pancreatic cancer
Conditions
Interventions
experimental group:Camrelizumab, albumin-bound paclitaxel and apatinib mesylate
Sponsors
Jiangsu Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 80 years, no gender limit; 2. Subjects with locally advanced or metastatic pancreatic ductal adenocarcinoma diagnosed by histology or cytology, and stage IIIb/IV tumors (judged according to UICC/AJCC staging system 2017 8th edition); 3. Have not previously received systemic treatment for locally advanced or metastatic pancreatic ductal adenocarcinoma. Chemotherapy and/or radiotherapy are allowed to be used as part of neoadjuvant/adjuvant therapy, as long as the treatment has ended before the diagnosis of late-stage or metastatic disease At least 12 months. 4. Have not received radiotherapy in the past (unless there is at least one measurable focus in a non-radiation area); 5. At least one measurable lesion (according to the RECIST1.1 standard, the CT scan length of the tumor lesion is >=10 mm, and the scan thickness is not greater than 5 mm); 6. ECOG PS score: 0-2; 7. The main organs are functioning well, that is, the relevant inspection indicators meet the following requirements in the 14 days before randomization: (1) Routine blood examination: 1) Hemoglobin >= 100 g/L (no blood transfusion within 14 days); 2) Neutrophil count> 1.5 x 10^9/L; 3) Platelet count >= 100 x 10^9/L; (2) Biochemical inspection: 1) Total bilirubin = 60 ml/min (Cockcroft-Gault formula); 8. Women of childbearing age must have a negative pregnancy test (ßHCG) before starting treatment. Women and men of childbearing age (have sex with women of childbearing age) must agree to contraception during treatment and within 6 months of the last treatment; 9. Subjects voluntarily joined the study, signed an informed consent form, had good compliance, and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: 1. Suffer from other uncured malignant tumors at the same time; 2. Subjects who can be surgically removed or treated with radical radiotherapy; 3. Subjects with a history of bleeding, and any bleeding event with a severity level of CTCAE4.0 or higher in the 4 weeks before screening; 4. Urine routine test showed urine protein >= ++ and confirmed 24-hour urine protein quantification > 1.0 g; 5. Poorly controlled hypertensive subjects; 6. Subjects who have had serious infections within 4 weeks before the first administration, including but not limited to infectious complications requiring hospitalization, bacteremia, severe pneumonia, etc. During the screening period, subjects with severe active infections requiring intravenous antibiotic treatment; 7. Subjects who need to use corticosteroids (>10 mg/day prednisone or equivalent) or other immunosuppressive agents for systemic treatment within 14 days before the first medication. In the absence of active autoimmune diseases, inhaled or topical corticosteroids and adrenal hormone replacement therapy with a dose > 10 mg/day of prednisone are allowed; 8. Have a history of chronic autoimmune diseases, such as systemic lupus erythematosus, ulcerative enteritis, Crohns disease and other inflammatory bowel diseases; hypothyroidism that only requires hormone replacement therapy and skin diseases that do not require systemic treatment ( Such as vitiligo, psoriasis or hair loss) except; 9. Subjects who are going to undergo or have previously received tissue/organ transplantation; 10. Subjects who have been vaccinated or will be vaccinated with live vaccine within 30 days before the first administration; 11. Subjects with a history of uncontrollable mental illness or severe intellectual or cognitive dysfunction; 12. Active hepatitis subjects: hepatitis B virus surface antigen (HBV sAg) positive and HBV DNA >= 500 IU/mL, hepatitis C virus antibody (HCV Ab) positive, HCV RNA positive, and abnormal liver function, combined Co-infection of hepatitis B and C; 13. Subjects with uncontrolled pleural effusion, pericardial effusion, or ascites that require repeated drainage; 14. Those who are allergic to test drugs; 15. Other situations that the researcher considers inappropriate to be included in the group.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Countries
China
Contacts
Public ContactShen Bo
Jiangsu Cancer Hospital
Outcome results
None listed