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

NCT03867370 | Terminated Phase 1

• 1 other identifier: JS001-020-Ib-HCC
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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)

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Pathological response rate

  CPR，MPR

  Up to 2 months

Secondary Outcomes (6)

• Objective response rate

  up to 2 months

• Percentage of R0 resection

  up to 8 months

• Time to operation

  up to 8 months

• Progression free survival

  up to 3 years

• Overall survival

  up to 3 years

Study Arms (3)

Group A

EXPERIMENTAL

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.

Drug: Toripalimab (JS001 )

Group B (Toripalimab, Lenvatinib)

EXPERIMENTAL

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.

Drug: Toripalimab (JS001 ) Lenvatinib

Group C (Toripalimab, Lenvatinib)

ACTIVE COMPARATOR

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.

Drug: Toripalimab (JS001 ) Lenvatinib

Interventions

Toripalimab (JS001 ) DRUG

Given IV

Group A

Toripalimab (JS001 ) Lenvatinib DRUG

Given IV 4 mg capsules

Group B (Toripalimab, Lenvatinib)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shanghai Junshi Bioscience Co., Ltd.: lead

Study Sites (1)

Fudan University Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (1)

• Fang Y, Liu W, Tang Z, Ji X, Zhou Y, Song S, Tian M, Tao C, Huang R, Zhu G, Jiang X, Gao J, Qu W, Wang H, Zhou P, Wu X, Jin L, Sun H, Ding Z, Peng Y, Zhao S, Zhou J, Fan J, Xu W, Shi Y. Monocarboxylate transporter 4 inhibition potentiates hepatocellular carcinoma immunotherapy through enhancing T cell infiltration and immune attack. Hepatology. 2023 Jan 1;77(1):109-123. doi: 10.1002/hep.32348. Epub 2022 Feb 7.

  PMID: 35043976 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

toripalimab; lenvatinib

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2019
• First Posted: March 8, 2019
• Study Start: April 26, 2019
• Primary Completion: August 8, 2023
• Study Completion: August 8, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-11

Locations

CN (1)