Clinical trial NCT02425137: A Study of S-1 in Combination With Gemcitabine as First-Line Treatment in Patients With Advanced Biliary Tract Cancer
Official title: A Study of S-1 in Combination With Gemcitabine as First-Line Treatment in Patients With Advanced Biliary Tract Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Advanced Biliary Tract Cancer(BTC)
Lead sponsor: TTY Biopharm
Sponsor class: INDUSTRY
Collaborators: name: National Cheng-Kung University Hospital
name: National Taiwan University Hospital
name: Taipei Veterans General Hospital, Taiwan
name: Chang Gung Memorial Hospital
First posted: 2015-04-23
Enrollment: 51
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Primary Objective:

To evaluate disease control rate (DCR) of S-1 in combination with gemcitabine in patients with advanced biliary tract cancer

Secondary Objectives:

* To evaluate overall response rate (ORR)
* To evaluate progression-free survival (PFS)
* To evaluate overall survival (OS)
* To assess the safety profile


Eligibility criteria: Inclusion Criteria:

* 1.histologically confirmed biliary tract carcinoma (including intrahepatic bile duct, extrahepatic bile duct, gallbladder, and ampulla of vater);
* 2.metastatic or unresectable disease;
* 3.no history of chemotherapy or radiotherapy for biliary tract cancer;
* 4.presence of at least one measurable tumor lesion which is defined as lesions that can be accurately measured in at least 1 dimension with longest diameter (LD) ≥20 mm using conventional techniques or ≥10 mm with spiral CT and MRI; measurable lymph nodes must be ≥15 mm in the short axis;
* 5.adequate hematopoietic function which is defined as below:

  1. hemoglobin level ≥ 9 g/dL;
  2. absolute neutrophil count (ANC) ≥ 1,500/mm3;
  3. platelet count ≥ 100,000/mm3;
* 6.adequate hepatic function which is defined as below:

  1. total bilirubin ≤ 1.5 times upper limit of normal (ULN) and \< 2 mg/dL, or total bilirubin \< 3 mg/dL if biliary drainage was performed;
  2. Alanine aminotransferase (ALT) ≤ 3 x ULN or ALT ≤ 5 x ULN in the presence of liver metastasis;
* 7.adequate renal function: creatinine clearance rate (CCr) ≥ 60 mL/min ((based upon 24-hour urine collection or calculated by Cockroft-Gault formula);
* 8.age of 20 years or above;
* 9.ECOG performance status 0-1;
* 10.life expectancy of at least 12 weeks;
* 11.ability to take oral medication;
* 12.ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

* 1.other malignancy within the past 5 years except for adequately treated basal or squamous cell skin cancer or cervical cancer in situ;
* 2.history or known presence of brain metastasis;
* 3.presence of grade 2 or above ascites or pleural effusion;
* 4.presence of grade 2 or above diarrhea;
* 5.presence of mental disease or psychotic manifestation;
* 6.active or uncontrolled infection;
* 7.significant medical conditions that is contraindicated to study medication or render patient at high risk from treatment complications based on investigator's discretion;
* 8.pregnant women or nursing mothers, or positive pregnancy test for women of childbearing potential. Patients with childbearing potential shall have effective contraception for both the patient and his or her partner during the study.

Primary outcomes:
measure: Disease control rate (DCR)
timeFrame: 2 years
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: 2 years
measure: progression-free survival (PFS)
timeFrame: 2 years
measure: overall survival (OS)
timeFrame: 2 years
measure: safety profile (percentage of patients with at least one occurrence of preferred term will be included,according to the most severe NCI-CTCAE v4.03 grade)
timeFrame: 2 years
Other outcomes:
Locations:
city: Linkou
country: Taiwan
facility: Chang Gung Memorial Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: National Institute of Cacer Research, National Health Research Institiutes
name: Li-Tzong Chen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Morizane C, Okusaka T, Mizusawa J, Takashima A, Ueno M, Ikeda M, Hamamoto Y, Ishii H, Boku N, Furuse J. Randomized phase II study of gemcitabine plus S-1 versus S-1 in advanced biliary tract cancer: a Japan Clinical Oncology Group trial (JCOG 0805). Cancer Sci. 2013 Sep;104(9):1211-6. doi: 10.1111/cas.12218. Epub 2013 Jul 25.
citation: Chiang NJ, Chen MH, Yang SH, Hsu C, Yen CJ, Tsou HH, Su YY, Chen JS, Shan YS, Chen LT. Multicentre, phase II study of gemcitabine and S-1 in patients with advanced biliary tract cancer: TG1308 study. Liver Int. 2020 Oct;40(10):2535-2543. doi: 10.1111/liv.14538. Epub 2020 Jun 9.