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RecruitingNCT06618664Updated Sep 25, 2026

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)

A Phase 3 interventional study of SHR-8068 and Adebrelimab in Advanced Hepatocellular Carcinoma, sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
590
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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).

02

Conditions studied

  • Advanced Hepatocellular Carcinoma
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Able and willing to provide a written informed consent.
  2. ≥ 18 years old, both male and female.
  3. Unresectable locally advanced or metastatic HCC confirmed by histopathologically/cytologically.
  4. At least one measurable lesion based on RECIST v1.1 criteria.
  5. Barcelona clinic liver cancer: Stage B or C.
  6. No previous systemic antitumor therapy for HCC.
  7. ECOG PS of 0-1.
  8. Child-Pugh score of A or B7.
  9. Expected survival period ≥ 12 weeks.
  10. Adequate organ function.
  11. Blood pregnancy negative (women of childbearing age) and non-breastfeeding, effective contraception.

Exclusion criteria

Exclusion Criteria:

  1. Hepatic cholangiocarcinoma, mixed hepatocellular carcinoma -cholangiocarcinoma, sarcomatoid hepatocellular carcinoma and fibrolamellar hepatocellular carcinoma.
  2. Patients with other malignancies currently or within the past 5 years.
  3. With known severe allergic reactions to any other monoclonal antibodies.
  4. Patients with known CNS metastasis or hepatic encephalopathy.
  5. Patients with liver tumor burden greater than 50% of total liver in volume or received liver transplants.
  6. Patients with symptomatic ascites or pleural effusion.
  7. Patients with hypertension which cannot be well controlled by antihypertensives.
  8. Uncontrolled cardiac diseases or symptoms.
  9. Known hereditary or acquired bleeding (e.g., coagulopathy) or a tendency to clot (e.g., hemophiliacs).
  10. Major vascular disease occurred in the 6 months before randomization.
  11. Gastrointestinal perforation or gastrointestinal fistula within 6 months before randomization.
  12. Major surgery within 28 days before randomization or expected to require major surgery during the study period.
  13. Active infection, or fever of unknown cause ≥ 38.5℃ in the first 7 days of randomization, or WBC > 15×109/L at baseline.
  14. Known positive history of human immunodeficiency virus test or acquired immunodeficiency syndrome, known HBV infection, known HCV infection.
  15. Patients who received live vaccines within 28 days before randomization, or are expected to be vaccinated during the treatment period
  16. Patients with other potential factors that may affect the study results.
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
590 participants (estimated)

Study arms

  • Experimental
    SHR-8068 combined with Adebrelimab and Bevacizumab

    Drug: SHR-8068 · Drug: Adebrelimab · Drug: Bevacizumab

  • Active comparator
    Sintilimab combined with Bevacizumab

    Drug: Bevacizumab · Drug: Sintilimab

Interventions

  • DrugSHR-8068

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

  • DrugAdebrelimab

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

  • DrugBevacizumab

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

  • DrugSintilimab

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

05

What researchers measure

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)

  5. Time to Response (TTR)

    TTR is defined as time from the randomization of Complete Response (CR) or Partial Response (PR) by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1.

    Time frame: From the first occurrence of complete response (CR) or partial response (PR) as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1 (up to approximately 36 months)

  6. The incidence, severity and relevance to investigational drugs of adverse events (AE) and serious adverse events (SAE) according to NCI-CTCAE v5.0

    Time frame: From the ICF date until the end of the safety follow-up or initiation of new anti-tumor therapy (up to approximately 36 months)

06

Study locations

1 of 1 sites recruiting
  • Anhui Provincial Hospital
    Hefei, Anhui 230000, China
    • Lianxin Liu · Contact · liulx@ustc.edu.cn · +86-13845159888
    • Shukui Qin · Contact · qinsk@csco.org.cn · +86-13905158713
    • Lianxin Liu · Principal investigator
    • Shukui Qin · Principal investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06618664
Lead sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Responsible party
Sponsor
First posted
Oct 1, 2024
Start date
Oct 28, 2024
Primary completion
Oct 2026 (estimated)
Completion
Dec 2030 (estimated)
Last update
Sep 25, 2026

Study contacts

Xin Shi
Contact
xin.shi.xs3@hengrui.com
+86-0518-82342973
Ying Sun
Contact
ying.sun.ys1@hengrui.com
+86-0518-82342973

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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