A Study on the Efficacy and Safety of Multi-mode Ablation Combined With Systemic Therapy Including PD-1 Inhibitor in the Treatment of Colorectal Cancer Liver Metastasis(CRCLM)

Status: Recruiting
Location: See location...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The goal of this study is to evaluate the efficacy and safety of multi-mode ablation combined with systemic therapy including PD-1(programmed death receptor 1) inhibitor for colorectal cancer liver metastasis and furthermore to clarify its application value by comparing preoperative and postoperative immune indicators.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Age 18-75 years, gender not specified;

• Pathologically or clinically confirmed colorectal cancer liver metastases, with liver lesions unsuitable for surgical resection or intolerance or refusal of surgical resection;

• In the case of an unresectable primary tumor or recurrence, the absence of serious complications such as bleeding or obstruction;

• Failure of first-line treatment, with disease progression or new liver metastases;

• No more than 5 liver lesions, with single lesion diameter ≤ 3cm;

• For those who have received previous chemotherapy, radiotherapy or local liver treatment, the interval from the last systemic treatment or local liver treatment should be at least 1 month;

• Child-Pugh A or B; bilirubin ≤ 3.0 mg/dL, creatinine ≤ 2.5 mg/dL, white blood cell count ≥ 2.0 ×10\^9/L, platelets ≥ 100 ×10\^9/L;

• ECOG PS ≤ 2;

• Willing to accept subsequent treatment regimens that include anti-PD-1 monoclonal antibody therapy.

Locations
Other Locations
China
Shanghai Sixth People's Hospital
RECRUITING
Shanghai
Contact Information
Primary
Chief physician of Medical Oncology
ssshenzan@163.com
13816067266
Backup
Chief physician of Medical Oncology
Time Frame
Start Date: 2024-03-12
Estimated Completion Date: 2027-12
Participants
Target number of participants: 20
Treatments
Experimental: Multi-mode thermal ablation combined with systemic therapy including PD-1 inhibitor
Multi-mode ablation therapy +systemic therapy including PD-1 inhibitor (sintilimab 200 mg IV D1+ mFOLFOX6 or FOLFIRI+bevacizumab or cetuximab(determined according to the subject's first-line chemotherapy regimen), Q3W, chemotherapy for 4-6 cycles. Sintilimab continues until disease progression, not exceeding a maximum of 2 years.)
Related Therapeutic Areas
Sponsors
Leads: Shanghai 6th People's Hospital

This content was sourced from clinicaltrials.gov