Toripalimab or Placebo as Neoadjuvant Therapy in Resectable Hepatocellular Carcinoma or Intrahepatic Cholangiocarcinoma

Overview

This study will evaluate efficacy and safety of Toripalimab Injection (JS001) as a Neoadjuvant Therapy in patients with Resectable Hepatocellular Carcinoma (HCC) or Intrahepatic Cholangiocarcinoma (ICC)

Full Title of Study: “A Phase Ib/II, Open-Label, Single-Center, Single-Arm Study Evaluating the Efficacy and Safety of Toripalimab Injection (JS001) as a Neoadjuvant Therapy for Patients With Resectable Hepatocellular Carcinoma (HCC) or Intrahepatic Cholangiocarcinoma (ICC)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 28, 2021

Interventions

  • Biological: TORIPALIMAB INJECTION(JS001 )
    • During the neoadjuvant period, the patients will receive a single JS001 intravenous infusion of 480 mg . After the operation, the patients wil receive JS001 240 mg Q3W.

Arms, Groups and Cohorts

  • Experimental: Group A
    • Group A:TORIPALIMAB 240mg ,Q3W, up to 48 Weeks;

Clinical Trial Outcome Measures

Primary Measures

  • Pathological response rate
    • Time Frame: Up to 9 months
    • assessed using the percentage of the non-viable cancer cells (necrotized or fibrotized) out of the surface expression of the total tumor area, which is: 100% – viable cancer cells %. If there are a number of tumors, then the mean value of the tumor percentages will be used.

Secondary Measures

  • Time to operation
    • Time Frame: Up to 8 months
    • Used for assessment of the feasibility of the neoadjuvant therapy.

Participating in This Clinical Trial

Inclusion Criteria

1. Confirmed by histopathological or cytological examination;

2. The criteria for resectability is met

3. Has at least one evaluable lesion according to the RECIST 1.1 standard and has not received local treatment

Exclusion Criteria

1. Patients who previously received anti-programmed death receptor-1 (PD-1) antibody, anti-programmed death ligand-1 (PD-L1) antibody, anti-programmed death ligand-2 (PD-L2) antibody or anti-cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) antibodies, including those who have participated in a JS001 clinical study;

2. Patients who previously received any TACE, radiofrequency ablation and other liver cancer treatments;

3. Patients with a history of gastroesophageal varices or active cardia ulcers associated with a high risk of bleeding;

4. Patients who have upper gastrointestinal hemorrhage within 1 year;

5. Patients known to have fibrous layer HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC; Other protocol defined inclusion/exclusion criteria could apply

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Shanghai Junshi Bioscience Co., Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Jia Fan, +86 13601669720, fan.jia@zs-hospital.sh.cn

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