CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 29 target
Drug / intervention
Tislelizumab +2 moredrug
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/NCT07010120
NCT07010120Phase 2RecruitingOn TrackUpdated 12mo ago

A Prospective, Single-arm Clinical Study of Immune-targeted Therapy Combined With Lysogenic HSV Virus for the Neoadjuvant Treatment of Surgically Resectable Head and Neck Squamous Carcinoma

West China Hospital·interventional·Posted Jun 8, 2025·Updated Jun 13, 2025

In Brief

A Phase 2 clinical trial evaluating Tislelizumab, Afatinib, and 1 other intervention for HNSCC and 4 related conditions. Currently recruiting, targeting 29 participants across 1 site.

Detailed Summary

Evaluation of the safety and tolerability of immune-targeted therapy combined with neoadjuvant therapy with lysogenic HSV virus for patients with surgically resectable squamous carcinoma of the head and neck.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

Phase 2Recruiting
20262027
First PostedJun 8, 2025
Enrollment StartJun 10, 2025
Primary CompletionMay 31, 2027
TodayJul 1, 2026
Enrollment to primary: 2.0 yearsPosted 1.1 years agoPrimary completion in 11 months

Interventions

Tislelizumabdrug

200mg IV Q3W

Afatinibdrug

30mg PO QD

Lysogenic HSV virus.biological

Lysosomal HSV virus injection (divided into a dose-escalation phase and a dose-expansion phase; in the dose-escalation phase, Group 1 took 106 pfu/mL and Group 2 took 108 pfu/mL, and in the dose-expansion phase the dose of lysosomal HSV virus with the highest MPR of the escalation phase was taken.) .. The dose of intralymph node injection of lysosomal HSV virus in patients was determined according to the size of metastatic lymph nodes, (diameter less than or equal to 1.5 cm, maximum 1 mL; diameter 1.5-2.5 cm, maximum 2 mL; diameter greater than 2.5 cm, maximum 4 mL). Two injections were given per patient, with each dose separated by 2 weeks.