Pancreatic ductal carcinoma
Conditions
Interventions
Intervention group:Cadonilimab plus albumin-bound paclitaxel and gemcitabine
Sponsors
Second Hospital of Lanzhou University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The patients are able to understand the informed consent form, voluntarily participate in the study, and sign the informed consent form; 2. The patients sign the informed consent form on the same day and are at least 18 years old or meet the local legal age standard for adults, regardless of gender; 3. Histopathological or cytological confirmation of pancreatic ductal adenocarcinoma (including adenosquamous carcinoma); 4. No prior systemic treatment for unresectable locally advanced or metastatic pancreatic cancer; 5. According to the RECIST 1.1 criteria, there is a measurable lesion at baseline; if the subject has only one measurable lesion at baseline, the lesion area must not have received radiation therapy before, or there is evidence that the lesion progressed markedly after radiation therapy; 6. An ECOG PS score of 0 or 1; 7. An expected life span of more than 3 months; 8. Laboratory tests conducted within 7 days of the first dose indicate good hematological and organ function; 9. Female patients with reproductive potential or male patients with reproductive potential who are partners agree to use highly effective contraception (annual failure rate of less than 1%) from 7 days before enrollment until 24 weeks after the last dose; female patients with reproductive potential must have a negative serum pregnancy test within 7 days before randomization; 10. patients are able and willing to comply with the study visit schedule, treatment plan, laboratory tests, and other research-related procedures as specified in the study protocol.
Exclusion criteria
Exclusion criteria: 1. Patients with untreated active brain metastases or meningeal metastasis; 2. Those with untreated vertebral compression fractures due to surgery and/or radiotherapy, patients with treated vertebral compression fractures must have stable disease for at least 2 weeks prior to randomization.; 3. Individuals assessed by the investigator as having a high risk of gastrointestinal or peritoneal bleeding; 4. Prior treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies, or any other agents targeting T cell co-stimulation or checkpoint pathways is an exclusion criterion; 5. Known carriers of germline BRCA1/2 mutations are not eligible for inclusion in this study; 6. This study included patients who had received anti-cancer treatments, such as chemotherapy, small molecule inhibitors, or immunotherapy (including interleukins, interferons, or thymosin), within 28 days prior to enrollment. Additionally, participants who had undergone herbal medicine treatment with anti-cancer indications within 14 days before the administration of the study drug were also excluded. 7. Patients were not eligible if they had undergone major surgery within 28 days prior to enrollment. 8. Patients were not eligible if they had received curative radiotherapy within 3 months prior to enrollment. 9. Patients were not eligible if they required systemic corticosteroids or immunosuppressive therapy within 14 days prior to enrollment. 10. Patients were not eligible if they had persistent low albumin levels that could not be corrected prior to enrollment. 11. Patients were not eligible if their ECOG performance status score increased by =1 point within 72 hours prior to enrollment compared to the score at the time of signing the ICF. 12. Patients were not eligible if they lost 10% or more of their body weight compared to the weight at the time of signing the ICF within 72 hours prior to enrollment. 13. Patients were not eligible if they had received a live vaccine (including attenuated live vaccines) within 28 days prior to enrollment.14.Prior history of interstitial pneumonia/lung disease that is non-active and does not require steroid treatment may exclude individuals unless determined otherwise by investigators. 15.History of autoimmune diseases 16.A previous diagnosis of another malignancy within 5 years prior to enrollment; 17.Liver metastases occupying more than half of total liver volume 18.Uncontrolled comorbidities including but not limited to: active HBV/HCV infection, known HIV infection/AIDS history, active syphilis, active tuberculosis, active infections, uncontrolled hypertension, symptomatic heart failure, active bleeding disorders 19.Failure to recover toxicities related to previous anticancer therapies beyond CTCAE grade <=1 (NCI-CTCAE v5.0), excluding alopecia (any grade allowed) and peripheral neuropathy (must recover <=grade2) 20.Prior history of allogeneic bone marrow or organ transplantation 21.Prior allergic reactions/hypersensitivity/intolerance against antibody drugs/history against drugs/food/substances 22.Pregnant and/or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate,DCR;Progression-free survival,PFS;Overall survival,OS;Duration of response, DoR;Time to response,TTR;Safety; | — |
Countries
China
Contacts
Public ContactHui Zhang
The second hospital of Lanzhou University
Outcome results
None listed