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

Biliary Tract Cancer Clinical Trial

Official title:

Phase II Study of Nab-paclitaxel Plus S-1 in First-line Treatment of Advanced Biliary Tract Adenocarcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03830606
• Other study ID #: CH-GI-091
• Status: Completed
• Phase: Phase 2
• Start date: March 23, 2016
• Est. completion date: September 1, 2019

Study information

• Verified date: January 2021
• Source: Chinese Academy of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: September 1, 2019
• Est. primary completion date: September 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Biliary Tract Cancer
• Biliary Tract Neoplasms

Intervention

Drug:
• Nab-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)

Locations

Country	Name	City	State
China	National Cancer Center/Cancer Hospital, Chinese ACademy of Medical Sciences and Peking Union Medical College	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Aiping Zhou

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	objective response rate(ORR)	Assessed by RESIST	6 month
Secondary	Progression free survival (PFS)	Assessed by Kaplan-Meier curve,From date of randomization until date of first documented PD, date of death	6 month
Secondary	overall survival time (OS)	Assessed by Kaplan-Meier curve,From date of randomization until date of death	1 year
Secondary	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	1 year