Combining biliary drainage with chemotherapy for advanced bile duct cancer

Prospective Multicentre Trial of Biliary Drainage Plus Hepatic Arterial Infusion Chemotherapy Versus Biliary Drainage Plus Best Supportive Care in Locally Advanced Perihilar Cholangiocarcinomas.

This study is testing if combining a special type of chemotherapy with a procedure to help drain bile can help people with advanced bile duct cancer live longer compared to just receiving standard care.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 127 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Peking University (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Beijing)
• Trial ID: NCT05024513 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of combining biliary drainage with hepatic arterial infusion chemotherapy using oxaliplatin and 5-fluorouracil in patients with locally advanced perihilar cholangiocarcinoma (pCCA). The study aims to compare this combination treatment against standard best supportive care to determine if it offers a survival benefit. Patients who are not candidates for surgery will be enrolled, and their health will be monitored throughout the trial. The goal is to provide a more effective treatment option for this aggressive cancer type.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with locally advanced unresectable perihilar cholangiocarcinoma.

Not a fit: Patients with severe complications, previous chemotherapy, or certain allergies may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve survival rates for patients with advanced pCCA.

How similar studies have performed: Previous studies have shown promising results with similar chemotherapy approaches, indicating potential for success in this trial.

Eligibility criteria

Inclusion Criteria:

1. Locally advanced perihilar cholangiocarcinoma proved by histology or cytology.
2. Locally advanced unresectable perihilar cholangiocarcinoma, decided by hepatobiliary doctor and radiologist.
3. Age from 18 years old to 75 years old.
4. The performance of Eastern Cooperative Oncology Group (ECOG) \<2
5. Child-Pugh A or Child-Pugh B (≤ grade 7).
6. Expectant survival time ≥ 3 months.
7. Baseline blood count test and blood biochemical must meet following criteria:

   1. Hemoglobin ≥ 90 g/L;
   2. Absolute neutrophil count ≥ 1.5×10\^9/L;
   3. Blood platelet count ≥ 100×10\^9/L;
   4. Serum creatinine ≤ 1.5 times of ULN;
   5. Albumin ≥ 30 g/L
8. Patients sign informed consent.

Exclusion Criteria:

1. Allergic to contrast agent.
2. Pregnant or lactational.
3. Allergic to 5-fluorouracil, or have metabolic disorder of 5-fluorouracil.
4. Previous systematic chemotherapy or radiotherapy.
5. Patients with complications such as bile leakage and bleeding after PTCD
6. N2 lymphatic metastasis, extrahepatic metastasis, or coinstantaneous a lot of malignant hydrothorax or ascites.
7. History of organ transplantation.
8. Coinstantaneous infection and need anti-infection therapy.
9. Coinstantaneous peripheral nervous system disorder or with history of obvious mental disorder and central nervous system disorder.
10. Diagnosed other kinds of malignant within 5 years, except for non-melanoma skin cancer and carcinoma in situ of cervix.
11. Without legal capacity.
12. Uncorrectable coagulation disorder.
13. Obvious abnormal in ECG or obvious clinical symptoms of heartdisease, like congestive heart failure (CHF), coronary heart disease with obvious clinical symptoms, unmanageable arrhythmia and hypertension.
14. Severe liver disease (like cirrhosis), renal disease, respiratory disease,unmanageable diabetes or other kinds of systematic disease.

Where this trial is running

Beijing

• Department of Interventional Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education),Peking University Cancer Hospital and Institute — Beijing, China (RECRUITING)

Study contacts

• Principal investigator: Xiaodong Wang — Department of Interventional Oncology, Peking University Cancer Hospital
• Study coordinator: Xiaodong Wang

Conditions: Perihilar Cholangiocarcinoma, Hepatic arterial infusion chemotherapy, Biliary Drainage, Best Supportive Care