Advanced Biliary Tract CancerPhase 2NCT04172402
NGS as the First-line Treatment in Advanced Biliary Tract Cancer
A Phase 2 study testing TS-1, Gemcitabine and Nivolumab in people with Advanced Biliary Tract Cancer, run by National Health Research Institutes, Taiwan at 6 sites in Taiwan.
Trial summary
To evaluate disease objective response rate (ORR) of nivolumab in combination with gemcitabine and TS1 in patients with advanced biliary tract cancer Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Advanced Biliary Tract Cancer
- What is being tested?
- TS-1, Gemcitabine and Nivolumab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 6 sitesTaiwan
- Study dates
- 27 Dec 2019to 31 Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Taiwan6 sites
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
Chang Gung Memorial Hospital
Linkou District
China Medical University Hospital
Taichung
National Cheng Kung University Hospital
Tainan
National Taiwan University Hospital
Taipei
Taipei Veterans General Hospital
Taipei
About this study
Official title: A Study of Nivolumab Combination Gemcitabine and S1 as the First-Line Treatment in Patients With Advanced Biliary Tract Cancer
To evaluate disease objective response rate (ORR) of nivolumab in combination with gemcitabine and TS1 in patients with advanced biliary tract cancer
Read the 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.
- Conditions
- Advanced Biliary Tract Cancer
- Being tested
- TS-1, Gemcitabine, Nivolumab
- Keywords
- Advanced Biliary Tract Cancer, Nivolumab, Phase 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TS-1Drug
Intervention is administered to patients in this Arm.
GemcitabineDrug
Intervention is administered to patients in this Arm.
NivolumabDrug
Intervention is administered to patients in this Arm.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: TS-1; Drug: Gemcitabine; Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start27 Dec 2019
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Biliary Tract CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Advanced Biliary Tract Cancer
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Health Research Institutes, Taiwan
- Sponsor type
- University, hospital or other
- Collaborators
- Taipei Veterans General Hospital, Taiwan, Chang Gung Memorial Hospital, China Medical University Hospital, National Cheng-Kung University Hospital, Kaohsiung Medical University Chung-Ho Memorial Hospital, National Taiwan University Hospital
- Responsible party
- Sponsor
- Investigators
- Chen Ming-Huang, MD, Study chair, Taipei Veterans General Hospital, Taipei, TAIWANChiang Nai-Jung, MD, Principal investigator, National Health Research Institutes, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04172402
- Sponsor's protocol ID
- T1219
- Status last verified
- Sep 2024
- First submitted
- 18 Nov 2019
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40885799
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Nivolumab Combination Gemcitabine and S1 as the First-Line Treatment in Patients With Advanced Biliary Tract Cancer
- ClinicalTrials.gov ID
- NCT04172402
- Acronym / sponsor ID
- T1219
- Conditions
- Advanced Biliary Tract Cancer
- Keywords
- Advanced Biliary Tract Cancer, Nivolumab, Phase 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- National Health Research Institutes, TaiwanUniversity, hospital or other
- Collaborators
- Taipei Veterans General Hospital, Taiwan, Chang Gung Memorial Hospital, China Medical University Hospital, National Cheng-Kung University Hospital, Kaohsiung Medical University Chung-Ho Memorial Hospital, National Taiwan University Hospital
- Study start
- 27 Dec 2019 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 21 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Advanced Biliary Tract Cancer
| Arm | Type | Receives |
|---|---|---|
| NGS | Experimental | Drug: TS-1, Drug: Gemcitabine, Drug: NivolumabEligible 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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:
- adequate hepatic function which is defined as below:
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TS-1Intervention is administered to patients in this Arm. | Drug | NGS |
| GemcitabineIntervention is administered to patients in this Arm. | Drug | NGS |
| NivolumabIntervention is administered to patients in this Arm. | Drug | NGS |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Derived from this study: PubMed 40885799Chiang 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.
Related trials for Advanced Biliary Tract Cancer
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Active, not recruitingPhase 2
Durvalumab and Tremelimumab in Combination With Propranolol and Chemotherapy for Treatment of Advanced Hepatopancreabiliary Tumors (BLOCKED)
Pancreatic Cancer, Hepatocellular Cancer
RecruitingPhase 2
Gemcitabine, Cisplatin, Nab-paclitaxel (GAP) and Cemiplimab for Locally Advanced Biliary Tract Cancer (BTC)
Colon and Rectal Cancer
RecruitingPhase 2
MP0317 in Combination With Chemoimmunotherapy in First Line Treatment for Patients With Advanced Biliary Tract Carcinoma
Advanced Biliary Tract Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chen Ming-Huang, MD study chair
Taipei Veterans General Hospital, Taipei, TAIWAN
Chiang Nai-Jung, MD principal investigator
National Health Research Institutes, Taiwan
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TS-1, Gemcitabine and Nivolumab in people with Advanced Biliary Tract Cancer, run by National Health Research Institutes, Taiwan at 6 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (ORR) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04172402, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.