Pancreatic cancer
Conditions
Interventions
Intervention group:Prag Therapy
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Sign written informed consent before implementing any trial-related procedures; 2. Male or female >=18 years old; 3. Histologically or cytologically confirmed pancreatic cancer assessed by the investigator, with first definite local recurrence after surgery (limited to pancreatic resection margin, pancreatic remnant, or root of the mesentery); 4. No distant metastasis, CA-199 =3 months; 6. At least one measurable lesion according to RECIST1.1 criteria; 7. ECOG PS score of 0-1; 8. Adequate organ function, subjects must meet the following laboratory criteria: - Absolute neutrophil count (ANC) >=1.5x10^9/L without using granulocyte colony-stimulating factor within the past 14 days. - Platelets >=100×10^9/L without transfusion within the past 14 days. - Hemoglobin >9 g/dL without transfusion or use of erythropoietin within the past 14 days. - Total bilirubin ULN but direct bilirubin =60 ml/min. - Good coagulation, defined as international normalized ratio (INR) or prothrombin time (PT) <=1.5×ULN. - Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within the normal range. If baseline TSH is outside the normal range, subjects may still be included if total T3 (or FT3) and FT4 are within normal limits. - Cardiac enzyme spectrum within normal range (subjects with laboratory abnormalities deemed clinically insignificant by the investigator may also be included). 9. For female subjects of childbearing potential, they must have a negative urine or serum pregnancy test within 3 days before the first dose of the study drug (Cycle 1, Day 1). If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. During the observation period and within 8 weeks after the last dose of the study drug, subjects must voluntarily use appropriate contraception. Non-childbearing females are defined as postmenopausal for at least 1 year or having undergone surgical sterilization or hysterectomy. Male subjects must use appropriate contraception during the observation period and within 8 weeks after the last dose of the study drug. 10. If there is any risk of pregnancy, all subjects (male or female) must use contraception with a failure rate of less than 1% per year throughout the treatment period and until 120 days after the last dose of the study drug (or 180 days after the last chemotherapy drug dose).
Exclusion criteria
Exclusion criteria: 1. Diagnosed with other malignant diseases other than pancreatic cancer within 5 years before the first dose (excluding radical basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or radically resected carcinoma in situ); 2. Currently participating in interventional clinical investigational treatment, or receiving other investigational drugs or using investigational devices within 4 weeks before the first dose; 3. Previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs targeting another stimulating or synergistic inhibition of T cell receptors (e.g., CTLA-4, OX-40, CD137); 4. Received systemic systemic therapy with anti-tumor indications or immunomodulatory drugs (including thymus peptides, interferon, interleukin, except for topical use to control ascites) with anti-tumor indications within 2 weeks before the first dose; 5. Active autoimmune disease requiring systemic treatment (such as the use of disease-modifying drugs, glucocorticoids, or immunosuppressants) within 2 years before the first dose. Replacement therapy (such as thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary insufficiency, etc.) is not considered systemic therapy; 6. Receiving systemic corticosteroid therapy (excluding topical glucocorticoids by nasal spray, inhalation, or other routes) or any other form of immunosuppressive therapy within 7 days before the first dose of the study; Note: The use of physiologic doses of glucocorticoids (<= 10 mg/day of prednisone or equivalent) is allowed; 7. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 8. Known allergy to the active ingredients or excipients of this study drug; 9. Has not recovered adequately from toxicity and/or complications caused by any intervention (i.e., <= grade 1 or at baseline, excluding fatigue or alopecia) prior to starting treatment; 10. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive); 11. Uncontrolled active hepatitis B (defined as HBsAg positivity with HBV-DNA copy number detected greater than the upper limit of normal in the laboratory department of the study center); Note: Hepatitis B subjects who meet the following criteria can also be enrolled: 1) HBV viral load <1000 copies/ml (200 IU/ml) before the first dose, and subjects should receive anti-HBV therapy throughout the treatment period of the study drug to avoid viral reactivation 2) For subjects with anti-HBc ( ), HBsAg (-), anti-HBs (-) and HBV viral load (-), prophylactic anti-HBV therapy is not required, but close monitoring of viral reactivation is required 12. Subjects with active HCV infection (positive for HCV antibody and HCV-RNA level above the lower limit of detection); 13. Vaccination with live vaccine within 30 days before the first dose (Cycle 1, Day 1); Note: Receiving injectable inactivated virus vaccine against seasonal influenza within 30 days before the first dose is allowed; however, receiving intranasal live attenuated influenza vaccine is not allowed. 14. Pregnant or lactating women; 15. The presence of any severe or uncontrollable systemic disease, such as: 1) Significant and symptomatic ECG abnormalities at rest that are difficult to control in rhythm, conduction, or morphology, such as complete left bundle branch block, second-degree or higher cardiac conduction block, ventricular arrhythmia, or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival(PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Local Control Rate;Overall survival;Safety and tolerability; | — |
Countries
China
Contacts
Public ContactXu Jin; Li Guichao
Fudan University Shanghai Cancer Center
Outcome results
None listed