pancreatic cancer
Conditions
Interventions
Experimental Group:GEM (Gemcitabine) 1000 mg/m2 administered intravenously over more than 30 minutes on day 1 (d1) and day 8 (d8)
Tegafur, Gimeracil, and Oteracil Potassium (Tegurot) 40 mg twice daily (bid) for patients with a body surface area (BSA) less than 1.25 m2 / 50 mg bid for BSA between 1.25 and 1.5 m2 / 60 mg bid for B
Cadonilimab (AK104) 10 mg/kg, administered intravenously over 120 minutes on day 1 (d1), given every 3 weeks (Q3W).Following six cycles of treatment with the GS regimen in combination with Cadonilimab
Sponsors
Sichuan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: Participants must be between 18 and 75 years old. 2. Diagnosis: Histologically or cytologically confirmed pancreatic ductal adenocarcinoma. 3. Treatment History: No prior systemic treatment for unresectable locally advanced or metastatic pancreatic cancer, including chemotherapy, targeted therapy, or immunotherapy. Palliative radiotherapy for local metastatic lesions must have been completed at least 2 weeks before the first administration of study treatment. 4. Performance Status: Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 5. Organ Function: Adequate organ function, including: - Hematological 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. - Hepatic function: Serum total bilirubin <=1.5× the upper limit of normal ; aspartate aminotransferase and alanine aminotransferase<=2.5× ULN(<=5× ULN for patients with liver metastases). - Renal function: Serum creatinine <=1.5× ULN. - No transfusions, recombinant human thrombopoietin, or colony-stimulating factors within 14 days prior to enrollment. 6. Informed Consent: Voluntary written informed consent must be obtained from the participant. 7. Life Expectancy: Expected survival of at least 12 weeks. 8. Measurable Disease: At least one lesion that meets the criteria for measurable disease according to RECIST v1.1.
Exclusion criteria
Exclusion criteria: 1. Pathology: Histological diagnosis of pancreatic cancer other than pancreatic ductal adenocarcinoma. 2. Severe Cardiopulmonary or Cerebral Diseases: Including but not limited to myocardial infarction, unstable angina, current NYHA Class III-IV heart failure, or LVEF (left ventricular ejection fraction) 450 msec for males or > 470 msec for females, hypertensive crisis, interstitial pneumonia, active pulmonary tuberculosis, severe pulmonary dysfunction, or cerebrovascular accident. 3. Allergy or Intolerance: Known allergy or intolerance to any component of the study medication. 4. Infection: Active infection requiring systemic antimicrobial therapy within 14 days prior to enrollment, except for prophylactic antibiotic treatment (e.g., for urinary tract infections or chronic obstructive pulmonary disease). 5. Prior Therapy: Received traditional Chinese medicine, patent medicine, or immunomodulatory drugs (including thymosin, interferon, interleukin, etc.) with antitumor indications within 2 weeks prior to the first administration. 6. Central Nervous System Metastases: Presence of active central nervous system metastases. 7. Uncontrolled Effusions: Uncontrolled pleural effusion, ascites, or other third-space effusions deemed unsuitable for enrollment by the investigator. 8. Other Active Malignancies: Active malignancies within the past 5 years or concurrent active malignancies. Participants with cured localized tumors, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, cervical carcinoma in situ, or ductal carcinoma in situ of the breast, are eligible. 9. 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, Sjogren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. Exceptions include participants with a history of autoimmune thyroid dysfunction controlled with thyroid hormone, participants with controlled Type 1 diabetes treated with insulin, and skin conditions (such as vitiligo, psoriasis, or alopecia) not requiring systemic immunosuppressive therapy, including corticosteroids. 10. Primary Immunodeficiency or HIV Infection: History of primary immunodeficiency or HIV infection. 11. Immunosuppressive Medications: Use of immunosuppressive drugs within 14 days prior to the first administration, excluding local corticosteroids (e.g., nasal, inhaled) or physiologic doses of systemic corticosteroids (i.e., not exceeding 10 mg/day prednisone or equivalent), or corticosteroids used for contrast agent allergy prevention. 12. Infections: Known or self-reported HIV infection, syphilis infection, or active hepatitis B or C. For hepatitis B serological screening, if hepatitis B surface antigen is positive, additional testing for hepatitis B virus DNA is required. Participants with a viral load =1 × 10^3 copies/ml are ineligible, while those with a viral load <1 × 10^3 copies/ml must undergo active hepatitis B monitoring after enrollment. For hepatitis C serological screening, if hepatitis C antibody is positive, additional testing for hepatitis C
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;duration of response;disease control rate;overall survival ;adverse events; | — |
Countries
China
Contacts
Public Contactyongdong.Jin
Sichuan Cancer Hospital
Outcome results
None listed