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

NCT06978829 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2025-05-18

No results posted yet for this study

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.

Conditions

  • LA HNSCC

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.

Sponsors & Collaborators

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

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-01
Primary Completion
2027-03-31
Completion
2027-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06978829 on ClinicalTrials.gov