ALPPS Combined With Tislelizumab in Liver Malignancy

NCT04996446 | Unknown Phase 2

• 1 other identifier: 2020-183-2103
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Malignant Tumors

Outcome Measures

Primary Outcomes (1)

• recurrence free survival

  recurrence free survival

  6 weeks

Secondary Outcomes (2)

• safety (incidence of adverse events and serious adverse events)

  3 weeks

• overall survival

  6 weeks

Study Arms (2)

Alpps plus Tislelizumab group

EXPERIMENTAL

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; Procedure: ALPPS surgery

Alpps group

ACTIVE COMPARATOR

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

Interventions

Tislelizumab DRUG

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 plus Tislelizumab group

ALPPS surgery PROCEDURE

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; Alpps plus Tislelizumab group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, 200062, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

tislelizumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Central Study Contacts

Lu C Wang, M.D.

CONTACT

+86-18121299357; w.lr@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of liver surgery department

Study Record Dates

• First Submitted: August 4, 2021
• First Posted: August 9, 2021
• Study Start: August 1, 2020
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: August 9, 2021

Record last verified: 2021-08

Locations

CN (1)