Overview

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