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A Clinical Study of SHR-8068 Combined With Adebrelimab and Bevacizumab Versus Sintilimab Combined With Bevacizumab for the Treatment of Advanced Hepatocellular Carcinoma (KYLIN-02)

ConditionAdvanced Hepatocellular Carcinoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorSuzhou Suncadia Biopharmaceuticals Co., Ltd.

About this trial

This study aims to evaluate the efficacy of SHR-8068 combined with Adebrelimab and Bevacizumab compared with Sintilimab combined with Bevacizumab for the first-line treatment of advanced HCC (KYLIN-02).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Able and willing to provide a written informed consent.

≥ 18 years old, both male and female.

Unresectable locally advanced or metastatic HCC confirmed by histopathologically/cytologically.

At least one measurable lesion based on RECIST v1.1 criteria.

Disqualifiers

Hepatic cholangiocarcinoma, mixed hepatocellular carcinoma -cholangiocarcinoma, sarcomatoid hepatocellular carcinoma and fibrolamellar hepatocellular carcinoma.

Patients with other malignancies currently or within the past 5 years.

With known severe allergic reactions to any other monoclonal antibodies.

Patients with known CNS metastasis or hepatic encephalopathy.

Trial design

Design model

Parallel

Treatments tested in this trial

  • SHR-8068

    Drug

    SHR-8068: injection, 50 mg/10 mL, intravenous infusion

  • Adebrelimab

    Drug

    Adebrelimab: injection, 600 mg/12 mL, intravenous infusion

  • Bevacizumab

    Drug

    Bevacizumab: injection, 100 mg/4 mL, intravenous infusion

  • Sintilimab

    Drug

    Sintilimab: injection, 100 mg/10 mL, intravenous infusion

Treatment groups

590 Participants
are divided into 2 treatment groups
Group A: SHR-8068 combined with Adebrelimab and BevacizumabExperimental treatment 3 interventions
Group B: Sintilimab combined with BevacizumabActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Progression Free Survival (PFS)

Time frame
From Randomization to the first occurrence of disease progression as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1 or initiation of new anti-tumor therapy (up to approximately 36 months)
2

Overall survival (OS)

OS is defined as the time from randomization to death from any cause.

Time frame
From randomization to death from any cause (whichever occurs first) (up to approximately 36 months)

Secondary outcomes

1

Time to Progression (TTP)

TTP is defined as the time from randomization to the until first evidence of disease progression as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1.

Time frame
From randomization to the first occurrence of disease progression as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1 (up to approximately 36 months)]
2

Disease Control Rate (DCR)

DCR is defined as the proportion of participants with Complete Response (CR), Partial Response (PR) or Stable Disease (SD), as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1.

Time frame
From Randomization to the first occurrence of disease progression as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1 or initiation of new anti-tumor therapy (up to approximately 36 months)
3

Objective Response Rate (ORR)

ORR is defined as the proportion of participants with Complete Response (CR) or Partial Response (PR), as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1.

Time frame
From Randomization to the first occurrence of disease progression or initiation of new anti-tumor therapy (up to approximately 36 months)
4

Duration of Response (DoR)

DOR is defined as the time from the first occurrence of a confirmed objective response to disease progression as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1 or death from any cause (whichever occurs first).

Time frame
From the first occurrence of a confirmed objective response to disease progression as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1 or death from any cause (whichever occurs first) (up to approximately 36 months)

Other outcomes

Sponsors and contacts

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

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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