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

  • STATUS
    Recruiting
  • End date
    Dec 30, 2022
  • participants needed
    160
  • sponsor
    Fudan University
Updated on 2 May 2021

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.

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.

Details
Condition Adenocarcinoma, Cholangiocarcinoma, Relapse, Biliary neoplasm, Neoplasm of unspecified nature of digestive system, Malignant neoplasm of gallbladder, Gallbladder Disease, Urothelial Tract Cancer, Gall Bladder Disorders, Malignant Adenoma, Gall Bladder Cancer, Biliary Tract Cancer, Digestive System Neoplasms, gallbladder cancer, relapse/recurrence
Treatment Capecitabine, S-1
Clinical Study IdentifierNCT04856761
SponsorFudan University
Last Modified on2 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female, age> 18 years old, and <75 years old
Diagnosis is gallbladder cancer or biliary adenocarcinoma via pathological histology
Patients have received curative surgery of gallbladder cancer or bile duct cancer, and postoperative pathology has confirmed R0 / R1 resection
Ability to comply with the study protocol, in the investigator's judgment
No tumor recurrence before the start of chemotherapy
No fluorouracil drugs were used in the past six months
The main organ function is good, that is, within 14 days before the start of medication, laboratory inspection confirmed that there is sufficient bone marrow function, liver function, renal function, heart function: hemoglobin 90g / L; neutral granulocyte count 1.5 109 / L; platelet 70 109 / L; alt, AST 3 ULN (normal value upper limit); total bilirubin 2.5 ULN (normal value upper limit)); serum creatinine <1.5 ULN (normal value upper limit); Serum albumin 30g / L; coagulation function: PT extended <2s
ECOG score <2\
Signed Informed Consent Form
Male and female subjects with potential fertility must agree to adopt high-efficiency contraceptive methods during the study of at least 3 months after receiving the last treatment

Exclusion Criteria

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

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What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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