A Clinical Study to Observe the Effectiveness and Safety of IBI310, Bevacizumab Combined With Sintilimab in the Treatment of Advanced Hepatocellular Carcinoma

NCT ID: NCT05363722

Last Updated: 2022-05-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-31
• Study Completion Date: 2024-04-30

Brief Summary

This is a randomized, open-label, multicenter Phase Ib study to evaluate the effectiveness and safety of different doses of IBI310, bevacizumab combined with sintilimab 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 progressive disease after surgical resection or local treatment.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A（IBI310 0.5mg/kg）

IBI310 0.5mg/kg IV d1 Q6W, sintilimab 200mg IV d1 Q3W, combined with bevacizumab 15mg/kg IV d1，Q3W

Group Type: EXPERIMENTAL

IBI310（0.5mg/kg）

Intervention Type: DRUG

IBI310 0.5mg/kg IV d1 Q6W

sintilimab

Intervention Type: DRUG

sintilimab 200 mg IV d1 Q3W

bevacizumab

Intervention Type: DRUG

bevacizumab 15 mg/kg IV d1，Q3W

Arm B（IBI310 0.3mg/kg）

IBI310 0.3mg/kg IV d1 Q6W, sintilimab 200mg IV d1 Q3W, combined with bevacizumab 15mg/kg IV d1，Q3W

Group Type: EXPERIMENTAL

IBI310（0.3mg/kg）

Intervention Type: DRUG

IBI310 0.3mg/kg IV d1 Q6W

sintilimab

Intervention Type: DRUG

sintilimab 200 mg IV d1 Q3W

bevacizumab

Intervention Type: DRUG

bevacizumab 15 mg/kg IV d1，Q3W

Interventions

IBI310（0.5mg/kg）

IBI310 0.5mg/kg IV d1 Q6W

Intervention Type: DRUG

IBI310（0.3mg/kg）

IBI310 0.3mg/kg IV d1 Q6W

Intervention Type: DRUG

sintilimab

sintilimab 200 mg IV d1 Q3W

Intervention Type: DRUG

bevacizumab

bevacizumab 15 mg/kg IV d1，Q3W

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Histologically/cytologically confirmed hepatocellular carcinoma, or meeting the clinical diagnostic criteria for hepatocellular carcinoma ;

2. Aged ≥18 years,≤75 years;

3. ECOG performance status score of 0 or 1 point;

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

5. No systemic antitumor treatment for hepatocellular carcinoma before the first administration;

6. At least 1 measurable lesion according to the Response Evaluation Criteria in Solid Tumors Version 1.1(RECIST V1.1), or measurable lesion with definite progression after local treatment (based on RECIST V1.1 criteria);

7. Child-Pugh Class A or B(≤7);

8. Adequate organ and bone marrow function.

9. Expected life time is over 12 weeks.

10. Take effective contraceptive measures

11. Willing to attend the study and having given the ICF

Exclusion Criteria

1. Known fibrolamellar HCC, sarcomatoid HCC, mixed cholangiocarcinoma and HCC

2. History of hepatic encephalopathy or liver transplantation

3. Pleural, ascites, and pericardial effusion with clinical symptoms requiring drainage

4. HBV-DNA>2000 IU/ML or 10^4 copies/ml；Untreated positive HCV-RNA；HbsAg and anti-HCV antibody were both positive

5. History of GI bleeding within 6 months, or severe (G3) varices at endoscopy within 3 months

6. Arteriovenous embolism within 6 months

7. The tumor thrombus involved both main and branch portal veins, main portal veins and mesenteric veins or inferior vena cava.

8. Antiplatelet drugs were administered for 10 days for therapeutic purposes 2 weeks before administration

9. Uncontrolled hypertension

10. Unrecovered AE（>CTCAE grade 1） due to previous treatment

11. Heart failure (NYHA Classification III-IV), or poorly controlled arrhythmias

12. History of gastrointestinal perforation, fistula, intestinal obstruction, extensive bowel resection, Crohn's disease, ulcerative colitis, or chronic diarrhea

13. With lung fibrosis, interstitial lung disease, pneumoconiosis, drug-associated pneumonia and serious impairment in lung function

14. Active tuberculosis

15. Infected with HIV or syphilis

16. Severe infections that are active or clinically poorly controlled

17. Use of immunosuppressive drugs within 4 weeks prior to initial dosing

18. Receipt of live attenuated vaccine within 4 weeks prior to randomization

19. Significant traumatic injury or major surgical procedure within 28 days prior to randomization

20. Other conditions that the investigator judged inappropriate for inclusion

21. Prior immunotherapy or targeted therapy

22. Treatment of Traditional Chinese medicine with anti-tumor indications or drugs with immunomodulatory effects whitin 2 weeks

23. Pregnant or breast-feeding women

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

CIBI310Y001

Identifier Type: -

Identifier Source: org_study_id