pancreatic cancer
Conditions
Interventions
Locally advanced unresectable pancreatic cancer:paclitaxel polymer micelles for injection combined with gemcitabine
Metastatic Pancreatic Cancer:paclitaxel polymer micelles for injection combined with gemcitabine
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 70 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 have signed the informed consent form; 2) Target Population a) Locally advanced/metastatic pancreatic adenocarcinoma confirmed by histopathological or cytology; b) At least one measurable objective lesion according to RECIST1.1 criteria; c) Subjects with locally advanced/metastatic pancreatic cancer who have not received chemotherapy targeted, immunotherapy; d) ECOG score of 0-2; e) Expected survival time= three months; f) Willing to comply with study procedures, able to perform treatment and follow-up; g) There are no contraindications to using paclitaxel polymer micelles and gemcitabine. 3) Abnormal results of physical examination and laboratory tests a) Hematologic abnormalities defined as i) absolute neutrophil (ANC) count =3×109/L; ii) platelet (PLT) count: =100×109/L; iii) Hemoglobin (Hb) level = 90 g/L. (During the screening period, if you receive component transfusion (red blood cells, platelets, etc.), you must recheck the blood routine at one week and meet the above criteria before considering continuing the screening). b) Abnormal liver function is defined as i) total bilirubin (TBil) levels: 1.5 times the upper limit of normal (ULN) =; ii) aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels = 2.5 times the ULN, and the upper limit of normal for ALT, AST, or ALP =5 × in subjects with liver metastases; Subjects with bone metastases ALP = 10× upper limit of normal. c) Definition of abnormal renal function: serum creatinine = 1.5 times ULN, or calculated creatinine clearance = 50ml/min. d) Definition of coagulopathy: International normalized ratio (INR) = 1.5 times ULN and prothrombin time (PT) or activated partial thromboplastin time (aPTT) = 1.5 times ULN, unless the subject is receiving anticoagulant therapy. 4) Subjects who are hepatitis B surface antigen positive (HBsAg) and have a peripheral blood hepatitis B virus deoxyribonucleic acid (HBV-DNA) titer = 1×103 copies/L; If HBsAg is positive and peripheral blood HBV-DNA = 1×103 copy number/L, the subject is eligible for inclusion if the investigator believes that the subject's chronic hepatitis B is in a stable phase and does not increase the subject's risk. 5) Subjects have no symptoms of cardiac insufficiency at baseline (NYHA cardiac function classification = grade II), and there is no obvious abnormality in ECG or abnormality is not clinically significant; 6) Age and reproductive status a) Males and females aged 18-70 years; 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 before the start of chemotherapy; c) Females must be non-lactating.
Exclusion criteria
Exclusion criteria: 1) Known allergy or intolerance to the ingredients or excipients of the drug used in this trial; 2) Primary brain tumors or central nervous metastases (including leptomeningeal metastases), except for single brain metastases, which are strictly controlled and asymptomatic; Central nervous system tumors are still accompanied by craniocerebral hypertension or neuropsychiatric symptoms after treatment; 3) Acute and chronic infections that have not been eliminated or subjects with other severe diseases at the same time; 4) Other malignant tumors within five years (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix); 5) Active hepatitis and tumor liver metastases exceeding 1/2 of the whole liver; 6) Presence of third space effusion that cannot be controlled by drainage or other methods (e.g., moderate-large pleural effusion, moderate-large pericardial effusion, ascites); A small amount of pleural effusion or ascites without clinical symptoms and not requiring clinical intervention can only be enrolled after strict control; 7) Psychiatric illness or mental disorder, poor compliance, inability to cooperate and narrate treatment response; 8) Patients with severe organic lesions or major organ failure, such as decompensated heart and lung failure, resulting in intolerance to chemotherapy; 9) Abnormal coagulation function (INR>1.5, APTT>1.5 ULN), patients with a bleeding tendency (such as active ulcer lesions in the stomach, fecal occult blood (++), melena and hematemesis within three months, hemoptysis) or lesions close to the location of large vessels; 10) Patients with grade I or above coronary heart disease, arrhythmia (including QTc interval prolongation >450 ms for men and 470 ms > for women), taking arrhythmia drugs or related underlying heart diseases and cardiac insufficiency 11) Patients with renal insufficiency, previous kidney disease, and positive urine protein (urine protein test 2+ or above, or 24-hour urine protein quantification >1.0g); 12) Organ transplant recipients; 13) Those who are addicted to drugs and other harmful drugs, long-term alcoholics, and infectious diseases such as AIDS; 14) Long-term adrenocorticosteroid or immunosuppressant users; 15) Those who have been vaccinated (including live vaccines and live attenuated vaccines), such as measles, mumps, rubella, chickenpox, yellow fever, rabies, BCG and typhoid (oral) vaccines, etc., within four weeks before enrollment, or those who plan to be vaccinated during the study administration; All types of COVID vaccines are permitted; 16) Subject is in the active phase of hepatitis B or hepatitis C (previous history of hepatitis B infection, regardless of drug control, HBV DNA = 1×104 copy number or =2000 IU/mL; Hepatitis C infection, HCV RNA=15 IU/mL); or positive for human immunodeficiency virus (HIV) antibodies (testing is not required if there is no clinical evidence of possible HIV infection); or positive for syphilis antibody (TPPA); 17) Patients with pancreatic cancer that has recurred and metastasized within six months after surgery; 18) In the opinion of the investigator, the subject cannot complete the entire trial process or other conditions that are not suitable for participating in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate, ORR;progression-free survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, OS;disease control rate, DCR;duration of remission, DOR;time to progress, TTP;Clinical benefit rate, CBR;security event; | — |
Countries
China
Contacts
Public ContactYu Xianjun
Fudan University Shanghai Cancer Center
Outcome results
None listed