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NGS as the First-line Treatment in Advanced Biliary Tract Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE2

NGS as the First-line Treatment in Advanced Biliary Tract Cancer

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

NCT04172402•National Health Research Institutes, Taiwan

View on ClinicalTrials.gov

Summary

To evaluate disease objective response rate (ORR) of nivolumab in combination with gemcitabine and TS1 in patients with advanced biliary tract cancer

Detailed Description

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.

Eligibility

Age

20 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. histologically confirmed locally advanced or metastatic biliary tract carcinoma (including intrahepatic bile duct, extrahepatic bile duct, gallbladder and ampulla of vater);
•2. 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.
•3. 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;
•4. 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;
•5. adequate hepatic function which is defined as below:
•1. total bilirubin \< 2 mg/dL;
•2. Alanine aminotransferase (ALT) ≤ 3 x ULN; ≤ 5 x ULN if liver metastasis
+6 more criteria

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.
•9. History of active autoimmune disease within 3 years or long-term use of steroid more than prednisolone 10mg/day.

Locations (6)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Chang Gung Memorial Hospital

Linkou District, Taiwan

China Medical University Hospital

Taichung, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Key Dates

Start Date

December 27, 2019

Primary Completion Date

December 31, 2024

Completion Date

December 31, 2024

Last Updated

July 22, 2025

Enrollment

ACTUAL participants

Conditions

Advanced Biliary Tract Cancer

Interventions

TS-1

DRUG

Gemcitabine

DRUG

Nivolumab

DRUG

HAIC With Oxaliplatin, 5-FU and Bevacizumab Plus Intravenous Toripalimab for Advanced BTC

NCT04217954

Advanced Biliary Tract Cancer

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UNKNOWNPHASE2

Toripalimab Plus Lenvatinib as Second-line Treatment in Advanced Biliary Tract Cancers

NCT04211168

Advanced Biliary Tract Cancer

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TERMINATEDPHASE2

Randomized Trial of Gemcitabine/Cisplatin Versus S-1/Cisplatin in Advanced Biliary Cancer

NCT01096745

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 22, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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