Biliary tract cancer cross-over study

Phase 2

Recruiting

• Conditions: biliary tract cancer

• Registration Number: JPRN-jRCT1041230014
• Lead Sponsor: Yamashita Tatsuya

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-04-22
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1) histologically or cytologically diagnosed as adenocarcinoma or adenosquamous carcinoma
2) radiollogically diagnosed as unresectable or recurrent biliary tract cancer
3) previously treated by GCS or GCD therapy
4) 20 years or older
5) ECOG Performance status 0 or 1
6) patients capable of oral intake (in GCS group)
7) preservation of major organ function
8) written informed consent by patient

Exclusion Criteria

1) double cancer
2) active infection
3) pregnant or lactating women, or women of childbearing potential
4) mental disorder
5) auto-immune disease
6) severe complication
7) metastases to central nervous system
8) contraindication for the study drug
9) patients who investigator regards as inappropriate for candidate

Study & Design

• Study Type: Interventional
• Study Design: Not specified