A Study of Nofazinlimab (CS1003) in Subjects With Advanced Hepatocellular Carcinoma

Phase 3

Active, not recruiting

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: Nofazinlimab (CS1003)+Lenvatinib; Drug: Nofazinlimab (CS1003) Placebo+Lenvatinib

• Registration Number: NCT04194775
• Lead Sponsor: CStone Pharmaceuticals

Brief Summary

This is a multi-center, double-blind, randomized, phase III study to investigate the efficacy and safety of Nofazinlimab (CS1003) in combination with lenvatinib and placebo in combination with lenvatinib in the treatment of subjects with no prior systemic treatment and with unresectable advanced hepatocellular carcinoma (HCC). Subjects cannot be eligible for locoregional therapy. In this study, Nofazinlimab (CS1003) (or placebo) and lenvatinib are both considered as the study treatment while Nofazinlimab (CS1003) (or placebo) is the investigational product of and lenvatinib is selected as the basic treatment for HCC.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-10
• Study First Submitted QC: 2019-12-10
• Study First Posted: 2019-12-11
• Study Start: 2019-12-13
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-17
• Last Update Posted: 2024-07-18
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 534

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nofazinlimab (CS1003)	Nofazinlimab (CS1003)+Lenvatinib	-
Nofazinlimab (CS1003) placebo	Nofazinlimab (CS1003) Placebo+Lenvatinib	-

Primary Outcome Measures

Name	Time	Method
Overall survival (OS)	Expected to be 5.5 years after the first patient is enrollment.

Secondary Outcome Measures

Name	Time	Method
Objective response rate (ORR) evaluated by investigators based on RECIST v1.1	Expected to be 5.5 years after the first patient is enrollment.
Duration of response (DoR) evaluated by blinded independent central review committee(BICR) based on Response Evaluation Criteria in Solid Tumors(RECIST) v1.1	Expected to be 5.5 years after the first patient is enrollment.
Duration of response (DoR) evaluated by investigators based on Response Evaluation Criteria in Solid Tumors(RECIST) v1.1	Expected to be 5.5 years after the first patient is enrollment.
Disease control rate (DCR) evaluated by blinded independent central review committee(BICR) based on Response Evaluation Criteria in Solid Tumors(RECIST) v1.1	Expected to be 5.5 years after the first patient is enrollment.
Disease control rate (DCR) evaluated by investigators based on Response Evaluation Criteria in Solid Tumors(RECIST) v1.1	Expected to be 5.5 years after the first patient is enrollment.
Percentage of Participants with Adverse Events	Expected to be 5.5 years after the first patient is enrollment.
Peak and trough serum concentrations of CS1003	Expected to be 5.5 years after the first patient is enrollment.
Number and percentage of subjects who develop anti-CS1003 antibody (ADA)	Expected to be 5.5 years after the first patient is enrollment.
Objective response rate (ORR) assessed by blinded independent central review committee(BICR)	Expected to be 5.5 years after the first patient is enrollment.
Progression-free survival(PFS) evaluated by investigator based on RECIST v1.1	Expected to be 5.5 years after the first patient is enrollment.
Progression-free survival(PFS) assessed by blinded independent central review committee(BICR) based on Response Evaluation Criteria in Solid Tumors(RECIST) v1.1	Expected to be 5.5 years after the first patient is enrollment.
Time to deterioration (TTD), defined as the time from randomization to the first deterioration of European Organization for the Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) scale	Expected to be 5.5 years after the first patient is enrollment.

Trial Locations

Locations (74)

Southern California Research Center; 🇺🇸 Coronado, California, United States

Inland Empire Liver Foundation; 🇺🇸 Rialto, California, United States

Mercy Medical Center; 🇺🇸 Baltimore, Maryland, United States

UMass Memorial Medical Center; 🇺🇸 Worcester, Massachusetts, United States

Stony Brook University Cancer Clinical Trials; 🇺🇸 Stony Brook, New York, United States

The First Affiliated Hospital of Bengbu Medical College; 🇨🇳 Bengbu, Anhui, China

The First Affiliated Hospital Of Anhui Medical University; 🇨🇳 Hefei, Anhui, China

The Second Affiliated Hospital of Anhui Medical University; 🇨🇳 Hefei, Anhui, China

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China

Beijing You'an Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Scroll for more (64 remaining)