locally advanced pancreatic cancer
Conditions
Interventions
Treatment group:Concurrent Radiotherapy With Envafolimab and Capecitabine
Sponsors
Cancer Hospital Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18-90 years old; 2. Pancreatic cancer confirmed by histology or cytology; 3. Locally or regionally advanced non-operable resectable pancreatic cancer without systemic metastases other than retroperitoneal lymph nodes; 4. Patients who have not received systemic chemotherapy in the past, or who have progressed on first-line therapy; 5. At least one measurable lesion (according to RECIST 1.1 criteria, the long diameter of the CT scan of the tumor lesion is >=10mm, and the short diameter of the CT scan of the lymph node lesion is >=15mm); 6. ECOG score: 0-1 points; 7. Estimated survival >= 3 months; 8. Normal function of major organs, that is, meet the following criteria: 9. The criteria for routine blood examination must be met (no blood transfusion and blood products within 14 days): (1) ANC>=1.5×10^9/L; (2) PLT>=80×10^9/L; 10. Biochemical examination shall meet the following standards: (1) TBIL 45 ml/min (Cockcroft-Gault formula); 11. Subjects voluntarily joined this study and signed the informed consent form, with good compliance and cooperation with follow-up.
Exclusion criteria
Exclusion criteria: 1.Presence of any active autoimmune disease or history of autoimmune disease in the subject. 2.Allergy to study-used medications. 3.Subjects who are on immunosuppressive, or systemic, or absorbable topical hormone therapy for immunosuppression (dose >10mg/day prednisone or other equipotent hormone) and who continue to be on it within 2 weeks prior to enrollment. 4.Class III-IV cardiac insufficiency according to NYHA criteria, or cardiac ultrasound suggesting left ventricular ejection fraction (LVEF) 1.5,APTT>1.5 ULN) and bleeding tendency. 6.Prolonged unhealed wounds or fractures; major surgical procedures or severe traumatic injuries, fractures or ulcers within 4 weeks. 7.Subjects with congenital or acquired immune deficiency (e.g., HIV-infected individuals), or active hepatitis (Hepatitis B reference: HBV DNA test value exceeding the upper limit of normal, Hepatitis C reference: HCV viral titer or RNA test value exceeding the upper limit of normal). 8.Subject has received other prior PD-1 antibody immunotherapy or other immunotherapy targeting PD-1 or PD-L1. 9.Known existing hereditary or acquired bleeding and thrombotic tendencies (e.g., hemophiliacs, coagulation disorders, thrombocytopenia, hypersplenism, etc.) or events of arterial or venous thrombosis in the last 6 months (up to the first medication use of envafolimab ). 10.Subjects with active infection or unexplained fever >38.5 degrees Celsius during screening and prior to the first dose. 11.Patients with central nervous system metastases; 12.Subjects who have had a live bacterial vaccine or live attenuated vaccine vaccine within 30 days prior to the first dose of study treatment. 13.Subjects with previous or concurrent other malignant tumors. 14.Women who are pregnant or breastfeeding. 15.Those with a history of psychotropic substance abuse that cannot be abstained from or patients with psychiatric disorders. 16.Patients with concomitant illnesses that, in the judgment of the investigator, seriously jeopardize patient safety or interfere with the patient's ability to complete the study. 17.Those who are not suitable for inclusion in the judgment of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate(ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Progress Free Survival(PFS);Overall Survival(OS);Diseases Control Rate(DCR);During of Response(DoR);Incidence of grade III or higher adverse events; | — |
Countries
China
Contacts
Public ContactChen Bo
Cancer Hospital Chinese Academy of Medical Sciences
Outcome results
None listed