NCT04401813

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2020

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 26, 2020

Completed
21 days until next milestone

Study Start

First participant enrolled

June 16, 2020

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

4 years

First QC Date

May 6, 2020

Last Update Submit

September 9, 2024

Conditions

Advanced Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (2)

  • adverse event

    21-42days

  • Evaluation of the objective response rate of IBI310 combined with 308 in the second-line treatment of advanced hepatocellular carcinoma

    21-42days

Secondary Outcomes (1)

  • Evaluate the ORR of IBI310 combined with 308 in the second-line treatment of advanced hepatocellular carcinoma (researched by the investigator according to RECIST V1.1).

    1years

Study Arms (1)

IBI310

EXPERIMENTAL

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

Drug: IBI308 200mg

Interventions

IBI308 200mgDRUG

Received IBI310 combined with sintilizumab 200mg

IBI310

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Histology contains fibrous lamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma and other components.
  • Have a history of hepatic encephalopathy, or have a history of liver transplantation.
  • Diffuse liver cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Hospital Affiliated to Fudan University

Shanghai, China

Location

MeSH Terms

Interventions

sintilimab

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2020

First Posted

May 26, 2020

Study Start

June 16, 2020

Primary Completion

June 21, 2024

Study Completion

June 21, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)