A Study of Capecitabine Versus S-1 as Adjuvant Therapy in Patients With Biliary Tract Carcinoma After Surgical Resection

Last updated: August 16, 2022
Sponsor: Fudan University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Gall Bladder Cancer

Biliary Tract Cancer

Abdominal Cancer

Treatment

N/A

Clinical Study ID

NCT04856761
HUASHAN005
  • Ages 18-75
  • All Genders

Study Summary

The purpose of this study is to assess the difference of safety and efficacy about Capecitabine and S-1 for treatment of patients with low-risk of recurrence after BTC surgery.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female, age> 18 years old, and <75 years old.
  2. Diagnosis is gallbladder cancer or biliary adenocarcinoma via pathological histology.
  3. Patients have received curative surgery of gallbladder cancer or bile duct cancer, andpostoperative pathology has confirmed R0 / R1 resection.
  4. Ability to comply with the study protocol, in the investigator's judgment.
  5. No tumor recurrence before the start of chemotherapy.
  6. No fluorouracil drugs were used in the past six months.
  7. The main organ function is good, that is, within 14 days before the start ofmedication, laboratory inspection confirmed that there is sufficient bone marrowfunction, liver function, renal function, heart function: hemoglobin ≥90g / L; neutralgranulocyte count ≥1.5 × 109 / L; platelet ≥ 70 × 109 / L; alt, AST ≤ 3 × ULN (normalvalue upper limit); total bilirubin ≤ 2.5 × ULN (normal value upper limit)); serumcreatinine <1.5 × ULN (normal value upper limit); Serum albumin ≥ 30g / L; coagulationfunction: PT extended <2s.
  8. ECOG score <2.
  9. Signed Informed Consent Form.
  10. Male and female subjects with potential fertility must agree to adopt high-efficiencycontraceptive methods during the study of at least 3 months after receiving the lasttreatment.

Exclusion

Exclusion Criteria:

  1. First chemotherapy start time > 16 postoperatively weeks.
  2. Patients with other tumors, or patients with recurrence before chemotherapy;
  3. History of allergic with study drugs;
  4. History of organ transplantation requires immunosuppressive treatment;
  5. Pregnancy or lactation women;
  6. Accept the following system treatment within 4 weeks before the start of treatment:cytotoxic treatment, signal conduction inhibitors, immunotherapy, hormone therapy.
  7. Participate in other clinical trials within 3 months;
  8. Abnormality of the peripheral nervous system (> NCI CTC 1), clinically significantmental abnormalities, have a history of abnormal history of the central nervoussystem;
  9. Electrocardiogram abnormal or clinically obvious heart disease, such as: congestiveheart failure, symptomatic coronary heart disease, arrhythmia, clinical manifestationsof heart disease, or epasus in the past 12 months; severe infection (> GRADE 2National Cancer Institute [NCI] -Common Terminology Criteria for AdverSe Events [CTCAE] Version 3.0), sepsis, severe metabolism or diabetes; Digestive ulcer activityperiod requires treatment, absorption disabilities, diarrhea, intestinal obstruction ,Destroyer of the upper deactivated tract integrity;
  10. History of HIV infection;
  11. Anti-viral treatment cannot be controlled or chronic hepatitis C;
  12. Renal failure requires blood or peritoneal dialysis;
  13. There are some other serious or unstable diseases or medical, social, sychologicalstates, can endanger the safety of the subject and / or his / her to study thecompliance or can prevent patients to participate in clinical research or Theassessment of the research results;
  14. Refused follow-up in accordance with the requirements set by this research program, aswell as refused to sign informed consent.
  15. Other factors that may affect patient income and assessment results;

Study Design

Total Participants: 160
Study Start date:
November 01, 2020
Estimated Completion Date:
December 30, 2024

Study Description

Patients received curative BTC surgery will be informed about the study. After being informed about the study and potential risks, all patients giving written informed consent will undergo a 1-week screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be observed for recurrence of BTC.

Connect with a study center

  • Huashan hospital

    Shanghai, 200040
    China

    Active - Recruiting

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