A Study on the Efficacy and Safety of Multi-mode Ablation Combined With Systemic Therapy in the Treatment of CRCLM
Recruiting · NCT06590259 · Interventional (participants receive a specific treatment) · Lead sponsor: Shanghai 6th People's Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Multi-mode tumor treatment systemSintilimab+mFOLFOX6 or FOLFIRI+bevacizumab or cetuximab
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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 it is running
1 location listed.
- Shanghai Sixth People's Hospital - Shanghai, China