A Study on the Efficacy and Safety of Multi-mode Ablation Combined With Systemic Therapy in the Treatment of CRCLM
About this study
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.
- Condition
- Colorectal Cancer Liver Metastasis
- Tested
- Multi-mode tumor treatment system, Sintilimab+mFOLFOX6 or FOLFIRI+bevacizumab or cetuximab
- Sponsor
- Shanghai 6th People's Hospital
Who can join
- Age
- 18 to 75 years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 12
- Minimum age: 18 years
- Maximum age: 75 years
- Study condition: Colorectal Cancer Liver Metastasis
- 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 8
- 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.
Where
1 site, 1 recruiting
Shanghai Sixth People's Hospital
Shanghai, China
Contact
-
Chief physician of Medical Oncology
13816067266 ssshenzan@163.com
-
Chief physician of Medical Oncology
Potential match only. Final eligibility is determined by the study team.