Pancreatic cancer
Conditions
Interventions
Gesitapine/albumin paclitaxel/S1 (Tegio)/Lunvatinib group:Add Lunvatinib
Sponsors
The First Affiliated Hospital of Xiamen University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) was confirmed by pathological diagnosis. Locally advanced PDAC was defined as tumor invasion that could not achieve R0 resection. 2. No previous anti-tumor treatment; 3. Be between 18 and 65 years of age; 4. Eastern Cooperative Oncology Group (ECOG) score 0-2; 5. Expected survival of more than 3 months with adequate organ and bone marrow function and no detectable active infectious disease or serious complications affecting survival. Adequate organ function was as follows: an absolute neutrophil count of at least 1500 per cubic millimeter, a platelet count of at least 100,000 per cubic millimeter, and a hemoglobin level of at least 9.0 g per deciliter. Total bilirubin, alanine aminotransferase and aspartate aminotransferase =60 ml/min, proteinuria <=2 g /24 h; Child-Pugh score < 7; Electrocardiogram was normal. 6. Both male and female patients had to be willing to use strict and reliable contraceptive methods (e.g., condom use, intrauterine device placement, etc.) during the trial and for 12 months after drug discontinuation; 7. Must be able to voluntarily participate in the study and sign informed consent.
Exclusion criteria
Exclusion criteria: 1. A known severe allergic reaction to any of the protocol drugs; 2. Synchronous or metachronous malignancy (excluding adequately treated basal cell carcinoma of the skin and carcinoma in situ of the cervix) within the past 5 years; 3. Pregnant or lactating women; 4. Patients with newly discovered or suspected evidence of uncontrolled brain metastases; 5. Other types of chemotherapy, radiotherapy or clinical trials were performed simultaneously during the trial; 6. Severe or uncontrolled infectious diseases (HIV, active pulmonary tuberculosis or HBV DNA>103/ml), significant coagulopathy, active bleeding and bleeding tendency or other major diseases of the cardiovascular, respiratory, digestive or immune systems; 7. Severe or uncontrolled pleural effusion or ascites; 8. Severe mental disorders; 9. The investigator determined that enrollment was not appropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR);Disease control rate(DCR);Progression-free survival (PFS) ; | — |
Countries
China
Contacts
Public ContactYanming Zhou
The First Affiliated Hospital of Xiamen University
Outcome results
None listed