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)
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
The goal of this single-arm, open-label, prospective clinical trial is to evaluate the safety, feasibility, and preliminary antitumor activity of intratumoral oncolytic virus (H101, recombinant human type 5 adenovirus) combined with immune checkpoint inhibitors (ICIs), and to explore the dynamic remodeling of the tumor immune microenvironment and potential predictive biomarkers, in patients with advanced metastatic colorectal cancer, gastric cancer, or hepatocellular carcinoma who have failed multiple prior lines of therapy. The main questions it aims to answer are: What are the incidence of treatment-related adverse events and serious adverse events, and the completion rate of the combination therapy (safety and feasibility)? What is the objective response rate and local control rate per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) (preliminary antitumor activity)? How does the combination therapy reshape the tumor immune microenvironment in terms of immune cell infiltration, subset proportions, functional status, and signaling pathways, and which differentially expressed genes or immune cell subtypes are associated with clinical response? This is a single-arm study; there is no comparator group. Participants will: Receive intratumoral H101 injection once per cycle (dose stratified by lesion size), followed 5-7 days later by intravenous ICI \[Anti-Programmed Cell Death Protein 1 Antibody (anti-PD-1) with or without Anti-Cytotoxic T-Lymphocyte-Associated Protein 4 Antibody (anti-CTLA-4)\], repeated every 2-3 weeks for a total of 4 cycles. Provide paired tumor biopsy samples and peripheral blood specimens at baseline and after 4 cycles for single-cell RNA sequencing and biomarker analyses. Undergo routine clinical assessments, imaging for tumor response evaluation, and safety monitoring with adverse event grading per Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0).
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Pacjenci w wieku od 18 do 75 lat.
- •Potwierdzony rak z przerzutami, który można poddać wstrzyknięciu wirusa (zmiana o średnicy co najmniej 1 cm).
- •Leczenie systemowe zakończone co najmniej 4 tygodnie temu i brak skutków ubocznych poprzedniego leczenia.
- •Pacjent i rodzina wyrażają zgodę na udział w badaniu.
✗ Disqualifies
- •Niska liczba białych krwinek.
- •Zmiana w pobliżu ważnych naczyń krwionośnych lub nerwów, z aktywnym zakażeniem lub owrzodzeniem.
- •Znana silna reakcja alergiczna na lek.
- •Ciężkie zakażenia, choroby autoimmunologiczne lub przyjmowanie leków immunosupresyjnych.
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Last updated (source)
- September 30, 2026
- Sex
- No restrictions
Locations (1)
Foshan Fosun Chancheng Hospital
Guangdong, China
Trial contact
Jie Yuan, Doctoral degree
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 10/1/2026.
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