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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
H101 combined with transarterial chemoembolization (TACE) for the treatment of recurrent or metastatic head and neck squamous cell carcinoma (r/m HNSCC)
H101 combined with transarterial chemoembolization (TACE) for the treatment of recurrent or metastatic head and neck squamous cell carcinoma (r/m HNSCC)
Objective Response Rate (ORR)
The proportion of participants achieving a complete response (CR) or partial response (PR) based on modified RECIST v1.1 (mRECIST) criteria for target lesions assessed via MRI or CT imaging.
Time frame: Tumor assessments performed at baseline, then every 6-12 weeks from the start of treatment until disease progression or study completion (up to 24 months).
Progression-Free Survival (PFS)
The time from the start of treatment to the first occurrence of disease progression as per mRECIST criteria or death from any cause, whichever occurs first.
Time frame: From the start of treatment until the first documented progression or death from any cause (assessed up to 24 months).
Overall Survival (OS)
The time from the start of treatment to death from any cause.
Time frame: From the start of treatment until death from any cause (assessed up to 24 months).
Incidence of Treatment-Related Adverse Events (AEs)
The frequency and severity of adverse events assessed according to CTCAE v5.0, including those related to the oncolytic virus H101 and transarterial chemoembolization (TACE), such as injection site reactions, flu-like symptoms, myelosuppression, and procedural complications.
Time frame: From the first administration of H101/TACE until 60 days after the last administration.
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