H101 Plus TACE for advanced head and neck cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional trial explores the safety and activity of combining H101, an oncolytic adenovirus, with transarterial chemoembolization (TACE) in adults with recurrent or metastatic head and neck squamous cell carcinoma. Eligible patients have failed at least two prior treatments and have adequate organ function and performance status. The goal is to see if the combination increases local tumor destruction and stimulates anti-tumor immunity while limiting toxicity. The study is led by West China Hospital in Chengdu, China. Previous data on each modality support exploring their joint use in this patient population.

Why it matters

Who can join: the full rules

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.

Where it's running

• West China hospital
  Chengdu, Sichuan, China Recruiting

Study contacts

• Study coordinator: Tao Hai
• Email: haitao42@hotmail.com
• Phone: 086-18982770417

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.