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

NCT07400094 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-02-10

No results posted yet for this study

Summary

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.

Conditions

  • Squamous Cell Carcinoma of Head and Neck
  • Laryngeal Neoplasms
  • Oral Cavity Neoplasm

Interventions

DRUG

Camrelizumab

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

DRUG

Paclitaxel

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

DRUG

carboplatin

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

PROCEDURE

Radical Surgery

Standard radical resection 4-6 weeks after neoadjuvant therapy

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Larisa V. Bolotina, MD, PhD · P.A. Hertsen Moscow Oncology Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-28
Primary Completion
2029-02-28
Completion
2029-02-28

Countries

  • Russia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07400094 on ClinicalTrials.gov