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| ID | Type | Description | Link |
|---|---|---|---|
| LEC #1187/132 | Other Identifier | Local Ethics Committee, P.A. Hertsen |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoadjuvant Chemoimmunotherapy | Experimental | Patients receive 3 cycles of camrelizumab + paclitaxel + carboplatin followed by surgery. Number of Participants: 50 (Anticipated) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab | Drug | 200 mg IV on Day 1, every 21 days for 3 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Rate of objective response by imaging (MRI/PET-CT) compared to historical TPF control | After 3 cycles of neoadjuvant therapy (approximately 9 weeks) |
| 3-Year Event-Free Survival (EFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Larisa V. Bolotina, MD, PhD | Contact | +79039686637 | lbolotina@yandex.ru | |
| Maxim S. Ruban, MD | Contact | +79204335470 | ruban.m.s@yandex.ru |
| Name | Affiliation | Role |
|---|---|---|
| Larisa V. Bolotina, MD, PhD | P.A. Hertsen Moscow Oncology Research Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| P.A. Hertsen Moscow Oncology Research Institute | Moscow | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38467604 | Background | 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. |
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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.
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| Paclitaxel | Drug | 175 mg/m² IV on Day 1, every 21 days for 3 cycles |
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| carboplatin | Drug | AUC 6 IV on Day 1, every 21 days for 3 cycles |
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| Radical Surgery | Procedure | Standard radical resection 4-6 weeks after neoadjuvant therapy |
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EFS compared to historical control (surgery + RT/CRT)
| 3 years from enrollment |
| Incidence of Adverse Events | Safety profile compared to standard TPF induction chemotherapy | 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 | At the time of surgery |
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D007822 | Laryngeal Neoplasms |
| D009062 | Mouth Neoplasms |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D010039 | Otorhinolaryngologic Neoplasms |
| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D010038 | Otorhinolaryngologic Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
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