Pancreatic Ductal Adenocarcinoma
Conditions
Interventions
100µg group:XH001 injection, 100ug
200µg group:XH001 injection, 200ug
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Provision of signed and dated informed consent form; 2.Aged 18 to 75 years old; 3.Histologically or cytologically confirmed pancreatic ductal adenocarcinoma; 4.R0 or R1 surgical resection as determined by pathology; 5.Postoperative pathological staging (pTNM): T1-3, N0-2, M0; 6.Expected life expectancy >= 12 months; 7.ECOG score is 0 or 1; 8.Postoperative recovery: Daily oral nutritional intake is greater than 1500 kcal; with no severe nausea or vomiting; 9.Have not received any prior neoadjuvant therapy; 10.If the laboratory test results do not meet the following criteria, a re-examination can be conducted within one week. If they still do not meet the standards, the screening is considered a failure: Blood routine (within 7 days before the first administration of XH001, no blood transfusion, transfusion of platelets, growth factors, or other supportive treatments were performed, except for recombinant erythropoietin): - White blood cell (WBC) count >= 3.0×10^9/L - Neutrophil (NE) count >= 1.0×10^9/L - Platelet (PLT) count >= 75×10^9/L - Hemoglobin (Hb) count >= 90g/L; Blood biochemistry - Creatinine clearance rate >= 50 mL/min (calculation formula for creatinine clearance rate: Cockcroft-Gault formula) - Alanine aminotransferase (ALT) 30g/L; Coagulation: Prothrombin time (PT) prolongation <= 4s; 11.If a stent has been placed for biliary obstruction, those with bilirubin levels meeting the inclusion criteria during screening can be included; 12.CA19-9 <100U/mL before initial chemotherapy; 13.Woman of childbearing potential must have a negative pregnancy test and follow contraceptive guidelines as defined per protocol.
Exclusion criteria
Exclusion criteria: 1.Borderline resectable pancreatic cancer; 2.Evidence of metastasis or disease recurrence following surgical resection at any time; 3.Evidence of malignant ascites; 4.Pre-existing inflammatory bowel disease or the presence of complete or partial bowel obstruction, or persistent severe diarrhea after surgery; 5.Needs to receive long-term systemic anti-allergic drug or known hypersensitivity (Grade 3 or above) to any component of the study treatment; 7.Acute myocardial infarction within 6 months before screening, or uncontrolled angina, uncontrolled arrhythmia, severe heart failure (see Appendix 3, New York Heart Association Heart Failure Classification Criteria NYHA Class = III) and other cardiovascular diseases; 8.Received immunomodulatory medications within 4 weeks prior to the date of the first dose (D1) of XH001, including but not limited to: IL-2, CTLA-4 inhibitors, CD40 agonists, CD137 agonists, IFN-a; 9.Received blood transfusion, erythropoietin (EPO), granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) within 7 days prior to the first dose of XH001; 10.The toxic and side effects caused by previous treatments have not yet returned to a CTCAE grade 10^3 IU/mL, HCV antibodies, and syphilis spirochete-specific antibodies were excluded;. 15.Hypertension that remains uncontrolled after treatment (defined as systolic blood pressure >= 160 mmHg and/or diastolic blood pressure >= 100 mmHg); 16.Those who had suffered from other malignant tumors within the previous 5 years, except for cervical carcinoma in situ, breast carcinoma in situ, and basal cell carcinoma of the skin that had been properly treated and reached the recovery standard; 17.Patients with any active autoimmune diseases or a history of autoimmune diseases which require long-term use of steroid hormones or other immunosuppressants; 18.Have received therapeutic tumor vaccines previously; 19.Subjects with congenital or acquired immune deficiencies; 20.Participating in other clinical trials at the screening period; 21.Pregnant or lactating women; 22.Unable or unwilling to comply with the study protocol due to potential health, mental or social conditions in the opinion of the investigator; 23.Other conditions that, in the opinion of the investigator, would make participation in this study inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Desease Free Survival (DFS);Overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Desease Free Survival Rate;Safety;Pharmacokinetic parameters;Metastasis-Free Survival;The changes in ctDNA compared to baseline;The change in CA19-9 compared to baseline;The response of antigen-specific T cells in peripheral blood; | — |
Countries
China
Contacts
Public ContactWenming Wu
Peking Union Medical College Hospital
Outcome results
None listed