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Clinical Trials in China / NCT07618624
Enrolling by invitation Phase 2

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

NCT07618624 · tracked via the Priya Life Science China tracker
Sponsor
Sun Yat-sen University
Phase
Phase 2
Started
2026-04-20
Last updated
2026-06-01

Condition(s) studied

Recurrent Head and Neck Squamous Cell CarcinomaHead and Neck Cancer

Investigational drug(s) / intervention(s)

FinotonlimabCetuximabDocetaxelSalvage SurgeryAdjuvant RadiotherapyPlatinum-based Chemotherapy

Finotonlimab: Finotonlimab

Cetuximab: Cetuximab

Docetaxel: Docetaxel

Salvage Surgery: Surgical resection after neoadjuvant therapy.

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

Platinum-based Chemotherapy: Adjuvant chemotherapy determined by team assessment of chemotherapy indications after surgery.

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
INCLUSION CRITERIA: 1. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 2. Age 18-75 years at time of consent 3. Histologically or cytologically confirmed recurrent head and neck squamous cell carcinoma with PD-L1 CPS at least 1 4. Disease progression after prior treatment including both PD-1(L1) inhibitor and platinum-based therapy (combined or sequential) 5. No EGFR-targeted therapy within 6 months prior to enrollment 6. Willing to provide archived tumor tissue or undergo fresh tumor biopsy for PD-L1 testing 7. At least one measurable extracranial lesion per RECIST v1.1; previously treated lesions must demonstrate clear progression 3 or more months after last local treatment 8. Resectable disease with no distant metastasis, as assessed by a multidisciplinary team 9. Adequate organ function within 7 days prior to enrollment: ANC at least 2.0 x 10\^9/L, platelet count at least 100 x 10\^9/L; total bilirubin less than 1.5 x ULN, ALT/AST less than 2.5 x ULN; serum creatinine less than 1.5 x ULN 10. Signed informed consent prior to any study-specific procedures 11. Life expectancy greater than 3 months 12. Effective contraception during study and for 6 months after last dose EXCLUSION CRITERIA: 1. History of other malignancies (except cured basal cell carcinoma or cervical carcinoma in situ) 2. Comorbidities requiring long-term immunosuppressive therapy or corticosteroids at immunosuppressive doses 3. Immunodeficiency or history of organ transplantation (including interstitial pneumonia, hepatitis, nephritis, hyperthyroidism, hypothyroidism) 4. HIV/AIDS; untreated active hepatitis B (HBV-DNA at least 500 IU/mL); hepatitis C (HCV-RNA above detection limit); or HBV/HCV co-infection 5. High-dose systemic corticosteroids within 4 weeks prior to enrollment 6. Pregnant or lactating women; fertile patients not using effective contraception 7. Laboratory values not meeting inclusion criteria within 7 days 8. Significantly impaired cardiac, hepatic, pulmonary, renal, or bone marrow function 9. Severe uncontrolled comorbidities or active infections 10. Concurrent participation in other clinical trials 11. Refusal or inability to sign informed consent 12. Other contraindications to study treatment as determined by the investigator 13. Psychiatric disorders or mental illness resulting in lack of legal capacity

Primary outcome measure(s)

Trial sites (9)

FacilityCityRegionStatus
The First People's Hospital of Foshan Foshan Guangdong
Affiliated Cancer Hospital and Institute of Guangzhou Medical University Guangzhou Guangdong
Guangzhou First People's Hospital Guangzhou Guangdong
Sun Yat-sen University Cancer Center Guangzhou Guangdong
The Third Affiliated Hospital of Sun Yat-sen University Guangzhou Guangdong
Zhujiang Hospital of Southern Medical University Guangzhou Guangdong
Cancer Hospital of Shantou University Medical College Shantou Guangdong
Shenzhen Second People's Hospital Shenzhen Guangdong
Affiliated Hospital of Guangdong Medical University Zhanjiang Guangdong

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07618624 on ClinicalTrials.gov ↗ ← All trials in China