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

Primary Purpose

Biliary Tract Cancer

Status

Completed

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Nab-paclitaxel,S-1

About this trial

This is an interventional treatment trial for Biliary Tract Cancer focused on measuring Nab-paclitaxel, S-1, Advanced Biliary Tract Adenocarcinoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nab-paclitaxel Plus S-1

Arm 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)

Outcomes

Primary Outcome Measures

objective response rate（ORR）

Assessed by RESIST

Secondary Outcome Measures

Progression free survival (PFS)

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

overall survival time (OS)

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

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

Full Information

NCT ID

NCT03830606

First Posted

August 16, 2017

Last Updated

January 29, 2021

Sponsor

Aiping Zhou

1. Study Identification

Unique Protocol Identification Number

NCT03830606

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Completed

Study Start Date

March 23, 2016 (Actual)

Primary Completion Date

September 2, 2018 (Actual)

Study Completion Date

September 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Aiping Zhou

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Biliary Tract Cancer

Keywords

Nab-paclitaxel, S-1, Advanced Biliary Tract Adenocarcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Model Description

Patients with untreated advanced biliary tract adenocarcinoma

Masking

None (Open Label)

Allocation

N/A

Enrollment

54 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nab-paclitaxel Plus S-1

Arm Type

Experimental

Arm 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)

Intervention Type

Drug

Intervention Name(s)

Nab-paclitaxel,S-1

Intervention Description

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)

Primary Outcome Measure Information:

Title

objective response rate（ORR）

Description

Assessed by RESIST

Time Frame

6 month

Secondary Outcome Measure Information:

Title

Progression free survival (PFS)

Description

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

Time Frame

6 month

Title

overall survival time (OS)

Description

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

Time Frame

1 year

Title

safety profile: assessed by CTCAE v4.0

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

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

City

Beijing

ZIP/Postal Code

100021

Country

China

12. IPD Sharing Statement

Learn more about this trial

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

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