Pancreatic cancer
Conditions
Interventions
One-arm:Chemotherapy (Tiggio + gemcitabine)/radiotherapy/chemotherapy combined with tirellizumab sequential therapy
Sponsors
Yunnan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The patient had histopathologically confirmed borderline resectable/locally advanced pancreatic cancer; 2. Patients =18 years old; 3.ECOG physical status <2 points; 4. The expected survival time is greater than 3 months; 5. The patient had normal organ and bone marrow function Absolute count of white blood cells =3.0×109/L; ? Platelet count = 75×109/L; ? Hemoglobin = 90 g/L under normal Child-Pugh liver function classification; ? Serum albumin = 30 g/L under normal Child-Pugh liver function classification; ? Serum total bilirubin =1.5× upper limit of normal range (ULN); ? Alanine aminotransferase (ALT), aspartate aminotransferase (AST) =2.5×ULN; ? PT=3 s extension ? Serum creatinine (Cr) =1.5×ULN 6. Voluntary participation, fully informed consent, signed written informed consent, and good compliance; 7. No prior systemic or local treatment for pancreatic cancer; 8. Have =1 measurable lesion according to RECIST 1.1 criteria.
Exclusion criteria
Exclusion criteria: 1. Previous history of malignant tumor; 2. Patients with confirmed central nervous system metastasis; 3. Patients with ascites with clinical symptoms who need puncture or drainage or who have received ascites drainage within the past 3 months; There is a third lacunar effusion other than ascites that is difficult to control within 4 weeks (such as a large pleural effusion or pericardial effusion); 4. Patients with partial or complete biliary obstruction that cannot be relieved after active treatment; 5. Gastrointestinal obstruction; 6. Severe heart, brain and vascular diseases within 6 months prior to enrollment, including but not limited to the following: Acute myocardial infarction, unstable angina pectoris, coronary angioplasty or stroke, severe pulmonary embolism; (2) New York Heart Association Class III or IV congestive heart failure or left ventricular ejection fraction (LVEF) 10mg/ day or equivalent doses of the same drug) or other immunosuppressants within 14 days prior to the first use of the investigational drug. Exceptions are: In the absence of active autoimmune disease, treatment with topical, ocular, intraarticular, intranasal, and inhaled corticosteroids 11. Known allergy to Tiggio, gemcitabine or any of the ingredients in the investigational drug; 12. Pregnant women; 13. The investigator believes that the subjects are not suitable to participate in this clinical trial for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR;Surgical conversion resection rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;OS;DCR;AE;SAE;QoL; | — |
Countries
China
Contacts
Public ContactYong Zha
Yunnan Cancer Hospital
Outcome results
None listed