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

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Brief Title

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

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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Overall response rate (ORR)


Condition

Advanced Biliary Tract Cancer

Intervention

TS-1

Study Arms / Comparison Groups

 NGS
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

48

Start Date

December 27, 2019

Completion Date

December 31, 2022

Primary Completion Date

December 31, 2022

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.
      

Gender

All

Ages

20 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

Taiwan

Location Countries

Taiwan

Administrative Informations


NCT ID

NCT04172402

Organization ID

T1219


Responsible Party

Sponsor

Study Sponsor

National Health Research Institutes, Taiwan

Collaborators

 Taipei Veterans General Hospital, Taiwan

Study Sponsor

, , 


Verification Date

October 2020