Neoadjuvant Chemoimmunotherapy (Camrelizumab + Paclitaxel + Carboplatin) for Resectable HNSCC (NeoCamre-HN)

February 3, 2026 updated by: National Medical Research Radiological Centre of the Ministry of Health of Russia

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)

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Russia
      • Moscow, Russia
        • P.A. Hertsen Moscow Oncology Research Institute
        • Contact:
        • Contact:
        • Principal Investigator:
          • Larisa V. Bolotina, MD, PhD
        • Sub-Investigator:
          • Tatiana I. Deshkina, MD, PhD
        • Sub-Investigator:
          • Andrey P. Polyakov, MD, PhD
        • Sub-Investigator:
          • Maxim S. Ruban, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Neoadjuvant Chemoimmunotherapy

Patients receive 3 cycles of camrelizumab + paclitaxel + carboplatin followed by surgery.

Number of Participants: 50 (Anticipated)
Drug: Camrelizumab
200 mg IV on Day 1, every 21 days for 3 cycles
Other Names:
  • SHR-1210
Drug: Paclitaxel
175 mg/m² IV on Day 1, every 21 days for 3 cycles
Other Names:
  • Taxol
Drug: carboplatin
AUC 6 IV on Day 1, every 21 days for 3 cycles
Other Names:
  • Paraplatin
Procedure: Radical Surgery
Standard radical resection 4-6 weeks after neoadjuvant therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
At the time of surgery (approximately 10-12 weeks from baseline)
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)
At the time of surgery (approximately 10-12 weeks from baseline)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
After 3 cycles of neoadjuvant therapy (approximately 9 weeks)
3-Year Event-Free Survival (EFS)
Time Frame: 3 years from enrollment
EFS compared to historical control (surgery + RT/CRT)
3 years from enrollment
Incidence of Adverse Events
Time Frame: From first dose until 30 days after surgery
Safety profile compared to standard TPF induction chemotherapy
From first dose until 30 days after surgery
Proportion Requiring Adjuvant Chemoradiation
Time Frame: At the time of surgery
Patients needing post-op CRT due to adverse pathological features vs historical control
At the time of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Study Chair: Larisa V. Bolotina, MD, PhD, P.A. Hertsen Moscow Oncology Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

February 1, 2029

Study Completion (Estimated)

February 1, 2029

Study Registration Dates

First Submitted

January 29, 2026

First Submitted That Met QC Criteria

February 3, 2026

First Posted (Actual)

February 10, 2026

Study Record Updates

Last Update Posted (Actual)

February 10, 2026

Last Update Submitted That Met QC Criteria

February 3, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NeoCamre-HN-01
  • LEC #1187/132 (Other Identifier: Local Ethics Committee, P.A. Hertsen)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This is an investigator-initiated, single-center study conducted in Russia. Individual participant data will not be shared due to patient confidentiality requirements and institutional data protection policies.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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