Pancreatic cancer
Conditions
Interventions
Cohort 1:Iparomlimab and Tuvonralimab+albumin-bound paclitaxel + gemcitabine+SBRT
Cohort 2:Iparomlimab and Tuvonralimab+albumin-bound paclitaxel
Sponsors
The First Affiliated Hospital of University of science and technology of China
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign an informed consent form; 2. Age between 18 and 75 years; 3. Histologically/cytologically confirmed pancreatic ductal adenocarcinoma; 4. Patients with unresectable locally advanced or previously untreated metastatic pancreatic cancer; 5. No prior systemic therapy (chemotherapy, targeted therapy, immunotherapy, etc.) for unresectable locally advanced or metastatic pancreatic cancer; if palliative radiotherapy for local metastases was administered, it must have concluded at least 2 weeks prior to the first dose; 6. ECOG performance status of 0 or 1; 7. Estimated survival of at least 12 weeks; 8. At least one measurable lesion meeting RECIST v1.1 criteria; 9. Adequate organ function, including: sufficient bone marrow reserve, normal hepatic and renal function: white blood cell count >=3 × 10^9/L, absolute neutrophil count >= 1.5 × 10^9/L; platelet count >= 75 × 10^9/L; hemoglobin >= 90 g/L, serum total bilirubin <=1.5 × upper limit of normal; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 2.5×Upper Limit of Normal (ULN) (patients with liver metastases should be <= 5×ULN); serum creatinine <= 1.5×ULN. No transfusion, recombinant human thrombopoietin, or colony-stimulating factor therapy within 14 days prior to enrollment; 10. For patients with active hepatitis B virus (HBV) infection: HBV DNA must be <500 IU/mL (if the study site only uses copies/mL as the measurement unit, then <2500 copies/mL). The patient must have received at least 14 days of anti-HBV therapy (based on local standard treatment, e.g., entecavir) prior to study treatment initiation and must be willing to continue antiviral therapy throughout the study period. HCV RNA-positive patients must receive antiviral therapy according to local standard treatment guidelines and have liver function elevations within CTCAE Grade 1; 11. Women of childbearing potential must have a negative pregnancy test (ß-HCG) prior to treatment initiation. Women of childbearing potential and males (engaging in sexual intercourse with women of childbearing potential) must agree to use contraception during treatment and for 6 months following the last dose. 12. Patients deemed likely to benefit by the investigator.
Exclusion criteria
Exclusion criteria: 1. Pathological diagnosis confirms pancreatic cancer of a histological type other than ductal adenocarcinoma; 2. Presence of severe cardiac, pulmonary, or cerebral disease (including but not limited to myocardial infarction within six months prior to initial dosing, unstable angina pectoris, current NYHA Class III–IV heart failure, or echocardiographic LVEF 450 msec in males or > 470 msec in females, hypertensive crisis, interstitial pneumonia, active pulmonary tuberculosis, severe pulmonary impairment, cerebrovascular accident, etc.); 3. Patients with known allergy or intolerance to any component of the study drug; 4. Concurrent infection-related fever or active infection requiring systemic antimicrobial therapy within 14 days prior to enrollment; except for prophylactic antibiotic therapy (e.g., for urinary tract infections or chronic obstructive pulmonary disease); 5. Patients who received treatment with Chinese herbal medicine, proprietary Chinese medicines, or immunomodulatory agents (including thymosin, interferon, interleukin, etc.) for antitumor indications within 2 weeks prior to the first study dose; 6. Patients with active central nervous system metastases; 7. Patients with uncontrolled pleural effusion, ascites, or other third-space effusions deemed ineligible for enrollment by the investigator; 8. Presence of other active malignancies within the past 5 years or concurrently. Patients with cured localized tumors, such as basal cell carcinoma, squamous cell carcinoma of the skin, cervical carcinoma in situ, or ductal carcinoma in situ of the breast, may be eligible; 9. HIV-positive patients; known active tuberculosis within one year prior to the first study treatment; known active syphilis infection; 10. Active autoimmune diseases: including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis, except for the following: Patients with a history of autoimmune-related hypothyroidism who are taking thyroxine and are stable are eligible for this study; controlled patients with type 1 diabetes receiving insulin therapy are eligible for this study; dermatological conditions not requiring systemic immunosuppressive therapy, particularly corticosteroids (e.g., vitiligo, psoriasis, or alopecia), are permitted; 11. Use of immunosuppressive drugs within 14 days prior to first dosing, excluding intranasal, inhaled, or other topical corticosteroids, or physiologically dosed systemic corticosteroids (i.e., not exceeding 10 mg/day prednisone or equivalent doses of other corticosteroids), or corticosteroids used for contrast medium allergy prophylaxis; 12. Participants currently enrolled in another clinical trial or planning to start a new trial within 2 weeks of completing the previous study treatment; 13. Participants who received a live vaccine within 28 days prior to enrollment (except for inactivated viral vaccines for seasonal influenza); 14. Participants scheduled for or who have previously undergone organ or bone marrow transplantation; 15. Female subjects with a positive screening blood pregnancy test; f
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival, PFS;Disease Control Rate, DCR;Duration of Response, DoR;Overall survival, OS; | — |
Countries
China
Contacts
Public ContactWei Wang
The First Affiliated Hospital of University of science and technology of China
Outcome results
None listed