ALPPS Combined With Tislelizumab in Liver Malignancy
Liver Malignant Tumors
About this trial
This is an interventional treatment trial for Liver Malignant Tumors
Eligibility Criteria
Inclusion Criteria:
- Age ≥18 years and ≤70 years;
- ECOG physical condition score: 0~1;
- Clinical/pathological diagnosis of primary liver cancer or intrahepatic metastatic colorectal cancer;
- Clinical evaluation requires (extended) hemihepatectomy;
- Liver function Child A level
- sFLR < 30%
The main organs function well, and the examination indicators meet the following requirements:
Routine blood tests:
Hemoglobin ≥90 g/L (no blood transfusion within 14 days); Neutrophil count ≥1.5×10^9/L; Platelet count ≥80×10^9/L;
Biochemical examination:
Total bilirubin ≤2×ULN (upper normal value); ALT or AST ≤ 2.5×ULN; Endogenous creatinine clearance ≥ 50 mL /min (Cockcroft-Gault formula);
- Sign the informed consent voluntarily;
- Good compliance, and family members willing to cooperate with follow-up.
Exclusion Criteria:
- Presence of extrahepatic organ/distant lymph node metastasis;
- Hilar lymph node metastasis cannot be radically resected;
- Patients with intrahepatic metastatic colorectal cancer had received second-line or above systemic therapy;
- Other uncured malignant tumors;
- Pregnant or lactating women who are pregnant during the study period need to withdraw from the clinical trial;
- Concurrent use of any other antitumor therapy in patients with primary liver cancer;
- Patients with intrahepatic metastatic colorectal cancer have been treated with antitumor therapy in addition to primary surgery and standard first-line/second-line therapy;
- Patients with a known history of other systemic serious diseases before screening;
- Long-term unhealed wounds or incomplete healing fractures;
- Previous organ transplantation history;
- Having a history of abuse of psychotropic substances and being unable to quit or having mental disorders;
- A history of immune deficiency or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
- Concomitant conditions that, in the investigator's judgment, seriously endanger the patient's safety or affect the patient's completion of the study.
Sites / Locations
- Fudan University Shanghai Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Alpps plus Tislelizumab group
Alpps group
Patients who meet the inclusion criteria will receive ALPPS stage I surgery, treated with Tislelizumab 2-4 weeks after stage I surgery, and receive ALPPS stage II surgery 2-4 weeks after Tislelizumab treatment, and treated with Tislelizumab q3W 6-12 months after stage II surgery.
Patients who meet the inclusion criteria will receive ALPPS stage I surgery, and receive ALPPS stage II surgery 3-6 weeks after stage I surgery.