Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
20 participants
INTERVENTIONAL
2020-08-01
2023-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Alpps plus Tislelizumab 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.
Tislelizumab
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.
ALPPS 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.
Alpps 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.
ALPPS 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.
Interventions
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Tislelizumab
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.
ALPPS 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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
70 Years
ALL
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Lu Wang, MD, PhD
Head of liver surgery department
Locations
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Fudan University Shanghai Cancer Center
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2020-183-2103
Identifier Type: -
Identifier Source: org_study_id
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