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

NCT04172402 | Completed Phase 2 DMC

• 1 other identifier: T1219
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Advanced Biliary Tract Cancer

Keywords

Advanced Biliary Tract Cancer; Nivolumab; Phase 2

Outcome Measures

Primary Outcomes (1)

• Overall response rate (ORR)

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

  1 year

Study Arms (1)

NGS

EXPERIMENTAL

Eligible patients will receive Nivolumab 240mg on day 1, gemcitabine 800 mg/m2/day on day 1 and S-1 orally 80-120 mg/day (depending on patient's body surface area (BSA)) on day 1 to 10 in a 2-week cycle. * BSA \< 1.25 m2: 80 mg/day * 1.25 m2 ≤ BSA \< 1.5 m2: 100 mg/day * BSA ≥ 1.5 m2: 120 mg/day The treatment will be administered until disease progression, intolerable toxicity, or consent withdrawal during any time of the study.

Drug: TS-1; Drug: Gemcitabine; Drug: Nivolumab

Interventions

TS-1 DRUG

Intervention is administered to patients in this Arm.

NGS

Gemcitabine DRUG

Intervention is administered to patients in this Arm.

NGS

Nivolumab DRUG

Intervention is administered to patients in this Arm.

NGS

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Health Research Institutes, Taiwan: lead
• Taipei Veterans General Hospital, Taiwan: collaborator
• Chang Gung Memorial Hospital: collaborator
• China Medical University Hospital: collaborator
• National Cheng-Kung University Hospital: collaborator
• Kaohsiung Medical University Chung-Ho Memorial Hospital: collaborator
• National Taiwan University Hospital: collaborator

Study Sites (6)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Location

Chang Gung Memorial Hospital

Linkou District, Taiwan

Location

China Medical University Hospital

Taichung, Taiwan

Location

National Cheng Kung University Hospital

Tainan, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Taipei Veterans General Hospital

Taipei, Taiwan

Location

Related Publications (1)

• Chiang NJ, Tang CY, Bai LY, Chang PC, Chen WM, Kang ST, Chen SC, Chen MH, Hsieh JC. Circulating miRNAs as potentially predictive biomarkers for chemoimmunotherapy in advanced biliary tract cancer: a post-hoc analysis of the phase II T1219 study. NPJ Precis Oncol. 2025 Aug 30;9(1):307. doi: 10.1038/s41698-025-01099-x.

  PMID: 40885799 DERIVED

MeSH Terms

Interventions

titanium silicide; Gemcitabine; Nivolumab

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Chen Ming-Huang, MD

  Taipei Veterans General Hospital, Taipei, TAIWAN

  STUDY CHAIR

• Chiang Nai-Jung, MD

  National Health Research Institutes, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Advanced Biliary Tract Cancer

Study Record Dates

• First Submitted: November 18, 2019
• First Posted: November 21, 2019
• Study Start: December 27, 2019
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 22, 2025

Record last verified: 2024-09

Locations

TW (6)