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.

• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03794440
• Collaborator: (none)
• Enrollment: 595
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 45.6
• Patients Per Site Per Month: 13

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma	Drug: Sintilimab; Drug: IBI305; Drug: Sorafenib	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 595 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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）
• Actual Study Start Date: Feb 11, 2019
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sintilimab +IBI305	Drug: Sintilimab; 200mg IV d1， Q3W; Other Names: IBI308 ; Drug: IBI305; 15mg/kg IV d1， Q3W; Other Names: anti-VEGF monoclonal antibody
Active Comparator: Sorafenib	Drug: Sorafenib; 400mg PO BID

Outcome Measures

Primary Outcome Measures

1. Overall survival (OS) [up to 24 months after randomization]

2. Progression-free survival (PFS) [up to 24 months after randomization]

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

Secondary Outcome Measures

1. PFS [up to 24 months after randomization]

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

2. Objective response rate (ORR) [up to 24 months after randomization]

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

3. Disease control rate (DCR) [up to 24 months after randomization]

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

4. Duration of response (DOR) [up to 24 months after randomization]

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

5. 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.]

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

6. Time to response (TTR) [up to 24 months after randomization]

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

7. PFS [up to 24 months after randomization]

   PFS in two arms based on mRECIST by IRRC.

8. Objective response rate (ORR) [up to 24 months after randomization]

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

9. Time to progression (TTP) [up to 24 months after randomization]

   TTP in two arms based on mRECIST by IRRC.

10. Duration of response (DOR) [up to 24 months after randomization]

    DOR in two arms based on mRECIST by IRRC.

11. Disease control rate (DCR) [up to 24 months after randomization]

    DCR in two arms based on mRECIST by IRRC.

12. Time to response (TTR) [up to 24 months after randomization]

    TTR in two arms based on mRECIST by IRRC.

13. Anti-drug antibody (ADA) [up to 24 months after randomization]

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

14. EORTC QLQ-C30 [up to 24 months after randomization]

15. EORTC QLQ-HCC18 [up to 24 months after randomization]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. 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).

2. ECOG performance status between 0 and 1

3. No systematic anti-tumor treatment has been performed.(End of postoperative adjuvant chemotherapy for more than 6 months allowed).

4. Barcelona Clinic Liver Cancer stage C. BCLC stage B, not suitable for radical surgery and/or local treatment.

5. At least 1 lesion with measurable disease at baseline by RECIST V1.1.

6. Child-Pugh: <=7

7. Adequate organ and bone marrow function.

Exclusion Criteria:

1. With fibrous lamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma components in tumor tissues.

2. Have a history of hepatic encephalopathy or have a history of liver transplantation.

3. With clinical symptoms requires drainage of pleural effusion, ascites or pericardial effusion.

4. Central nervous system (CNS) metastasis.

5. Uncontrolled high blood pressure, systolic blood pressure >140mmHg or diastolic blood pressure >90mmHg after optimal medical treatment.

6. Local treatment for liver lesions within 4 weeks.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital of Fudan University	Shanghai	Shanghai	China	200032

Sponsors and Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Innovent Biologics (Suzhou) Co. Ltd.
• ClinicalTrials.gov Identifier: NCT03794440
• Other Study ID Numbers: CIBI338B301
• First Posted: Jan 7, 2019
• Last Update Posted: Jan 22, 2021
• Last Verified: May 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Carcinoma; Carcinoma, Hepatocellular; Sorafenib

Study Results

No Results Posted as of Jan 22, 2021