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ENROLLING BY INVITATION
NCT07618624
PHASE2

BRIDGE Study: Neoadjuvant Finotonlimab, Cetuximab, and Docetaxel in Resectable Recurrent HNSCC After Immunotherapy Progression

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

Summary

This is a multicenter, single-arm, phase II clinical study evaluating the efficacy and safety of neoadjuvant finotonlimab (anti-PD-1), cetuximab (anti-EGFR), and docetaxel in patients with resectable recurrent head and neck squamous cell carcinoma (HNSCC) who have progressed after prior PD-1(L1) inhibitor plus platinum-based therapy. A total of 42 patients (PD-L1 CPS at least 1) will be enrolled using Simon's two-stage design across 9 centers in China (Stage 1: 25 patients; Stage 2: 17 additional patients with 5% dropout). Enrolled patients will receive 3 cycles of neoadjuvant finotonlimab (200 mg, IV, Q3W), cetuximab (500 mg/m2, IV, Q3W), and docetaxel (75 mg/m2, IV, Q3W), followed by salvage surgery (3-4 weeks later), adjuvant radiotherapy +/- chemotherapy per NCCN/CSCO guidelines, and maintenance finotonlimab 200 mg + cetuximab 500 mg/m2 Q3W for up to 12 cycles or until disease progression or unacceptable toxicity. The primary endpoint is major pathological response (MPR) rate. Historical MPR is 14% with dual immunotherapy neoadjuvant therapy; target MPR is 30% (alpha=0.05, power=0.8, one-sided). Secondary endpoints include ORR, pCR, mOS, mPFS, DoR, 6-month and 12-month PFS rate, and safety (AEs/SAEs per CTCAE v5.0).

Official title: Finotonlimab Combined With Cetuximab and Docetaxel as Neoadjuvant Therapy for Resectable Recurrent Head and Neck Squamous Cell Carcinoma After Immunotherapy Progression: A Multicenter, Single-Arm, Phase II Clinical Study

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

42

Start Date

2026-04-20

Completion Date

2029-12-31

Last Updated

2026-06-01

Healthy Volunteers

No

Interventions

DRUG

Finotonlimab

Finotonlimab

DRUG

Cetuximab

Cetuximab

DRUG

Docetaxel

Docetaxel

PROCEDURE

Salvage Surgery

Surgical resection after neoadjuvant therapy.

RADIATION

Adjuvant Radiotherapy

Adjuvant radiotherapy: after surgery, the team will assess whether the patient has indications for radiotherapy to determine whether to administer it.

DRUG

Platinum-based Chemotherapy

Adjuvant chemotherapy determined by team assessment of chemotherapy indications after surgery.

Locations (9)

The First People's Hospital of Foshan

Foshan, Guangdong, China

Affiliated Cancer Hospital and Institute of Guangzhou Medical University

Guangzhou, Guangdong, China

Guangzhou First People's Hospital

Guangzhou, Guangdong, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Cancer Hospital of Shantou University Medical College

Shantou, Guangdong, China

Shenzhen Second People's Hospital

Shenzhen, Guangdong, China

Affiliated Hospital of Guangdong Medical University

Zhanjiang, Guangdong, China