pancreatic cancer
Conditions
Interventions
case series:Nil
Sponsors
Department of Pancreatic Surgery, Huashan Hospital affiliated to Fudan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For enrolled treatment, patients must meet the following criteria: (1) Sign the informed consent; (2) Aged 18 and above, 75 and below; (3) Histopathologically confirmed pancreatic ductal adenocarcinoma; (4) Patients who plan to receive preoperative neoadjuvant chemotherapy without contraindications according to doctors' evaluation and patients' wishes; (5) ECOG score is 0-1, and the expected survival time is more than 1 year; (6) The function of major organs and bone marrow is basically normal, and all functional indicators should be tested within 21 days before the initial treatment: blood tests: white 2000 cells/mm3 or higher; Absolute neutrophil count (ANC) >= 1500/ MCL3; Platelet count >= 100,000 / MCL; Hemoglobin >= 9 g/dL; The international standardized rate (INR) <= 1.5 (or 2-3 in the case of long-term and stable administration of farwarin), and the prothrombin time (PTT) <= the upper limit of the normal value (ULN); renal function tests, serum creatinine/creatinine clearance acuities were 1.5 times of the normal limit; liver function test: bilirubin (total) within the normal range (organization specify the normal range, total bilirubin of Gilbert syndrome < 3.0 mg/dL); AST/SGOT, ALT/SGPT and alkaline phosphatase <= 2.5 times of the normal upper limit; cardiopulmonary function test: cardiopulmonary function evaluation show that patients can tolerate surgery. (7) The woman should be a patient who has used a contraceptive method (such as an intrauterine device (IUD), contraceptive pill or condom); Negative serum or urine pregnancy test within 7 days prior to study inclusion, and must be non-lactating; Men should agree to use contraception during the study period and for six months after the end of the study period. (8) Willing to provide blood and tumor tissue samples according to the design of the study plan; (9) Good compliance, willing to accept postoperative follow-up. (10) Voluntarily bear the testing expenses. (11) Use of injectable paclitaxel (albumin binding) in combination with gemcitabine regimen as a neoadjuvant chemotherapy regimen.
Exclusion criteria
Exclusion criteria: (1) Non-primary pancreatic tumor; (2) The presence of two or more tumors; (3) Within 72 hours before the first treatment, if the urine test is positive or can not be confirmed as negative, a further confirmation of serum pregnancy is required; Pregnant or lactating women; (4) A history of other malignant tumors within five years; (5) Patients with surgical contraindications; (6) Perioperative (30 days) death; (7) persons who have a history of abuse of psychotropic substances and cannot be cured or have mental disorders; Patients with bleeding tendencies (e.g., active gastrointestinal ulcers) or those treated with anticoagulants or vitamin K antagonists such as warfarin, heparin, or their analogues; (8) Other concomitant diseases that, according to the judgment of the researcher, seriously endanger the safety of the patient or affect the completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival, OS;disease-free survival, DFS;Detection rate of ctDNA; | — |
Countries
China
Contacts
Public ContactDeliang Fu
Huashan Hospital, Fudan University
Outcome results
None listed