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A Study of TACE in Combination With SHR-8068, Adebrelimab, and Bevacizumab Versus TACE in Participants With Incurable Hepatocellular Carcinoma

2. juli 2026 opdateret af: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

A Phase III, Randomized, Double-blind, Multicenter Study of SHR-8068 and Adebrelimab Plus Bevacizumab in Combination With TACE in Participants With Incurable Hepatocellular Carcinoma

This is a multicenter, Phase 3 clinical trial to evaluate the efficacy and safety of SHR-8068, Adebrelimab, and Bevacizumab and TACE versus Placebo with TACE in incurable hepatocellular carcinoma.

Participants will continue treatment until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

690

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Kina
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kina, 200032
        • Zhongshan Hospital,Fudan University
        • Ledende efterforsker:
          • Jia Fan

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  1. Age 18-75 years old, male or female;
  2. Diagnosis confirmed HCC by pathologically or clinically;
  3. At least one measurable lesion;
  4. Child-Pugh liver function grade A;
  5. ECOG-PS score: 0 or 1;
  6. Eligible for TACE treatment as assessed by the investigator;
  7. Participants with HBV or HCV infection must be on and remain on standard antiviral therapy throughout the study period;
  8. Consent to contraception

Exclusion Criteria:

  1. Fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma or mixed cholangiocarcinoma / hepatocellular carcinoma; Participants with other malignancies currently or within the past 5 years;
  2. Participants with any active, known or suspected autoimmune disorder;
  3. Participants with hypertension which cannot be well controlled by antihypertensives;
  4. Uncontrolled cardiac diseases or symptoms;
  5. Participants with hepatic encephalopathy;
  6. Prior esophageal and/or gastric varices bleeding within 6 months prior to initiation of study treatment
  7. History of gastrointestinal perforation and/or fistula,
  8. Participants with other potential factors that may affect the study results.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Treatment group A
SHR-8068+ Adebrelimab+ Bevacizumab +Transarterial Chemoembolization(TACE)
Medicin: SHR-8068+ Adebrelimab+ Bevacizumab
SHR-8068+ Adebrelimab+ Bevacizumab,intravenous infusion，Transarterial Chemoembolization(TACE)
Aktiv komparator: Treatment group B
SHR-8068 Placebo+ Adebrelimab Placebo+ Bevacizumab Placebo+Transarterial Chemoembolization(TACE)
Medicin: SHR-8068 Placebo+ Adebrelimab Placebo+ Bevacizumab Placebo
SHR-8068 Placebo+ Adebrelimab Placebo+ Bevacizumab Placebo,intravenous infusion，Transarterial Chemoembolization(TACE)
Eksperimentel: Treatment group C
SHR-8068 Placebo+Adebrelimab+ Bevacizumab +Transarterial Chemoembolization(TACE)
Medicin: SHR-8068 Placebo +Adebrelimab+ Bevacizumab
SHR-8068 Placebo +Adebrelimab+ Bevacizumab,intravenous infusion，Transarterial Chemoembolization(TACE)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Progression-free survival (PFS) assessed by investigator
Tidsramme: Until progression, assessed up to approximately 2 years
Until progression, assessed up to approximately 2 years

Sekundære resultatmål

Resultatmål
Tidsramme
Progression-free survival (PFS) assessed by Blinded Independ Review Committee( BIRC)
Tidsramme: Until progression, assessed up to approximately 2 years
Until progression, assessed up to approximately 2 years
Overall survival (OS)
Tidsramme: Until study completion, assessed up to approximately 2 years
Until study completion, assessed up to approximately 2 years
Objective response rate (ORR)
Tidsramme: Until study completion,assessed up to approximately 2 years
Until study completion,assessed up to approximately 2 years
Disease control rate (DCR)
Tidsramme: Until study completion,assessed up to approximately 2 years
Until study completion,assessed up to approximately 2 years
Duration of objective tumor response (DoR)
Tidsramme: Until study completion,assessed up to approximately 2 years
Until study completion,assessed up to approximately 2 years
Adverse events (AEs)
Tidsramme: Until study completion,assessed up to approximately 2years
Until study completion,assessed up to approximately 2years
Serious adverse events (SAEs)
Tidsramme: Until study completion,assessed up to approximately 3 years
Until study completion,assessed up to approximately 3 years
Pharmacokinetics parameters of SHR-8068 、Adebrelimab:serum concentration
Tidsramme: Approximately 90 days post-last dose
Approximately 90 days post-last dose
Immunogenicity indicators of SHR-8068 、Adebrelimab: drug resistant antibody (ADA) and neutralizing antibody (NAb)
Tidsramme: Approximately 90 days post-last dose
Approximately 90 days post-last dose

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

1. april 2031

Studieafslutning (Anslået)

1. april 2031

Datoer for studieregistrering

Først indsendt

2. juli 2026

Først indsendt, der opfyldte QC-kriterier

2. juli 2026

Først opslået (Faktiske)

9. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SHR-8068-305

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

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