Locally advanced and metastatic pancreatic cancer
Conditions
Interventions
experimental group :The albumin binding paclitaxel + teggio/gemcitabine + oxaliplatin regimen was sequential and alternating
Sponsors
Affiliated Cancer Hospital of Harbin Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Volunteer to participate in the trial and sign the informed consent; 2. 18 3 months; 6. CT or MRI examination must be performed within 1 week; 7. At least one lesion that can be measured by RECIST v1.1 criteria; 8. No chemotherapy (postoperative adjuvant chemotherapy must be completed after more than 6 months); 9. Not treated with radiotherapy (unless there is at least one measurable target lesion in a non-irradiated area); 10. Laboratory examination within 14 days prior to study entry: absolute neutrophil count (ANC) >= 1.5 x 10^9/L; Platelets acuity 100 x10^9 / L; Hb 90 g/L or higher (9 g/dL); AST and ALT <= 2.5 times normal upper limit (ULN) (without evidence of liver metastasis); AST, ALT<=5.0 times normal upper limit (ULN) (with evidence of liver metastasis); Upper limit of creatinine <= 1.5 normal (ULN); Total bilirubin <= 1.5 upper limit of normal value (ULN); HbsAg (-) . 11. Negative urine pregnancy test (female), and contraceptive use during the trial period to 3 months after the end of the trial; 12. Patients were able to follow the protocol and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; Or is fertile but refuses to use contraception; 2. Severe active infections requiring intravenous antibiotic therapy occurred during enrollment; 3. Allergic to test drugs; 4. Presence of neuropathy >= grade 2 (CTCAE 4.0); 5. Uncontrolled, symptomatic brain metastasis or a history of uncontrollable mental illness; Severe intellectual or cognitive impairment; 6. Congestive heart failure, uncontrollable arrhythmia, myocardial infarction within 6 months, unstable angina pectoris, stroke or transient ischemic attack; 7. Other malignancies within 5 years other than carcinoma in situ of the cervix or skin squamous cell carcinoma that has been adequately treated, or basal cell carcinoma of the skin that has been basically controlled; 8. Patients have already participated in another clinical trial; 9. A person deprived of his liberty or guardianship; 10. Unable to receive medical supervision during the trial for geographical, social or psychological reasons; 11. The researchers did not consider participants to be eligible for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of patients alive without progression 6 months after inclusion, m6PFSR; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;ORR;PFS;safety;safety; | — |
Countries
China
Contacts
Public ContactZhiwei Li
Affiliated Cancer Hospital of Harbin Medical University
Outcome results
None listed