The Efficacy and Safety of Nab-paclitaxel Plus S-1 in First-line Treatment of Advanced Biliary Tract Adenocarcinoma

• Status: Completed
• Trial end date: 2019-09-01
• Target enrollment: 0
• Participant gender: All

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 adenocarcinoma for the first-line treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aiping Zhou
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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