Clinical trial NCT05024513: Biliary Drainage Plus HAIC in Locally Advanced PCCA
Official title: Prospective Multicentre Trial of Biliary Drainage Plus Hepatic Arterial Infusion Chemotherapy Versus Biliary Drainage Plus Best Supportive Care in Locally Advanced Perihilar Cholangiocarcinomas.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Perihilar Cholangiocarcinoma
Keywords: Perihilar Cholangiocarcinoma
Hepatic arterial infusion chemotherapy
Biliary Drainage
Best Supportive Care
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2021-08-27
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Overall survival
timeFrame: 1 year
Secondary outcomes:
measure: Duration of jaundice remission
timeFrame: 1 year
Other outcomes:
measure: Adverse effects
timeFrame: 6 months
Locations:
city: Beijing
country: China
facility: Department of Interventional Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education),Peking University Cancer Hospital and Institute
Study officials:
affiliation: Department of Interventional Oncology, Peking University Cancer Hospital
name: Xiaodong Wang
role: PRINCIPAL_INVESTIGATOR
References:
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