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

A

Aiping Zhou

Status and phase

Completed
Phase 2

Conditions

Biliary Tract Cancer

Treatments

Drug: Nab-paclitaxel,S-1

Study type

Interventional

Funder types

Other

Identifiers

NCT03830606
CH-GI-091

Details and patient eligibility

About

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.

Full 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.

Enrollment

54 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

54 participants in 1 patient group

Nab-paclitaxel Plus S-1
Experimental group
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)
Treatment:
Drug: Nab-paclitaxel,S-1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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