A Clinical Study on Neoadjuvant Treatment of Resectable Head and Neck Squamous Carcinoma With Immune-targeted Therapy and Lysogenic HSV Virus

PHASE1RecruitingINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

December 15, 2024

Primary Completion Date

December 15, 2026

Study Completion Date

December 15, 2026

Conditions
HNSCCLysogenic HSV VirusNeoadjuvant TherapyImmunotherapyTargeted Therapy
Interventions
BIOLOGICAL

Lysogenic HSV virus.

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.

DRUG

Tislelizumab

200mg IV Q3W

DRUG

Afatinib

30mg PO QD

Trial Locations (1)

610041

RECRUITING

West China Hospital, Sichuan University, Chengdu

All Listed Sponsors
lead

West China Hospital

OTHER