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

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Brief Title

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

Official Title

Phase II Study of Nab-paclitaxel Plus S-1 in First-line Treatment of 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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

objective response rate(ORR)

Secondary Outcome

 Progression free survival (PFS)

Condition

Biliary Tract Cancer

Intervention

Nab-paclitaxel,S-1

Study Arms / Comparison Groups

 Nab-paclitaxel Plus S-1
Description:  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)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

54

Start Date

March 23, 2016

Completion Date

September 1, 2019

Primary Completion Date

September 2, 2018

Eligibility 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
      

Gender

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT03830606

Organization ID

CH-GI-091


Responsible Party

Sponsor-Investigator

Study Sponsor

Aiping Zhou


Study Sponsor

, , 


Verification Date

January 2021