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RECRUITING
NCT06978829
PHASE2

Cetuximab + Tislelizumab + Chemotherapy in the Treatment of Unresectable LA HNSCC

Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

View on ClinicalTrials.gov

Summary

This prospective, single-arm, Phase II study aims to evaluate the efficacy, safety, and surgical conversion rate of Cetuximab combined with Tislelizumab and chemotherapy for unresectable LA HNSCC.

Official title: Cetuximab Combined With Tislelizumab and Chemotherapy in the Treatment of Unresectable Locally Advanced Head and Neck Squamous Cell Carcinoma: A Prospective, Single-Arm, Phase II Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

42

Start Date

2025-03-01

Completion Date

2027-12-31

Last Updated

2025-05-18

Healthy Volunteers

No

Conditions

Interventions

DRUG

TP + Cetuximab + Tislelizumab

Conversion therapy stage: TP regimen: Albumin-bound paclitaxel+Platinum (Cisplatin or Carboplatin) Albumin-bound paclitaxel: 100 mg/m² by IV infusion, D1/D8, every 3 weeks (Q3W) Platinum: Cisplatin 75 mg/m² by IV infusion or Carboplatin AUC=5 mg/mL/min Q3W Cetuximab: The initial dose is 400 mg/m² by IV infusion for 1 week. Subsequently followed by 250 mg/m² IV infusion, D1/D8, Q3W. Tislelizumab: 200 mg by IV infusion, Q3W. 3 weeks/cycle, 3 cycles in total. Patients who have completed conversion therapy undergo efficacy evaluation. Radical therapy stage: Evaluated as operable: Undergo surgery, followed by one cycle of adjuvant chemotherapy according to the preoperative regimen. Evaluated as inoperable: Receive radical radiotherapy. Maintenance therapy stage: Tislelizumab for 1 year or until disease progression, intolerable toxicity, or patient refusal to continue treatment.

Locations (1)

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Chongqing, Chongqing Municipality, China