pancreatic cancer
Conditions
Interventions
Postoperative adjuvant chemotherapy for pancreatic cancer:chemotherapy
Postoperative adjuvant chemotherapy for pancreatic cancer:chemotherapy combined with immunotherapy
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Sign the informed consent form. Received a full explanation and understanding of the purpose, content, predicted efficacy, pharmacological effects, and risks of this trial, and the subjects signed the informed consent form. Subjects voluntarily joined this study, had good compliance, were able to carry out treatment and follow-up, and voluntarily complied with the relevant provisions of this study; 2) Target Audience a) Radical resection with pathologically confirmed pancreatic ductal adenocarcinoma; b) Good postoperative recovery, no serious postoperative complications, no abnormalities in liver and kidney function, and blood routine c) No prior neoadjuvant chemotherapy, radiotherapy, immune checkpoint inhibitor therapy, or targeted therapy; d) ECOG PS score: 0~1 or Karnofsky performance status (KPS) before enrollment (KPS) greater than or equal to 70 points; 3) There is no abnormality in the results of physical examination and laboratory examination a) no abnormalities in a hematologic function defined as i) absolute neutrophil (ANC) count =1.5×109/L; ii) Platelet (PLT) count: =70×109/L; iii) Hemoglobin (Hb) level = 90 g/L. b) Absence of abnormal liver function is defined as i) total bilirubin (TBil) levels: 1.5 times the upper limit of normal (ULN) =, and ii) aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels = 3 times the ULN. c) Renal function absence is defined as serum creatinine = 1.5 times ULN or calculated creatinine clearance = 50ml/min. d) No abnormal coagulation function is defined as international normalized ratio (INR) = 1.5 times the ULN, and the prothrombin time (PT) or activated partial thromboplastin time (aPTT) = 1.5 times the ULN; 4) Age and reproductive status a) males and females between the ages of 18 and 75; b) Subjects of childbearing potential must agree to use effective contraception for the duration of the trial; Women of childbearing potential must have a negative serum or urine pregnancy test 24 hours prior to the start of chemotherapy; c) Females must be non-lactating.
Exclusion criteria
Exclusion criteria: 1) Pancreatic cancer patients undergoing palliative resection; 2) Live vaccine, or any investigational drug, less than four weeks prior to study administration or possibly during the study period; 3) Prior treatment with anti-PD-1 or anti-PD-L1 antibodies; 4) Enrollment in another clinical study at the same time, unless it is an observational (non-interventional) clinical study or an interventional clinical study follow-up; 5) Medical history and intercurrent illness a) Uncontrolled medical severe illness that, in the opinion of the investigator, will affect the subject's ability to receive treatment under the study protocol, such as concomitant serious medical diseases, including severe heart disease, cerebrovascular disease, uncontrolled diabetes mellitus, uncontrolled hypertension, uncontrolled infection, active peptic ulcer. b) Subject has active, known, or suspected autoimmune disease, including systemic lupus erythematosus, Hashimoto's thyroiditis, scleroderma, polyarteritis nodosa, or autoimmune hepatitis; Subjects with type I diabetes mellitus, hypothyroidism requiring hormone replacement only, skin conditions that do not require systemic treatment (such as vitiligo, psoriasis, or alopecia), or conditions that are not expected to recur in the absence of external triggers are allowed to participate; c) Have an active tuberculosis infection. Patients with active tuberculosis infection within one year before administration, even if they have been treated, should be excluded. Patients with a history of active tuberculosis infection more than one year ago are also excluded unless previous treatment with standardized antituberculosis therapy is demonstrated. d) Previous interstitial lung disease or (non-infectious) pneumonitis requiring oral or intravenous steroid therapy. e) Long-term treatment with systemic hormones (dose equivalent to 10 mg prednisone/day) or any other form of immunosuppressive therapy. Subjects using inhaled or topical corticosteroids may be enrolled; f) Heart disease that is not well controlled, such as: (1) New York Heart Association (NYHA) grade 2 or above heart failure; (2) unstable angina; (3) Myocardial infarction within one year; (4) Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; g) Dementia, altered mental status, or any psychiatric illness that would preclude understanding or giving informed consent or filling out questionnaires. h) Subject has a known history of psychotropic substance abuse, alcoholism, or drug abuse. i) History of allergy or hypersensitivity to any of the therapeutic components. j) Malignancy other than pancreatic cancer within five years prior to randomization, except for adequately treated basal cell or squamous epithelial cell carcinoma of the skin, localized prostate cancer after radical resection, and ductal carcinoma in situ of the breast after radical resection. k) Subjects with Grade = 2 Peripheral Neuropathy according to CTCAE version 5.0. l) Active infection requiring systemic therapy. m) Positive for hepatitis C virus (HCV) antibody or human immunodeficiency virus (HIV) antibody. 6) It needs to be combined with other anti-tumor drugs. 7) In the opinion of the investigator, the subject should be excluded from this study; for example, in the judgment of the investigator, the subject has other factors that may lead to the forced termination of the study, s
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DFS;treatment safety; | — |
Countries
China
Contacts
Public ContactXu Jin
Fudan University Shanghai Cancer Center
Outcome results
None listed