A Prospective Real-World Observational Study of Intratumoral Oncolytic Virus Injection Combined With Immune Checkpoint Inhibitors for Metastatic Tumors (Colorectal Cancer, Gastric Cancer, and Hepatocellular Carcinoma)

Official record

Identifier

NCT07850882

Recruiting locations

country

China

Interventions studied

Not provided in the official record

Lead sponsor

Jie Yuan，MD

Target enrolment

30 participants

Study type

OBSERVATIONAL

Phase

Not provided in the official record

Status

Recruiting

First posted

Sep 30, 2026

Last updated on the registry

Sep 30, 2026

Age

18 Years – 75 Years

Sex

ALL

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

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.

Indexed under

Liver Cancer