NCT04720716

Brief Summary

This is a randomized, open-label, controlled, multicenter Phase III study to evaluate the effectiveness and safety of IBI310 combined with sintilimab and sorafenib in patients with locally advanced or metastatic HCC who have not previously received systemic therapy, are unsuitable for radical surgical resection or local treatment, or have had progressive disease after surgical resection or local treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
344

participants targeted

Target at P50-P75 for phase_3 hepatocellular-carcinoma

Timeline
Completed

Started Feb 2021

Typical duration for phase_3 hepatocellular-carcinoma

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

January 13, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
16 days until next milestone

Study Start

First participant enrolled

February 7, 2021

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

4.9 years

First QC Date

January 13, 2021

Last Update Submit

March 18, 2026

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (2)

  • Overall survival (OS)

    up to 24 months after randomization

  • Objective response rate (ORR)

    Objective response rate (ORR) in two arms based on RECIST V1.1 by the IRRC

    up to 24 months after randomization

Secondary Outcomes (6)

  • Progression-free survival (PFS)

    up to 24 months after randomization

  • Duration of response(DOR)

    up to 24 months after randomization

  • Disease control rate(DCR)

    up to 24 months after randomization

  • Time to progression(TTP)

    up to 24 months after randomization

  • Time to response(TTR)

    up to 24 months after randomization

  • +1 more secondary outcomes

Study Arms (2)

Sintilimab combined with IBI310

EXPERIMENTAL
Drug: IBI310Drug: Sintilimab

Sorafenib

ACTIVE COMPARATOR
Drug: Sorafenib

Interventions

IBI310DRUG

IBI310 IV d1, Q6W

Sintilimab combined with IBI310
SintilimabDRUG

sintilimab IV d1, Q3W

Sintilimab combined with IBI310
SorafenibDRUG

Sorafenib 400mg po

Sorafenib

Eligibility Criteria

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

You may qualify if:

  • Histologically/cytologically confirmed hepatocellular carcinoma, or liver cirrhosis meeting the clinical diagnostic criteria;
  • ECOG performance status score of 0 or 1 point;
  • No systemic antitumor treatment for hepatocellular carcinoma before the first administration;
  • Barcelona Clinic Liver Cancer stage C, or Stage B not suitable for radical surgery and/or local treatment;
  • At least 1 measurable lesion according to RECIST V1.1);
  • Child-Pugh:≤6
  • Adequate organ and bone marrow function.

You may not qualify if:

  • With fibrous lamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma components in tumor tissues.
  • Have a history of hepatic encephalopathy or have a history of liver transplantation.
  • With clinical symptoms requires drainage of pleural effusion, ascites or pericardial effusion.
  • Central nervous system (CNS) metastasis.
  • Uncontrolled high blood pressure, systolic blood pressure \>140mmHg or diastolic blood pressure \>90mmHg after optimal medical treatment.
  • Local treatment for liver lesions within 4 weeks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan Universtiy Zhongshan Hospital

Shanghai, Shanghai Municipality, 200000, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

sintilimabSorafenib

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Phenylurea CompoundsUreaAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsNiacinamideNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2021

First Posted

January 22, 2021

Study Start

February 7, 2021

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

March 19, 2026

Record last verified: 2026-03

Locations

CN(1)