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Hepatocellular CarcinomaPhase 2/3NCT03794440

A Study to Evaluate the Efficacy and Safety of Sintilimab in Combination With IBI305 (Anti-VEGF Monoclonal Antibody) Compared to Sorafenib as the First-Line Treatment for Advanced Hepatocellular Carcinoma.

A Phase 2/3 study testing Sintilimab, IBI305 and Sorafenib in people with Hepatocellular Carcinoma, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
Sintilimab, IBI305 and Sorafenib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
595 participants
Where
1 siteChina
Study dates
11 Feb 2019to Dec 2022
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Hospital of Fudan University

    Shanghai, Shanghai Municipality, 200032

Other trials in China

About this study

Official title: A Randomized, Open-label，Multi-center Study to Evaluate the Efficacy and Safety of the Combination of Sintilimab and IBI305 Compared to Sorafenib in the First-Line Treatment of Patients With Advanced Hepatocellular Carcinoma. （ORIENT-32）

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.

Being tested
Sintilimab, IBI305, Sorafenib
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SintilimabDrug

    Also called IBI308

    200mg IV d1， Q3W

  • IBI305Drug

    Also called anti-VEGF monoclonal antibody

    15mg/kg IV d1， Q3W

  • SorafenibDrug

    400mg PO BID

Study groups in NCT03794440
Study groupRoleWhat they receive
Sintilimab +IBI305ExperimentalNot described
Receives: Drug: Sintilimab; Drug: IBI305
SorafenibActive comparatorNot described
Receives: Drug: Sorafenib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival (OS)

    Measured: up to 24 months after randomization

  2. Progression-free survival (PFS)

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

    Measured: up to 24 months after randomization

Secondary outcomes (15)

  1. PFS

    PFS in two arms based on RECIST V1.1 by investigator.

    Measured: up to 24 months after randomization

  2. Objective response rate (ORR)

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

    Measured: up to 24 months after randomization

  3. Disease control rate (DCR)

    DCR in two arms based on RECIST V1.1 by IRRC and investigator.

    Measured: up to 24 months after randomization

  4. Duration of response (DOR)

    DOR in two arms based on RECIST V1.1 by IRRC and investigator.

    Measured: up to 24 months after randomization

  5. Time to progression (TTP)

    TTP in two arms based on RECIST V1.1 by IRRC and investigator.

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

  6. Time to response (TTR)

    TTR in two arms based on RECIST V1.1 by IRRC and investigator.

    Measured: up to 24 months after randomization

  7. PFS

    PFS in two arms based on mRECIST by IRRC.

    Measured: up to 24 months after randomization

  8. Objective response rate (ORR)

    Objective response rate (ORR) in two arms based on mRECIST by IRRC.

    Measured: up to 24 months after randomization

  9. Time to progression (TTP)

    TTP in two arms based on mRECIST by IRRC.

    Measured: up to 24 months after randomization

  10. Duration of response (DOR)

    DOR in two arms based on mRECIST by IRRC.

    Measured: up to 24 months after randomization

  11. Disease control rate (DCR)

    DCR in two arms based on mRECIST by IRRC.

    Measured: up to 24 months after randomization

  12. Time to response (TTR)

    TTR in two arms based on mRECIST by IRRC.

    Measured: up to 24 months after randomization

  13. Anti-drug antibody (ADA)

    Immunogenicity measured by anti-drug antibody (ADA) for Sintilimab and IBI305.

    Measured: up to 24 months after randomization

  14. EORTC QLQ-C30

    Measured: up to 24 months after randomization

  15. EORTC QLQ-HCC18

    Measured: up to 24 months after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2019
  2. Study start11 Feb 2019
  3. Primary completionDec 2022 (estimated)
  4. Study completionDec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
595 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03794440
Sponsor's protocol ID
CIBI338B301
Status last verified
May 2020
First submitted
3 Jan 2019
Last updated
22 Jan 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 34143971

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Sintilimab, IBI305 and Sorafenib in people with Hepatocellular Carcinoma, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (OS) (time frame: up to 24 months after randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03794440, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2021.

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