Recurrent/Oligometastatic Pancreatic Cancer
Conditions
Interventions
Experimental group:SBRT Combined with a PD-1/CTLA-4 Bispecific Antibody and Chemotherapy
Sponsors
The second affiliated hospital of Zhejiang University school of medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically confirmed pancreatic ductal adenocarcinoma (including adenosquamous carcinoma); 2. Patients with recurrent pancreatic cancer or advanced pancreatic cancer with oligometastases; 3. Disease progression occurring during or after at least one systemic treatment (including chemotherapy, immunotherapy, or targeted therapy); 4. At least one month since the last systemic treatment (including chemotherapy, immunotherapy, or targeted therapy); 5. No history of radiotherapy, or if undergoing second radiotherapy, the site does not overlap with the original radiotherapy site; 6. Signed written informed consent and understanding and agreement to comply with study requirements and the study visit schedule; 7. Male or female subjects aged >= 18 years and =10 mm (excluding lymph nodes, lymph nodes must have a short axis >=15 mm), and the lesion is suitable for repeated accurate measurement. Lesions located in areas that have previously received radiation or biopsy can be considered measurable target lesions if there is clear evidence of disease progression according to RECIST v1.1; 10. Expected survival time >=3 months; 11. Sufficient bone marrow and organ function (no use of any cellular therapy, blood components, colony-stimulating factors, or cytokine treatment within 14 days prior to laboratory tests): (1) Complete blood count: ANC >= 1.5×10^9/L or within normal range; platelet count (PLT) >= 100×10^9/L; hemoglobin (HGB) >= 90 g/L; (2) Liver function: total bilirubin (TBIL) = 28 g/L; (3) Kidney function: serum creatinine (Cr) = 60 mL/min (calculated using the Cockcroft-Gault formula or measured by 24-hour urine collection); urinalysis shows urine protein =2, a 24-hour urine collection should be conducted with urine protein content <1g within 24 hours (if both methods are used, the value measured from the 24-hour urine collection will be used to determine eligibility); (4) Coagulation function: international normalized ratio (INR) <= 1.5; activated partial thromboplastin time (APTT) <= 1.5×ULN. 12. Male and female subjects who are infertile or agree to use at least one effective method of contraception during the study (from 14 days prior to screening or first dosing, whichever occurs first, and continuing until 180 days after the last dose of the study drug).
Exclusion criteria
Exclusion criteria: 1. History of allergy to any component of PD-1/CTLA-4 antibodies; 2. Extensive diffuse metastasis (more than 3 metastatic organs or more than 5 metastatic lesions); 3. Known active brain metastases or meningeal metastases; 4. Liver metastases accounting for more than 50% of total liver volume; 5. Expected survival data 2) within 4 weeks before the first administration of the study drug, including severe pneumonia, bacteremia, complication infections requiring hospitalization, active pulmonary inflammation on baseline chest imaging, infection symptoms and signs within 4 weeks before the first administration of the study drug, or requiring oral or intravenous antibiotic treatment. 11. Active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes). However, patients with autoimmune hypothyroidism receiving a stable dose of thyroid hormone replacement therapy and patients with type 1 diabetes receiving a stable dose of insulin are not excluded. Patients with vitiligo or childhood asthma/allergies that resolve in adulthood without intervention are also eligible to participate. 12. History of immunodeficiency, including HIV positive test, history of acquired or congenital immunodeficiency disorders, or history of organ transplantation and allogeneic bone marrow transplantation. 13. Interstitial lung disease (excluding radiation pneumonitis not treated with steroids) or history of non-infectious pneumonia. 14. Evidence of active tuberculosis infection bas
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Disease control rate;Progression free survival; | — |
Countries
China
Contacts
Public ContactYongjie Shui
The second affiliated hospital of Zhejiang University school of medicine
Outcome results
None listed