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

Advanced Biliary Tract Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04172402
• Other study ID #: T1219
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: December 27, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2022
• Source: National Health Research Institutes, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 48
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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. 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

7. age of 20 years or above;

8. ECOG performance status 0-1;

9. life expectancy of at least 12 weeks;

10. patients with childbearing potential shall have effective contraception for both the patient and his or her partner during the study.

11. 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.

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

Related Conditions & MeSH terms

• Advanced Biliary Tract Cancer
• Biliary Tract Neoplasms

Intervention

Drug:
• TS-1
Intervention is administered to patients in this Arm.
• Gemcitabine
Intervention is administered to patients in this Arm.
• Nivolumab
Intervention is administered to patients in this Arm.

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung
Taiwan	Chang Gung Memorial Hospital	Linkou
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

Sponsors (7)

Lead Sponsor	Collaborator
National Health Research Institutes, Taiwan	Chang Gung Memorial Hospital, China Medical University Hospital, Kaohsiung Medical University Chung-Ho Memorial Hospital, National Cheng-Kung University Hospital, National Taiwan University Hospital, Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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