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ALPPS Combined With Tislelizumab in Liver Malignancy

Primary Purpose

Liver Malignant Tumors

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Tislelizumab
ALPPS surgery
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Malignant Tumors

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fudan University Shanghai Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Alpps plus Tislelizumab group

Alpps group

Arm Description

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.

Outcomes

Primary Outcome Measures

recurrence free survival
recurrence free survival

Secondary Outcome Measures

safety (incidence of adverse events and serious adverse events)
incidence of adverse events and serious adverse events
overall survival
overall survival

Full Information

First Posted
August 4, 2021
Last Updated
August 5, 2021
Sponsor
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT04996446
Brief Title
ALPPS Combined With Tislelizumab in Liver Malignancy
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Malignant Tumors

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Alpps plus Tislelizumab group
Arm Type
Experimental
Arm Description
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.
Arm Title
Alpps group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Tislelizumab
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
ALPPS surgery
Intervention Description
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.
Primary Outcome Measure Information:
Title
recurrence free survival
Description
recurrence free survival
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
safety (incidence of adverse events and serious adverse events)
Description
incidence of adverse events and serious adverse events
Time Frame
3 weeks
Title
overall survival
Description
overall survival
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lu C Wang, M.D.
Phone
+86-18121299357
Email
w.lr@hotmail.com
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
ZIP/Postal Code
200062
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lu Wang, M.D.
Phone
+86-18121299357
Email
w.lr@hotmail.com

12. IPD Sharing Statement

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ALPPS Combined With Tislelizumab in Liver Malignancy

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