Status:
RECRUITING
A Study on the Efficacy and Safety of Multi-mode Ablation Combined With Systemic Therapy in the Treatment of CRCLM
Lead Sponsor:
Shanghai 6th People's Hospital
Conditions:
Colorectal Cancer Liver Metastasis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 me...
Detailed Description
This is a single-center, single-arm, prospective study to evaluate the efficacy and safety of multi-mode ablation combined with systemic therapy including PD-1 inhibitor in the treatment of colorectal...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Liver function Child-Pugh class C;
- Expected survival \< 3 months;
- Major organ insufficiency or failure;
- Active infection;
- Irreversible coagulation disorders;
- Refractory massive ascites, pleural effusion or cachexia;
- Unable to cooperate with treatment;
- Any other factors deemed inappropriate for inclusion or that may affect the subject's participation in the study, as determined by the investigator.
Key Trial Info
Start Date :
March 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06590259
Start Date
March 12 2024
End Date
December 1 2027
Last Update
September 19 2024
Active Locations (1)
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1
Shanghai Sixth People's Hospital
Shanghai, China