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Alternating HAIC and Systemic Chemotherapy With or Without Adebrelimab and Apatinib for Unresectable Biliary Tract Cancer

29 aprile 2026 aggiornato da: Tie Jun, Air Force Military Medical University, China

A Prospective, Real-World Study of Alternating Hepatic Arterial Infusion Chemotherapy and Systemic Chemotherapy With or Without Adebrelimab and Apatinib in Patients With Unresectable Biliary Tract Cancer

This prospective real-world study aims to evaluate the effectiveness and safety of an alternating treatment regimen combining hepatic arterial infusion chemotherapy (HAIC) with systemic chemotherapy, with or without adebrelimab and apatinib, in patients with unresectable biliary tract cancer receiving first-line treatment. The study comprises two cohorts: one receiving alternating HAIC and systemic chemotherapy alongside adebrelimab and apatinib, and the other receiving alternating HAIC and systemic chemotherapy alone. Treatment allocation follows real-world clinical decision-making. Patients will be monitored throughout the treatment period to assess tumor response, survival outcomes, and safety profiles. The study aims to generate evidence on the clinical benefits of integrating immunotherapy and targeted therapy into HAIC-based regimens for this patient population.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Biliary tract cancer (BTC), which includes intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer, is an aggressive malignancy associated with a generally poor prognosis. For patients with unresectable, locally advanced, or metastatic disease, first-line systemic chemotherapy using gemcitabine and cisplatin remains the standard of care, although treatment outcomes are ofter suboptimal. HAIC has gained increasing attention in clinical practice, paticularly in China, for its ability to enhance local drug delivery and improve tumor control in cases of liver-dominant disease. Alternating HAIC with systemic chemotherapy may provide additive benefits by simultaneously targeting both intrahepatic and extrahepatic lesions.

Recent advances in immunotherapy and anti-angiogenic therapy have shown promise results in BTC. Adebrelimab, a PD-L1 inhibitor, and apatinib, a VEGFR2 inhibitor, have demonstrated antitumor activity in various solid tumors. Combining these agents with chemotherapy and HAIC may yield synergistic effects, potentially improving response rates and extending survival.

This prospective real-world study is designed to evaluate the effectiveness and safety of an alternating regimen of HAIC and systemic chemotherapy (gemcitabine plus cisplatin), with or without adebrelimab and apatinib, in patients with previously untreated, unresectable, locally advanced or metastatic BTC. Participants will be assigned to one of two cohorts based on patient preference and clinician judgment: Cohort A will receive HAIC and systemic chemotherapy combined with adebrelimab and apatinib, while Cohort B will receive HAIC and systemic chemotherapy alone. Dosing and administration will follow the standard treatment protocols.

The study will capture real-world data on objective tumor response, progression-free survival, overall survival, and safety profiles. Exploratory analyses may include patterns of disease progression, treatment adherence, and the influence of clinical and biological factors on outcomes. The results are anticipated to offer valuable evidence to guide clinical decision-making and help optimize first-line treatment strategies for patients with advanced BTC in routine practice.

Tipo di studio

Interventistico

Iscrizione (Stimato)

124

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Cina
    • Shaanxi
      • Xi'an, Shaanxi, Cina, 710032
        • Reclutamento
        • Air Force Military Medical University
        • Contatto:
          • Jun Tie, M.D.,Ph.D. Jun Tie, M.D.,Ph.D.
          • Numero di telefono: +862984771537
          • Email: tiejun7776@163.com

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

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  1. Age ≥ 18 years at the time of enrollment.
  2. Histologically or cytologically confirmed diagnosis unresectable, locally advanced, or metastatic BTC, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer.
  3. No prior systemic therapy for BTC, including chemotherapy, immunotherapy, or small-molecule targeted therapy.
  4. Patients with disease recurrence ≥6 months after curative resection and completion of adjuvant therapy (chemotherapy or radiotherapy) are eligible.
  5. Adequate liver function: defined as Child-Pugh Class A (score 5-6) or well-compensated Class B (score ≤7).
  6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  7. At least one measurable lesion as defined by RECIST 1.1.
  8. Assessed by the investigator as being able to tolerate and comply with the study treatment regimen.
  9. Provision of written informed consent, voluntarily agreeing to participate after full explanation of the study protocol.

