ALPPS Combined With Tislelizumab in Liver Malignancy

Liver Malignant Tumors Clinical Trial

Official title:

Safety and Efficacy of the Combinationg of Associating Liver Partition and Portal Vein Ligation for Staged Hepatectomy (ALPPS) and Tislelizumab in Liver Malignancy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04996446
• Other study ID #: 2020-183-2103
• Status: Recruiting
• Phase: Phase 2
• Start date: August 1, 2020
• Est. completion date: August 2023

Study information

• Verified date: August 2021
• Source: Fudan University
• Contact: Lu C Wang, M.D.
• Phone: +86-18121299357
• Email: w.lr[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: August 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Liver Malignant Tumors
• Liver Neoplasms
• Neoplasms

Intervention

Drug:
• 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.

Procedure:
• 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.

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recurrence free survival	recurrence free survival	6 weeks
Secondary	safety (incidence of adverse events and serious adverse events)	incidence of adverse events and serious adverse events	3 weeks
Secondary	overall survival	overall survival	6 weeks