Biliary Drainage Plus HAIC in Locally Advanced PCCA

Phase 2

Recruiting

• Conditions: Perihilar Cholangiocarcinoma
• Interventions: Drug: oxaliplatin and 5-fluorouracil; Procedure: Biliary Drainage; Procedure: External biliary drainage; Other: Best Supportive Care

• Registration Number: NCT05024513
• Lead Sponsor: Peking University

Brief Summary

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.

Detailed Description

When a patient is not eligible for surgery, chemotherapy with gemcitabine and cisplatin can be considered for advanced biliary tract cancer. However, in the Advanced Biliary Tract Cancer, or ABC-02 trial in patients with pCCA, the efficacy of this regimen was not significantly higher than that of gemcitabine alone. Therefore, an optimal chemotherapeutic regimen has not been established for this subtype of cholangiocarcinoma. Currently, biliary drainage and stent placement remains to be the main palliative treatment choice, and the life expectancy is only 4-6 months. Previous single center prospective phase 2 trial showed that HAI with oxaliplatin and 5-fluorouracil was an encouraging treatment choice for advanced PCC due to its high tumor control, survival benefit, and low toxicity. So the multicenter prospective controlled trial was designed to explore and confirm the survival benefit of biliary drainage plus hepatic arterial infusion of oxaliplatin and 5-fluorouracil compared with biliary drainage plus best support care treatment in locally advanced pCCA patients.

Study Timeline

• Study First Submitted: 2021-08-23
• Study First Submitted QC: 2021-08-23
• Study First Posted: 2021-08-27
• Study Start: 2021-11-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-01
• Last Update Posted: 2024-12-04
• Primary Completion: 2025-03-31
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 127

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BD-HAIC (Biliary drainage & HAIC)	oxaliplatin and 5-fluorouracil	The patients enrolled in this arm would receive external percutaneous biliary drainage plus 3Cir-OFF hepatic arterial infusion chemotherapy （HAIC）with oxaliplatin and 5-fluorouracil.
BD-HAIC (Biliary drainage & HAIC)	External biliary drainage	The patients enrolled in this arm would receive external percutaneous biliary drainage plus 3Cir-OFF hepatic arterial infusion chemotherapy （HAIC）with oxaliplatin and 5-fluorouracil.
BD-BSC (Biliary Drainage & Best supportive care)	Biliary Drainage	The patients enrolled in this arm would receive biliary drainage, biliary stents,or biliary stents with Iodine-125 seed strands, plus best supportive care.
BD-BSC (Biliary Drainage & Best supportive care)	Best Supportive Care	The patients enrolled in this arm would receive biliary drainage, biliary stents,or biliary stents with Iodine-125 seed strands, plus best supportive care.

Primary Outcome Measures

Name	Time	Method
Overall survival	1 year	Overall survival is measured from the date of first biliary drainage to death

Secondary Outcome Measures

Name	Time	Method
Duration of jaundice remission	1 year	The time between remission of total bilirubin to less than 2 times of the upper limit of the normal value and time of rising again of bilirubin above more than 2 times of upper limit of the normal level.

Trial Locations

Locations (1)

Department of Interventional Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education),Peking University Cancer Hospital and Institute; 🇨🇳 Beijing, China