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)
Major Pathological Response Rate (MPR) — At time of surgery, approximately 12 weeks after enrollment Proportion of patients with less than or equal to 10% viable tumor cells in the surgically resected specimen after neoadjuvant therapy, assessed by central pathology review.
Trial sites (9)
Facility
City
Region
Status
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
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.
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