Pancreatic cancer
Conditions
Interventions
The experimental group:Camrelizumab+RFA +chemotherapy
Sponsors
Jiangsu Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Subjects aged from 18 to 80, regardless of gender; 2. Subjects with primary pancreatic lesions resected by R0 / R1; 3. Those subjects with pathologically confirmed liver oligometastasis of pancreatic cancer, and the number of intrahepatic lesions was less than 5, and the length of a single lesion was less than 3 cm; 4. Patients who are allowed to resect pv-smv for revascularization and achieve R0 / R1 resection; 5. Subjects who have not received immunotherapy in the past but have received gemcitabine or fluorouracil monotherapy or multidrug adjuvant chemotherapy can be included; 6. Subjects without previous radiotherapy (unless there is at least one measurable lesion in the non radiation area); 7. Patients with at least one measurable lesion (according to mrecist standard, the CT scan length of tumor lesion is more than or equal to 10 mm, and the scan slice thickness is less than or equal to 5 mm); 8. Subjects with ECoG PS score: 0-2; 9. The subjects with good function of main organs, i.e. the relevant examination indexes within 14 days before randomization, meet the following requirements: (1) Blood routine examination: Hemoglobin >= 100 g / L (no blood transfusion within 14 days); Neutrophil count > 1.5 x 10^9/L; Platelet count >= 100 x 10^9/L. (2) Biochemical examination: Total bilirubin = 60 ml / min (Cockcroft Gault formula); 10. Women of childbearing age must be tested for pregnancy before starting treatment (ß HCG) was negative. Women of childbearing age and men (having sex with women of childbearing age) must agree to contraception during treatment and within 6 months of the last treatment; 11. The subjects who volunteered to join the study signed the informed consent with good compliance and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with other incurable malignant tumors at the same time; 2. Subjects with liver metastases found within 90 days after pancreatic surgery; 3. Patients who have used PD-1 / PD-L1 antibody in the past; 4. For those patients with history of bleeding, any bleeding event with severity grade of ctcae4.0 or above occurred within 4 weeks before screening; 5. Those patients with severe active infection requiring intravenous antibiotic treatment during the screening period; 6. Patients with a history of chronic autoimmune diseases, such as systemic lupus erythematosus, ulcerative enteritis, Crohn's disease and other inflammatory bowel diseases; Patients with hypothyroidism who only need hormone replacement therapy and skin diseases (such as vitiligo, psoriasis or alopecia) who do not need systemic treatment are excluded; 7. Patients with a history of uncontrollable mental illness or severe intellectual or cognitive impairment; 8. Subjects allergic to the test drug; 9. Women who are pregnant, lactating or have given birth but refuse to take contraceptive measures; 10. Other circumstances that the researcher thinks are not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Countries
China
Contacts
Public ContactKuirong Jiang
Jiangsu Provincial People's Hospital
Outcome results
None listed