Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 1:22 PM
Study NCT ID:
NCT07400094
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-10
First Post:
2026-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neoadjuvant Chemoimmunotherapy (Camrelizumab + Paclitaxel + Carboplatin) for Resectable HNSCC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}, {'id': 'D007822', 'term': 'Laryngeal Neoplasms'}, {'id': 'D009062', 'term': 'Mouth Neoplasms'}], 'ancestors': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D007818', 'term': 'Laryngeal Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000631724', 'term': 'camrelizumab'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D016190', 'term': 'Carboplatin'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D056831', 'term': 'Coordination Complexes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2029-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-03', 'studyFirstSubmitDate': '2026-01-29', 'studyFirstSubmitQcDate': '2026-02-03', 'lastUpdatePostDateStruct': {'date': '2026-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pathological Complete Response (pCR) Rate', 'timeFrame': 'At the time of surgery (approximately 10-12 weeks from baseline)', 'description': 'Rate of complete pathological response (absence of viable tumor cells in resected specimen)'}, {'measure': 'Major Pathological Response (MPR) Rate', 'timeFrame': 'At the time of surgery (approximately 10-12 weeks from baseline)', 'description': 'Rate of major pathological response (\\<10% viable tumor cells in resected specimen)'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'After 3 cycles of neoadjuvant therapy (approximately 9 weeks)', 'description': 'Rate of objective response by imaging (MRI/PET-CT) compared to historical TPF control'}, {'measure': '3-Year Event-Free Survival (EFS)', 'timeFrame': '3 years from enrollment', 'description': 'EFS compared to historical control (surgery + RT/CRT)'}, {'measure': 'Incidence of Adverse Events', 'timeFrame': 'From first dose until 30 days after surgery', 'description': 'Safety profile compared to standard TPF induction chemotherapy'}, {'measure': 'Proportion Requiring Adjuvant Chemoradiation', 'timeFrame': 'At the time of surgery', 'description': 'Patients needing post-op CRT due to adverse pathological features vs historical control'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Head and Neck Squamous Cell Carcinoma', 'Neoadjuvant Therapy', 'Camrelizumab', 'Paclitaxel', 'Carboplatin', 'Pathological Complete Response', 'PD-1 Inhibitor'], 'conditions': ['Squamous Cell Carcinoma of Head and Neck', 'Laryngeal Neoplasms', 'Oral Cavity Neoplasm']}, 'referencesModule': {'references': [{'pmid': '38467604', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nFifty 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).\n\nThe 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.\n\nStudy period: 2026-2029.', 'detailedDescription': 'Investigator-initiated, single-arm, phase II study conducted at P.A. Hertsen Moscow Oncology Research Institute. Protocol approved by Local Ethics Committee (#1187/132).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed squamous cell carcinoma of the oral cavity and/or larynx, Stage III-IVA (cT1-2N1-2M0, cT3-4aN0-2M0)\n* Resectable disease planned for surgical treatment\n* Age 18-75 years\n* No prior antitumor therapy for the current diagnosis\n* Tumor sample available for PD-L1 expression assessment\n* No other malignancies in anamnesis (except basal cell carcinoma of skin and carcinoma in situ of cervix)\n* Absence of comorbidities preventing systemic chemotherapy and immunotherapy\n\nExclusion Criteria:\n\n* Patient refusal to undergo planned treatment\n* Protocol violations not related to medical indications'}, 'identificationModule': {'nctId': 'NCT07400094', 'acronym': 'NeoCamre-HN', 'briefTitle': 'Neoadjuvant Chemoimmunotherapy (Camrelizumab + Paclitaxel + Carboplatin) for Resectable HNSCC', 'organization': {'class': 'OTHER', 'fullName': 'National Medical Research Radiological Centre of the Ministry of Health of Russia'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'NeoCamre-HN-01'}, 'secondaryIdInfos': [{'id': 'LEC #1187/132', 'type': 'OTHER', 'domain': 'Local Ethics Committee, P.A. Hertsen'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Neoadjuvant Chemoimmunotherapy', 'description': 'Patients receive 3 cycles of camrelizumab + paclitaxel + carboplatin followed by surgery.\n\nNumber of Participants: 50 (Anticipated)', 'interventionNames': ['Drug: Camrelizumab', 'Drug: Paclitaxel', 'Drug: carboplatin', 'Procedure: Radical Surgery']}], 'interventions': [{'name': 'Camrelizumab', 'type': 'DRUG', 'otherNames': ['SHR-1210'], 'description': '200 mg IV on Day 1, every 21 days for 3 cycles', 'armGroupLabels': ['Neoadjuvant Chemoimmunotherapy']}, {'name': 'Paclitaxel', 'type': 'DRUG', 'otherNames': ['Taxol'], 'description': '175 mg/m² IV on Day 1, every 21 days for 3 cycles', 'armGroupLabels': ['Neoadjuvant Chemoimmunotherapy']}, {'name': 'carboplatin', 'type': 'DRUG', 'otherNames': ['Paraplatin'], 'description': 'AUC 6 IV on Day 1, every 21 days for 3 cycles', 'armGroupLabels': ['Neoadjuvant Chemoimmunotherapy']}, {'name': 'Radical Surgery', 'type': 'PROCEDURE', 'description': 'Standard radical resection 4-6 weeks after neoadjuvant therapy', 'armGroupLabels': ['Neoadjuvant Chemoimmunotherapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Moscow', 'country': 'Russia', 'contacts': [{'name': 'Larisa V. Bolotina, MD, PhD', 'role': 'CONTACT', 'email': 'lbolotina@yandex.ru', 'phone': '+79039686637'}, {'name': 'Maxim S. Ruban, MD', 'role': 'CONTACT', 'email': 'ruban.m.s@yandex.ru', 'phone': '+79204335470'}, {'name': 'Larisa V. Bolotina, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Tatiana I. Deshkina, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Andrey P. Polyakov, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Maxim S. Ruban, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'P.A. Hertsen Moscow Oncology Research Institute', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'centralContacts': [{'name': 'Larisa V. Bolotina, MD, PhD', 'role': 'CONTACT', 'email': 'lbolotina@yandex.ru', 'phone': '+79039686637'}, {'name': 'Maxim S. Ruban, MD', 'role': 'CONTACT', 'email': 'ruban.m.s@yandex.ru', 'phone': '+79204335470'}], 'overallOfficials': [{'name': 'Larisa V. Bolotina, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'P.A. Hertsen Moscow Oncology Research Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Medical Research Radiological Centre of the Ministry of Health of Russia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}