ALPPS Combined With Tislelizumab in Liver Malignancy

• Sponsor: Fudan University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04996446
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 36
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Malignant Tumors	Drug: Tislelizumab; Procedure: ALPPS surgery	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Aug 1, 2020
• Anticipated Primary Completion Date: Aug 1, 2023
• Anticipated Study Completion Date: Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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.
Active Comparator: 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.	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.

Outcome Measures

Primary Outcome Measures

1. recurrence free survival [6 weeks]

   recurrence free survival

Secondary Outcome Measures

1. safety (incidence of adverse events and serious adverse events) [3 weeks]

   incidence of adverse events and serious adverse events

2. overall survival [6 weeks]

   overall survival

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts 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);

1. Sign the informed consent voluntarily;

2. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fudan University Shanghai Cancer Center	Shanghai		China	200062

Sponsors and Collaborators

• Fudan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lu Wang, MD, PhD, Head of liver surgery department, Fudan University
• ClinicalTrials.gov Identifier: NCT04996446
• Other Study ID Numbers: 2020-183-2103
• First Posted: Aug 9, 2021
• Last Update Posted: Aug 9, 2021
• Last Verified: Aug 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neoplasms; Liver Neoplasms

Study Results

No Results Posted as of Aug 9, 2021