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/AClinical Study ID
NCT04856761
HUASHAN005
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
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, andpostoperative 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 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.
- ECOG score <2.
- Signed Informed Consent Form.
- 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:
- 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 significantmental abnormalities, have a history of abnormal history of the central nervoussystem;
- 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;
- 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, 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;
- Refused follow-up in accordance with the requirements set by this research program, aswell as refused to sign informed consent.
- 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
Connect with a study center
Huashan hospital
Shanghai, 200040
ChinaActive - Recruiting
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