A Phase 2 interventional study of Finotonlimab and Cetuximab in Recurrent Head and Neck Squamous Cell Carcinoma and Head and Neck Cancer, sponsored by Sun Yat-sen University. Enrolling by invitation at 9 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-06-01.
Sponsored by Sun Yat-sen University · Phase 2, Interventional, and Treatment
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).
Recurrent head and neck squamous cell carcinoma (HNSCC) remains a significant clinical challenge, with recurrence rates of 40-60% after curative treatment. Salvage surgery is the standard of care, yet approximately 50% of patients experience re-recurrence within 2 years. For patients who have progressed on prior PD-1 inhibitor and platinum-based therapy, no standard neoadjuvant regimen exists.
Finotonlimab (SCT-I10A) is a recombinant humanized anti-PD-1 monoclonal antibody approved by NMPA for first-line R/M HNSCC in combination with platinum-based chemotherapy. Phase III data showed mOS 14.1 months and ORR 39.9% (Nature Medicine, 2024). Cetuximab is an anti-EGFR monoclonal antibody approved for R/M HNSCC. Cetuximab plus taxane regimens showed ORR of 54.9-69.6% as second-line therapy after immunotherapy failure. Retrospective data suggest EGFR inhibition may enhance anti-tumor immune response and improve efficacy of PD-1 rechallenge (ORR 46.4%). Docetaxel is a standard taxane chemotherapeutic agent.
This study investigates a novel neoadjuvant triplet regimen combining finotonlimab (immunotherapy), cetuximab (EGFR targeting), and docetaxel (chemotherapy) in resectable recurrent HNSCC after immunotherapy progression.
TREATMENT REGIMEN:
Simon's two-stage design: Stage 1 (25 patients; at least 3 MPR required to proceed) to Stage 2 (17 additional, total 42). H0 MPR=14%, H1 MPR=30% (alpha=0.05, power=0.8). If 9 or fewer total responses, the trial is considered negative.
1,680 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 539 are open to participants now.
This study's planned enrollment of 42 is below the median of 49 across 1,432 interventional studies indexed under Squamous Cell Carcinoma of Head and Neck.
Browse Squamous Cell Carcinoma of Head and Neck studies →Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.
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EXCLUSION CRITERIA:
Neoadjuvant Finotonlimab + Cetuximab + Docetaxel
Drug: Finotonlimab · Drug: Cetuximab · Drug: Docetaxel · Procedure: Salvage Surgery · Radiation: Adjuvant Radiotherapy · Drug: Platinum-based Chemotherapy
Finotonlimab
Cetuximab
Docetaxel
Surgical resection after neoadjuvant therapy.
Adjuvant radiotherapy: after surgery, the team will assess whether the patient has indications for radiotherapy to determine whether to administer it.
Adjuvant chemotherapy determined by team assessment of chemotherapy indications after surgery.
Major Pathological Response Rate (MPR)
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.
Time frame: At time of surgery, approximately 12 weeks after enrollment
Objective Response Rate (ORR)
Proportion of patients achieving complete response (CR) or partial response (PR) per RECIST v1.1.
Time frame: After 3 cycles of neoadjuvant therapy, approximately 9 weeks
Pathological Complete Response Rate (pCR)
Proportion of patients with no residual viable tumor cells in the surgically resected specimen.
Time frame: At time of surgery
Median Overall Survival (mOS)
Time from enrollment to death from any cause.
Time frame: Up to 60 months from enrollment
Median Progression-Free Survival (mPFS)
Time from enrollment to disease progression per RECIST v1.1 or death from any cause.
Time frame: Up to 60 months from enrollment
Duration of Response (DoR)
Time from first documented CR or PR to disease progression or death.
Time frame: Up to 60 months
6-Month Progression-Free Survival Rate
Proportion of patients alive without disease progression at 6 months after completion of study treatment.
Time frame: 6 months after end of treatment
12-Month Progression-Free Survival Rate
Proportion of patients alive without disease progression at 12 months after completion of study treatment.
Time frame: 12 months after end of treatment
Incidence of Adverse Events (AEs)
Safety assessed per NCI CTCAE v5.0. Incidence and severity of all AEs, treatment-emergent AEs, and immune-related AEs.
Time frame: Through study completion, up to 90 days after last dose
Incidence of Serious Adverse Events (SAEs)
Incidence of serious adverse events assessed per CTCAE v5.0.
Time frame: Through study completion, up to 90 days after last dose
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