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

Phase 2Not Yet RecruitingNCT07400094

National Medical Research Radiological Centre of the Ministry of Health of Russia50 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

CamrelizumabDRUG

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

PaclitaxelDRUG

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

carboplatinDRUG

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

Radical SurgeryPROCEDURE

Standard radical resection 4-6 weeks after neoadjuvant therapy

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Pathological Complete Response (pCR) Rate

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

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

Major Pathological Response (MPR) Rate

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

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

Secondary Outcomes

Objective Response Rate (ORR)

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

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

3-Year Event-Free Survival (EFS)

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

Time frame: 3 years from enrollment

Incidence of Adverse Events

Safety profile compared to standard TPF induction chemotherapy

Time frame: From first dose until 30 days after surgery

Proportion Requiring Adjuvant Chemoradiation

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

Time frame: At the time of surgery