NCT06978829

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study plans to enroll 42 patients. After screening and qualifying the patients, they will be given the treatment of Cetuximab combined with Tislelizumab and the TP chemotherapy regimen. One cycle lasts for 3 weeks, and a total of 3 cycles will be carried out, followed by efficacy evaluation. 1. Patients evaluated as resectable will undergo surgical treatment. After the surgery, based on the postoperative pathology, it will be determined whether radiotherapy is needed. And then, 1 cycle of combined chemotherapy will be continued, followed by 1 - year maintenance treatment with Tislelizumab. 2. Patients evaluated as unsuitable for surgery will receive radical radiotherapy, followed by 1 - year maintenance treatment with Tislelizumab, until disease progression, intolerable adverse reactions occur, or the patient refuses to continue treatment.

Conditions

• LA HNSCC

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-03-01
• Primary completion: 2027-03-31
• Completion: 2027-12-31
• First posted: 2025-05-18
• Last updated: 2025-05-18

Locations

1 site across 1 country: China