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

NCT05363722 | Unknown Phase 1 DMC

• 1 other identifier: CIBI310Y001
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  efficacy

  The proportion of patients with complete response or partial response, through study completion, an average of 3 years

Secondary Outcomes (10)

• Duration of Response（DOR）according to RECIST V1.1 criteria

  From date of randomization until the date of first documented progression, up to 48 months

• Duration of Response（DOR）according to mRECIST criteria

  From date of randomization until the date of first documented progression, up to 48 months

• Disease Control Rate（DCR） according to RECIST V1.1 criteria

  The percentage of patients whose therapeutic intervention has led to a complete response, partial response, or stable disease, through study completion, an average of 3 years

• Disease Control Rate（DCR） according to mRECIST criteria

  The percentage of patients whose therapeutic intervention has led to a complete response, partial response, or stable disease, through study completion, an average of 3 years

• Time to Progression（TTP）according to RECIST V1.1 criteria

  From date of randomization until the date of first documented progression, up to 48 months

Study Arms (2)

Arm A（IBI310 0.5mg/kg）

EXPERIMENTAL

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

Drug: IBI310（0.5mg/kg）; Drug: sintilimab; Drug: bevacizumab

Arm B（IBI310 0.3mg/kg）

EXPERIMENTAL

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

Drug: IBI310（0.3mg/kg）; Drug: sintilimab; Drug: bevacizumab

Interventions

IBI310（0.5mg/kg） DRUG

IBI310 0.5mg/kg IV d1 Q6W

Arm A（IBI310 0.5mg/kg）

IBI310（0.3mg/kg） DRUG

IBI310 0.3mg/kg IV d1 Q6W

Arm B（IBI310 0.3mg/kg）

sintilimab DRUG

sintilimab 200 mg IV d1 Q3W

Arm A（IBI310 0.5mg/kg）; Arm B（IBI310 0.3mg/kg）

bevacizumab DRUG

bevacizumab 15 mg/kg IV d1，Q3W

Arm A（IBI310 0.5mg/kg）; Arm B（IBI310 0.3mg/kg）

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

sintilimab; Bevacizumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2022
• First Posted: May 6, 2022
• Study Start: May 1, 2022
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2024
• Last Updated: May 6, 2022

Record last verified: 2022-05