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A Study on the Efficacy and Safety of Multi-mode Ablation Combined With Systemic Therapy in the Treatment of CRCLM

RecruitingPhase 2Ages 18 Years - 75 YearsAllShanghai 6th People's Hospital
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Age 18-75 years, gender not specified; 2. Pathologically or clinically confirmed colorectal cancer liver metastases, with liver lesions unsuitable for surgical resection or intolerance or refusal of surgical resection; 3. In the case of an unresectable primary tumor or recurrence, the absence of serious complications such as bleeding or obstruction; 4. Failure of first-line treatment, with disease progression or new liver metastases; 5. No more than 5 liver lesions, with single lesion diameter โ‰ค 3cm; 6. 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; 7. Child-Pugh A or B; bilirubin โ‰ค 3.0 mg/dL, creatinine โ‰ค 2.5 mg/dL, white blood cell count โ‰ฅ 2.0 ร—10\^9/L, platelets โ‰ฅ 100 ร—10\^9/L; 8. ECOG PS โ‰ค 2; 9. Willing to accept subsequent treatment regimens that include anti-PD-1 monoclonal antibody therapy. Exclusion Criteria: 1. Liver function Child-Pugh class C; 2. Expected survival \< 3 months; 3. Major organ insufficiency or failure; 4. Active infection; 5. Irreversible coagulation disorders; 6. Refractory massive ascites, pleural effusion or cachexia; 7. Unable to cooperate with treatment; 8. Any other factors deemed inappropriate for inclusion or that may affect the subject's participation in the study, as determined by the investigator.
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What it tests

  • Multi-mode tumor treatment system
  • Sintilimab+mFOLFOX6 or FOLFIRI+bevacizumab or cetuximab
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Where

1 site
Shanghai Sixth People's Hospital
Shanghai, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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