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A Single-arm, Phase II, Multi-center Clinical Trial of Sintilimab During the Perioperative Period in Patients With Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma

NCT07379424 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2026-01-30

No results posted yet for this study

Summary

This study is a single-arm, multi-center Phase II clinical trial. As depicted in the following study design diagram, its objective is to observe and assess the efficacy and safety of sintilimab during the perioperative period in patients with resectable locally advanced head and neck squamous cell carcinoma.

Conditions

  • Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma

Interventions

COMBINATION_PRODUCT

Adjuvant therapy: sintilimab combined with radiotherapy

The efficacy was assessed following 2 cycles of neoadjuvant therapy. Patients with efficacy evaluated as CR/PR/SD/PD underwent surgical resection. After surgical resection, sintilimab combined with radiotherapy was initiated as adjuvant therapy, and sintilimab was administered at a dosing interval of Q3W for 15 cycles.

Sponsors & Collaborators

  • chen chao Professor

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-28
Primary Completion
2027-08-25
Completion
2028-08-25

Countries

  • China

Study Locations

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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 NCT07379424 on ClinicalTrials.gov