Biliary Tract Cancer
Conditions
Keywords
Nab-paclitaxel, S-1, Advanced Biliary Tract Adenocarcinoma
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 adenocarcinoma for the first-line treatment.
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, nab-Paclitaxel may be a promising regimen, and S-1 has been approved for biliary tract cancer in Japan. Untreated patients with advanced biliary tract adenocarcinoma will receive Nab-paclitaxel 120 mg/m2 (D1, D8, q3w) and S-1 (40mg BID for body surface area\<1.25 m2; 50mg BID for body surface area of 1.25-1.5 m2; and 60mg BID for body surface area\>1.5 m2; D1-14, q3w) as the first-line treatment. The investigators will investigate the efficacy and safety of the combination treatment, and expect to provide a more effective treatment plan for patients with advanced biliary tract cancer in China.The primary endpoint is objective response rate(ORR), and the secondary endpoints are progression-free survival(PFS), overall survival(OS) and the safety.
Interventions
DRUGNab-paclitaxel,S-1
Nab-paclitaxel 120 mg/m2 (D1, D8, q3w) and S-1 (40mg BID for body surface area \< 1.25 m2; 50mg BID for body surface area of 1.25-1.5 m2; and 60mg BID for body surface area \>1.5 m2; D1-14, q3w)
Sponsors
Aiping Zhou
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients with untreated advanced biliary tract adenocarcinoma
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| objective response rate（ORR） | 6 month | Assessed by RESIST |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival (PFS) | 6 month | Assessed by Kaplan-Meier curve，From date of randomization until date of first documented PD, date of death |
| overall survival time (OS) | 1 year | Assessed by Kaplan-Meier curve，From date of randomization until date of death |
| safety profile: assessed by CTCAE v4.0 | 1 year | Patients with treatment-related adverse events assessed by CTCAE v4.0 to determine the tolerability of patients with Advanced Biliary Tract Adenocarcinoma |
Countries
China
Outcome results
None listed