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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)

22. september 2026 oppdatert av: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

A Randomized, Controlled, Open-label, Multicenter Phase III Clinical Study of Anti CTLA-4 Antibody SHR-8068 Combined With Adebrelimab and Bevacizumab Versus Sintilimab Combined With Bevacizumab for the First-line Treatment of Advanced Hepatocellular Carcinoma (KYLIN-02)

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).

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

590

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Kina
    • Anhui
      • Hefei, Anhui, Kina, 230000
        • Rekruttering
        • Anhui Provincial Hospital
        • Hovedetterforsker:
          • Shukui Qin
        • Hovedetterforsker:
          • Lianxin Liu
        • Ta kontakt med:
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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:

  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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: SHR-8068 kombinert med Adebrelimab og Bevacizumab
Legemiddel: SHR-8068

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

Legemiddel: Adebrelimab

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

Legemiddel: Bevacizumab

Bevacizumab: injection, 100 mg/4 mL, intravenous infusion
Aktiv komparator: Sintilimab kombinert med Bevacizumab
Legemiddel: Bevacizumab

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

Legemiddel: Sintilimab

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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Progression Free Survival (PFS)
Tidsramme: 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)
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)
Overall survival (OS)
Tidsramme: From randomization to death from any cause (whichever occurs first) (up to approximately 36 months)

OS is defined as the time from randomization to death from any cause.
From randomization to death from any cause (whichever occurs first) (up to approximately 36 months)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Forekomst, alvorlighetsgrad og relevans for undersøkelsesmedisiner av bivirkninger (AE) og alvorlige bivirkninger (SAE) i henhold til NCI-CTCAE v5.0
Tidsramme: Fra ICF-datoen til slutten av sikkerhetsoppfølgingen eller oppstart av ny antitumorbehandling (opptil ca. 36 måneder)
Fra ICF-datoen til slutten av sikkerhetsoppfølgingen eller oppstart av ny antitumorbehandling (opptil ca. 36 måneder)
Time to Progression (TTP)
Tidsramme: 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)]

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.
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)]
Disease Control Rate (DCR)
Tidsramme: 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)

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.
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)
Objective Response Rate (ORR)
Tidsramme: From Randomization to the first occurrence of disease progression or initiation of new anti-tumor therapy (up to approximately 36 months)

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.
From Randomization to the first occurrence of disease progression or initiation of new anti-tumor therapy (up to approximately 36 months)
Duration of Response (DoR)
Tidsramme: 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)

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).
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)
Time to Response (TTR)
Tidsramme: 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)

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.
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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

28. oktober 2024

Primær fullføring (Antatt)

1. oktober 2026

Studiet fullført (Antatt)

1. desember 2030

Datoer for studieregistrering

Først innsendt

26. september 2024

Først innsendt som oppfylte QC-kriteriene

26. september 2024

Først lagt ut (Faktiske)

1. oktober 2024

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

25. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

22. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • SHR-8068-301

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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