tumors of the biliary tract
Conditions
Interventions
experimental group:S-1
experimental group:Capecitabine
Control group:placebo
Sponsors
JIANGSU HENGRUI MEDICINE CO., LTD.
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Male or female: older than 18 years old; 2. Histopathological diagnosis of gallbladder or bile duct adenocarcinoma; 3. Patients have undergone radical gallbladder cancer or cholangiocarcinoma surgery, and no tumor recurrence before maintenance treatment; 4. ECOG =0-2 points; 5. Within 7 days after the start of randomized treatment, laboratory tests confirmed that there was adequate bone marrow function, liver function, renal function, and heart function: hemoglobin = 90g/L; absolute neutrophil count (ANC) = 1.5×10^9/L; platelet =70×10^9/L; ALT, AST =3 ULN; serum creatinine <1.5 ULN; Serum albumin =30g/L; 6. The patient is willing to sign an informed consent form and agrees to follow-up postoperatively according to the requirements of this study design; 7. Male and female subjects with potential fertility must agree to use highly effective methods of contraception throughout the study period and for at least 3 months after receiving the last treatment.
Exclusion criteria
Exclusion criteria: 1. Patients with other tumors, or patients who have relapsed before chemotherapy; 2. The perioperative chemotherapy period is greater than 6 months before and after surgery; 3. Test related drug allergies; 4. History of organ transplantation, need immunosuppressive treatment; 5. Pregnant mothers; 6. Other factors that may affect the patient's enrollment and assessment results; 7. The following systemic treatments were received within 4 weeks prior to the start of treatment: cytotoxic therapy, signalling inhibitors, immunotherapy, hormone therapy; 8. Peripheral nervous system abnormalities (>NCI CTC Level 1), clinically significant mental abnormalities, history of central nervous system abnormalities, or episodes of seizures; 9. Abnormal electrocardiogram or clinically obvious heart disease, such as: congestive heart failure, symptomatic coronary heart disease, arrhythmia, clinically manifest heart disease, or myocardial ischemia 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 Metabolic Disorders or Diabetes; People with Peptic Ulcer Active, Absorption, Diarrhea, Obstruction and with destruction of the integrity of the upper digestive tract; 10. History of HIV infection; 11. There are active or chronic hepatitis B or C hepatitis that cannot be controlled by antiviral therapy; 12. Renal failure requires blood or peritoneal dialysis; 13. There are some other serious or unstable diseases or medical, social, psychological conditions that can compromise the subjects safety and/or his/her compliance with the study or can prevent the patient from participating in clinical studies or Assessment of the results of the study.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| overall survival;objective response rate;disease controlled rate; | — |
Primary
| Measure | Time frame |
|---|---|
| Disease free survival; | — |
Countries
China
Contacts
Public ContactFuyu Li
West China Hospital, Sichuan University
Outcome results
None listed