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

Aiping Zhou54 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Biliary Tract Cancer

Interventions

Nab-paclitaxel,S-1DRUG

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)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

National Cancer Center/Cancer Hospital, Chinese ACademy of Medical Sciences and Peking Union Medical College

Beijing, China

Outcomes

Primary Outcomes

objective response rate（ORR）

Assessed by RESIST

Time frame: 6 month

Secondary Outcomes

Progression free survival (PFS)

Assessed by Kaplan-Meier curve，From date of randomization until date of first documented PD, date of death

Time frame: 6 month

overall survival time (OS)

Assessed by Kaplan-Meier curve，From date of randomization until date of death

Time frame: 1 year

safety profile: assessed by CTCAE v4.0

Patients with treatment-related adverse events assessed by CTCAE v4.0 to determine the tolerability of patients with Advanced Biliary Tract Adenocarcinoma

Time frame: 1 year

Data from ClinicalTrials.gov

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