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

29 avril 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

124

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Chine
    • Shaanxi
      • Xi'an, Shaanxi, Chine, 710032
        • Recrutement
        • Air Force Military Medical University
        • Contact:
          • Jun Tie, M.D.,Ph.D. Jun Tie, M.D.,Ph.D.
          • Numéro de téléphone: +862984771537
          • E-mail: tiejun7776@163.com

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Procédure: HAIC
HAIC is administered using a gemcitabine plus cisplatin regimen, with dosing and administration according to each participating center's standard treatment protocols.
Médicament: 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.
Médicament: Adebrelimab
Adebrelimab administered intravenously at a dose of 1200 mg every 3 weeks until disease progression or unacceptable toxicity.
Médicament: Apatinib
Apatinib administered orally at a dose of 250 mg once daily until disease progression or unacceptable toxicity.
Comparateur actif: 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.
Procédure: HAIC
HAIC is administered using a gemcitabine plus cisplatin regimen, with dosing and administration according to each participating center's standard treatment protocols.
Médicament: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Overall Survival (OS)
Délai: 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.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Progression-free Survival (PFS)
Délai: 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)
Délai: 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)
Délai: 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.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Air Force Military Medical University, China

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

10 décembre 2025

Achèvement primaire (Estimé)

30 décembre 2028

Achèvement de l'étude (Estimé)

30 décembre 2028

Dates d'inscription aux études

Première soumission

4 décembre 2025

Première soumission répondant aux critères de contrôle qualité

29 avril 2026

Première publication (Réel)

6 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

6 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

29 avril 2026

Dernière vérification

1 avril 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • KY20252547-C-1

Plan pour les données individuelles des participants (IPD)

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INDÉCIS

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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