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.
NCT ID: NCT03794440
Last Updated: 2021-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
595 participants
INTERVENTIONAL
2019-02-11
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Sintilimab +IBI305
Sintilimab
200mg IV d1， Q3W
IBI305
15mg/kg IV d1， Q3W
Sorafenib
Sorafenib
400mg PO BID
Interventions
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Sintilimab
200mg IV d1， Q3W
IBI305
15mg/kg IV d1， Q3W
Sorafenib
400mg PO BID
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Innovent Biologics (Suzhou) Co. Ltd.
INDUSTRY
Responsible Party
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Locations
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Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Countries
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References
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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.
Other Identifiers
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CIBI338B301
Identifier Type: -
Identifier Source: org_study_id
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