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Recruiting Phase 2

H101 Plus TACE for r/m HNSCC

NCT07398664 · tracked via the Priya Life Science China tracker
Phase
Phase 2
Started
2026-03-02
Last updated
2026-07-17

Condition(s) studied

Head and Neck Squamous Cell CarcinomaOncolytic VirusTACE

Investigational drug(s) / intervention(s)

H101 →TACE

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

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age between 18 and under 80 years old. 2. Pathologically confirmed head and neck malignancies (including nasopharyngeal carcinoma, oral cavity cancer, oropharyngeal cancer, laryngeal cancer, hypopharyngeal cancer, salivary gland cancer, nasal cavity and paranasal sinus cancer, etc.); patients who have failed at least two lines of standard treatment (including cetuximab and immuno check point inhibitors). 3. Expected survival ≥3 months. 4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-2. 5. Pre-treatment peripheral blood tests meet the following conditions: neutrophil count \>2000/mm³, platelet count \>100,000/mm³. 6. Pre-treatment liver and kidney function meet the following: bilirubin \<1.5 mg/dL, AST or ALT \<1.5 times the upper limit of normal, serum creatinine \<1.5 mg/dL, creatinine clearance \>60 mL/min. 7. Agreement to follow the trial treatment plan and visit schedule, voluntary participation, and written informed consent. Exclusion Criteria: 1. Expected survival less than 3 months. 2. Positive pregnancy test for women of childbearing age. 3. Concurrent diseases or conditions that affect the patient's ability to enroll normally or safety during the study period. 4. Active psychiatric disorders or other psychological conditions that affect the patient's ability to sign the informed consent or understand the study. 5. Severe coagulation abnormalities and/or active infection requiring intravenous anti-infective therapy. 6. History of another malignancy within 5 years prior to screening, except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or microscopic papillary thyroid carcinoma that have been treated with potential curative therapy. 7. Severe cardiac arrhythmia or conduction abnormalities, and clinically uncontrolled hypertension (systolic blood pressure \>150 mmHg and/or diastolic blood pressure \>90 mmHg). 8. Adverse reactions from prior anti-tumor treatments have not recovered to CTCAE version 5.0 Grade \<1 (except for toxicities judged by the investigator to pose no safety risk, such as alopecia, Grade 2 peripheral neuropathy, etc.). 9. History of infectious diseases, such as positive HIV antibody test, active hepatitis B (defined as HBsAg positive during screening, with HBV-DNA levels above the upper limit of normal at the local laboratory), or hepatitis C (defined as positive HCV-Ab test during screening with positive HCV-RNA). 10. Other conditions considered by the investigator to potentially affect patient compliance or make the patient unsuitable for participation in this study.

Primary outcome measure(s)

  • Objective Response Rate (ORR) — 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).
    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.

Trial sites (1)

FacilityCityRegionStatus
West China hospital Chengdu Sichuan Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07398664 on ClinicalTrials.gov ↗ ← All trials in China