Pancreatic cancer
Conditions
Interventions
Intervention group:Albumin-bound paclitaxel: 125 mg/m^2, intravenous infusion, on days 1 and 8, every 3 weeks
Gemcitabine: 1000 mg/m^2, intravenous infusion, on days 1 and 8, every 3 weeks
Glutamine: 4 g per dose, oral administration after meals, 3 times daily. It can be mixed with warm water, milk, juice, etc. for consumption. Take at the same time every day during the treatment period
Sponsors
The Second Affiliated Hospital Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years, body weight>50kg, male or female; 2. Patients must have an expected survival of at least 12 weeks at the time of screening; 3. Patient type and disease characteristics: (1) Histologically or cytologically confirmed unresectable locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC; stage III or IV according to the AJCC 8th edition), with a KRAS G12D mutation confirmed by genetic testing, and no prior systemic anticancer therapy; (2) Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1; (3) At least one measurable target lesion as per RECIST 1.1 criteria at baseline; (4) No prior immune-mediated treatment, including but not limited to anti-CTLA-4, anti-PD-1, anti-PD-L1, or anti-PD-L2 antibodies (therapeutic anti-tumor vaccines excluded); (5) Adequate organ and bone marrow function, defined as: (1) Hemoglobin >= 9.0 g/dL; (2) Absolute neutrophil count >= 1.5 x 10^9/L; (3) Platelet count >= 100 x 10^9/L; (4) Serum bilirubin <= 2.0 x upper limit of normal (ULN) (excluding patients with confirmed Gilbert’s syndrome); (5) ALT and AST <= 2.5 x ULN; for liver metastases, ALT and AST <= 5 x ULN.
Exclusion criteria
Exclusion criteria: 1. History of allogeneic organ transplantation; 2. Active or documented history of autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn’s disease], diverticulitis [excluding diverticulosis], systemic lupus erythematosus, sarcoidosis syndrome, Wegener’s syndrome [e.g., granulomatosis with polyangiitis, Graves’ disease, rheumatoid arthritis, hypophysitis, uveitis]); 3. Uncontrolled intercurrent illness, including but not limited to: symptomatic congestive heart failure, uncontrolled diabetes mellitus, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, active interstitial lung disease (ILD), severe chronic gastrointestinal disease associated with diarrhea, or psychiatric/social conditions that may limit compliance with study requirements, substantially increase the risk of adverse events, or compromise the subject’s ability to provide written informed consent; 4. History of other primary malignancies, except for: (1) Malignancies treated with curative intent and with no known active disease for >=5 years before the first dose and low potential risk of recurrence; (2) Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; (3) Adequately treated carcinoma in situ with no evidence of disease; 5. History of leptomeningeal carcinomatosis; 6. Active primary immunodeficiency; 7. Active infection, including tuberculosis (clinical evaluation encompassing clinical history, physical examination, and radiographic findings, as well as tuberculosis testing consistent with local practice), or human immunodeficiency virus (positive for HIV1/2 antibodies); 8. Any unresolved toxicity >= Grade 2 per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) from prior anticancer therapy, except for alopecia, vitiligo, and laboratory values defined in the inclusion criteria; 9. Brain metastases or spinal cord compression (including asymptomatic or adequately treated cases); 10. Known allergy or hypersensitivity to any of the study drugs or any of their excipients; 11. Concurrent use of any chemotherapy, biologic therapy, or hormonal therapy for cancer treatment; 12. Prior radiotherapy (including palliative radiotherapy) is not permitted before the study; 13. Administration of a live attenuated vaccine within 30 days before the first dose; 14. Major surgical procedure within 28 days prior to the first dose; 15. Prior treatment with immune-mediated therapy (including but not limited to anti-PD-1, anti-PD-L1, or anti-CTLA-4 agents); 16. Prior local therapy, such as radioembolization; 17. Female patients who are pregnant or breastfeeding, or male or female patients of childbearing potential unwilling to practice effective contraception from screening until 180 days after the last dose of study treatment; 18. Patients considered by the investigator as unlikely to comply with study procedures, restrictions, and requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, OS;Progression Free Survival, PFS;Duration of remission, DoR;Disease Control Rate, DCR; | — |
Countries
China
Contacts
Public ContactWeilin Wang
The Second Affiliated Hospital Zhejiang University School of Medicine
Outcome results
None listed