CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 9 enrolled
Drug / intervention
Tislelizumab +2 morebiological
Likely dose
Tislelizumab 200mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06494189
NCT06494189Phase 1Completed
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A Prospective, Single-arm Clinical Study of Low-dose Radiotherapy Plus Tislelizumab in Combination With Afatinib for Neoadjuvant Treatment of Surgically Resectable Head and Neck Squamous Carcinoma

West China Hospital·interventional·Posted Jul 10, 2024·Updated Dec 29, 2025

In Brief

A Phase 1 clinical trial evaluating Tislelizumab, Afatinib, and 1 other intervention for Head and Neck Cancer. Completed, enrolled 9 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHead and Neck Cancer
CountriesChina
Collaborators--

Timeline

Phase 1CompletedFinished
20252026
First PostedJul 10, 2024
Enrollment StartJul 31, 2024
Primary CompletionApr 10, 2025
TodayJul 1, 2026
Enrollment to primary: 8 monthsPosted 2.0 years ago

Interventions

Tislelizumabbiological

200mg ivgtt q3w

Afatinibdrug

30mg po qd

Low dose radiotherapyradiation

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.