NCT07398664

H101 Plus TACE for r/m HNSCC

Recombinant Human Adenovirus 5 (H101) Combined With Transcatheter Arterial Chemoembolization (TACE) for the Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma: A Single-Center, Prospective Study

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: West China Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates H101 combined with transarterial chemoembolization (TACE) to enhance local tumor killing and immune activation while minimizing toxicity in r/m HNSCC patients.

Detailed description

Recurrent or metastatic head and neck squamous cell carcinoma (r/m HNSCC) carries a dismal prognosis (median OS 7-9 months) and lacks effective treatments. H101, an oncolytic adenovirus approved for nasopharyngeal carcinoma, selectively lyses p53-deficient tumor cells \[3\]. This study evaluates H101 combined with transarterial chemoembolization (TACE) to enhance local tumor killing and immune activation while minimizing toxicity. Supported by prior safety and efficacy data of both modalities, this regimen represents a promising novel approach for r/m HNSCC.

Conditions

• Head and Neck Squamous Cell Carcinoma
• Oncolytic Virus
• TACE

Interventions

Type	Name	Description
DRUG	H101	H101 combined with transarterial chemoembolization (TACE) for the treatment of recurrent or metastatic head and neck squamous cell carcinoma (r/m HNSCC)
PROCEDURE	TACE	H101 combined with transarterial chemoembolization (TACE) for the treatment of recurrent or metastatic head and neck squamous cell carcinoma (r/m HNSCC)

Timeline

• Start date: 2026-02-15
• Primary completion: 2027-02-15
• Completion: 2028-02-15
• First posted: 2026-02-10
• Last updated: 2026-02-10