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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)

StatusRecruiting
PhasePhase 3
Started2024-10-28
View on ClinicalTrials.gov ↗

Amendment history

2026-09-26
Interventions modified
2026-04-28
Study Identification, Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v3
Primary completion date2026-03-31→2026-09
Completion date2030-12-31→2030-12
InterventionsAdebrelimab (Drug), Bevacizumab (Drug), SHR-8068 (Drug), Sintilimab (Drug)→Adebrelimab (Drug), Atezolizumab injection (Drug), Bevacizumab (Drug), SHR-8068 (Drug), Sintilimab (Drug)
Eligibility criteria+26 characters
Inclusion Criteria: 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. Barcelona clinic liver cancer: Stage B or C. No previous systemic antitumor therapy for HCC. ECOG PS of 0-1. Child-Pugh score of A or B7. Expected survival period ≥ 12 weeks. Adequate organ function. Blood pregnancy negative (women of childbearing age) and non-breastfeeding, effective contraception. Exclusion Criteria: Hepatic [...] [...]
Secondary endpointsdetails revised at 5 of 6 entries
Study sitescontacts updated at 1 of 1 site
Study title+27 characters
A Clinical Study of SHR-8068 Combined With Adebrelimab and Bevacizumab Versus Sintilimab or Atezolizumab Combined With Bevacizumab for the Treatment of Advanced Hepatocellular Carcinoma
2025-05-12
Study Status, Study Design, Outcome Measures v2
Enrollment target560→590
Secondary endpoints7 to 6 entries
Progression-Free-Survival (PFS)
Primary endpoints2 entries, revised
ObjectiveProgression ResponseFree RateSurvival (ORRPFS)
2024-11-12
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-10-30→confirmed 2024-10-28
Study sitesdetails revised at 1 of 1 site
2024-09-26
Original filing
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).
Trial Details
NCT Number NCT06618664
Lead Sponsor Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Conditions Advanced Hepatocellular Carcinoma
Enrollment 590 participants
Start Date 2024-10-28
Primary Completion 2026-10 (estimated)
Study Completion 2030-12 (estimated)
Updated on ClinicalTrials.gov 2026-09-25