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Low-dose Radiotherapy Plus Tislelizumab in Combination With Afatinib for Neoadjuvant Treatment of Surgically Resectable Head and Neck Squamous Carcinoma

NCT06494189 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2025-12-29

No results posted yet for this study

Summary

The purpose of this study was to evaluate the safety and tolerability of low-dose radiotherapy plus tislelizumab in combination with afatinib neoadjuvant therapy for patients with surgically resectable squamous carcinoma of the head and neck.

Conditions

Interventions

BIOLOGICAL

Tislelizumab

200mg ivgtt q3w

DRUG

Afatinib

30mg po qd

RADIATION

Low dose radiotherapy

The phase Ia clinical trial took low dose radiotherapy doses of 2Gy/1f (on day 1) for group 1, 4Gy/2f (from days 1 to 2) for group 2, and 10Gy/5f (from days 1 to 5) for group 3. The radiotherapy doses in phase Ib were judged according to the efficacy and toxicity of phase Ia.

Sponsors & Collaborators

  • West China Hospital

    lead OTHER

Principal Investigators

  • Xingchen Peng, Professor · West China Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-31
Primary Completion
2025-04-10
Completion
2025-04-10

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT06494189 on ClinicalTrials.gov