life expectancy is more than 3 months; ⑥Have at least one measurable lesion according to RECIST1.1 standards; ⑦Women of childbearing age must have a negative pregnancy test within 7 days before the first medication, and agree to receive the necessary contraceptive measures;

⑧The patient must have adequate liver, kidney, bone marrow, heart and lung and other organ functions:

⑨Understanding and voluntarily signing informed consent prior to performing any research-related evaluation/operation;

⑩Ability to comply with research visit schedules and other programmatic requirements.

Exclusion criteria

  • Known hypersensitivity or delayed anaphylaxis to any agents in this trial;
  • Major surgery had been performed within 4 weeks prior to the start of the study and did not fully recover;
  • Have received a live vaccine within 4 weeks before the start of the study or plan to receive any vaccine during the study period ;
  • To study the occurrence of arterial/venous thrombosis events within 6 months before medication;
  • Major cardiovascular diseases;
  • Is suffering from uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung disease, interstitial lung disease, cirrhosis, etc.;
  • Is suffering from an active infection that requires systemic treatment;
  • History of active tuberculosis; ⑨ Positive human immunodeficiency virus (HIV) test result; ⑩ Patients with chronic hepatitis B or active hepatitis C. ⑪Conditions that the investigator believes will affect the safety or compliance of the drug therapy in this study ⑫Female/male who is pregnant or breastfeeding or who intends to give birth;

Treatment and study plan

Cohort 1 (HER2-positive, RC48-ADC)

Drug

Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop.

Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent.

Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate.

Other names: HER2,Vedolizumab

Cohort 2 (NTRK-fusion or NTRK-mutant)

Drug

Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop.

Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent.

Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate.

Other names: NTRK-inhibitor

Cohort 3 (AR-positive, leuprolide + bicalutamide + abiraterone)

Drug

Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop.

Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent.

Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate.

Other names: AR,leuprolide + bicalutamide + abiraterone

TROP2 ADC

Drug

Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop.

Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent.

Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate.

Other names: Cohort 4 (TROP2 ADC)

TKI

Drug

Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop.

Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent.

Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate.

Other names: Cohort 5 (ACC-TKI)

Albumin-paclitaxel + platinum

Drug

Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop.

Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent.

Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate.

Other names: Cohort 6 (albumin-bound paclitaxel + platinum)

Albumin-paclitaxel + carboplatin + apatinib + camrelizumab

Drug

Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop.

Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent.

Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate.

Other names: Cohort 7 (albumin-bound paclitaxel + carboplatin + apatinib + camrelizumab)

albumin-bound paclitaxel+trastuzumab+pyrotinib

Drug

Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop.

Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent.

Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate.

Other names: Cohort8 (HER2-positive, albumin-bound paclitaxel + trastuzumab + pyrotinib)

HER2,trastuzumab deruxtecan± pertuzumab

Drug

Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop.

Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent.

Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate.

Other names: Cohort9(HER2-positive, DS-8201 ± pertuzumab)

AR,AR antagonist ++ goserelin + pertuzumab + trastuzumab

Drug

Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop.

Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent.

Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate.

Other names: Cohort 10 (HER2+/AR+, AR antagonist + goserelin + pertuzumab + trastuzumab)

AR,AR antagonist +goserelin +docetaxel

Drug

Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop.

Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent.

Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate.

Other names: Cohort 11 (AR-positive, AR antagonist + goserelin ± docetaxel)

ivonescimab + investigator-choice platinum doublet+

Drug

Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop.

Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent.

Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate.

Other names: Cohort 12 (ivonescimab)

iparomlimab + tuvonralimab

Drug

Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop.

Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent.

Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate.

Other names: Cohort 13 (iparomlimab + tuvonralimab)

cadonilimab

Drug

Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop.

Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent.

Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate.

Other names: Cohort 14 (cadonilimab)

CDK4/6 inhibitor+AI or fulvestrant

Drug

Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop.

Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent.

Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate.

Other names: Cohort 15 (HR-positive)

alpelisib+fulvestrant

Drug

Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop.

Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent.

Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate.

Other names: Cohort 16 (PI3K-mutant)

PARP inhibitor

Drug

Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop.

Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent.

Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate.

Other names: Cohort 17 (homologous-recombination-deficient)

Enfortumab vedotin

Drug

Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop.

Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent.

Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate.

Other names: Cohort 18 (Nectin-4 ADC)

HER2, pyrotinib + pertuzumab/trastuzumab

Drug

Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop.

Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent.

Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate.

Other names: Cohort 19 (HER2-positive, pyrotinib + pertuzumab + trastuzumab)

vebecotutamab ±lenvatinib

Drug

Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop.

Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent.

Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate.

Other names: Cohort 20 (vebecotutamab ±lenvatinib)

Primary outcomes

  1. ORR

    Time frame: ORR at the end of Cycle 2 (each cycle is 21 days)

    ORR rates for neoadjuvant and translational therapy in patients with locally advanced/recurrent and advanced oligometastatic salivary gland cancer and ORR rate of salvage therapy for locally advanced/recurrent or distantly metastatic salivary gland carcinoma with rapid progression that cannot tolerate or refuses surgery

Secondary outcomes

  1. MPR;

    Time frame: MPR rate at the end of surgical treatment

    MPR rates in patients who received neoadjuvant and translational therapy and then underwent surgery

  2. R0 resection rate;

    Time frame: R0 resection rate at the end of surgical treatment

    R0 resection rate in patients who received neoadjuvant and translational therapy and then underwent surgery

  3. Facial nerve protection rate

    Time frame: Facial nerve protection rate at the end of surgical treatment

    Facial nerve protection rate in patients who received neoadjuvant and translational therapy and then underwent surgery

  4. DFS

    Time frame: DFS rates at 3-year

    3-year DFS rates for patients who underwent surgery

  5. PFS;

    Time frame: PFS Rate at 2-Year

    2-Year PFS Rate for Patients Receiving Rescue Therapy

  6. OS

    Time frame: OS rate at 5-year

    OS for all patients

Study contacts

Contact information is provided by the study sponsor or research team.

fei Ma

CONTACT

[email protected]

13910217780

Sponsors and collaborators

Lead sponsor

Peking Union Medical College

Other

Collaborators

  • Peking University Hospital of Stomatology

Registry information

Official study title

Cancer Hospital, Chinese Academy of Medical Sciences/National Cancer Center of China

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Nov 24, 2023
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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