Virus and chemo combo takes on hard-to-treat head and neck cancer
NCT ID NCT07398664
First seen Jun 27, 2026 · Last updated Jul 17, 2026 · Updated 1 time
Summary
This study tests a combination of a modified virus (H101) and a targeted chemotherapy procedure (TACE) in 20 adults with head and neck cancer that has returned or spread after at least two standard treatments. The goal is to shrink tumors and boost the immune system while limiting side effects. Participants will be monitored for tumor response, survival, and safety.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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West China hospital
RECRUITINGChengdu, Sichuan, 610041, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can immunotherapy before surgery stop early oral cancer from returning?
- Can a glowing dye show surgeons where head and neck tumors end?
- Can a Four-Part combo before surgery wipe out head and neck tumors?
- Can a new drug shrink advanced solid tumors?
- Can steroid shots shield salivary glands from radiation damage?