Oncolytic Virus (H101) + SBRT + Chemotherapy + Targeted Therapy + Immunotherapy for Unresectable CRLM
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJun Huang
About this trial
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.
Eligibility criteria
Qualifiers
The patient or their legal representative understands and signs the informed consent form.
Patients with pMMR/MSS colorectal adenocarcinoma.
Aged 18-75 years.
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).
Disqualifiers
Synchronous colorectal cancer liver metastases.
Active hepatitis, cirrhosis, or Child-Pugh class C.
Extralepatic metastases to: central nervous system / bone marrow / brain (UICC 8th edition).
Liver metastases not measurable.
Trial design
Treatments tested in this trial
- SBRT
- PD-1 Antibody
- H101
- Target Therapy
- FOLFIRI
- Chemotherapy
Treatment groups
114 Participants
are divided into 2 treatment groupsLocations
1Sixth Affiliated Hospital, Sun Yat-sen University GuangzhouGuangdong, China
Sponsors and collaborators
Jun Huang
Lead sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor institution
Source ClinicalTrials.gov