Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07751276

Perioperative Finotonlimab Plus Chemotherapy in Untreated Stage II HNSCC

This multicenter, randomized, open-label, parallel-controlled clinical trial aims to evaluate the efficacy and safety of surgery combined with postoperative chemoradiotherapy versus finotonlimab plus induction chemotherapy followed by postoperative finotonlimab maintenance therapy in patients with locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN).

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Head and Neck Squamous Cell Carcinoma HNSCC Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Squamous Cell Carcinoma of Head and Neck

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18-75 years
  • Pathologically confirmed primary head and neck squamous cell carcinoma (excluding nasopharyngeal carcinoma)
  • Clinical stage II (8th edition TNM staging), no distant metastasis, primary tumor resectable
  • ECOG sccore 0-1
  • No prior radiotherapy, chemotherapy, immunotherapy, or biological therapy for the current head and neck tumor
  • Willing to undergo surgical treatment
  • No significant contraindications to immunotherapy, radiotherapy, or chemotherapy
  • Major organ function meets the following criteria: a) Hematologic: WBC ≥ 4.0 × 10⁹/L, ANC ≥ 1.5 × 10⁹/L, PLT ≥ 100 × 10⁹/L, Hb ≥ 90 g/L (no blood transfusion or blood products, no G-CSF or other hematopoietic growth factors within 14 days); b) Biochemistry: serum albumin ≥ 3.0 g/dL (30 g/L), TBIL ≤ 1.5 × ULN, ALT and AST ≤ 2.5 × ULN, BUN and CRE ≤ 1.5 × ULN or endogenous creatinine clearance ≥ 60 mL/min (Cockcroft-Gault formula); c) Adequate coagulation: defined as INR or PT ≤ 1.5 × ULN; if the subject is receiving anticoagulation therapy, PT within the intended therapeutic range of the anticoagulant is acceptable
  • Both male and female subjects are eligible; women of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days prior to enrollment and must agree to use effective contraception during the study and for 2 months after the last dose of anti-PD-1 antibody. Male subjects with female partners of childbearing potential must agree to use effective contraception during the study and for 2 months after the last dose of anti-PD-1 antibody
  • The subject voluntarily enrolls in this study, signs the informed consent form, demonstrates good compliance, and cooperates with follow-up

Exclusion criteria

  • Prior treatment with anti-PD-1/PD-L1 antibodies, anti-PD-L2 antibodies, anti-CD137 antibodies, CTLA-4 antibodies, or other drugs/antibodies targeting T-cell co-stimulation or checkpoint pathways
  • Active severe autoimmune disease. Subjects in stable condition not requiring systemic immunosuppressive therapy are eligible, such as type 1 diabetes mellitus, hypothyroidism requiring only hormone replacement therapy, and skin conditions not requiring systemic treatment (e.g., vitiligo, psoriasis, alopecia)
  • Congenital or acquired immunodeficiency (e.g., HIV infection), active hepatitis B (HBV-DNA ≥ 10⁴ copies/mL), or hepatitis C (HCV antibody positive and HCV-RNA above the lower limit of detection)
  • Known hypersensitivity to the study drug or any of its excipients, or history of severe allergic reaction to other monoclonal antibodies
  • Within 6 months prior to randomization: myocardial infarction, severe/unstable angina, NYHA class ≥ 2 cardiac dysfunction, clinically significant supraventricular or ventricular arrhythmias, or symptomatic congestive heart failure
  • Receipt of a live vaccine within 4 weeks prior to the first dose of study drug; inactivated influenza vaccine administered by injection is permitted, while intranasal live attenuated influenza vaccine is not permitted
  • Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation
  • Known history of psychotropic substance abuse or drug addiction
  • Pregnant or lactating women
  • Diagnosis of any other malignancy within 5 years prior to study entry, except for curatively treated localized cancers including basal cell carcinoma or squamous cell carcinoma of the skin, superficial bladder cancer, cervical carcinoma in situ, ductal carcinoma in situ of the breast, and papillary thyroid carcinoma
  • Any other severe physical or psychiatric illness or laboratory abnormality that may increase the risk of study participation, interfere with study results, or render the patient unsuitable for study participation in the opinion of the investigator

Treatment and study plan

Neoadjuvant Finotonlimab Plus Chemotherapy

Drug

Participants receive neoadjuvant finotonlimab 200 mg intravenously on Day 1, albumin-bound paclitaxel 100 mg/m² intravenously on Days 1, 8, and 15, and carboplatin at an area under the concentration-time curve of 4 intravenously on Day 1 of each 21-day cycle for 2 cycles before surgery. Cisplatin 75 mg/m² intravenously on Day 1 may be substituted for carboplatin.

Surgery

Procedure

Participants undergo definitive surgery. Postoperative radiotherapy or concurrent chemoradiotherapy may be administered according to postoperative pathological risk factors.

Postoperative Finotonlimab Maintenance

Drug

Participants receive postoperative finotonlimab 200 mg intravenously on Day 1 of each 21-day cycle for up to 6 cycles. Treatment begins 3 to 6 weeks after surgery or, for participants receiving postoperative radiotherapy or concurrent chemoradiotherapy, within 2 weeks after completion of radiotherapy.

