NCT04856761

A Study of Capecitabine Versus S-1 as Adjuvant Therapy in Patients With Biliary Tract Carcinoma After Surgical Resection

A Phase II, Open-Label Study of Capecitabine Versus S-1 as Adjuvant Therapy in Patients With Biliary Tract Carcinoma After Surgical Resection

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 160 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the difference of safety and efficacy about Capecitabine and S-1 for treatment of patients with low-risk of recurrence after BTC surgery.

Detailed description

Patients received curative BTC surgery will be informed about the study. After being informed about the study and potential risks, all patients giving written informed consent will undergo a 1-week screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be observed for recurrence of BTC.

Conditions

• Biliary Tract Neoplasms
• Recurrence
• Cholangiocarcinoma
• Gall Bladder Cancer

Interventions

Type	Name	Description
DRUG	S-1	S-1 was administered at a dose of 80-120 mg/day on 14 days of a tri-weekly cycle for 8 cycles.
DRUG	Capecitabine	Capecitabine was administered at a dose of 1250 mg/m² bid on 14 days of a tri-weekly cycle for 8 cycles.

Timeline

• Start date: 2020-11-01
• Primary completion: 2022-12-30
• Completion: 2024-12-30
• First posted: 2021-04-23
• Last updated: 2022-08-18

Locations

1 site across 1 country: China