Overview

Gemcitabine+ Capecitabine Vs Capecitabine in Curatively Resected Biliary Tract Cancer

Status:
Not yet recruiting
Trial end date:
2025-03-30
Target enrollment:
0
Participant gender:
All
Summary
This clinical trial is an open-label, multicenter, phase 3 clinical trial to study the efficacy and safety of adjuvant gemcitabine + capecitabine combination treatment in patients with resectable biliary tract cancer according to imaging studies after surgery. All the patients must complete a consent forms before participating in the clinical trial, and the estimated enrollment period is 36 months after IRB approval. Drug Dose and Schedule: - Cohort 1: Gemcitabine/Capecitabine, every 4 weeks, total 6 cycles gemcitabine1,000 mg/m2 over 30 min D1, D8, D15 capecitabine 1660 mg/m2, D1-21 - Cohort 2: Capecitabine, everu 3 weeks, total 8 cycles capecitabine 2,500 mg/m2 D1-14
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Samsung Medical Center
Treatments:
Capecitabine
Gemcitabine
Criteria
Inclusion Criteria:

1. Patients with histologically confirmed adenocarcinoma of biliary tract canacer
(intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, or gallbladder
cancer) after curative intent R0 or R1 surgical resection

2. Pathologic disease stage of T2-4, N0-2, M0 after surgery, according to AJCC 8th TNM
staging

3. Patients who complete resection (R0 or R1 resection) for biliary tract cancer within
12 weeks of the adjuvant chemotherapy

4. No distant metastasis

5. ECOG performance sstatus score of 0 or 1

6. Age 19 years or older

7. Adequate bone marrow fuction (neutrophils ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L and
hemoglobin ≥9 g/dL)

8. Adequate liver function (total bilirubin < 1.5 fold the upper limit of normal of the
study site (ULN), alanine aminotransferase (ALT) or aspartate aminotransferase (AST) <
5.0 x ULN)

9. Adequate kidney function (Creatinine < 1.5 x ULN)

10. Unresolved systemic active infection (except for chronic viral hepatitis taking
antiviral drugs)

11. Not receiving other drugs for clinical trials or chemotherapy within 30 days prior to
randomization

12. A female participant who is not post-menopausal or amenorrhea less than 12 consecutive
months without specific reasons is eligible to participate if she is not pregnant,
confirmed by serum tests within 7 days before the initiation of chemotherapy

13. The participants provide written informed consent for the study.

14. No prior chemotherapy for biliary tract cancer

15. Participants of childbearing potential must agree to use an adequate method of
contraception for the course of the study throught 120 days after the last dose of
chemotherapy (oral contraceptives or mechanical contraception such as intrauterine
devices or contraceptive barriers and etc). Childbearing potential female is who is
not post-menopausal or amenorrhea less than 12 consecutive months without specific
reasons

Exclusion Criteria:

1. Other histology type than adenocarcinoma (such as HCC-CCC mixed type or neuroendocrine
tumor)

2. Ampula of vater cancer

3. Has known additional malignancy (participants with non-melanoma skin cancer, or
carcinoma in situ (e.g. breast carcinoma, prostate cancer) that have undergone
potentially curative therapy without recurrence for more than 3 years are not
excluded)

4. Has a history or current evidence of any condition, therapy, or laboratory abnormality
that might confound the results of the study, interfere with the subject's
participation for the full duration of the study, or is not in the best interest of
the subject to participate, in the opinion of the treating investigator.

5. Has an active infection requiring systemic therapy (bacteria, virus, fungal, etc)

6. Has a known history of Human Immunodeficiency Virus (HIV)

7. Has an active of hepatitis A or B (patients under anti-B-viral treatment with HBV DNA
1000≤copies/ml is allowed to particiapte).

8. Has a history of severe hemorrhage (gastrointestinal or neurologic) within 2 weeks
prior randomization

9. Is unable to take oral drug due to gastrointestinal obstruction or any other
conditions.

10. Any history of significant cardiac disease within 3 months prior to randomization
including unstable angina, NYHA (The New York Heart Association )III or IV congestive
heart failure, myocardiac infarction, or severe uncontrolled arrhythmias

11. Pregnant, breast-feeding or pregnancy test positive female patients

12. Has any contraindications for investigational drug

- History of hypersensitivity to capecitabine or gemcitabine

- Any hypersensitivity to fluorouracil drugs

- Concurrent administration with sorivudine or brivudine

- DPD(dihydro-pyridine dehydrogenase) deficiency

- History of TS-1(tegafur / gimeracil / oteracil) administration

- Galactose intolerance, Lapp lactase deficince, glucose-galactose malabsorption

- Interstitial pneumonia or pulmonary fibrosis