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
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• The subject voluntarily participates, signs the Informed Consent Form (ICF), and is able to comply with the study procedures;

• Patients with locally advanced head and neck squamous cell carcinoma confirmed by cytology or histology, for whom complete surgical resection is difficult;

• No prior treatment for head and neck squamous cell carcinoma;

• No prior treatment with cetuximab or PD-(L)1 inhibitors;

• At least one measurable lesion according to RECIST v1.1;

• No gender restriction, age ≥18;

• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;

• Expected survival period ≥ 3 months;

• Organ function levels meet the following criteria:

∙ Blood routine: Hemoglobin ≥90 g/L, absolute neutrophil count (ANC) ≥1.5×10\^9/L, platelets ≥90×10\^9/L;

‣ Blood biochemistry: ALT, AST ≤2.5×ULN (≤5×ULN if liver metastasis is present), total serum bilirubin ≤1.5×ULN, serum creatinine ≤1.5×ULN, serum albumin ≥30 g/L;

‣ Cardiac function: Left ventricular ejection fraction \>50% as shown by echocardiography.

⁃ Women of childbearing potential must have taken reliable contraceptive measures or undergone a pregnancy test (serum or urine) within 7 days before enrollment, with a negative result, and be willing to use appropriate contraceptive methods during the trial and for 8 weeks after the last administration of the trial drug.

Locations
Other Locations
China
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
RECRUITING
Chongqing
Contact Information
Primary
Juan Li
lljuan1019@tmmu.edu.cn
86+13883272120
Time Frame
Start Date: 2025-03-01
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 42
Treatments
Experimental: Experimental arm
Conversion therapy stage:TP+Cetuximab+Tislelizumab. Radical therapy stage: Those assessed as operable receive curative surgery, while those assessed as inoperable undergo radical radiotherapy.~Maintenance therapy stage: Tislelizumab for 1 year.
Sponsors
Leads: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

This content was sourced from clinicaltrials.gov