Primary outcomes

  1. Event-Free Survival (EFS)

    Time frame: 2 years after randomization

    Event-free survival (EFS) is defined as the time from randomization to the first occurrence of disease recurrence or metastasis after surgery; disease progression according to RECIST version 1.1 that prevents definitive surgery during preoperative treatment or occurs in participants who do not undergo definitive surgery; a second primary malignancy; or death from any cause. Disease progression during preoperative treatment that does not prevent definitive surgery is not considered an EFS event. Failure to undergo definitive surgery for reasons other than disease progression is not itself considered an EFS event. Participants without an EFS event will be censored at the date of the last adequate disease assessment. EFS will be estimated using the Kaplan-Meier method. The planned primary EFS analysis will be performed after all participants have had the opportunity for at least 24 months of follow-up after randomization.

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: 2 years after randomization

    Overall survival (OS) is defined as the time from randomization to death from any cause. Participants without a documented death will be censored at the date they were last known to be alive. OS will be estimated using the Kaplan-Meier method. The planned primary OS analysis will be performed after all participants have had the opportunity for at least 24 months of follow-up after randomization.

  2. Major Pathological Response (MPR) Rate

    Time frame: Within 2 weeks after surgery

    The proportion of participants in the experimental-arm intention-to-treat population who achieve a major pathological response. MPR is defined as 10% or less residual viable tumor in the resected primary tumor and sampled regional lymph nodes, calculated as the area of residual viable tumor divided by the total tumor bed area.

  3. Pathologic Complete Response (pCR) Rate

    Time frame: Within 2 weeks after surgery

    The proportion of participants in the experimental-arm intention-to-treat population who achieve a pathologic complete response. pCR is defined as the absence of residual viable tumor cells in the resected primary tumor and all sampled regional lymph nodes.

  4. 5-Year Overall Survival (OS)

    Time frame: 5 years after randomization

    Overall survival (OS) is defined as the time from randomization to death from any cause. Participants without a documented death will be censored at the date they were last known to be alive or at 5 years after randomization, whichever occurs first. OS will be estimated using the Kaplan-Meier method.

  5. 5-Year Event-Free Survival (EFS)

    Time frame: 5 years after randomization

    Event-free survival (EFS) is defined as the time from randomization to the first occurrence of disease recurrence or metastasis after surgery; disease progression according to RECIST version 1.1 that prevents definitive surgery during preoperative treatment or occurs in participants who do not undergo definitive surgery; a second primary malignancy; or death from any cause. Disease progression during preoperative treatment that does not prevent definitive surgery is not considered an EFS event. Failure to undergo definitive surgery for reasons other than disease progression is not itself considered an EFS event. Participants without an EFS event will be censored at the date of the last adequate disease assessment or at 5 years after randomization, whichever occurs first. EFS will be estimated using the KaplanMeier method.

  6. 2-Year Distant Metastasis-Free Survival (DMFS)

    Time frame: 2 years after randomization

    Distant metastasis-free survival (DMFS) is defined as the time from randomization to the first occurrence of distant metastasis or death from any cause, whichever occurs first. Participants who remain alive and distant metastasis-free will be censored at the date of the last adequate disease assessment. DMFS will be estimated using the Kaplan-Meier method.

  7. 5-Year Distant Metastasis-Free Survival (DMFS)

    Time frame: 5 years after randomization

    Distant metastasis-free survival (DMFS) is defined as the time from randomization to the first occurrence of distant metastasis or death from any cause, whichever occurs first. Participants who remain alive and distant metastasis-free will be censored at the date of the last adequate disease assessment. DMFS will be estimated using the Kaplan-Meier method.

  8. 2-Year Locoregional Recurrence-Free Survival (LRFS)

    Time frame: 2 years after randomization

    Locoregional recurrence-free survival (LRFS) is defined as the time from randomization to the first occurrence of locoregional recurrence or death from any cause, whichever occurs first. Participants who remain alive and free of locoregional recurrence will be censored at the date of the last adequate disease assessment. LRFS will be estimated using the Kaplan-Meier method.

  9. 5-Year Locoregional Recurrence-Free Survival (LRFS)

    Time frame: 5 years after randomization

    Locoregional recurrence-free survival (LRFS) is defined as the time from randomization to the first occurrence of locoregional recurrence or death from any cause, whichever occurs first. Participants who remain alive and free of locoregional recurrence will be censored at the date of the last adequate disease assessment. LRFS will be estimated using the Kaplan-Meier method.

  10. Incidence of Adverse Events

    Time frame: From initiation of assigned treatment through 30 days after treatment completion or discontinuation; serious adverse events and adverse events of special interest through 90 days after treatment completion or discontinuation.

    The number and proportion of participants who experience adverse events, serious adverse events, Grade 3 or higher adverse events, treatment-related adverse events, and adverse events leading to treatment modification or discontinuation. Adverse events will be coded using MedDRA version 25.0 by preferred term and system organ class. Treatment-emergent adverse events are defined as adverse events occurring after initiation of the assigned study treatment.

Sponsors and collaborators

Lead sponsor

Yanjie Zhang, MD

Other

Registry information

Official study title

A Multicenter, Randomized Controlled Clinical Trial of Finotonlimab Combined With Chemotherapy as Perioperative Therapy for Untreated Stage II Head and Neck Squamous Cell Carcinoma

Important dates

Study start
2026
Primary completion
2029
Study completion
2032
First posted
Aug 7, 2026
Registry last updated
Aug 7, 2026

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

View the official ClinicalTrials.gov record (opens in a new tab)

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.