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Oncolytic Virus (H101) + SBRT + Chemotherapy + Targeted Therapy + Immunotherapy for Unresectable CRLM

NCT07381309 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2026-04-28

No results posted yet for this study

Summary

This prospective study aims to investigate the efficacy and safety of peritumoral injection of the oncolytic virus H101 in combination with stereotactic body radiotherapy (SBRT), PD-1 monoclonal antibody, chemotherapy, and targeted therapy for the treatment of patients with unresectable, microsatellite stable/mismatch repair proficient (MSS/pMMR) colorectal adenocarcinoma liver metastases. The ultimate goal is to provide high-level evidence-based medical support for this combined modality approach.

Conditions

  • CRC
  • Liver Metastasis Colon Cancer

Interventions

RADIATION

SBRT

Stereotactic Body Radiotherapy

DRUG

PD-1 Antibody

PD-1 Antibody every 21 days

DRUG

H101

Peritumoral Injection of oncolytic virus (H101)

DRUG

Target Therapy

Targeted agents selected based on genetic testing results

COMBINATION_PRODUCT

FOLFIRI

FOLFIRI is a standard biweekly chemotherapy regimen for metastatic colorectal cancer. It consists of irinotecan, leucovorin, and fluorouracil (5-FU) administered sequentially over a 46-hour infusion period per cycle.

COMBINATION_PRODUCT

Chemotherapy

Fluorouracil-based chemotherapy regimens, such as FOLFOX, CAPOX, or FOLFIRI.

Sponsors & Collaborators

  • Jun Huang

    lead OTHER

Principal Investigators

  • Jun Huang · Sun Yat-sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2028-02-01
Completion
2029-02-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07381309 on ClinicalTrials.gov