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

29 de abril de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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 de estudio

Intervencionista

Inscripción (Estimado)

124

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Jun Tie, Dr
  • Número de teléfono: +8618629507963
  • Correo electrónico: tiejun7776@163.com

Ubicaciones de estudio

  • Porcelana
    • Shaanxi
      • Xi'an, Shaanxi, Porcelana, 710032
        • Reclutamiento
        • Air Force Military Medical University
        • Contacto:
          • Jun Tie, M.D.,Ph.D. Jun Tie, M.D.,Ph.D.
          • Número de teléfono: +862984771537
          • Correo electrónico: tiejun7776@163.com

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Procedimiento: 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.
Comparador activo: 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.
Procedimiento: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Overall Survival (OS)
Periodo de tiempo: 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.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Progression-free Survival (PFS)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Air Force Military Medical University, China

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

10 de diciembre de 2025

Finalización primaria (Estimado)

30 de diciembre de 2028

Finalización del estudio (Estimado)

30 de diciembre de 2028

Fechas de registro del estudio

Enviado por primera vez

4 de diciembre de 2025

Primero enviado que cumplió con los criterios de control de calidad

29 de abril de 2026

Publicado por primera vez (Actual)

6 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

6 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

29 de abril de 2026

Última verificación

1 de abril de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • KY20252547-C-1

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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