Gemicitabine/Cisplatin/nab-paclitaxel for biliary tract cancers (GCA in BTC)

JRCT ID: jRCTs051180178

Registered date:26/03/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Biliary tract cancer
• Date of first enrollment: 12/02/2018
• Target sample size: 20
• Study type: Interventional

Intervention(s)

gemcitabine 600, 800, 1000 mg/m2
cisplatin 25 mg/m2
nab-PTX 80, 100, 125 mg/m2
day 1 and8, every 3 weeks
2 cycles.

Outcome(s)

Primary Outcome

Phase I: Feasibilty (MTD and RD)
Phase II: Response rate, Tumor control rate, Resectability and R0 resection rate

• Secondary Outcome: Histological effect, safety, completion rate, PFS, OS, 1-year and 2-year OS, 1-year and 2-year PFS, site of progression

Key inclusion & exclusion criteria

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

Include criteria

1) age> 20.
2) PS 0-1
3) no impairment of bone marrow, liver, renal, cardiac, and pulmonary function:
3-a) neutrophil >= 2000/mm3
3-b) platelet >= 100,000/mm3
3-c) hemoglobin >= 9.0 g/dL
3-d) bilirubin <= 2.0 mg/dL
3-e) AST, ALT <= 5 x UNL
3-f) creatinine <= 1.5 mg/dL
4) written informed consent

Exclude criteria

1) distant metastasis
2) estimated remnant liver volume after PTPE would become under 35% because the measurement includes resectability
3) active cancers, without carcinoma in situ
4) suspected or definitive pulmonary fibrosis or interstitial pneumonia
5) watery diarrhea
6) active infection without viral hepatitis nor cholangitis
7) severe complications: cardiac, renal, liver failure, bleeding peptic ulcer, bowel paralysis, bowel obstruction, uncontrollable diabetes mellitus
8) pregnancy
9) severe mental disorder
10) severe allergy
11) entry on other studies
12) inappropriate by the investigators

Related Information

• Primary Sponsor: Kobayashi Shogo
• Secondary ID(s): UMIN000029490