pancreatic cancer
Conditions
Interventions
Group 1:Paclitaxel for injection (albumin-binding) +gemcitabine regimen combined with neoadjuvant radiotherapy and chemotherapy
Sponsors
Hu'nan Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Puncture biopsy confirmed pancreatic adenocarcinoma; 2. According to the NCCN Guidelines (2018.V1), radiological examinations identified unresectable locally advanced pancreatic cancer: (1) artery: Head/uncinate process of pancreas: 1) Tumors invade superior mesenteric artery more than 180 degrees; 2) Tumors invade abdominal trunk more than 180 degrees; 3) Invasion of the first jejunal branch of superior mesenteric artery by tumors. (2) Pancreatic body and tail: 1) Tumors invade superior mesenteric artery or celiac trunk more than 180 degrees; 2) Tumors invade the abdominal trunk and aorta; (3) vein: Head/uncinate process of pancreas: 1) Invasion or embolization of tumors (thrombus or thrombus) leading to unresectable reconstruction of superior mesenteric vein or portal vein; 2) The proximal jejunal drainage branch of most superior mesenteric veins invaded by tumors. Pancreatic body and tail: Invasion or embolization of tumors (thrombus or thrombus) leading to unresectable reconstruction of superior mesenteric vein or portal vein. 3. There are measurable lesions; 4. First-line treatment; 5. Aged 18 to 75 years old male and female; 6. Physical condition score ECOG 0-1; 7. Blood routine: neutrophils (>1.5 *10^9/L), platelets (>100 *10^9/L) and hemoglobin (>90 g/L); 8. Blood biochemical indicators: transaminase < 2.5 times the normal upper limit, total bilirubin < 2 mg/dl (less than 3.0 mg/dl in patients with biliary drainage), creatinine within the normal range; 9. There were no serious abnormalities of blood system, heart and lung function and immune deficiency (refer to their respective standards); 10. Voluntary participation and signing of informed consent; 11. Ability to comply with research visits and other program requirements.
Exclusion criteria
Exclusion criteria: 1. Distant metastasis; 2. Complicated with other malignant tumors of the system; 3. Anti-cancer therapy including ablation, radiotherapy, chemotherapy and molecular targeted therapy was performed before admission; 4. Any other research drugs were used within 5 weeks before admission; 5. Central nervous system diseases, psychiatric disorders, unstable angina pectoris, congestive heart failure, severe arrhythmia and other serious uncontrollable diseases; 6. Have a history of drug allergy to research drugs or similar structures; 7. Pregnant and lactating women; 8. Any condition that may impair patient safety or integrity of research data, including serious medical risk factors, medical conditions, and laboratory abnormalities; 9. The patient is unwilling or unable to follow the research procedure, or may be separated from the observation for one course or more during the course of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Surgical resection rate;R0 resection rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Therapeutic evaluation (RECIST criteria);Progression-free survival;Overall survival;Safety and Tolerance of Chemotherapeutic Drugs (CTCAE);Changes of CA-199 before and after treatment; | — |
Countries
China
Contacts
Public ContactHuaxin Duan
Hu'nan Provincial People's Hospital
Outcome results
None listed