Biliary tract cancer cross-over study

JRCT ID: jRCT1041230014

Registered date:22/04/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: biliary tract cancer
• Date of first enrollment: 02/05/2023
• Target sample size: 50
• Study type: Interventional

Intervention(s)

(1) GCD therapy The following agents are administered every 3 weeks until tumor progression or unacceptable adverse events
Gemcitabine, 1,000 mg/m2, days 1 and 8
Cisplatin, 25 mg/m2, days 1 and 8
Durvalumab, 1,500 mg/body, day1
(2) GCS therapy The following agents are administered every 3 weeks until tumor progression or unacceptable adverse events
Gemcitabine, 1,000 mg/m2, day 1
Cisplatin, 25 mg/m2, day 1
S-1, 80/100/120 mg/day, days 1-7

Outcome(s)

• Primary Outcome: Progression-free survival
• Secondary Outcome: Overall survival, Progression-free survival from first-line therapy, Overall survival from first-line therapy, Objective response rate, Tumor control rate, Adverse events, Subsequent therapy

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Yamashita Tatsuya