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

• Status: Active, not recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Health Research Institutes, Taiwan
• Collaborators: 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
• Treatments: Gemcitabine; Nivolumab

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.