A Clinical Trial of Neoadjuvant Targeted Therapy, Immunotherapy, and Lysogenic HSV-Based Virotherapy in Resectable Head and Neck Squamous Cell Carcinoma

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

29

Participants

Timeline

Start Date

June 10, 2025

Primary Completion Date

May 31, 2027

Study Completion Date

May 31, 2027

Conditions
HNSCCLysogenic HSV VirusNeoadjuvant TherapyImmunotherapyTargeted Therapy
Interventions
DRUG

Tislelizumab

200mg IV Q3W

DRUG

Afatinib

30mg PO QD

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.

Trial Locations (1)

610000

RECRUITING

Department of Radiation Oncology, Chengdu

All Listed Sponsors
lead

West China Hospital

OTHER

NCT07010120 - A Clinical Trial of Neoadjuvant Targeted Therapy, Immunotherapy, and Lysogenic HSV-Based Virotherapy in Resectable Head and Neck Squamous Cell Carcinoma | Biotech Hunter | Biotech Hunter