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New Virus-Immunotherapy combo tackles Hard-to-Treat cancers

NCT ID NCT07154108

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2025

An estimate. Start dates often move.

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • 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.