New combo injection targets Hard-to-Treat head and neck tumors
NCT ID NCT07625423
First seen Jun 25, 2026 · Last updated Sep 03, 2026 · Updated 3 times
Summary
This early-phase trial is testing a new approach for people with head and neck cancer that has returned or spread after standard chemotherapy. The treatment combines a gene therapy injection (EDS01) given directly into a tumor with an immunotherapy drug (toripalimab) given through a vein. The study will enroll 9 adults to check safety and see if the tumors shrink.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- recombinant human endostatin adenovirus (EDS01) and toripalimab
- What this could lead to
- If it works, this could point toward a new treatment option for people with head and neck cancer that has come back or spread.
- What could go wrong
- This is a very early, small Phase 1 trial with only 9 participants, so it is mainly checking safety. The combination may not shrink tumors or may cause side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 9 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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Mar 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 65 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: Adults aged 18 to 65 years. Histologically or cytologically confirmed recurrent or metastatic head and neck tumor. Previously received at least 1 standard platinum-based systemic chemotherapy regimen for recurrent/metastatic disease, or had platinum-insensitive or platinum-intolerant disease after prior curative-intent treatment. Not suitable for surgery or radiotherapy. At least 1 target lesion suitable for intratumoral injection of recombinant human endostatin adenovirus injection. At least 1 measurable lesion with diameter ≥2 cm on imaging, according to RECIST version 1.1. No chemotherapy, radiotherapy, biologic antitumor therapy, or antiviral therapy within 4 weeks before enrollment. Estimated life expectancy of at least 12 weeks. ECOG performance status 0 to 1. Male or female participants of childbearing potential must agree to use reliable contraception during treatment and for at least 6 months after treatment. Recovery of prior treatment-related toxicities to NCI CTCAE grade 1 or baseline, with screening laboratory results within 1 week before enrollment meeting protocol requirements: ANC ≥1.5×10\^9/L, platelet count ≥80×10\^9/L, total bilirubin ≤1.5 × ULN, ALT and AST ≤2 × ULN, and coagulation parameters ≤1.25 × ULN. Willing and able to provide written informed consent. Exclusion Criteria: Known allergy to the study drugs. Lesions involving major blood vessels or nerves and therefore unsuitable for local injection. Receiving radiotherapy to the study lesion at the same time. Prior anti-angiogenic therapy. Receiving immunosuppressive therapy or systemic corticosteroids for immunosuppressive purposes at a dose greater than prednisone 10 mg/day (or equivalent) within 2 weeks before enrollment. Active autoimmune disease or history of autoimmune disease. Congenital or acquired immunodeficiency. Risk of major nasopharyngeal hemorrhage or deep nasopharyngeal ulceration. Severe coagulation disorder or bleeding tendency. Severe uncontrolled medical disease or myocardial infarction within 3 months before enrollment. Acute infection. Pregnant or breastfeeding women. Any condition that, in the investigator's judgment, makes the participant unsuitable for enrollment.
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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, China, 610041, China
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Other studies related to the condition(s) this trial covers.
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- Can a guided missile for chemo hit tumors harder and spare healthy tissue?
- Can a targeted drug outperform chemotherapy in Tough-to-Treat nasopharyngeal cancer?
- A pill to stop cancer treatment from stealing appetite?
- Can an experimental drug shrink advanced solid tumors?