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

Fudan University logo

Fudan University

Status and phase

Not yet enrolling
Phase 1

Conditions

Hepatocellular Carcinoma

Treatments

Drug: IBI310(0.3mg/kg)
Drug: IBI310(0.5mg/kg)
Drug: bevacizumab
Drug: sintilimab

Study type

Interventional

Funder types

Other

Identifiers

NCT05363722
CIBI310Y001

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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 criteria

  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

80 participants in 2 patient groups

Arm A(IBI310 0.5mg/kg)
Experimental group
Description:
IBI310 0.5mg/kg IV d1 Q6W, sintilimab 200mg IV d1 Q3W, combined with bevacizumab 15mg/kg IV d1,Q3W
Treatment:
Drug: bevacizumab
Drug: sintilimab
Drug: IBI310(0.5mg/kg)
Arm B(IBI310 0.3mg/kg)
Experimental group
Description:
IBI310 0.3mg/kg IV d1 Q6W, sintilimab 200mg IV d1 Q3W, combined with bevacizumab 15mg/kg IV d1,Q3W
Treatment:
Drug: bevacizumab
Drug: sintilimab
Drug: IBI310(0.3mg/kg)

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems