NCT05024513CompletedPhase 2
Biliary Drainage Plus HAIC in Locally Advanced pCCA
Prospective Multicentre Trial of Biliary Drainage Plus Hepatic Arterial Infusion Chemotherapy Versus Biliary Drainage Plus Best Supportive Care in Locally Advanced Perihilar Cholangiocarcinomas.
Source: ClinicalTrials.gov · Last updated 18 Dec 2025
Brief summary (registry, in English)
Biliary drainage and stent placement remains to be the main palliative treatment choice for advanced perihiliar cholangiocarcinoma (pCCA), and the life expectancy is only 4-6 months. Previous single center prospective phase 2 trial showed that hepatic arterial infusion chemotherapy (HAIC) with oxaliplatin and 5-fluorouracil was an encouraging treatment choice for advanced pCCA due to its high tumor control, survival benefit, and low toxicity. Thus, the multicenter prospective controlled trial was designed to explore and confirm the survival benefit of biliary drainage plus hepatic arterial infusion chemotherapy with oxaliplatin and 5-fluorouracil compared with biliary drainage plus best support care treatment in locally advanced pCCA patients.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 127 (actual)
- First submitted
- 23 Aug 2021
- Start date
- 1 Nov 2021
- Primary completion date
- 20 Oct 2025
- Lead sponsor
- Peking University
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT05024513
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 127
- From 1 Nov 2021 to the primary completion date, 20 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous systematic chemotherapy or radiotherapy.
Other illness
- Allergic to contrast agent.
- Allergic to 5-fluorouracil, or have metabolic disorder of 5-fluorouracil.
- Patients with complications such as bile leakage and bleeding after PTCD
- N2 lymphatic metastasis, extrahepatic metastasis, or coinstantaneous a lot of malignant hydrothorax or ascites.
- History of organ transplantation.
- Coinstantaneous infection and need anti-infection therapy.
- Coinstantaneous peripheral nervous system disorder or with history of obvious mental disorder and central nervous system disorder.
- Diagnosed other kinds of malignant within 5 years, except for non-melanoma skin cancer and carcinoma in situ of cervix.
- Uncorrectable coagulation disorder.
- 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.
- Severe liver disease (like cirrhosis), renal disease, respiratory disease,unmanageable diabetes or other kinds of systematic disease.
Other
- Pregnant or lactational.
- Without legal capacity.
Who the study is looking for
- Locally advanced perihilar cholangiocarcinoma proved by histology or cytology.
- Locally advanced unresectable perihilar cholangiocarcinoma, decided by hepatobiliary doctor and radiologist.
- Age from 18 years old to 80 years old.
- The performance of Eastern Cooperative Oncology Group (ECOG) \<2
- Child-Pugh A or Child-Pugh B (≤ grade 7).
- Expectant survival time ≥ 3 months.
- Baseline blood count test and blood biochemical must meet following criteria:
- Hemoglobin ≥ 90 g/L;
- Absolute neutrophil count ≥ 1.5×10\^9/L;
- Blood platelet count ≥ 100×10\^9/L;
- Serum creatinine ≤ 1.5 times of ULN;
- Albumin ≥ 30 g/L
- Patients sign informed consent.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Interventional Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education),Peking University Cancer Hospital and Institute Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.