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Anti-PD-1 Therapy in Recurrent and Metastatic Head and Neck Squamous Cell Carcinoma

NCT07751289 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 217

Last updated 2026-08-07

No results posted yet for this study

Summary

The goal of this clinical trial is to determine whether a perioperative PD-1 antibody-based treatment strategy, consisting of neoadjuvant PD-1 antibody plus chemotherapy followed by adjuvant PD-1 antibody after surgery, improves outcomes compared with the current standard treatment in patients with resectable locally recurrent head and neck squamous cell carcinoma (HNSCC). The study will also evaluate the safety of this perioperative treatment approach.

The main questions it aims to answer are:

Does perioperative PD-1 antibody-based therapy improve event-free survival compared with the current standard treatment? What adverse events occur during treatment with neoadjuvant PD-1 antibody plus chemotherapy and adjuvant PD-1 antibody?

Researchers will compare a perioperative PD-1 antibody-based treatment strategy with the current standard treatment to determine which approach provides better clinical outcomes.

Participants will:

Be randomly assigned to one of two study groups. Receive either neoadjuvant PD-1 antibody plus chemotherapy followed by surgery and adjuvant PD-1 antibody, or undergo upfront surgery followed by standard postoperative treatment as indicated.

Visit the clinic regularly for physical examinations, blood tests, imaging assessments, and other study procedures.

Be followed after treatment to monitor disease status, treatment response, survival outcomes, and adverse events.

Conditions

  • Recurrent Head and Neck Squamous Cell Carcinoma

Interventions

DRUG

Neoadjuvant PD-1 antibody plus chemotherapy

Administered once every 3 weeks for 2 to 4 cycles before surgery

PROCEDURE

surgery

Surgery followed by postoperative radiotherapy or chemoradiotherapy as clinically indicated.

DRUG

Adjuvant PD-1 antibody

Administered postoperatively every 3 weeks for up to 15 cycles.

Sponsors & Collaborators

  • Yanjie Zhang, MD

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 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 NCT07751289 on ClinicalTrials.gov