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

ConditionsCRCLiver Metastasis Colon Cancer
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • SBRT

    Radiation

    Stereotactic Body Radiotherapy

  • PD-1 Antibody

    Drug

    PD-1 Antibody every 21 days

  • H101

    Drug

    Peritumoral Injection of oncolytic virus (H101)

  • Target Therapy

    Drug

    Targeted agents selected based on genetic testing results

  • FOLFIRI

    Combination product

    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.

  • Chemotherapy

    Combination product

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

Treatment groups

114 Participants
are divided into 2 treatment groups
Group A: H101 + SBRT + PD-1 Antibody + Targeted Therapy + ChemotherapyExperimental treatment 5 interventions
Group B: Folfiri + Targeted TherapyActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

ORR

Objective Response Rate

Time frame
1 year

Secondary outcomes

1

1 year PFS

1 year Progression Free Survival

Time frame
1 year
2

1 year OS

1 year Overall Survival

Time frame
1 year
3

R0 Resection Rate

R0 Resection Rate

Time frame
1 year
4

pCR

Pathological Complete Response

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jun Huang

Lead sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: