Last updated: August 31, 2023
Sponsor: Changhai Hospital
Overall Status: Active - Recruiting
Phase
2
Condition
Digestive System Neoplasms
Treatment
Gemcitabine
Tislelizumab
Nab paclitaxel
Clinical Study ID
NCT04902261
CHEC2020-144
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients with radiologically or histologically confirmed postoperative RecurrentPancreatic Cancer
- Patients with at least one measurable lesion (according to RECIST 1.1 criteria);
- Have not received gemcitabine-based regimen after surgery
- No systemic treatment after diagnosis of recurrence
- ECOG score 0-1
- Expected survival ≥ 3 months;
- Liver function is essentially normal: absolute neutrophil count > 1500/mm ³; plateletcount > 100,000/mm ³; creatinine less than 1.5 times the upper limit of normal orcalculated creatinine clearance (CRCI) > 45 mL/min; total bilirubin ≤ 2.0 mg/dL;aspartate aminotransferase (AST) and alanine aminotransferase less than 2.5 times theupper limit of normal
- Appropriate to participate in this trial as assessed by the investigator beforeentering the study
- Male and female subjects of childbearing potential must agree to use an effectivemethod of contraception throughout the study
- Signed Informed Consent Form
Exclusion
Exclusion Criteria:
- Patients who only undergo abdominal laparotomy but do not undergo resection ofpancreatic tumor tissue
- Received gemcitabine-based regimen after surgery
- Systemic treatment after diagnosis of recurrence
- Patients with previous allergic reactions to similar drugs
- Pregnant or lactating patients
- Presence of pericardial effusion, uncontrolled pleural effusion, or clinicallysignificant ascites at screening (including detectable ascites or ascites requiringpuncture and aspiration on physical examination at screening)
- History of interstitial lung disease, pneumonitis, or uncontrolled systemic disease,including diabetes, hypertension, pulmonary fibrosis, acute lung disease, etc
- Patients with severe cardiovascular diseases within 12 months before enrollment, suchas symptomatic coronary heart disease, ≥ grade II congestive heart failure,uncontrolled arrhythmia, myocardial infarction, etc
- Presence of any active immunodeficiency or autoimmune disease and/or history of anyimmunodeficiency or autoimmune disease that may recur at screening (e.g.,hypothyroidism or hyperthyroidism, interstitial pneumonia, enteritis, hepatitis,hypophysitis, vasculitis, myocarditis, etc)
- Use of steroids or other systemic immunosuppressive therapy 14 days prior toenrollment
- Patients with other previous malignancies who are not cured
- Immunodeficient patients, such as HIV-positive
- Uncontrollable psychosis
Study Design
Total Participants: 140
Treatment Group(s): 3
Primary Treatment: Gemcitabine
Phase: 2
Study Start date:
November 20, 2020
Estimated Completion Date:
November 20, 2023
Study Description
Connect with a study center
Changhai Hospital
Shanghai, 200433
ChinaActive - Recruiting
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