New Virus-Immunotherapy combo tackles Hard-to-Treat cancers
NCT ID NCT07154108
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This early-phase trial is testing a new approach for people with recurrent or metastatic head/neck cancer or esophageal cancer. The treatment combines a virus that delivers endostatin directly into tumors with an immunotherapy drug (PD-1 inhibitor). The goal is to see if the combination is safe and can shrink tumors. About 40 participants will be enrolled across two groups.
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 (a virus that delivers endostatin to tumors) plus a PD-1 inhibitor (immunotherapy)
- What this could lead to
- If this works, it could point toward a new combination treatment for advanced head/neck and esophageal cancers that have stopped responding to standard therapy.
- What could go wrong
- This is a very early Phase 1 trial with only 40 people, so it is primarily testing safety. The combination may not shrink tumors or may cause serious side effects. Success is far from guaranteed.
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 40 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2025
An estimate. Start dates often move.
- Expected to finish
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Aug 2027
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 75 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.
* Cohort A (Head and Neck Cancer) * Cohort B (Esophageal Squamous Cell Carcinoma) Inclusion Criteria: 1. Age ≥18 years * Cohort A (Head and Neck Cancer): ≤70 years * Cohort B (Esophageal Squamous Cell Carcinoma): ≤75 years 2. Histologically or cytologically confirmed recurrent or metastatic: * Cohort A: Head and Neck Cancer * Cohort B: ESCC, AJCC 9th edition stage IV 3. Prior treatment: * Cohort A: ≥1 prior platinum-based chemotherapy regimen or platinum-refractory/intolerant * Cohort B: Prior immune checkpoint inhibitor (ICI) therapy with documented acquired resistance after prior PR or SD 4. At least one lesion accessible for intratumoral injection * Cohort A: measurable lesion ≥2 cm by RECIST 1.1 * Cohort B: superficial metastatic lymph nodes (cervical or supraclavicular) 5. ECOG performance status * Cohort A: 0-2 * Cohort B: 0-1 6. Adequate organ function 7. Life expectancy ≥12 weeks (Cohort A) 8. No anti-tumor therapy (chemotherapy, radiotherapy, biotherapy, antiviral) within 4 weeks prior to enrollment (Cohort A) 9. Availability of fresh tumor tissue specimen or pathological slides from the injection target lesion (Cohort B) 10. Male/female patients of childbearing potential must use effective contraception during study and for at least 6 months after treatment 11. Voluntary participation with signed informed consent Exclusion Criteria: 1. Known allergy or hypersensitivity to study drugs 2. Lesions unsuitable for injection due to proximity to major blood vessels, nerves, or hollow organs, or with extensive necrosis 3. Deeply located lesions with high procedural difficulty (Cohort B) 4. Concurrent radiotherapy to target lesion(s) (Cohort A) 5. Prior anti-angiogenic therapy (Cohort A) 6. Immunosuppressive therapy or systemic corticosteroids \>10 mg/day prednisone (or equivalent) within 2 weeks prior to enrollment 7. Active autoimmune disease or history of autoimmune disease 8. Congenital or acquired immunodeficiency 9. Severe coagulopathy, bleeding tendency, or high-risk lesions (Cohort B) 10. Poor nutritional status (Cohort B) 11. Interstitial lung disease with symptoms or radiographic evidence (Cohort B) 12. Severe uncontrolled systemic disease or recent myocardial infarction (\<3 months) 13. Acute infection 14. Pregnancy or breastfeeding 15. Other malignancy besides ESCC (Cohort B) 16. Patients unlikely to comply with follow-up or participation requirements 17. Any condition deemed unsuitable for enrollment by the investigator
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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 of Sichuan University
Chengdu, Sichuan, 610041, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Blood proteins may predict who beats esophageal cancer with chemoradiation
- New Antibody-Drug conjugate put to the test against Hard-to-Treat cancers
- Can a direct hit to tumors make immunotherapy work better?
- New antibody aims to preserve immune checkpoint while fighting cancer
- Can a guided missile for chemo hit tumors harder and spare healthy tissue?
- Can a new drug shrink tumors that resist standard care?