Hepatic Arterial Infusion Chemotherapy Versus Capecitabine as Adjuvant Therapy for Resected Biliary Tract Cancer (HAIC-BTC)
A Prospective, Open-label, Randomized Controlled Clinical Study of Hepatic Arterial Infusion Chemotherapy (HAIC) Versus Capecitabine as Adjuvant Therapy for Biliary Tract Malignancies After Radical Resection
This is a prospective, open-label, randomized controlled clinical study. The purpose of this study is to evaluate the efficacy and safety of Hepatic Arterial Infusion Chemotherapy (HAIC) compared with Capecitabine monotherapy as adjuvant therapy for patients with biliary tract cancer after radical resection.
Patients with histologically confirmed biliary tract cancer (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer) who have undergone R0 or R1 resection will be enrolled. A total of approximately 90 eligible patients will be randomized in a 1:1 ratio to receive either HAIC (Oxaliplatin plus 5-Fluorouracil) or Capecitabine.
The primary endpoint is Recurrence-Free Survival (RFS). The secondary endpoints include Overall Survival (OS) and safety profiles. This study aims to provide high-level evidence for a more effective adjuvant treatment strategy to reduce recurrence and improve survival for patients with resected biliary tract cancer.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Background: Biliary tract cancer (BTC) is highly malignant with a high recurrence rate even after radical resection. The BILCAP trial established Capecitabine as the standard of care for adjuvant therapy. However, further improvements in survival are needed. HAIC has shown promising anti-tumor activity in liver malignancies by increasing local drug concentration and reducing systemic toxicity. Our preliminary data suggest the potential benefit of local chemotherapy in biliary tract cancer.
Study Design: This is a prospective, open-label, randomized controlled trial. Patients will be randomized 1:1 into two arms.
Interventions:
HAIC Arm: Patients will receive Oxaliplatin (40 mg/m2 for 2h) followed by 5-Fluorouracil (800 mg/m2 continuous infusion for 22h) on days 1-3 of each 4-week cycle. Treatment will continue for 3-4 cycles.
Capecitabine Arm: Patients will receive oral Capecitabine 1250 mg/m2 twice daily on days 1-14 of each 3-week cycle for 8 cycles.
Follow-up: Patients will be followed up with imaging every 2 cycles during treatment, and then every 2-3 months until disease recurrence, withdrawal of consent, or death. Survival follow-up will continue to assess overall survival.
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 3
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Wenlong Zhai, MD
- Número de teléfono: +86-371-66913095
- Correo electrónico: fcczhaiwl@zzu.edu.cn
Ubicaciones de estudio
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Henan
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Zhengzhou, Henan, Porcelana, 450052
- The First Affiliated Hospital of Zhengzhou University
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Contacto:
- Wenlong Zhai, MD
- Número de teléfono: +86-371-66913095
- Correo electrónico: fcczhaiwl@zzu.edu.cn
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Age ≥ 18 years, male or female.
Histopathologically confirmed biliary tract malignancy (intrahepatic cholangiocarcinoma, perihilar cholangiocarcinoma, gallbladder cancer, and distal cholangiocarcinoma) and underwent radical surgery with negative surgical margins.
No history of other tumors, and no prior anti-tumor therapy (including but not limited to chemotherapy, immunotherapy, radiotherapy, targeted therapy, etc.) before or after surgery.
ECOG performance status: 0~1.
Baseline blood counts and biochemistry must meet: hemoglobin ≥ 80 g/L; absolute neutrophil count ≥ 1.5 × 10^9/L; platelet count ≥ 60 × 10^9/L; ALT/AST ≤ 3 times ULN; total bilirubin ≤ 2 times ULN; serum creatinine ≤ 1.5 times ULN; albumin ≥ 30 g/L; INR < 1.7 or PT prolonged ≤ 4 seconds.
Women of childbearing potential must agree to use contraception during the study and for 6 months after; negative pregnancy test within 7 days prior to enrollment; non-lactating. Men must agree to use contraception.
Patients with active HBV infection must receive anti-HBV therapy starting from screening and willing to continue; HCV RNA positive patients must receive standard antiviral therapy and liver function within CTCAE grade 1 elevation.
Voluntary participation, signed informed consent, good compliance, willing to cooperate with follow-up.
Exclusion Criteria:
- Pregnant or lactating.
Received anti-tumor drug therapy for cholangiocarcinoma before or after surgery.
Cardiac, pulmonary, or renal insufficiency, severe hepatic insufficiency (Child-Pugh C): (1) severe cardiovascular diseases; (2) severe respiratory diseases; (3) renal disease: chronic renal failure, MDRD ≥ stage III; (4) uncontrolled active infection; (5) ASA > 3; (6) BMI ≥ 35.
Active gastrointestinal bleeding, ulcer, refractory ascites.
Uncorrectable hypertension, coagulopathy, or severe portal hypertension.
Tumor recurrence within 1 month after surgery.
History of other malignancies.
Received other investigational drugs within 28 days.
Deemed unsuitable by the investigator.
Allergy & Contraindications: severe allergy to iodine contrast media unmanageable by premedication, or contraindications to angiography.
Postoperative pathology confirmed non-cholangiocarcinoma.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Experimental: HAIC Group
Oxaliplatin (40 mg/m2 for 2h) followed by 5-Fluorouracil (800 mg/m2 continuous infusion for 22h) on days 1-3 of each 4-week cycle for 3-4 cycles. |
Administered via hepatic arterial infusion (HAI) at 40 mg/m2 for 2 hours on days 1-3 of each 4-week cycle. Administered via hepatic arterial infusion (HAI) at 800 mg/m2 continuous infusion for 22 hours on days 1-3 of each 4-week cycle.
Otros nombres:
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Comparador activo: Active Comparator: Capecitabine Group
Oral Capecitabine 1250 mg/m2 twice daily on days 1-14 of each 3-week cycle for 8 cycles. |
Administered orally at 1250 mg/m2 twice daily on days 1-14 of each 3-week cycle for 8 cycles.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Recurrence-Free Survival (RFS)
Periodo de tiempo: From surgery up to 36 months
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Time from surgery to the first documented recurrence of disease or death from any cause. |
From surgery up to 36 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Overall Survival (OS)
Periodo de tiempo: From randomization up to 60 months
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Time from randomization to death from any cause. |
From randomization up to 60 months
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Incidence and severity of adverse events
Periodo de tiempo: From first dose up to 30 days after the last dose
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Incidence, nature, and severity of adverse events (including serious adverse events) and drug exposure, graded according to NCI CTCAE v5.0. |
From first dose up to 30 days after the last dose
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Neoplasias por sitio
- Neoplasias
- Neoplasias por tipo histológico
- Neoplasias del Sistema Digestivo
- Enfermedades del Sistema Digestivo
- Enfermedades del Tracto Biliar
- Neoplasias Glandulares y Epiteliales
- Adenocarcinoma
- Carcinoma
- Enfermedades de la vesícula biliar
- Neoplasias del Tracto Biliar
- Colangiocarcinoma
- Neoplasias de vesícula biliar
- Químicos orgánicos
- Compuestos heterocíclicos, 1 anillo
- Compuestos heterocíclicos
- Ácidos nucleicos, nucleótidos y nucleósidos
- Complejos de coordinación
- Desoxicitidina
- Citidina
- Nucleósidos de pirimidina
- Pirimidinas
- Nucleósidos
- Uracílico
- Pirimidinonas
- Desoxirribonucleósidos
- Capecitabina
- Oxaliplatino
- Fluorouracilo
Otros números de identificación del estudio
- ZZU-HAIC-2026-001
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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