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Efficacy and Safety of Hepatic Arterial Infusion Chemotherapy Combined With Tislelizumab and Regorafenib as First-Line Therapy for Advanced Cholangiocarcinoma

27. maj 2026 opdateret af: zhen li, The First Affiliated Hospital of Zhengzhou University

Efficacy and Safety of Hepatic Arterial Infusion Chemotherapy Combined With Tislelizumab and Regorafenib as First-Line Therapy for Advanced Cholangiocarcinoma: A Single-Centre, Single-Arm, Phase II Trial

The goal of this clinical trial is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) combined with tislelizumab and regorafenib as first-line therapy in patients with locally advanced or metastatic cholangiocarcinoma.

The main questions it aims to answer are:

  1. What is the objective response rate (ORR) of this combination regimen according to RECIST 1.1 criteria
  2. What are the disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety profile associated with this treatment

Participants will:Receive hepatic arterial infusion chemotherapy (HAIC)+ tislelizumab (PD-1 inhibitor)+regorafenib (oral multikinase inhibitor). Undergo regular imaging assessments to evaluate tumor response per RECIST 1.1.Be monitored for survival outcomes and adverse events throughout treatment and follow-up.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

31

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Kina
    • Henan
      • Zhengzhou, Henan, Kina, 450052
        • The First Affiliated Hospital of Zhengzhou University

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 ;
  2. Histologically or cytologically confirmed unresectable locally advanced or metastatic intra- or extrahepatic cholangiocarcinoma ;
  3. Clinical stage III-IV according to the 8th edition of the AJCC TNM classification ;
  4. No prior antitumor therapy;
  5. Child-Pugh liver function class A or B ;
  6. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
  7. At least one measurable lesion per RECIST 1.1 ;
  8. Adequate haematologic and hepatic/renal function;
  9. Total bilirubin ≤ 2× upper limit of normal (patients who have undergone biliary drainage are eligible) ;
  10. Adequate cardiac and pulmonary reserves to tolerate interventional procedures ;
  11. Signed informed consent, good compliance, and ability to attend follow-up visits.

Exclusion Criteria:

  1. Contraindications to transarterial chemoembolization, targeted therapy, or immunotherapy ;
  2. Prior antitumor treatment ;
  3. Concurrent primary malignancies;
  4. Child-Pugh class C;
  5. Severe cardiac, pulmonary, or renal dysfunction ;
  6. Active autoimmune disease or need for long-term immunosuppressive therapy ;
  7. Hypersensitivity to contrast agents or study drugs ;
  8. Pregnancy or lactation;
  9. Anticoagulant or thrombolytic therapy within 3 months before enrollment or bleeding diathesis.

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: HAIC combined with tislelizumab and regorafenib
Medicin: HAIC Combined with Tislelizumab and Regorafenib
A combination therapy including hepatic arterial infusion chemotherapy (HAIC), tislelizumab, and regorafenib for first-line treatment of advanced cholangiocarcinoma.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
objective response rate (ORR)
Tidsramme: From first dose until disease progression, death, or up to approximately 24 months
From first dose until disease progression, death, or up to approximately 24 months

Sekundære resultatmål

Resultatmål
Tidsramme
disease control rate (DCR)
Tidsramme: From first dose until disease progression or last tumor assessment, whichever occurs first (up to approximately 24 months)
From first dose until disease progression or last tumor assessment, whichever occurs first (up to approximately 24 months)
Progression-Free Survival (PFS)
Tidsramme: From first dose to disease progression or death from any cause, whichever occurs first (up to approximately 24 months)
From first dose to disease progression or death from any cause, whichever occurs first (up to approximately 24 months)
Overall Survival (OS)
Tidsramme: From first dose to death from any cause (up to approximately 36 months)
From first dose to death from any cause (up to approximately 36 months)
adverse events
Tidsramme: From first dose until 30 days after the last dose of study treatment
From first dose until 30 days after the last dose of study treatment

Samarbejdspartnere og efterforskere

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

Sponsor

The First Affiliated Hospital of Zhengzhou University

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 (Faktiske)

22. juli 2022

Primær færdiggørelse (Faktiske)

30. september 2025

Studieafslutning (Faktiske)

30. september 2025

Datoer for studieregistrering

Først indsendt

27. maj 2026

Først indsendt, der opfyldte QC-kriterier

27. maj 2026

Først opslået (Faktiske)

2. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ChiECRCT20220109

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Kliniske forsøg med Cholangiocarcinom

Kliniske forsøg med HAIC Combined with Tislelizumab and Regorafenib

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