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

Sponsor
National Medical Research Radiological Centre of the Ministry of Health of Russia
Study ID
NCT07400094
Phase
PHASE2
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Camrelizumab — DRUG
    200 mg IV on Day 1, every 21 days for 3 cycles
  • Paclitaxel — DRUG
    175 mg/m² IV on Day 1, every 21 days for 3 cycles
  • carboplatin — DRUG
    AUC 6 IV on Day 1, every 21 days for 3 cycles
  • Radical Surgery — PROCEDURE
    Standard radical resection 4-6 weeks after neoadjuvant therapy

Study Details

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.

Key Dates

Start date
Feb 28, 2026
Status verified
Feb 2026
Primary completion
Feb 28, 2029
Completion
Feb 28, 2029

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Neoadjuvant Chemoimmunotherapy
    Patients receive 3 cycles of camrelizumab + paclitaxel + carboplatin followed by surgery. Number of Participants: 50 (Anticipated)

Primary Outcome Measure

Pathological Complete Response (pCR) Rate [ Time Frame: At the time of surgery (approximately 10-12 weeks from baseline) ]

Central Contacts

Related Studies