Efficacy and Safety of IBI310 Combined with Sintilimab in Patients with Advanced Hepatocellular Carcinoma

NCT ID: NCT04401813

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-16

Study Completion Date

2024-06-21

Brief Summary

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An open-label, single-arm, Ib study of the efficacy and safety of IBI310 combined with sintilimab in patients with advanced hepatocellular carcinoma

Detailed Description

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In this study, approximately 18 to 47 patients who have previously received sorafenib, lenvatinib, or oxaliplatin-containing chemotherapy . After determining the dose of IBI310, the study will enter the expansion phase

Conditions

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Advanced Hepatocellular Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IBI310

An open-label, single-arm, Ib study of the efficacy and safety of IBI310 combined with sintilimab in patients with advanced hepatocellular carcinoma

Group Type EXPERIMENTAL

IBI308 200mg

Intervention Type DRUG

Received IBI310 combined with sintilizumab 200mg

Interventions

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IBI308 200mg

Received IBI310 combined with sintilizumab 200mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Locally advanced or metastatic hepatocellular carcinoma, confirmed by histology/cytology.
2. Disease progression after surgery and / or local treatment.
3. Previous standard systemic treatments for advanced hepatocellular carcinoma have failed or developed intolerable toxicity.

Exclusion Criteria

1. Histology contains fibrous lamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma and other components.
2. Have a history of hepatic encephalopathy, or have a history of liver transplantation.
3. Diffuse liver cancer.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Innovent Biologics (Suzhou) Co. Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Zhongshan Hospital Affiliated to Fudan University

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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CIBI310C101

Identifier Type: -

Identifier Source: org_study_id

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