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Toripalimab in Combination With Lenvatinib as Neoadjuvant Therapy in Resectable Hepatocellular Carcinoma

Primary Purpose

Hepatocellular Carcinoma

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Toripalimab (JS001 )
Toripalimab (JS001 ) Lenvatinib
Toripalimab (JS001 ) Lenvatinib
Sponsored by
Shanghai Junshi Bioscience Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Confirmed by histopathological or cytological examination; The criteria for resectability is met; Has at least one evaluable lesion according to the RECIST 1.1 standard and has not received local treatment;

Exclusion Criteria:

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;

Patients with a history of gastroesophageal varices or active cardia ulcers associated with a high risk of bleeding; Patients who have upper gastrointestinal hemorrhage within 1 year; Patients known to have fibrous layer HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC; Other protocol defined inclusion/exclusion criteria could apply

Sites / Locations

  • Fudan University Zhongshan HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Group A

Group B (Toripalimab, Lenvatinib)

Group C (Toripalimab, Lenvatinib)

Arm Description

During the neoadjuvant period, the patients will receive a single dose JS001 intravenous infusion of 480 mg. After the operation, the patients will receive JS001 240 mg Q3W for up to 48 weeks.

During the neoadjuvant period, the patients will receive a single dose JS001 intravenous infusion of 480 mg in combination with oral lenvatinib at a starting dose of 8 or 12 mg once a day. After the operation, the patients will receive JS001 240 mg Q3W and lenvatinib for up to 48 weeks.

During the neoadjuvant period, the patients will receive a single dose JS001 intravenous infusion of 480 mg in combination with oral lenvatinib at a starting dose of 8 or 12 mg once a day. After the operation, the patients will receive JS001 240 mg Q3W for up to 48 weeks.

Outcomes

Primary Outcome Measures

Pathological response rate
CPR，MPR

Secondary Outcome Measures

Objective response rate
ORR is defined as the percentage of participants who achieved CR or PR
Percentage of R0 resection
Used for assessment of the feasibility of the neoadjuvant therapy.
Time to operation
Used for assessment of the feasibility of the neoadjuvant therapy.
Progression free survival
Used for assessment of the efficacy.
Overall survival
Used for assessment of the efficacy.
Incidence of adverse events
Graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Safety will be recorded through the incidence of adverse events, serious adverse events and specific laboratory abnormalities (worst grade) in each treatment arm.

Full Information

First Posted
March 1, 2019
Last Updated
March 25, 2021
Sponsor
Shanghai Junshi Bioscience Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03867370
Brief Title
Toripalimab in Combination With Lenvatinib as Neoadjuvant Therapy in Resectable Hepatocellular Carcinoma
Official Title
A Phase Ib/II, Open-Label, Multi-Center Study Evaluating the Efficacy and Safety of Neoadjuvant Toripalimab Injection (JS001) or Toripalimab in Combination With Lenvatinib for Patients With Resectable Hepatocellular Carcinoma (HCC)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 26, 2019 (Actual)
Primary Completion Date
July 27, 2022 (Anticipated)
Study Completion Date
October 19, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Junshi Bioscience Co., Ltd.

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
This study will evaluate efficacy and safety of Toripalimab Injection (JS001) with or without Lenvatinib as a Neoadjuvant Therapy in patients with Resectable Hepatocellular Carcinoma (HCC)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
During the neoadjuvant period, the patients will receive a single dose JS001 intravenous infusion of 480 mg. After the operation, the patients will receive JS001 240 mg Q3W for up to 48 weeks.
Arm Title
Group B (Toripalimab, Lenvatinib)
Arm Type
Experimental
Arm Description
During the neoadjuvant period, the patients will receive a single dose JS001 intravenous infusion of 480 mg in combination with oral lenvatinib at a starting dose of 8 or 12 mg once a day. After the operation, the patients will receive JS001 240 mg Q3W and lenvatinib for up to 48 weeks.
Arm Title
Group C (Toripalimab, Lenvatinib)
Arm Type
Active Comparator
Arm Description
During the neoadjuvant period, the patients will receive a single dose JS001 intravenous infusion of 480 mg in combination with oral lenvatinib at a starting dose of 8 or 12 mg once a day. After the operation, the patients will receive JS001 240 mg Q3W for up to 48 weeks.
Intervention Type
Drug
Intervention Name(s)
Toripalimab (JS001 )
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
Toripalimab (JS001 ) Lenvatinib
Intervention Description
Given IV 4 mg capsules
Intervention Type
Drug
Intervention Name(s)
Toripalimab (JS001 ) Lenvatinib
Intervention Description
Given IV 4 mg capsules
Primary Outcome Measure Information:
Title
Pathological response rate
Description
CPR，MPR
Time Frame
Up to 2 months
Secondary Outcome Measure Information:
Title
Objective response rate
Description
ORR is defined as the percentage of participants who achieved CR or PR
Time Frame
up to 2 months
Title
Percentage of R0 resection
Description
Used for assessment of the feasibility of the neoadjuvant therapy.
Time Frame
up to 8 months
Title
Time to operation
Description
Used for assessment of the feasibility of the neoadjuvant therapy.
Time Frame
up to 8 months
Title
Progression free survival
Description
Used for assessment of the efficacy.
Time Frame
up to 3 years
Title
Overall survival
Description
Used for assessment of the efficacy.
Time Frame
up to 3 years
Title
Incidence of adverse events
Description
Graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Safety will be recorded through the incidence of adverse events, serious adverse events and specific laboratory abnormalities (worst grade) in each treatment arm.
Time Frame
up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Confirmed by histopathological or cytological examination; The criteria for resectability is met; Has at least one evaluable lesion according to the RECIST 1.1 standard and has not received local treatment; Exclusion Criteria: 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; Patients with a history of gastroesophageal varices or active cardia ulcers associated with a high risk of bleeding; Patients who have upper gastrointestinal hemorrhage within 1 year; Patients known to have fibrous layer HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC; Other protocol defined inclusion/exclusion criteria could apply
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jia Fan
Phone
+86-021-64041990
Email
fan.jia@zs-hospital.sh.cn
Facility Information:
Facility Name
Fudan University Zhongshan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jia Fan
Phone
021-64041990

12. IPD Sharing Statement

Learn more about this trial

Toripalimab in Combination With Lenvatinib as Neoadjuvant Therapy in Resectable Hepatocellular Carcinoma

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