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.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Estimado)
Estágio
- Fase 3
Contactos e Locais
Contato de estudo
- Nome: Wenlong Zhai, MD
- Número de telefone: +86-371-66913095
- E-mail: fcczhaiwl@zzu.edu.cn
Locais de estudo
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Henan
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Zhengzhou, Henan, China, 450052
- The First Affiliated Hospital of Zhengzhou University
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Contato:
- Wenlong Zhai, MD
- Número de telefone: +86-371-66913095
- E-mail: fcczhaiwl@zzu.edu.cn
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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.
Outros nomes:
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Comparador Ativo: 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.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Recurrence-Free Survival (RFS)
Prazo: From surgery up to 36 months
|
Time from surgery to the first documented recurrence of disease or death from any cause. |
From surgery up to 36 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Overall Survival (OS)
Prazo: From randomization up to 60 months
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Time from randomization to death from any cause. |
From randomization up to 60 months
|
|
Incidence and severity of adverse events
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Neoplasias por local
- Neoplasias
- Neoplasias por Tipo Histológico
- Neoplasias do Aparelho Digestivo
- Doenças do aparelho digestivo
- Doenças das vias biliares
- Neoplasias Glandulares e Epiteliais
- Adenocarcinoma
- Carcinoma
- Doenças da Vesícula Biliar
- Neoplasias das Vias Biliares
- Colangiocarcinoma
- Neoplasias da Vesícula Biliar
- Produtos químicos orgânicos
- Compostos heterocíclicos, 1 anel
- Compostos heterocíclicos
- Ácidos nucleicos, nucleotídeos e nucleosídeos
- Complexos de coordenação
- Desoxicitidina
- Citidina
- Nucleosídeos de pirimidina
- Pirimidinas
- Nucleosídeos
- Uracil
- Pirimidinonas
- Desoxirribonucleosídeos
- Capecitabina
- Oxaliplatina
- Fluorouracila
Outros números de identificação do estudo
- ZZU-HAIC-2026-001
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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