pancreatic cancer
Conditions
Interventions
Test group:Different doses of LH011 with GN (albumin bound paclitaxel 125 mg / M2 + gemcitabine 1000 mg / m2)
Sponsors
Cancer Hospital Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) 18= age = 75 years old (2) Patients with locally advanced or recurrent metastatic pancreatic cancer who are not suitable for radical radiotherapy or surgery with histological or cytology confirmed; (3) Patients who have not received systemic anti-tumor therapy before; (4) According to the Efficacy Evaluation Criteria for Solid Tumors (RECIST) version 1.1, there is at least one measurable lesion, and the lesion that has been previously treated by radiotherapy or locoregional treatment must have imaging evidence of disease progression to be regarded as a target lesion. Target lesions meet the following criteria: short diameter = 15 mm for lymph node lesions or a maximum diameter of =10 mm for non-nodal lesions; (5) The level of organ function must meet the following requirements (no blood products or hematopoietic growth factor treatment within 2 weeks before the first dose, such as granulocyte colony-stimulating factor, erythropoietin, etc.): have suitable organ and hematopoietic function, and confirm that there is no serious liver and kidney function abnormalities according to the following laboratory tests and auxiliary examinations; Absolute neutrophil count (ANC) =1.5×109/L; Platelet (PLT) =100×109/L; Hemoglobin (HGB) =90g/L; In the absence of liver metastases, serum total bilirubin (TBIL) = twice that of ULN; In the presence of liver metastases, serum total bilirubin (TBIL) = 3 times ULN; Serum creatinine = 1.5 times that of ULN; In the absence of liver metastases, ALT and AST = 2.5 times the ULN; In the presence of liver metastases, ALT and AST = 5 times the ULN; Prothrombin time (PT), thrombin time (TT), and activated partial thromboplastin time (APTT) are within the normal range (±15%). (6) ECOG Performance Status (PS) = 2 points; (7) The expected survival is greater than 3 months; (8) Effective contraception from the signing of the informed consent form until 3 months after the last dose; (9) Sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Patients with important coagulation diseases or bleeding diseases in the past or present, such as thrombotic diseases or hemophilia (2) Patients who underwent anticoagulation or thrombolytic therapy 4 weeks before the start of treatment (except for patients who were judged to be using low-dose anticoagulation therapy by the investigator, including unfractionated heparin = 15000 IU/d, low molecular weight heparin = 5000 IE anti-Xa activity or acetylsalicylic acid =100 mg/day); (3) Anti-tumor therapy was carried out within 4 weeks before the start of treatment in this study, including chemotherapy (of which nitrosourea or mitomycin were within 6 weeks before the start of treatment in this study), radiotherapy, biological therapy, immunotherapy or targeted therapy; (4) Proprietary Chinese medicines, Chinese medicine decoctions or other anti-tumor treatments for pancreatic cancer were carried out within 2 weeks before the start of treatment in this study; (5) Toxic reactions (such as leukocytes/platelets/anemia/bleeding, etc.) have not recovered to the level of 0 or 1 (except hair loss) after previous anti-cancer treatment; (6) Patients with central nervous system metastases such as brain metastases, leptomeningeal metastases or spinal cord compression; (7) Patients with malignant tumors other than pancreatic cancer, excluding cured cervical carcinoma in situ or skin basal cell carcinoma and other malignant tumors that have been cured for 5 years; (8) Patients suffering from the following digestive tract diseases; Patients with active gastric or duodenal ulcer or intestinal obstruction; Those who have had abdominal fistula, gastrointestinal perforation or intra-abdominal abscess, or active gastrointestinal bleeding in the past 6 months; Patients with chronic enteritis and/or obstructive inflammatory bowel disease. (9) Patients with active uncontrollable bacterial, viral or fungal infections who require systemic treatment; (10) Have uncontrollable or significant cardiovascular disease, including; New York Heart Association (NYHA) grade II or above congestive heart failure, unstable angina, myocardial infarction, or arrhythmias requiring treatment at the time of screening within 6 months; Primary cardiomyopathy (such as dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, amorphous cardiomyopathy); Clinically significant electrocardiogram (ECG) abnormalities or arrhythmias; Symptomatic coronary heart disease requiring medication; Diagnosed pulmonary hypertension; Uncontrolled moderate hypertension (SBP > 160mmHg or DBP >100mmHg after drug intervention, measured 3 times a day). (11) Nephrotic syndrome or moderate to severe proteinuria (urine protein=2+); (12) Those who have undergone major surgery or trauma within 4 weeks before participating in the trial, the surgical wound has not healed, ulcerated or fractured, or received open wounds caused by tooth extraction and other dental operations, and have not fully recovered; (13) Inability to take oral medications, previous surgical history or severe gastrointestinal diseases such as dysphagia, etc., which the investigator believes may affect the absorption of the study drug; (14) History of liver disease with known clinical significance, including viral or other hepatitis or cirrhosis; HBsAg positive and HBV DNA = 2000 IU/mL; Positive for HCV antibodies or positive for HCV-RNA. (15) Those wh
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression free survival;objective response rate;disease control rate;duration of overall response; | — |
Countries
China
Contacts
Public ContactYuankai Shi
Cancer Hospital Chinese Academy of Medical Sciences
Outcome results
None listed