Biliary Drainage Plus HAIC in Locally Advanced pCCA

  • STATUS
    Recruiting
  • End date
    Jun 1, 2024
  • participants needed
    127
  • sponsor
    Peking University
Updated on 7 January 2022

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.

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.

Details
Condition Perihilar Cholangiocarcinoma
Treatment Best supportive care, External biliary drainage, Biliary drainage, oxaliplatin and 5-fluorouracil
Clinical Study IdentifierNCT05024513
SponsorPeking University
Last Modified on7 January 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 75 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

Exclusion Criteria

Allergic to contrast agent
Pregnant or lactational
Allergic to 5-fluorouracil, or have metabolic disorder of 5-fluorouracil
Previous systematic chemotherapy or radiotherapy
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
Without legal capacity
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
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