NALIRI-XELOX+AK104 for First-line Treatment of Advanced PDAC

Inclusion Criteria:

1. Age ≥18, male or female;

2. Has histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC);

3. Has not received prior systemic treatment for their locally advanced or metastaticPDAC;

4. Has presence of measurable disease as defined by Response Evaluation Criteria inSolid Tumours (RECIST 1.1);

5. Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG)Performance Status;

6. Has a life expectancy of at least 3 months;

7. Has adequate organ function;

8. If female of childbearing potential, have a negative serum pregnancy test within 7days prior to first trial treatment;

9. If female of childbearing potential or a male subject with a partner withchildbearing potential, be willing to use a highly effective method of contraception (with a failure rate of less than 1.0% per year) from first study treatment to 24weeks after completion of the trial treatment.

Exclusion Criteria:

1. Untreated active CNS metastasis or leptomeningeal metastasis.

2. Is currently participating and receiving an investigational drug or has participatedin a study of an investigational drug within 4 weeks or within 5 times of half-life (no less than 2 weeks), whichever is shorter prior to the first dose of trialtreatment;

3. Has received other anti-tumor treatment within 4 weeks or within 5 times ofhalf-life (no less than 2 weeks), whichever is shorter prior to the first trialtreatment;

4. Major surgery for any reason, except diagnostic biopsy, within 4 weeks of the firstadministration of trial treatment and/or if the subject has not fully recovered fromthe surgery within 4 weeks of the first administration of trial treatment;

5. Curative radiation within 3 months of the first dose of trial treatment. Radiationto more than 30% of the bone marrow or with a wide field of radiation should not beused within 4 weeks prior to the first administration of trial treatment;

6. Subjects receiving immunosuppressive agents (such as steroids) for any reason shouldbe tapered off these drugs before initiation of trial treatment (with the exceptionof subjects with adrenal insufficiency, who may continue corticosteroids atphysiologic replacement doses, equivalent to < 10 mg prednisone daily, inhaledsteroids and topical use of steroids);

7. Vaccination within 28 days of the first administration of trial treatment, exceptfor administration of inactivated vaccines (e.g., inactivated influenza vaccines);

8. Has interstitial lung disease, or a history of pneumonitis that required oral orintravenous glucocorticoids to assist with management;

9. History or current active autoimmune disease that might deteriorate when receivingan immunostimulatory agent；

10. Previous malignant disease History of uncontrolled intercurrent illness Priortherapy with any antibody/drug targeting T cell coregulatory proteins Known severehypersensitivity reactions to antibody drug；

11. Is pregnant or breastfeeding;

12. Other medical conditions that at the discretion of investigator interfere with therequirements of the trial in terms of safety or efficacy evaluation, or treatmentcompliance.