Possible removal of locally advanced pancreatic cancer
Conditions
Interventions
Group 1:Tegafur, Paclitaxel-albumin and apatinib
Group 2:Tegafur, Paclitaxel-albumin
Sponsors
Affiliated Cancer Hospital of Harbin Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years Male or female; 2. Locally advanced pancreatic cancer was diagnosed by histopathology and/or cytology; 3. Surgeons have judged that surgical resection is difficult for patients with locally advanced pancreatic cancer without distant metastasis; 4. Patients with locally advanced pancreatic cancer who have not received chemotherapy and target lesions have not received radiotherapy; 5. According to RECIST v1.1 guidelines, at least one lesion (previously untreated by radiotherapy) was accurately measured at baseline by computed tomography (CT) or magnetic resonance imaging (MRI) (preferred intravenous contrast agent). The longest diameter of the lesion was greater than 10 mm (except for lymph nodes, the short axis of the lymph nodes must be greater than 15 mm), and the lesion was suitable for repeated and accurate measurements; 6. ECOG PS 0-1; 7. The function of main organs is normal, the following criteria should be met: Blood routine: Hb=90 g/L(No blood transfusion within 14 days); ANC=1.5×10^9/L; PLT=75×10^9/L; Biochemical tests are subject to the following criteria: TBIL=1.5×ULN (Upper Limit Of Normal); ALT and AST=2.5×ULN; If there is liver metastasis ALT and AST=5×ULN; Serum creatinine=1.5×ULNCCR(Creatinine Clearance Rate)=50ml/min (Based on Cockroft and Gault formulas); 8. Estimated lifetime=3 months; 9. Subjects voluntarily joined the study, signed informed consent 10. Women of childbearing age must undergo a pregnancy test (serum or urine) within 7 days before enrollment and the results are negative, and are willing to use appropriate methods of contraception during the trial and 8 weeks after the last administration of the test drug.
Exclusion criteria
Exclusion criteria: 1. Heart disease patients in any of the following situations: Recent history of heart disease (within 6 months): - Acute coronary syndrome - Acute heart failure (NYHA grade III or IV) - Significant ventricular arrhythmias (persistent ventricular tachycardia, ventricular fibrillation and sudden death after resuscitation) Patients with NYHA grade III or IV heart failure; Patients have severe conduction block and permanent pacemaker is ineffective (second and third degree atrioventricular block, sinoatrial block); Unidentified syncope occurred within 3 months; According to the researcher's judgment, uncontrolled severe hypertension or symptomatic hypertension. 2. There are many factors affecting oral drug absorption (such as inability to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction); 3. ECOG score (> 2); 4. Coagulation dysfunction (INR > 1.5 *ULN, APTT > 1.5 *ULN), with bleeding tendency; 5. Distant metastasis; 6. Have any history of allergic or hypersensitive reactions to research drugs or their adjuvants; 7. Known HIV infection and/or active hepatitis B virus infection; 8. Any condition that may damage patient safety or integrity of research data, including serious medical risk factors, physical condition, laboratory abnormalities; 9. Pregnant or lactating women; 10. Patients not considered suitable for inclusion by other medical practitioners; 11. Special attention: Patients at risk of gastrointestinal bleeding should not be included in the group, including: (1) active peptic ulcer lesions and occult blood in stool (++); (2) patients with a history of melena and hematemesis within 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OS; | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 resection rate;ORR;DCR;PFS;DFS; | — |
Countries
China
Contacts
Public ContactYu Han
Affiliated Cancer Hospital of Harbin Medical University
Outcome results
None listed