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 settembre 2026 aggiornato da: 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).
Panoramica dello studio
Stato
Reclutamento
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Stimato)
590
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Xin Shi
- Numero di telefono: +86-0518-82342973
- Email: xin.shi.xs3@hengrui.com
Backup dei contatti dello studio
- Nome: Ying Sun
- Numero di telefono: +86-0518-82342973
- Email: ying.sun.ys1@hengrui.com
Luoghi di studio
-
-
Anhui
-
Hefei, Anhui, Cina, 230000
- Reclutamento
- Anhui Provincial Hospital
-
Investigatore principale:
- Shukui Qin
-
Investigatore principale:
- Lianxin Liu
-
Contatto:
- Lianxin Liu
- Numero di telefono: +86-13845159888
- Email: liulx@ustc.edu.cn
-
Contatto:
- Shukui Qin
- Numero di telefono: +86-13905158713
- Email: qinsk@csco.org.cn
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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 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.
- Patients with liver tumor burden greater than 50% of total liver in volume or received liver transplants.
- Patients with symptomatic ascites or pleural effusion.
- Patients with hypertension which cannot be well controlled by antihypertensives.
- Uncontrolled cardiac diseases or symptoms.
- Known hereditary or acquired bleeding (e.g., coagulopathy) or a tendency to clot (e.g., hemophiliacs).
- Major vascular disease occurred in the 6 months before randomization.
- Gastrointestinal perforation or gastrointestinal fistula within 6 months before randomization.
- Major surgery within 28 days before randomization or expected to require major surgery during the study period.
- Active infection, or fever of unknown cause ≥ 38.5℃ in the first 7 days of randomization, or WBC > 15×109/L at baseline.
- Known positive history of human immunodeficiency virus test or acquired immunodeficiency syndrome, known HBV infection, known HCV infection.
- Patients who received live vaccines within 28 days before randomization, or are expected to be vaccinated during the treatment period
- Patients with other potential factors that may affect the study results.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: SHR-8068 combinato con Adebrelimab e Bevacizumab
|
SHR-8068: injection, 50 mg/10 mL, intravenous infusion Adebrelimab: injection, 600 mg/12 mL, intravenous infusion Bevacizumab: injection, 100 mg/4 mL, intravenous infusion |
|
Comparatore attivo: Sintilimab combinato con Bevacizumab
|
Bevacizumab: injection, 100 mg/4 mL, intravenous infusion Sintilimab: injection, 100 mg/10 mL, intravenous infusion |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Progression Free Survival (PFS)
Lasso di tempo: 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)
Lasso di tempo: 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)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
L'incidenza, la gravità e la rilevanza per i farmaci sperimentali degli eventi avversi (AE) e degli eventi avversi gravi (SAE) secondo NCI-CTCAE v5.0
Lasso di tempo: Dalla data dell’ICF fino alla fine del follow-up di sicurezza o all’inizio di una nuova terapia antitumorale (fino a circa 36 mesi)
|
Dalla data dell’ICF fino alla fine del follow-up di sicurezza o all’inizio di una nuova terapia antitumorale (fino a circa 36 mesi)
|
|
|
Time to Progression (TTP)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
28 ottobre 2024
Completamento primario (Stimato)
1 ottobre 2026
Completamento dello studio (Stimato)
1 dicembre 2030
Date di iscrizione allo studio
Primo inviato
26 settembre 2024
Primo inviato che soddisfa i criteri di controllo qualità
26 settembre 2024
Primo Inserito (Effettivo)
1 ottobre 2024
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
25 settembre 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
22 settembre 2026
Ultimo verificato
1 settembre 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- SHR-8068-301
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
INDECISO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .