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NCT Number: NCT07400094

Neoadjuvant Chemoimmunotherapy (Camrelizumab + Paclitaxel + Carboplatin) for Resectable HNSCC

This phase II study evaluates the efficacy and safety of neoadjuvant chemoimmunotherapy consisting of camrelizumab (PD-1 inhibitor), paclitaxel, and carboplatin in patients with resectable locally advanced (Stage III-IVA) squamous cell carcinoma of the oral cavity and/or larynx.

Fifty patients will receive 3 cycles of therapy (camrelizumab 200 mg IV, paclitaxel 175 mg/m2 IV, carboplatin AUC6 IV, Day 1 every 21 days) followed by radical surgery 4-6 weeks later. Patients are then stratified to risk-adapted adjuvant therapy based on pathological findings (radiation or chemoradiation with cisplatin if adverse features present).

The primary endpoint is the pathological complete response (pCR) rate and major pathological response (MPR, <10% viable tumor cells) rate at surgery. Secondary endpoints include objective response rate (ORR) by imaging (MRI/PET-CT), correlation of PET-CT metabolic response with pathological response, proportion requiring adjuvant chemoradiation, and 3-year event-free survival compared to historical controls.

Study period: 2026-2029.

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Key information

Conditions

Squamous Cell Carcinoma of Head and Neck Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Laryngeal Diseases Laryngeal Neoplasms Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Oral Cavity Neoplasm Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Stomatognathic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

P.A. Hertsen Moscow Oncology Research Institute

Moscow, Russia

Location contact

Andrey P. Polyakov, MD, PhD

SUB_INVESTIGATOR

Larisa V. Bolotina, MD, PhD

CONTACT

[email protected]

+79039686637

Larisa V. Bolotina, MD, PhD

PRINCIPAL_INVESTIGATOR

Maxim S. Ruban, MD

CONTACT

[email protected]

+79204335470

Maxim S. Ruban, MD

SUB_INVESTIGATOR

Tatiana I. Deshkina, MD, PhD

SUB_INVESTIGATOR

About this study

Investigator-initiated, single-arm, phase II study conducted at P.A. Hertsen Moscow Oncology Research Institute. Protocol approved by Local Ethics Committee (#1187/132).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Histologically confirmed squamous cell carcinoma of the oral cavity and/or larynx, Stage III-IVA (cT1-2N1-2M0, cT3-4aN0-2M0)
  • Resectable disease planned for surgical treatment
  • Age 18-75 years
  • No prior antitumor therapy for the current diagnosis
  • Tumor sample available for PD-L1 expression assessment
  • No other malignancies in anamnesis (except basal cell carcinoma of skin and carcinoma in situ of cervix)
  • Absence of comorbidities preventing systemic chemotherapy and immunotherapy

Exclusion criteria

  • Patient refusal to undergo planned treatment
  • Protocol violations not related to medical indications

Treatment and study plan

Camrelizumab

Drug

200 mg IV on Day 1, every 21 days for 3 cycles

Other names: SHR-1210

paclitaxel

Drug

175 mg/m² IV on Day 1, every 21 days for 3 cycles

Other names: Taxol

carboplatin

Drug

AUC 6 IV on Day 1, every 21 days for 3 cycles

Other names: Paraplatin

Radical surgery

Procedure

Standard radical resection 4-6 weeks after neoadjuvant therapy

Primary outcomes

  1. Pathological Complete Response (pCR) Rate

    Time frame: At the time of surgery (approximately 10-12 weeks from baseline)

    Rate of complete pathological response (absence of viable tumor cells in resected specimen)

  2. Major Pathological Response (MPR) Rate

    Time frame: At the time of surgery (approximately 10-12 weeks from baseline)

    Rate of major pathological response (<10% viable tumor cells in resected specimen)

Secondary outcomes

  1. Objective Response Rate (ORR)

    Time frame: After 3 cycles of neoadjuvant therapy (approximately 9 weeks)

    Rate of objective response by imaging (MRI/PET-CT) compared to historical TPF control

  2. 3-Year Event-Free Survival (EFS)

    Time frame: 3 years from enrollment

    EFS compared to historical control (surgery + RT/CRT)

  3. Incidence of Adverse Events

    Time frame: From first dose until 30 days after surgery

    Safety profile compared to standard TPF induction chemotherapy

  4. Proportion Requiring Adjuvant Chemoradiation

    Time frame: At the time of surgery

    Patients needing post-op CRT due to adverse pathological features vs historical control

Study contacts

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

Larisa V. Bolotina, MD, PhD

CONTACT

[email protected]

+79039686637

Maxim S. Ruban, MD

CONTACT

[email protected]

+79204335470

Sponsors and collaborators

Lead sponsor

National Medical Research Radiological Centre of the Ministry of Health of Russia

Other

Registry information

Official study title

Prospective Non-Randomized Phase II Study of Neoadjuvant Camrelizumab Combined With Paclitaxel and Carboplatin in Patients With Resectable Locally Advanced Squamous Cell Carcinoma of the Oral Cavity and Larynx (Stage III-IVA)

Acronym: NeoCamre-HN

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Feb 10, 2026
Registry last updated
Feb 10, 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.

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