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

NCT03830606 | Completed Phase 2

• 1 other identifier: CH-GI-091
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Biliary Tract Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• objective response rate（ORR）

  Assessed by RESIST

  6 month

Secondary Outcomes (3)

• Progression free survival (PFS)

  6 month

• overall survival time (OS)

  1 year

• safety profile: assessed by CTCAE v4.0

  1 year

Study Arms (1)

Nab-paclitaxel Plus S-1

EXPERIMENTAL

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)

Drug: Nab-paclitaxel,S-1

Interventions

Nab-paclitaxel,S-1 DRUG

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)

Nab-paclitaxel Plus S-1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aiping Zhou: lead

Study Sites (1)

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

Beijing, 100021, China

Location

MeSH Terms

Conditions

Biliary Tract Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: UNKNOWN
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief physician

Model Details: Patients with untreated advanced biliary tract adenocarcinoma

Study Record Dates

• First Submitted: August 16, 2017
• First Posted: February 5, 2019
• Study Start: March 23, 2016
• Primary Completion: September 2, 2018
• Study Completion: September 1, 2019
• Last Updated: February 1, 2021

Record last verified: 2021-01

Locations

CN (1)