Health TrialsbyHealthPanel

A Study to Evaluate the Efficacy and Safety of IBI310 and Sintilimab Combination Therapy in Patients With Hepatocellular Carcinoma as First-line Treatment.

ConditionHepatocellular Carcinoma (HCC)
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorInnovent Biopharmaceutical Technology (Hangzhou) Co., LTD.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically or cytologically confirmed hepatocellular carcinoma (HCC).

Age ≥18 years and ≤75 years.

Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1.

Barcelona Clinic Liver Cancer (BCLC) staging of Stage C, or Stage B that is unsuitable for curative-intent surgery and/or locoregional therapy.

Disqualifiers

Histologically or cytologically confirmed diagnosis of fibrolamellar hepatocellular carcinoma (HCC), sarcomatoid HCC, cholangiocarcinoma, or other mixed hepatic malignancies containing these components.

History of hepatic encephalopathy or prior liver transplantation.

Clinically symptomatic pleural effusion, ascites, or pericardial effusion requiring therapeutic drainage; participants with only minimal (radiologically detected), asymptomatic effusions may be enrolled.

Known central nervous system (CNS) metastases or symptomatic spinal cord compression.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bevacizumab

    Biological/Vaccine

    15 mg/kg intravenous infusion, administered on Day 1 of each 3-week treatment cycle

  • Capecitabine

    Drug

    1000 mg/m² orally, administered on Days 1-14 of each 3-week treatment cycle, maximum 4 cycles.

  • Oxaliplatin

    Drug

    85 mg/m² intravenous infusion, administered on Day 1 of each 3-week treatment cycle, maximum 4 cycles.

  • IBI310

    Biological/Vaccine

    1 mg/kg intravenous infusion, administered on Day 1 of each 6-week treatment cycle

  • Sintilimab

    Biological/Vaccine

    200 mg intravenous infusion, administered on Day 1 of each 3-week treatment cycle

Treatment groups

680 Participants
are divided into 4 treatment groups
Group A: Control GroupActive comparator 2 interventions
Group B: Treatment Group2Experimental treatment 3 interventions
Group C: Treatment Group3Experimental treatment 4 interventions
Group D: Treatment Group1Experimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Phase II: ORR （Objective Response Rate） assessed by investigator per RECIST 1.1.

Time frame
up to 2 years
2

Phase II: PFS（Progression-Free Survival） assessed by investigator per RECIST 1.1.

Time frame
up to 2 years
3

Phase II: AEs（Adverse Event）

Time frame
up to 2 years
4

Phase II: TRAES（Treatment Emergent Adverse Event）

Time frame
up to 2 years

Secondary outcomes

1

Phase II: OS

Time frame
up to 2 years
2

Phase II: Incidence and characteristics of ADA&Nab.

Time frame
up to 2 years
3

Phase II: DoR (Duration of Response )

Time frame
up to 2 years
4

Phase II: DCR (Disease Control Rate )

Time frame
up to 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.

Lead sponsor

Source ClinicalTrials.gov
Apply now