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Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036449
Receipt No. R000041509
Scientific Title Randomized Phase II study of adjuvant chemotherapy with GC versus GS in patients with BTC undergoing curative resection without major hepatectomy
Date of disclosure of the study information 2019/04/17
Last modified on 2019/06/28

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Basic information
Public title Randomized Phase II study of adjuvant chemotherapy with gemcitabine plus cisplatin versus gemcitabine plus S-1 in patients with biliary tract cancer undergoing curative resection without major hepatectomy(KHBO1901)
Acronym Randomized Phase II study of adjuvant chemotherapy with GC versus GS in patients with BTC undergoing curative resection without major hepatectomy
Scientific Title Randomized Phase II study of adjuvant chemotherapy with GC versus GS in patients with BTC undergoing curative resection without major hepatectomy
Scientific Title:Acronym KHBO1901

Condition biliary tract cancer
Classification by specialty
Hepato-biliary-pancreatic medicine Hematology and clinical oncology Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Narrative objectives1 Comparison of the efficacy for GC and GS as adjuvant chemotherapy in patients with BTC undergoing curative resection without major hepatectomy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Primary outcomes Recurrence-free survival (2-year recurrence-free survival rate)
Key secondary outcomes 1)Overall survival
2)Proportion of treatment completion
3)Relative dose intensity
4)Proportion of adverse events
5)Relapse-free survival rate and overall survival of lymph node positive/lymph node negative case
6)Relapse-free survival rate and overall survival of R0/R1 case
7)Relapse-free survival rate and overall survival of each primary site

Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Active
Dynamic allocation
Institution consideration

No. of arms 2
Purpose of intervention Treatment
Type of intervention
Interventions/Control_1 Adjuvant GC chemotherapy consisted of
intravenous GEM(1000mg/mm2) and CDDP (25mg/m2) on days 1 and 8, with 1 week rest.
Interventions/Control_2 Adjuvant GS chemotherapy consisted of
intravenous GEM(800mg/mm2) on days 1 and 8, and oral S-1(50mg/mm2/day) administered
twice daily on days 1-14, with a 1 week rest.

Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Diagnosed as having biliary tract adenocarcinoma or adenosquamous carcinoma(IHBD, EHBD, GB or AV cancer) in resected specimen.
2) R0 or R1 residual disease.
3) Pathological disease stage according to the UICC classification, seventh Edition: T2-4, N0, M0 or T1-4, N1, M0 (for patients with EHBD, GB or AV cancer), or T1-4, N0-1, M0 (for patients with IHBD cancer).
4) Age over 20 years
5) ECOG performance status 0 or 1
6)No treatment other than surgery except of drainage
7) No distant metastasis according to the radiological findings after operation.
8) Adequate organ functions
a) Neutrophil count >=1,500/mm3
b) Platelet count >= 100,000/mm3
c) Serum aspartate transaminase <=150U/l
d) Serum alanine transaminase <=150U/l
e) Serum total bilirubin <=1.5 mg/dl
f) Serum creatinine <=1.2 mg/dl
g) Creatinine clearance >=60 ml/min
9) Adequate oral intake.
10) Between 3 and 12 weeks after resection.
11) Written informed consent.
Key exclusion criteria 1)Distant metastasis except of positive CY
2) Not performed lobectomy
3) Other concurrent active cancer (synchronous double cancer or heterochronous double cancer with a disease-free interval of 3 years or shorter, excluding lesions consistent with intraepithelial cancer, i.e., intramucosal cancer that are assessed as cured by endoscopical treatment.)
4) Patients with a history of severe drug hypersensitivity or drug allergy.
5) Serious complicating disorders (Interstitial pneumonia, pulmonary fibrosis or severe emphysema, hepatic cirrhosis, uncontrollable-diabetes, cardiac disease, renal failure, liver failure, hemorrhagic peptic ulcer etc).
6) Active infection requiring systemic therapy
7) Pregnant or lactating women, women with childbearing potential, males males who wish a pregnancy of his partner.
8) Severe psychiatric disease.
9) Inappropriate for this study judged by the attending physician
Target sample size 106

Research contact person
Name of lead principal investigator
1st name Hiroaki
Middle name
Last name Yanagimoto
Organization Kobe University Graduate School of Medicine
Division name Division of Hepato-biliary-pancreatic surgery, Department of Surgery
Zip code 650-0017
Address 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
TEL 078-382-6302

Public contact
Name of contact person
1st name Tatsuya
Middle name
Last name Ioka
Organization Kansai Hepato-Biliary Oncology Group (KHBO)
Division name Department of Cancer Survey and Gastrointestinal Oncology,Osaka International Cancer Institute
Zip code 541-8567
Address 3-1-69 Otemae, Chuo-ku, Osaka-shi, Osaka , Japan
TEL 06-6945-1181(6383)
Homepage URL

Institute Kansai Hepatobiliary Oncology Group (KHBO)

Funding Source
Organization none
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Name of secondary funder(s)

IRB Contact (For public release)
Organization Institutional Review Board of Osaka International Cancer Institute
Address 3-1-69 Otemae, Chuo-ku, Osaka 541-8567, Japan.
Tel 06-6945-1181

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2


Other administrative information
Date of disclosure of the study information
2019 Year 04 Month 17 Day

Related information
URL releasing protocol
Publication of results Unpublished

URL related to results and publications
Number of participants that the trial has enrolled
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Recruitment status Preinitiation
Date of protocol fixation
2019 Year 02 Month 24 Day
Date of IRB
Anticipated trial start date
2019 Year 04 Month 17 Day
Last follow-up date
2024 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other related information

Management information
Registered date
2019 Year 04 Month 09 Day
Last modified on
2019 Year 06 Month 28 Day

Link to view the page

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name

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