Status:
COMPLETED
The Efficacy and Safety of Nab-paclitaxel Plus S-1 in First-line Treatment of Advanced Biliary Tract Adenocarcinoma
Lead Sponsor:
Aiping Zhou
Conditions:
Biliary Tract Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Advanced biliary tract adenocarcinoma has a poor prognosis with limited therapeutic options. Nab-paclitaxel plus S-1 chemotherapy will be given to untreated patients with advanced biliary tract adenoc...
Detailed Description
Gemcitabine/Nab-paclitaxel has become a standard therapy in advanced pancreatic cancer. Given the morphologic and histologic similarities between pancreatic cancer and biliary tract adenocarcinoma, na...
Eligibility Criteria
Inclusion
- Age, years: 18-70
- Histologically and cytologically confirmed advanced biliary tract adenocarcinoma, unresectable, measurable lesions according to RECIST criteria; ECOG score of 0-1; life expectancy ≥12 weeks;
- Untreated; more than 6 months after the last adjuvant chemotherapy (does not include taxanes and S1);
- Laboratory examination within 14 days before entering the study should meet following requirements:
- ANC ≥ 1.5 x 10\^9/L; PLT ≥ 100 x 10\^9/L; Hb ≥ 90g/L (9g/dL); AST, ALT ≤ 2.5 x ULN (with no liver metastasis), ≤ 5 x ULN（with liver metastasis); creatinine ≤ 1.5 x ULN; TBIL ≤ 1.5 x ULN
- Both male and female subjects of potential fertility have to agree effective birth control during the entire study
- Informed consent
Exclusion
- Concurrent other effective treatment (including radiotherapy)
- Resectable patients
- Allergy history to other drugs in the same class patients with pregnancy or lactation
- Known severe internal medical diseases
- Abnormal heart function or relevant history of myocardial infarction and severe arrhythmia
- Immunocompromised patients, such as HIV positive
- Uncontrollable mental illness
- Other conditions the researchers considered ineligible for the study
Key Trial Info
Start Date :
March 23 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2019
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT03830606
Start Date
March 23 2016
End Date
September 1 2019
Last Update
February 1 2021
Active Locations (1)
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1
National Cancer Center/Cancer Hospital, Chinese ACademy of Medical Sciences and Peking Union Medical College
Beijing, China, 100021