Laryngeal Neoplasms, Oral Cavity Neoplasm, Squamous Cell Carcinoma of Head and Neck
Conditions
Keywords
Head and Neck Squamous Cell Carcinoma, Neoadjuvant Therapy, Camrelizumab, Paclitaxel, Carboplatin, Pathological Complete Response, PD-1 Inhibitor
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.
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
DRUGCamrelizumab
200 mg IV on Day 1, every 21 days for 3 cycles
DRUGPaclitaxel
175 mg/m² IV on Day 1, every 21 days for 3 cycles
DRUGcarboplatin
AUC 6 IV on Day 1, every 21 days for 3 cycles
PROCEDURERadical Surgery
Standard radical resection 4-6 weeks after neoadjuvant therapy
Sponsors
National Medical Research Radiological Centre of the Ministry of Health of Russia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathological Complete Response (pCR) Rate | At the time of surgery (approximately 10-12 weeks from baseline) | Rate of complete pathological response (absence of viable tumor cells in resected specimen) |
| Major Pathological Response (MPR) Rate | At the time of surgery (approximately 10-12 weeks from baseline) | Rate of major pathological response (\<10% viable tumor cells in resected specimen) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | After 3 cycles of neoadjuvant therapy (approximately 9 weeks) | Rate of objective response by imaging (MRI/PET-CT) compared to historical TPF control |
| 3-Year Event-Free Survival (EFS) | 3 years from enrollment | EFS compared to historical control (surgery + RT/CRT) |
| Incidence of Adverse Events | From first dose until 30 days after surgery | Safety profile compared to standard TPF induction chemotherapy |
| Proportion Requiring Adjuvant Chemoradiation | At the time of surgery | Patients needing post-op CRT due to adverse pathological features vs historical control |
Countries
Russia
Contacts
CONTACTLarisa V. Bolotina, MD, PhD
CONTACTMaxim S. Ruban, MD
STUDY_CHAIRLarisa V. Bolotina, MD, PhD
P.A. Hertsen Moscow Oncology Research Institute
Outcome results
None listed