NCT03794440

Brief Summary

The purpose of the study is to assess the safety, tolerability and effectiveness of Sintilimab in combination with IBI305 in patients with HCC as the first-line treatment compared with Sorafenib. This study is a randomised, Open-label，Multi-center Study. The primary endpoint is overall survival.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
595

participants targeted

Target at P75+ for phase_2 hepatocellular-carcinoma

Timeline
Completed

Started Feb 2019

Typical duration for phase_2 hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
unknown

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 3, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 7, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

February 11, 2019

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

January 22, 2021

Status Verified

May 1, 2020

Enrollment Period

3.8 years

First QC Date

January 3, 2019

Last Update Submit

January 21, 2021

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (2)

  • Overall survival (OS)

    up to 24 months after randomization

  • Progression-free survival (PFS)

    Progression-free survival (PFS) in two arms based on RECIST V1.1 by Independent Radiological Review Committee, IRRC.

    up to 24 months after randomization

Secondary Outcomes (15)

  • PFS

    up to 24 months after randomization

  • Objective response rate (ORR)

    up to 24 months after randomization

  • Disease control rate (DCR)

    up to 24 months after randomization

  • Duration of response (DOR)

    up to 24 months after randomization

  • Time to progression (TTP)

    One assessment was performed every 6 weeks (±7 days) from the time of randomization, and once every 12 weeks (±7 days) after 48 weeks.

  • +10 more secondary outcomes

Study Arms (2)

Sintilimab +IBI305

EXPERIMENTAL
Drug: SintilimabDrug: IBI305

Sorafenib

ACTIVE COMPARATOR
Drug: Sorafenib

Interventions

SintilimabDRUG

200mg IV d1， Q3W

Also known as: IBI308
Sintilimab +IBI305
IBI305DRUG

15mg/kg IV d1， Q3W

Also known as: anti-VEGF monoclonal antibody
Sintilimab +IBI305
SorafenibDRUG

400mg PO BID

Sorafenib

Eligibility Criteria

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

You may qualify if:

  • Hepatocellular carcinoma confirmed by histology/cytology. Cirrhosis meets the clinical diagnostic criteria for hepatocellular carcinoma of the American Association for the Diagnosis of Liver Diseases (AASLD).
  • ECOG performance status between 0 and 1
  • No systematic anti-tumor treatment has been performed.(End of postoperative adjuvant chemotherapy for more than 6 months allowed).
  • Barcelona Clinic Liver Cancer stage C. BCLC stage B, not suitable for radical surgery and/or local treatment.
  • At least 1 lesion with measurable disease at baseline by RECIST V1.1.
  • Child-Pugh: \<=7
  • 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)

Hospital of Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (1)

  • Ren Z, Xu J, Bai Y, Xu A, Cang S, Du C, Li Q, Lu Y, Chen Y, Guo Y, Chen Z, Liu B, Jia W, Wu J, Wang J, Shao G, Zhang B, Shan Y, Meng Z, Wu J, Gu S, Yang W, Liu C, Shi X, Gao Z, Yin T, Cui J, Huang M, Xing B, Mao Y, Teng G, Qin Y, Wang J, Xia F, Yin G, Yang Y, Chen M, Wang Y, Zhou H, Fan J; ORIENT-32 study group. Sintilimab plus a bevacizumab biosimilar (IBI305) versus sorafenib in unresectable hepatocellular carcinoma (ORIENT-32): a randomised, open-label, phase 2-3 study. Lancet Oncol. 2021 Jul;22(7):977-990. doi: 10.1016/S1470-2045(21)00252-7. Epub 2021 Jun 15.

    PMID: 34143971DERIVED

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 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2019

First Posted

January 7, 2019

Study Start

February 11, 2019

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

January 22, 2021

Record last verified: 2020-05

Locations

CN(1)