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

Sponsor
Shanghai Zhongshan Hospital
Study ID
NCT05363722
Phase
PHASE1
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • IBI310（0.5mg/kg） — DRUG
    IBI310 0.5mg/kg IV d1 Q6W
  • IBI310（0.3mg/kg） — DRUG
    IBI310 0.3mg/kg IV d1 Q6W
  • sintilimab — DRUG
    sintilimab 200 mg IV d1 Q3W
  • bevacizumab — DRUG
    bevacizumab 15 mg/kg IV d1，Q3W

Study Details

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.

Key Dates

First listed
May 6, 2022
Start date
May 31, 2022
Status verified
May 2022
Primary completion
Apr 30, 2023
Completion
Apr 30, 2024

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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
  • Experimental: 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

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: The proportion of patients with complete response or partial response, through study completion, an average of 3 years ]

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