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Perioperative Finotonlimab Plus Chemotherapy in Untreated Stage II HNSCC

NCT07751276 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2026-08-07

No results posted yet for this study

Summary

This multicenter, randomized, open-label, parallel-controlled clinical trial aims to evaluate the efficacy and safety of surgery combined with postoperative chemoradiotherapy versus finotonlimab plus induction chemotherapy followed by postoperative finotonlimab maintenance therapy in patients with locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN).

Conditions

  • Head and Neck Squamous Cell Carcinoma HNSCC

Interventions

DRUG

Neoadjuvant Finotonlimab Plus Chemotherapy

Participants receive neoadjuvant finotonlimab 200 mg intravenously on Day 1, albumin-bound paclitaxel 100 mg/m² intravenously on Days 1, 8, and 15, and carboplatin at an area under the concentration-time curve of 4 intravenously on Day 1 of each 21-day cycle for 2 cycles before surgery. Cisplatin 75 mg/m² intravenously on Day 1 may be substituted for carboplatin.

PROCEDURE

Surgery

Participants undergo definitive surgery. Postoperative radiotherapy or concurrent chemoradiotherapy may be administered according to postoperative pathological risk factors.

DRUG

Postoperative Finotonlimab Maintenance

Participants receive postoperative finotonlimab 200 mg intravenously on Day 1 of each 21-day cycle for up to 6 cycles. Treatment begins 3 to 6 weeks after surgery or, for participants receiving postoperative radiotherapy or concurrent chemoradiotherapy, within 2 weeks after completion of radiotherapy.

Sponsors & Collaborators

  • Yanjie Zhang, MD

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2029-12-31
Completion
2032-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07751276 on ClinicalTrials.gov