Neoadjuvant Chemoimmunotherapy (Camrelizumab + Paclitaxel + Carboplatin) for Resectable HNSCC
NeoCamre-HN
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)
2 other identifiers
interventional
50
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Feb 2026
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 29, 2026
CompletedStudy Start
First participant enrolled
February 1, 2026
CompletedFirst Posted
Study publicly available on registry
February 10, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2029
February 10, 2026
February 1, 2026
3 years
January 29, 2026
February 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Pathological Complete Response (pCR) Rate
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
Rate of major pathological response (\<10% viable tumor cells in resected specimen)
At the time of surgery (approximately 10-12 weeks from baseline)
Secondary Outcomes (4)
Objective Response Rate (ORR)
After 3 cycles of neoadjuvant therapy (approximately 9 weeks)
3-Year Event-Free Survival (EFS)
3 years from enrollment
Incidence of Adverse Events
From first dose until 30 days after surgery
Proportion Requiring Adjuvant Chemoradiation
At the time of surgery
Study Arms (1)
Neoadjuvant Chemoimmunotherapy
EXPERIMENTALPatients receive 3 cycles of camrelizumab + paclitaxel + carboplatin followed by surgery. Number of Participants: 50 (Anticipated)
Interventions
200 mg IV on Day 1, every 21 days for 3 cycles
175 mg/m² IV on Day 1, every 21 days for 3 cycles
AUC 6 IV on Day 1, every 21 days for 3 cycles
Standard radical resection 4-6 weeks after neoadjuvant therapy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patient refusal to undergo planned treatment
- Protocol violations not related to medical indications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
P.A. Hertsen Moscow Oncology Research Institute
Moscow, Russia
Related Publications (1)
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: 38467604BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Larisa V. Bolotina, MD, PhD
P.A. Hertsen Moscow Oncology Research Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 29, 2026
First Posted
February 10, 2026
Study Start
February 1, 2026
Primary Completion (Estimated)
February 1, 2029
Study Completion (Estimated)
February 1, 2029
Last Updated
February 10, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share
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.