This study is a randomized, controlled, open-label, multicenter, seamless Phase II/III trial designed to evaluate the efficacy and safety of the combination regimen of IBI310 and sintilimab in participants with locally advanced or metastatic hepatocellular carcinoma (HCC) who are: (1) treatment-naive to systemic therapy; and (2) either unsuitable for curative-intent surgical resection or local therapy, or have experienced disease progression following prior surgical resection or local therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
680
15 mg/kg intravenous infusion, administered on Day 1 of each 3-week treatment cycle
1000 mg/m² orally, administered on Days 1-14 of each 3-week treatment cycle, maximum 4 cycles.
85 mg/m² intravenous infusion, administered on Day 1 of each 3-week treatment cycle, maximum 4 cycles.
1 mg/kg intravenous infusion, administered on Day 1 of each 6-week treatment cycle
200 mg intravenous infusion, administered on Day 1 of each 3-week treatment cycle
The First Affiliated Hosptial of USTC
Hefei, Anhui, China
RECRUITINGZhongshan Hospital, Fudan university
Shanghai, Shanghai Municipality, China
NOT_YET_RECRUITINGPhase II: ORR (Objective Response Rate) assessed by investigator per RECIST 1.1.
Time frame: up to 2 years
Phase II: PFS(Progression-Free Survival) assessed by investigator per RECIST 1.1.
Time frame: up to 2 years
Phase II: AEs(Adverse Event)
Time frame: up to 2 years
Phase II: TRAES(Treatment Emergent Adverse Event)
Time frame: up to 2 years
Phase II: SAEs(Serious Adverse Event)
Time frame: up to 2 years
Phase III: OS(Overall Survival)
Time frame: up to 2 years
Phase III: PFS(Progression-Free Survival)assessed by the Independent Radiologic Review Committee (IRRC) per RECIST 1.1.
Time frame: up to 2 years
Phase II: OS
Time frame: up to 2 years
Phase II: Incidence and characteristics of ADA&Nab.
Time frame: up to 2 years
Phase II: DoR (Duration of Response )
Time frame: up to 2 years
Phase II: DCR (Disease Control Rate )
Time frame: up to 2 years
Phase II: TTR (Time to Response )
Time frame: up to 2 years
Phase II:Cmax (maximum plasma concentration)
One of the Pharmacokinetics parameters
Time frame: up to 2 years
Phase II:Tmax (time to reach maximum concentration)
One of the Pharmacokinetics parameters
Time frame: up to 2 years
Phase II: AUC (time curve)
One of the Pharmacokinetics parameters
Time frame: up to 2 years
PhaseIII: ORR (Objective Response Rate)assessed by IRRC according to RECIST1.1.
Time frame: up to 2 years
PhaseIII: DoR (Duration of Response)assessed by IRRC according to RECIST1.1.
Time frame: up to 2 years
PhaseIII: DCR (Time to Response)assessed by IRRC according to RECIST1.1.
Time frame: up to 2 years
PhaseIII: TTR(Time to Response) assessed by IRRC according to RECIST1.1.
Time frame: up to 2 years
PhaseIII: ORR (Objective Response Rate)assessed by the investigator according to RECIST1.1.
Time frame: up to 2 years
PhaseIII: PFS (Progression-Free Survival)assessed by the investigator according to RECIST1.1.
Time frame: up to 2 years
PhaseIII: DoR (Duration of Response)assessed by the investigator according to RECIST1.1.
Time frame: up to 2 years
PhaseIII: DCR(Time to Response) assessed by the investigator according to RECIST1.1.
Time frame: up to 2 years
PhaseIII: TTR (Time to Response) assessed by the investigator according to RECIST1.1.
Time frame: up to 2 years
Phase III: ORR (Objective Response Rate)assessed by IRRC according to mRECIST.
Time frame: up to 2 years
Phase III: PFS(Progression-Free Survival) assessed by IRRC according to mRECIST.
Time frame: up to 2 years
Phase III: DoR(Duration of Response) assessed by IRRC according to mRECIST.
Time frame: up to 2 years
Phase III: DCR(Disease Control Rate) assessed by IRRC according to mRECIST.
Time frame: up to 2 years
Phase III: TTR(Time to Response) assessed by IRRC according to mRECIST.
Time frame: up to 2 years
Phase III: incidence rate of AEs(Adverse Event)
Time frame: up to 2 years
Phase III: incidence rate of TEAEs(Treatment Emergent Adverse Event)
Time frame: up to 2 years
Phase III: incidence rate of SAEs(Serious Adverse Event)
Time frame: up to 2 years
Phase III: Cmax
One of the Pharmacokinetics parameters
Time frame: up to 2 years
Phase III: CL(Clearance)
One of the Pharmacokinetics parameters
Time frame: up to 2 years
Phase III: t1/2 (Half-Life)
One of the Pharmacokinetics parameters
Time frame: up to 2 years
Phase III: Volume
One of the Pharmacokinetics parameters
Time frame: up to 2 years
Phase III: AUC (Area Under the Curve)
One of the Pharmacokinetics parameters
Time frame: up to 2 years
Phase III: Incidence and characteristics of ADA&Nab.
Time frame: up to 2 years
Phase II: Volume(PK)
One of the Pharmacokinetics parameters
Time frame: up to 2 years
Phase II: t1/2 (Half-Life)
One of the Pharmacokinetics parameters
Time frame: up to 2 years
phase III: score of (European Organization for Research and Treatment of Cancer, EORTC)EORTC QLQ-C30
Time frame: up to 2 years
phase III: score of (Eropean Organization for Research and Treatment of Cancer, EORTC)EORTC QLQ-HCC18
Time frame: up to 2 years
Phase II: CL (Clearance)
One of the Pharmacokinetics parameters
Time frame: up to 2 years
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