Pancreatic cancer
Conditions
Interventions
Experimental group:Nanoparticle polymeric micellar paclitaxel combined with gemcitabine
Sponsors
Jiangsu Province Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Age =18 years old, =70 years old, male or female; 2) Can understand the purpose of clinical trials, benefits and risks, voluntarily participate in and sign informed consent; 3) ECOG score 0-2; 4) The subject has a histologically or cytologically proven tissue type of metastatic pancreatic cancer; 5) Subjects with metastatic pancreatic cancer who have not received chemotherapy, targeted or immunotherapy; Patients with metastatic pancreatic cancer who have previously received postoperative adjuvant chemotherapy, have not received targeted or immunotherapy, and have received the last chemotherapy for more than half a year or more; 6) There is at least one measurable objective lesion (including primary or metastatic lesion) according to RECIST1.1 criteria; 7) Expected survival time = 3 months; 8) The functions of major organs such as heart, lung, liver and kidney are basically normal; 9) Blood routine examination must meet the following criteria (no blood transfusion, no use of blood products, granulocyte colony stimulating factor or other hematopoietic growth factor within 7 days prior to the blood routine examination) : a) White blood cell count =3.0×10^9/L and neutrophil count =1.5×10^9/L; b) Platelet count =100×10^9/L; c) Hemoglobin =90g/L; d) During the screening period, if receiving component transfusion (red blood cells, platelets, etc.), the blood routine review at an interval of 1 week should meet the above criteria before further screening can be considered; 10) Blood biochemical examination shall meet the following criteria: a) Plasma total bilirubin =1.5× upper limit of normal value; b) ALT, AST or ALP=2.5× upper limit of normal (ALT, AST or ALP=5× upper limit of normal for subjects with liver metastasis; Bone metastasis subjects ALP=10× upper limit of normal value); c) Creatinine removal rate =50 mL/min calculated by Cockcroft-Gault formula (Cockcroft-Gault formula: Male sex Ccr = [(140 - years of age) by body weight (kg)] / [0.818 x Scr (mu mol/L)] or Ccr = (140 - years of age) by body weight (kg)/72×Scr(mg/dl), female Ccr calculated by male ×0.85); 11) The subjects had no symptoms of centerless dysfunction at baseline (NYHA heart function rating = Class II), no obvious abnormality in electrocardiogram or no clinical significance; 12) Good compliance, voluntary compliance with the clinical trial protocol during the study period, accept the investigator's interview; 13) The subjects of childbearing age voluntarily take contraceptive measures during the trial; 14) Women must be non-lactating.
Exclusion criteria
Exclusion criteria: 1) Known allergy or intolerance to the drug ingredients or excipients used in this test; 2) Primary brain tumor or central nerve metastasis (including pia meningeal metastasis), except for single brain metastasis strictly controlled asymptomatic; Patients with central nerve tumor still accompanied by craniocerebral hypertension or neuropsychiatric symptoms after treatment; 3) Acute and chronic infections that have not been eliminated, or subjects suffering from other serious diseases; 4) Other malignancies within 5 years (except cured skin basal cell carcinoma and cervical carcinoma in situ); 5) Active hepatitis, tumor liver metastases more than 1/2 of the whole liver; 6) There is third space effusion that cannot be controlled by drainage or other methods (such as medium-large pleural effusion, medium-large pericardial effusion, ascites); A small amount of pleural fluid or ascites without clinical symptoms and requiring no clinical intervention can be included in the group only after strict control; 7) Mental illness or mental disorder, poor compliance, unable to cooperate with and describe treatment responses; 8) Patients with severe organic diseases or major organ failure, such as decompensated heart and lung failure, which can not tolerate chemotherapy; 9) Abnormal coagulation function (INR>1.5, APTT>1.5 ULN), with bleeding tendency (such as active ulcer lesions in stomach, occult blood in stool (++), black stool and/or hematemesis within 3 months, hemoptysis) or lesions near the location of large blood vessels; 10) Patients with grade I or above coronary heart disease, arrhythmia (including prolonged QTc interval > 450 ms in men and > 470 ms in women), taking arrhythmia drugs or related underlying heart diseases and cardiac insufficiency; 11) Patients with renal insufficiency, previous kidney disease, and positive urinary protein (urinary protein test 2+ or above, or 24-hour urinary protein quantity >1.0g); 12) Organ transplants; 13) Drug addicts, long-term alcoholics and people with infectious diseases such as AIDS; 14) long-term adrenal corticosteroids or immunosuppressants; 15) Those who received live and attenuated vaccines such as measles, mumps, rubella, chickenpox, yellow fever, rabies, BCG and typhoid (oral) vaccines within 4 weeks prior to enrollment or planned to receive vaccines during study administration; Allowing all types of COVID-19 vaccines; 16) The subjects were active in hepatitis B or hepatitis C (previous history of hepatitis B infection, regardless of drug control, HBV DNA=1×10^4 copy number or =2000 IU/mL; Hepatitis C infection, HCV RNA=15 IU/mL); Or HIV antibody positive (no testing required if there is no clinical evidence of possible HIV infection); Or syphilis antibody (TPPA) positive; 17) Pancreatic cancer patients with recurrence and metastasis within six months after surgery; 18) The investigator considers that the subject is not able to complete the entire course of the study or is otherwise unfit to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;DCR;OS;DOR;TTP;CBR; | — |
Countries
China
Contacts
Public ContactTu Min
Jiangsu Province Hospital
Outcome results
None listed