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Clinical Trials List

Protocol NumberT1219
NCT Number(ClinicalTrials.gov Identfier)NCT04172402
Completed

2019-12-01 - 2022-12-31

Phase II

Recruiting7

ICD-10C24.8

Malignant neoplasm of overlapping sites of biliary tract

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9156.8

Malignant neoplasm of other specified sites of gallbladder and extrahepatic bile ducts

A Study of Nivolumab Combination Gemcitabine and S1 as the First-Line Treatment in Patients With Advanced Biliary Tract Cancer

  • Trial Applicant

    National Health Research Institutes

  • Sponsor

    National Health Research Institutes, Taiwan

  • Trial scale

    Taiwan Multiple Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Yan-Shen Shan Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Jen-Shi Chen Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ming-Huang Chen Division of Hematology & Oncology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Li-Yuan Bai Division of Hematology & Oncology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator TSUNG-HAO LIU Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 姜乃榕 Division of General Internal Medicine
National Health Research Institutes

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Li-Tzong Chen Digestive System Department
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Advanced Biliary Tract Cancer

Objectives

To evaluate disease objective response rate (ORR) of nivolumab in combination with gemcitabine and TS1 in patients with advanced biliary tract cancer The primary endpoint will be evaluating overall response rate (ORR) of nivolumab in combination with gemcitabine and TS-1 in patients with advanced BTC. Simon's two-stage design will be used. If there are 3 or fewer subjects with controlled disease in these 19 patients, the study will be stopped. Otherwise, 25 additional patients will be accrued for a total of 44. The null hypothesis will be rejected if 11 or more subjects with controlled disease are observed in 44 patients.

Test Drug

OPDIVO

Active Ingredient

Nivolumab

Dosage Form

IVT

Dosage

100

Endpoints

Primary Outcome Measures :
Overall response rate (ORR) [ Time Frame: 1 year ]
To evaluate disease objective response rate (ORR) of nivolumab in combination with gemcitabine and TS1 in patients with advanced biliary tract cancer

Secondary Outcome Measures:
• Disease control rate (DCR)
• Progression-free survival (PFS)
• Overall survival (OS)
• Duration of response (DOR)

Inclution Criteria

Inclusion Criteria:
histologically confirmed locally advanced or metastatic biliary tract carcinoma (including intrahepatic bile duct, extrahepatic bile duct, gallbladder and ampulla of vater);
no history of chemotherapy or radiotherapy for biliary tract cancer, except those delivered as adjuvant setting that completed at least 6 months before documentation of recurrence by imaging study.
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;
adequate hematopoietic function which is defined as below:
hemoglobin level ≥ 9 g/dL;
absolute neutrophil count (ANC) ≥ 1,500/mm3;
platelet count ≥ 100,000/mm3;
adequate hepatic function which is defined as below:

total bilirubin < 2 mg/dL;
Alanine aminotransferase (ALT) ≤ 3 x ULN; ≤ 5 x ULN if liver metastasis
adequate renal function: creatinine clearance rate (CCr) ≥ 50 mL/min ((based upon Cockroft-Gault formula or 24-hour urine collection); < Cockroft-Gault formula > Male: ((140 - age) × weight [kg])/(72 × serum creatinine[mg/dL]) Female: 0.85 x estimate for male
age of 20 years or above;
ECOG performance status 0-1;
life expectancy of at least 12 weeks;
patients with childbearing potential shall have effective contraception for both the patient and his or her partner during the study.
ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria

Exclusion Criteria:
other malignancy within the past 5 years except for adequately treated basal or squamous cell skin cancer or cervical cancer in situ;
history or known presence of brain metastasis;
presence of grade 2 or above ascites or pleural effusion;
presence of grade 2 or above diarrhea;
presence of mental disease or psychotic manifestation;
active or uncontrolled infection;
significant medical conditions that is contraindicated to study medication or render patient at high risk from treatment complications based on investigator's discretion;
pregnant women or nursing mothers, or positive pregnancy test for women of childbearing potential.
History of active autoimmune disease within 3 years or long-term use of steroid more than prednisolone 10mg/day.

The Estimated Number of Participants

  • Taiwan

    48 participants

  • Global

    48 participants

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