Status:
UNKNOWN
A Clinical Study to Observe the Effectiveness and Safety of IBI310, Bevacizumab Combined With Sintilimab in the Treatment of Advanced Hepatocellular Carcinoma
Lead Sponsor:
Shanghai Zhongshan Hospital
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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 advanc...
Eligibility Criteria
Inclusion
- Histologically/cytologically confirmed hepatocellular carcinoma, or meeting the clinical diagnostic criteria for hepatocellular carcinoma ;
- Aged ≥18 years,≤75 years;
- ECOG performance status score of 0 or 1 point;
- Barcelona Clinic Liver Cancer (BCLC) stage C, or Stage B not suitable for radical surgery and/or local treatment;
- No systemic antitumor treatment for hepatocellular carcinoma before the first administration;
- 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);
- Child-Pugh Class A or B(≤7);
- Adequate organ and bone marrow function.
- Expected life time is over 12 weeks.
- Take effective contraceptive measures
- Willing to attend the study and having given the ICF
Exclusion
- Known fibrolamellar HCC, sarcomatoid HCC, mixed cholangiocarcinoma and HCC
- History of hepatic encephalopathy or liver transplantation
- Pleural, ascites, and pericardial effusion with clinical symptoms requiring drainage
- HBV-DNA\>2000 IU/ML or 10\^4 copies/ml；Untreated positive HCV-RNA；HbsAg and anti-HCV antibody were both positive
- History of GI bleeding within 6 months, or severe (G3) varices at endoscopy within 3 months
- Arteriovenous embolism within 6 months
- The tumor thrombus involved both main and branch portal veins, main portal veins and mesenteric veins or inferior vena cava.
- Antiplatelet drugs were administered for 10 days for therapeutic purposes 2 weeks before administration
- Uncontrolled hypertension
- Unrecovered AE（\>CTCAE grade 1） due to previous treatment
- Heart failure (NYHA Classification III-IV), or poorly controlled arrhythmias
- History of gastrointestinal perforation, fistula, intestinal obstruction, extensive bowel resection, Crohn's disease, ulcerative colitis, or chronic diarrhea
- With lung fibrosis, interstitial lung disease, pneumoconiosis, drug-associated pneumonia and serious impairment in lung function
- Active tuberculosis
- Infected with HIV or syphilis
- Severe infections that are active or clinically poorly controlled
- Use of immunosuppressive drugs within 4 weeks prior to initial dosing
- Receipt of live attenuated vaccine within 4 weeks prior to randomization
- Significant traumatic injury or major surgical procedure within 28 days prior to randomization
- Other conditions that the investigator judged inappropriate for inclusion
- Prior immunotherapy or targeted therapy
- Treatment of Traditional Chinese medicine with anti-tumor indications or drugs with immunomodulatory effects whitin 2 weeks
- Pregnant or breast-feeding women
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2024
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05363722
Start Date
May 1 2022
End Date
April 1 2024
Last Update
May 6 2022
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