Pancreatic Cancer
Conditions
Interventions
single arm:Oncorine intratumor injection+Sintilimab Injection+ Oral chemotherapy with Tegafur,Gimeracil and Oteracil Porassium Capsules.
Sponsors
Nantong University Affiliated Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with unresectable pancreatic ductal adenocarcinoma (stage III or IV) confirmed by histology or cytology based on the general principles of pancreatic cancer research (7th edition) have never received anticancer treatment or trials. 2. Patients with primary lesions will undergo intratumoral injection of Oncorine by EUS (endoscopic ultrasound). 3. The patient must be >= 18 years old. 4. According to the RECIST 1.1 standard, patients must have at least one measurable lesion on a computed tomography (CT) scan. 5. The patient must have a life expectancy of >= 12 weeks. 6. The patient has no serious organ dysfunction. 7. Score according to the US Eastern Cancer Cooperative Group (ECOG) scoring system, at least 0-2 points. 8. Women of childbearing age must have a negative urine or serum pregnancy test within 1 week before starting treatment. 9. The patient must be able to understand the study and be willing to sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with tumor hemorrhage or abnormal blood coagulation cannot safely perform intratumoral injection or biopsy; 2. Suffering from diseases of the immune system (such as lupus erythematosus, ulcerative colitis, Crohn's disease, etc.); 3. Has received an organ transplant; 4. Heart, lung, liver, kidney and other organ dysfunction; 5. Patients with central nervous system metastasis. 6. Ascites patients, except for mild ascites. 7. Patients with multiple cancers. 8. The patient needs to treat anticoagulant or antiplatelet drugs; 9. Patients are allergic to Oncorine, Sintilimab and Tegafur,Gimeracil and Oteracil Porassium Capsules or other similar biological agents.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical efficacy and assessment of adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of tumor immune microenvironment;Tumor tissue and whole blood second generation gene sequencing;Quantitative assessment of dynamic changes of peripheral blood lymphocyte subsets before and after treatment;Quantitative assessment of dynamic changes of peripheral blood cytokines before and after treatment; | — |
Countries
China
Contacts
Public ContactMao Zhenbiao
Nantong University Affiliated Hospital
Outcome results
None listed