Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Antineoplastic Agents

All Drugs and Chemicals

Lenvatinib

Bevacizumab

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Experimental group:

Toripalimab combined with Bevacizumab

Experimental group:

Toripalimab, 240mg, IV infusion, every 3 weeks (q3w). combined with Lenvatinib 15 mg/kg (IV infusion, every 3 weeks (q3w).. Continuous infusion, in a cycle of 3 weeks (21 days), until occurrence of termination event specified in the protocol.

Toripalimab combined with Bevacizumab

This is an open-label, single-arm, national multicenter phase II clinical study to preliminarily observe and evaluate the efficacy and safety of Toripalimab combined with Bevacizumab as the first-line therapy for advanced HCC The study will use safety/tolerability and ORR as the primary study objectives and indicators, and plans to enroll about 50-60 patients.

A Single-arm, Open-label, Multi-center Phase II Clinical Study to Evaluate the Safety and Efficacy of Toripalimab Injection (JS001) Combined With Bevacizumab as the First-line Therapy for Advanced Hepatocellular Carcinoma (HCC)

Correlation between PD-L1 expression level in tumor tissue, proportion of strong positive expression of PD-L1

Correlation betweenTumor mutation burden (TMB) and the efficacy

Pharmacokinetic profile in HCC patients of observed maximum plasma concentration

Analysis of anti-drug antibody (ADA) during treatment.

Frequency table will be used to summarize occurrence of each treatment-emergent AE

Number and incidence of abnormal laboratory examinations by treatment group.

The rate of participants that achieve either a complete response (CR) or a partial response (PR).

The time from the first assessment of CR or PR to the first assessment of PD or death due to any cause.

The percentage of cases with remission (PR + CR) and stable lesions (SD) after treatment was assessable.

time from the start of treatment to progression of diease.

PFS is defined as time from the start of treatment to progression of disease or death.

Overall survival is defined as time from the start of treatment until death due to any reason.

Shanghai Junshi Bioscience Co., Ltd.

Sorafenib

Protein Kinase Inhibitors

Enzyme Inhibitors

Experimental group:

Toripalimab, 240mg, IV infusion, every 3 weeks (q3w). combined with Bevacizumab 15mg/kg, IV infusion, every 3 weeks (q3w), Continuous infusion, in a cycle of 3 weeks (21 days), until occurrence of termination event specified in the protocol.

Control group:

Sorafenib 400mg, po, Bid, continuous administration, until occurrence of termination event specified in the protocol.

This is a prospective, randomized, open-label, parallel-group, active controlled, multi-center phase III registration clinical study to observe, compare and evaluate the efficacy and safety of Toripalimab (hereafter referred to as JS001) combined with Bevacizumab versus Sorafenib as the first-line therapy for advanced HCC This study will enroll the patients with locally advanced or metastatic hepatocellular carcinoma who could not be radically cured and not receive any prior systemic therapy. The study will use PFS and OS as the co-primary endpoints, with approximately 280 patients planned to be enrolled.

Evaluate the Safety and Efficacy of Toripalimab Combined With Bevacizumab Versus Sorafenib Therapy for HCC

A Randomized, Open-label, Multi-center Phase III Clinical Study to Evaluate the Safety and Efficacy of Toripalimab (JS001) Combined With Bevacizumab Versus Sorafenib as First-line Therapy for Advanced Hepatocellular Carcinoma

A duration from the date of initial treatment with Toripalimab Plus Bevacizumab or Sorafenib to disease progression (defined by RECIST 1.1) or death of any cause, whichever comes first.

Duration from the date of initial treatment with Toripalimab Plus Bevacizumab or Sorafenib monotherapy to the date of death due to any cause.

Duration from the first time reported partial response or complete response to the first time of disease progression or death.

Proportion of patients with reduction and non-change in tumor burden of a predefined amount, including complete remission, partial remission and stable disease

Define as the time from randomization to the first documented disease progression

Analysis of adverse events (AEs) are based on treatment-related AEs (trAEs) and immune-related AEs (irAEs), and all-grade AEs and grade 3-4 AEs. AEs are evaluated by investigators according to the Common Terminology Criteria for Adverse Events, version 5.0

Correlation between tumor mutation burden (TMB) and the efficacy of Toripalimab combined with Bevacizumab

Serum levels and incidence of Anti-drug antibody of Toripalimab combined with Bevacizumab treatment group

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Single-arm, Open-label, Multi-center Phase II Clinical Study to Evaluate the Safety and Efficacy of Toripalimab Injection (JS001) Combined With Bevacizumab as the First-line Therapy for Advanced Hepatocellular Carcinoma (HCC)	NCT04605796	Advanced Hepato...	Toripalimab com...	18 Years - 70 Years	Shanghai Junshi Bioscience Co., Ltd.
Evaluate the Safety and Efficacy of Toripalimab Combined With Bevacizumab Versus Sorafenib Therapy for HCC	NCT04723004	Advanced Hepato...	Toripalimab com... Sorafenib	18 Years - 75 Years	Shanghai Junshi Bioscience Co., Ltd.
Evaluate the Safety and Efficacy of Toripalimab Combined With Bevacizumab Versus Sorafenib Therapy for HCC	NCT04723004	Advanced Hepato...	Toripalimab com... Sorafenib	18 Years - 75 Years	Shanghai Junshi Bioscience Co., Ltd.
A Single-arm, Open-label, Multi-center Phase II Clinical Study to Evaluate the Safety and Efficacy of Toripalimab Injection (JS001) Combined With Bevacizumab as the First-line Therapy for Advanced Hepatocellular Carcinoma (HCC)	NCT04605796	Advanced Hepato...	Toripalimab com...	18 Years - 70 Years	Shanghai Junshi Bioscience Co., Ltd.

Spots Global Cancer Trial Database for toripalimab combined with bevacizumab