The Efficacy and Safety of Nab-paclitaxel Plus S-1 in First-line Treatment of Advanced Biliary Tract Adenocarcinoma
- Conditions
- Biliary Tract Cancer
- Interventions
- Drug: Nab-paclitaxel,S-1
- Registration Number
- NCT03830606
- Lead Sponsor
- Aiping Zhou
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Nab-paclitaxel Plus S-1 Nab-paclitaxel,S-1 Nab-paclitaxel 120 mg/m2 (D1, D8, q3w) S-1 (40mg BID for body surface area\<1.25 m2; 50mg BID for body surface area of 1.25-1.5m2; and 60mg BID for body surface area\>1.5 m2; D1-14, q3w)
- Primary Outcome Measures
Name Time Method objective response rate（ORR） 6 month Assessed by RESIST
- Secondary Outcome Measures
Name Time Method 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
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
Trial Locations
- Locations (1)
National Cancer Center/Cancer Hospital, Chinese ACademy of Medical Sciences and Peking Union Medical College
🇨🇳Beijing, China