Virus cocktail takes on tough liver tumors
NCT ID NCT07381309
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tests whether injecting an oncolytic virus (H101) directly into liver tumors, along with radiation, chemotherapy, targeted therapy, and immunotherapy, can shrink or control colorectal cancer that has spread to the liver and cannot be removed by surgery. The study will enroll 114 adults with a specific type of colorectal cancer (MSS/pMMR). The goal is to see if this powerful combination improves response rates and helps patients live longer without their cancer growing.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- oncolytic virus H101
- What this could lead to
- If successful, this combination approach could offer a new treatment option for people with hard-to-treat colorectal cancer that has spread to the liver.
- What could go wrong
- This is an early phase 2 trial with only 114 participants, so results may not apply to everyone. Combining multiple therapies also raises the risk of 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
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 114 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Jun 2026
An estimate. Start dates often move.
- Expected to finish
-
Feb 2029
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 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. The patient or their legal representative understands and signs the informed consent form. 2. Patients with pMMR/MSS colorectal adenocarcinoma. 3. Aged 18-75 years. 4. Patients with histologically or cytologically confirmed colorectal cancer liver metastases. There must be at least one injectable lesion in the liver, which must also meet the criteria for a measurable target lesion according to RECIST version 1.1 (≥10 mm in the longest diameter on spiral CT/MRI scan with a slice thickness of no greater than 5 mm). 5. Patients with definitively unresectable metachronous liver metastases; OR patients deemed surgically resectable but who refuse surgery, provided the liver metastases meet the following requirements: ① The number of metastatic lesions must be no more than 5, and the sum of the longest diameters of all metastatic lesions must be ≤100 mm; ② The longest diameter of a single lesion must be ≤100 mm; ③ The longest diameter of the lesion to be injected must be ≥10 mm and ≤80 mm. 6. The liver metastases have not received prior radiotherapy, OR the area of the liver near the planned radiotherapy site has not been previously irradiated. At least 700 cc of liver volume must be preserved outside the treatment area. 7. Prior treatments such as hepatic resection, systemic chemotherapy, local ablation therapy, or hepatic artery infusion pump chemotherapy are allowed, provided a washout period of 2 weeks is observed. Patients must have recovered from prior anti-tumor therapy-related adverse events to baseline or Grade ≤1 (according to CTCAE version 5.0) (excluding alopecia and Grade 2 anemia). 8. Child-Pugh score A or B 9. ECOG Performance Status 0-1 10. Peripheral blood counts and liver/renal function within the allowable ranges (tested within 15 days before treatment initiation) 11. No prior history of other concomitant malignancies. Patients must not be pregnant or breastfeeding and should use effective contraception during the study and for 6 months after the last dose. 12. Life expectancy ≥6 months. Exclusion Criteria: 1. Synchronous colorectal cancer liver metastases. 2. Active hepatitis, cirrhosis, or Child-Pugh class C. 3. Extralepatic metastases to: central nervous system / bone marrow / brain (UICC 8th edition). 4. Liver metastases not measurable. 5. Prior history of oncolytic virus therapy (e.g., T-VEC). 6. Liver metastases not meeting the requirements for peritumoral injection volume or unsuitable for peritumoral injection. 7. History of severe drug allergy (e.g., to oncolytic adenovirus, PD-1 monoclonal antibody, platinum agents, 5-FU, leucovorin, 5-HT3 receptor antagonists, bevacizumab, etc.). 8. Antiviral therapy (e.g., acyclovir, ganciclovir, valacyclovir, vidarabine) within 4 weeks prior to the first dose of study treatment. 9. Participation in another clinical trial within 4 weeks or ongoing participation. 10. History of prior therapy targeting PD-1, PD-L1, PD-L2, CTLA-4, or any other T-cell co-stimulation or checkpoint pathway. 11. Severe electrolyte abnormalities. 12. Significant portal hypertension: history of upper gastrointestinal bleeding or severe hypersplenism. 13. Arterial or deep venous thrombosis within the past 6 months; history or evidence of bleeding tendency within the past 2 months. 14. Pregnant or breastfeeding women, or women with a positive pregnancy test before the first dose; or female participants and their partners unwilling to use strict contraception during the study. 15. Active autoimmune disease requiring systemic treatment (e.g., immunomodulators, corticosteroids, immunosuppressants) within the past 2 years. 16. Past or current other active malignancies (except malignancies cured \>3 years ago or carcinoma in situ treated curatively). 17. Severe ECG abnormalities; active coronary artery disease, severe/unstable angina, newly diagnosed angina, or myocardial infarction within 12 months; New York Heart Association (NYHA) class II or higher congestive heart failure. 18. Active infection (with fever \>38°C). 19. Poorly controlled hypercalcemia, hypertension, or diabetes. 20. Severe pulmonary disease (interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc.). 21. Psychiatric disorder affecting clinical treatment or history of central nervous system disease. 22. Severe complications (intestinal obstruction, renal insufficiency, hepatic insufficiency, cerebrovascular disorders, etc.). 23. Persistent toxicity ≥ Grade 2 (CTCAE v5.0) from prior therapy (except anemia, alopecia, skin pigmentation). 24. Use of any other investigational drug or participation in another interventional trial within 14 days prior to study treatment. 25. Pregnant, breastfeeding, or planning pregnancy during the study; men or women unwilling to use effective contraception. 26. Any unstable medical condition that may affect patient safety or compliance, as judged by the investigator to be unsuitable for the trial.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Colorectal adenocarcinoma are added.
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
-
Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Experimental drug put to the test against Hard-to-Treat GI cancers
- Can berry compounds tame inflammation during colorectal cancer care?
- Can a vaccine stop GI cancers from returning?
- Blood test guides immunotherapy for hidden cancer cells
- Can blocking a cancer cell survival protein open a new path for colorectal cancer?
- Can blocking a DNA repair protein make immunotherapy work better against colorectal cancer?