Clinical trial NCT04172402: NGS as the First-line Treatment in Advanced Biliary Tract Cancer
Official title: A Study of Nivolumab Combination Gemcitabine and S1 as the First-Line Treatment in Patients With Advanced Biliary Tract Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Advanced Biliary Tract Cancer
Keywords: Advanced Biliary Tract Cancer
Nivolumab
Phase 2
Lead sponsor: National Health Research Institutes, Taiwan
Sponsor class: OTHER
Collaborators: name: Taipei Veterans General Hospital, Taiwan
name: Chang Gung Memorial Hospital
name: China Medical University Hospital
name: National Cheng-Kung University Hospital
name: Kaohsiung Medical University Chung-Ho Memorial Hospital
name: National Taiwan University Hospital
First posted: 2019-11-21
Enrollment: 48
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Advanced Biliary Tract Cancer
Primary purpose: TREATMENT

Brief 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 criteria: 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.

Primary outcomes:
measure: Overall response rate (ORR)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Linkou
country: Taiwan
facility: Chang Gung Memorial Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Taipei Veterans General Hospital, Taipei, TAIWAN
name: Chen Ming-Huang, MD
role: STUDY_CHAIR
affiliation: National Health Research Institutes, Taiwan
name: Chiang Nai-Jung, MD
role: PRINCIPAL_INVESTIGATOR
References: