Menu
Not yet recruiting NCT07400094

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

Phase II Interventional Squamous Cell Carcinoma of Head and Neck Laryngeal Neoplasms Oral Cavity Neoplasm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Camrelizumab, Paclitaxel, carboplatin, Radical Surgery.
Who it may be relevant to
Registry conditions: Squamous Cell Carcinoma of Head and Neck, Laryngeal Neoplasms, Oral Cavity Neoplasm. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Russia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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)

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.

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).

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

Primary outcome measures

  • Pathological Complete Response (pCR) Rate [Time frame: 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)]
Secondary outcome measures (4)
  • Objective Response Rate (ORR) [Time frame: After 3 cycles of neoadjuvant therapy (approximately 9 weeks)]
  • 3-Year Event-Free Survival (EFS) [Time frame: 3 years from enrollment]
  • Incidence of Adverse Events [Time frame: From first dose until 30 days after surgery]
  • Proportion Requiring Adjuvant Chemoradiation [Time frame: At the time of surgery]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Russia · 1 center
  • P.A. Hertsen Moscow Oncology Research Institute — Moscow

Publications

  • Wu D, Li Y, Xu P, Fang Q, Cao F, Lin H, Li Y, Su Y, Lu L, Chen L, Li Y, Zhao Z, Hong X, Li G, Tian Y, Sun J, Yan H, Fan Y, Zhang X, Li Z, Liu X. Neoadjuvant chemo-immunotherapy with camrelizumab plus nab-paclitaxel and cisplatin in resectable locally advanced squamous cell carcinoma of the head and neck: a pilot phase II trial. Nat Commun. 2024 Mar 11;15(1):2177. doi: 10.1038/s41467-024-46444-z. PMID 38467604

Identifiers

NCT: NCT07400094 · NeoCamre-HN-01 · LEC #1187/132

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