Intratumoral oncolytic virus plus immune checkpoint inhibitors in metastatic colorectal, gastric, or liver cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-arm, open-label observational study evaluating safety, feasibility, and preliminary anti-tumor activity of intratumoral H101 combined with immune checkpoint inhibitors in patients with metastatic colorectal cancer, gastric cancer, or hepatocellular carcinoma. The study also aims to explore how the tumor immune environment changes and identify potential biomarkers that predict response. Participants must have tumors of at least 1 cm suitable for direct injection and have recovered from prior therapies. Primary focus is on treatment-related adverse events, serious adverse events, safe delivery of the combination, and preliminary tumor responses by RECIST 1.1. The investigation is investigator-initiated and conducted at Foshan Fosun Chancheng Hospital in Guangdong, China.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients aged 18-75 years.
* Pathologically confirmed solid tumors, including superficial metastatic lesions and intra-abdominal or intrathoracic tumors, that are amenable to intratumoral injection with a longest diameter ≥1.0 cm.
* For superficial metastatic lesions that have not received local radiotherapy, ablation, or surgical resection; if such treatments have been performed, at least 4 weeks must have elapsed since completion and the lesion must show documented progression.
* Prior systemic therapy must have been completed at least 4 weeks or 5 half-lives ago, and the patient must have recovered from previous treatment-related toxicities.
* Adequate cardiopulmonary, hepatic, and renal function to tolerate Oncorine® (H101) intratumoral injection.
* The patient and their family members are willing to participate in this study and provide written informed consent.

Exclusion Criteria:

* Peripheral blood lymphocyte count \<1.0×10⁹/L；
* Target superficial or body cavity tumors located adjacent to major blood vessels or nerves, with a high risk of puncture or injection; or lesions with active infection or ulceration；
* Known severe hypersensitivity to Oncorine® (H101) or any of its components；
* Active intra-abdominal infection or uncontrolled ascites；
* Currently receiving systemic glucocorticoids or other potent immunosuppressive agents；
* Planned receipt of other antitumor therapies during the study period (except supportive care)；
* Concurrent other malignancy or a history of prior malignancy；
* Tumors complicated by rupture with hemorrhage, massive gastrointestinal bleeding, intestinal obstruction, or other conditions requiring emergency surgery；
* American Society of Anesthesiologists (ASA) classification ≥ IV and/or Eastern Cooperative Oncology Group (ECOG) performance status score \>2；
* Active autoimmune disease, or history of autoimmune disease requiring systemic therapy; uncontrolled severe infections (e.g., HIV, active hepatitis B with HBV-DNA above the lower limit of detection, active hepatitis C); severe cardiovascular or cerebrovascular disease; history of organ transplantation; active bleeding or high bleeding risk；
* History of severe psychiatric illness；
* Pregnant or breastfeeding women；
* Uncontrolled active infection；
* Other clinical or laboratory conditions that, in the opinion of the nvestigator, render the patient unsuitable for participation in this trial.

Where it's running

• Foshan Fosun Chancheng Hospital
  Guangdong, Foshan, China Recruiting

Study contacts

• Study coordinator: Jie Yuan, Doctoral degree
• Email: candlewjy@163.com
• Phone: +86 13016007353

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.