Liver Malignant Tumors
Conditions
Brief summary
Study design: Prospective, single-center, phase IIa clinical trial; Primary endpoint: Recurrence free survival; Secondary endpoints: Safety, overall survival; Main characteristics of patients: Liver malignancy, required (extended) hemihepatectomy, insufficient liver reserve; Study approaches: The experimental group is treated with ALPPS combined with Tislelizumab, and the control group was treated with ALPPS; Sample size: 20 (10:10); Study process: In experimental 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; In control group, 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.
Interventions
DRUGTislelizumab
In experimental 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.
PROCEDUREALPPS surgery
In experimental group, patients who meet the inclusion criteria will receive ALPPS stage I surgery, and receive ALPPS stage II surgery 4-8 weeks after stage I surgery; In control group, 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.
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years and ≤70 years; 2. ECOG physical condition score: 0\ 1; 3. Clinical/pathological diagnosis of primary liver cancer or intrahepatic metastatic colorectal cancer; 4. Clinical evaluation requires (extended) hemihepatectomy; 5. Liver function Child A level 6. sFLR \< 30% 7. 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); 8. Sign the informed consent voluntarily; 9. Good compliance, and family members willing to cooperate with follow-up.
Exclusion criteria
1. Presence of extrahepatic organ/distant lymph node metastasis; 2. Hilar lymph node metastasis cannot be radically resected; 3. Patients with intrahepatic metastatic colorectal cancer had received second-line or above systemic therapy; 4. Other uncured malignant tumors; 5. Pregnant or lactating women who are pregnant during the study period need to withdraw from the clinical trial; 6. Concurrent use of any other antitumor therapy in patients with primary liver cancer; 7. Patients with intrahepatic metastatic colorectal cancer have been treated with antitumor therapy in addition to primary surgery and standard first-line/second-line therapy; 8. Patients with a known history of other systemic serious diseases before screening; 9. Long-term unhealed wounds or incomplete healing fractures; 10. Previous organ transplantation history; 11. Having a history of abuse of psychotropic substances and being unable to quit or having mental disorders; 12. A history of immune deficiency or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 13. Concomitant conditions that, in the investigator's judgment, seriously endanger the patient's safety or affect the patient's completion of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| recurrence free survival | 6 weeks | recurrence free survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| safety (incidence of adverse events and serious adverse events) | 3 weeks | incidence of adverse events and serious adverse events |
| overall survival | 6 weeks | overall survival |
Countries
China
Contacts
Primary ContactLu C Wang, M.D.
Outcome results
None listed