Exclusion Criteria:

  1. Hepatic tumor burden occupying ≥50% of total liver volume.
  2. History of liver transplantation.
  3. Major surgery or invasive procedure (excluding intravenous catheter placement or percutaneous drainage) within 4 weeks prior to enrollment.
  4. History or evidence of clinically significant bleeding, including: bleeding >30 mL within 3 months prior to enrollment (including hematemesis, melena, or hematochezia), hemoptysis (>5 mL of fresh blood) within 4 weeks prior to enrollment, or thromboembolic events (including stroke or transient ischemic attack) within the past 12 months.
  5. Known active infection with human immunodeficiency virus (HIV).
  6. Pregnant (a positive pregnancy test prior to study drug administration) or breastfeeding women.
  7. Any condition, in the investigator's judgment, that could compromise patient satety, affect the assessment of study outcomes, or lead to premature discontinuation. this includes, but is not limited to: active alcohol or substance abuse, severe uncontrolled comorbidities, significant laboratory abnormalities, or social/family circumstances that could interfere with protocol compliance.

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: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Alternating HAIC and Systemic Chemotherapy Plus Adebrelimab and Apatinib
Participants in this arm will receive alternating cycles of HAIC and systemic chemotherapy with gemcitabine plus cisplatin, combined with adebrelimab (1200 mg every 3 weeks) and apatinib (250 mg orally once daily). The dosing and administration of HAIC and systemic chemotherapy follow each center's standard treatment protocols.
Procedura: HAIC
HAIC is administered using a gemcitabine plus cisplatin regimen, with dosing and administration according to each participating center's standard treatment protocols.
Droga: Gemcitabine plus Cisplatin
Gemcitabine and cisplatin administered intravenously according to institutional standard first-line regimens for biliary tract cancer. Dosing and schedule follow each center's standard treatment protocols.
Droga: Adebrelimab
Adebrelimab administered intravenously at a dose of 1200 mg every 3 weeks until disease progression or unacceptable toxicity.
Droga: Apatinib
Apatinib administered orally at a dose of 250 mg once daily until disease progression or unacceptable toxicity.
Comparatore attivo: Alternating HAIC and Systemic Chemotherapy Alone
Participants in this arm will receive alternating cycles of HAIC and systemic chemotherapy with gemcitabine plus cisplatin. The dosing and administration of HAIC and systemic chemotherapy follow each center's standard treatment protocols.
Procedura: HAIC
HAIC is administered using a gemcitabine plus cisplatin regimen, with dosing and administration according to each participating center's standard treatment protocols.
Droga: Gemcitabine plus Cisplatin
Gemcitabine and cisplatin administered intravenously according to institutional standard first-line regimens for biliary tract cancer. Dosing and schedule follow each center's standard treatment protocols.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Overall Survival (OS)
Lasso di tempo: The maximum time from receiving treatment to dying for any reason is 3 years.
Overall survival (OS) was defined as the time from initiation of study treatment (first dose) to death from any cause.
The maximum time from receiving treatment to dying for any reason is 3 years.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Progression-free Survival (PFS)
Lasso di tempo: Progression-free survival (PFS) analysis based on investigator assessment per RECIST 1.1, and will be assessed up to 2 years.
Progression-free survival (PFS), assessed by investigators per RECIST version 1.1, was defined as the time from initiation of study treatment (first dose) to the first documentation of objective disease progression or death from any cause, which ever occurred first.
Progression-free survival (PFS) analysis based on investigator assessment per RECIST 1.1, and will be assessed up to 2 years.
Objective Response Rate (ORR)
Lasso di tempo: Every 6 weeks for the first 24 weeks, then every 8 weeks until disease progression or study completion, up to 1 years.
Disease assessments based on investigator assessments were determined by using RECIST version 1.1 guidelines. The ORR was defined as the percentage of patients with confirmed complete response (CR) or confirmed partial response (PR). The CR was defined as disappearance of all target and non-target lesions and no new lesions. The PR was defined as >= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new non-target lesion.
Every 6 weeks for the first 24 weeks, then every 8 weeks until disease progression or study completion, up to 1 years.
Disease Control Rate (DCR)
Lasso di tempo: Every 6 weeks for the first 24 weeks, then every 8 weeks until disease progression or study completion, up to 1 years.
Disease control rate based on investigator assessments according to RECIST version 1.1 was defined as the rate of best objective response of complete response (CR), partial response (PR) or stable disease (SD).
Every 6 weeks for the first 24 weeks, then every 8 weeks until disease progression or study completion, up to 1 years.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Air Force Military Medical University, China

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)

10 dicembre 2025

Completamento primario (Stimato)

30 dicembre 2028

Completamento dello studio (Stimato)

30 dicembre 2028

Date di iscrizione allo studio

Primo inviato

4 dicembre 2025

Primo inviato che soddisfa i criteri di controllo qualità

29 aprile 2026

Primo Inserito (Effettivo)

6 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 aprile 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • KY20252547-C-1

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 .

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