About this trial
This study aims to evaluate the efficacy and safety of adebrelimab combined with the AG regimen in patients with unresectable locally advanced or metastatic pancreatic cancer who have received at least one prior line of systemic therapy but have not undergone gemcitabine-based treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Sign informed consent;
Aged 18-75 years (inclusive);
Histologically or cytologically confirmed pancreatic cancer;
Unresectable locally advanced or metastatic pancreatic cancer, as determined by the investigator;
Disqualifiers
The subject has any known active autoimmune disease;
Subjects have any complications requiring systemic treatment with corticosteroids such as prednisone (> 10mg/ day) or have used immunosuppressive drugs within 14 days prior to initial administration;
Subjects received tumor vaccines or other immune-activating antitumor drugs (such as interferon, interleukin, thymosin, or immune cell therapy) within 1 month prior to initial administration;
Subjects are participating in another clinical trial or have received a drug intervention from another clinical trial within 4 weeks prior to the first dose;
Trial design
Single group
Treatments tested in this trial
Adebrelimab
DrugAdebrelimab: 1200mg,iv,d1,q3w;
AG
DrugGemcitabine: 1000 mg/m² ,iv,d1、d8,q3w; Nab-paclitaxel: 125 mg/m² ,iv,d1、d8,q3w;
Treatment groups
Trial outcomes
Primary outcomes
ORR
Objective response rate
Secondary outcomes
PFS
Progression-free survival
OS
Overall survival
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Safety will be evaluated according to the NCI CTCAE Version 5.0. All observations pertinent to the safety of the study medication will be recorded on the CRF and included in the final report.
Sponsors and contacts
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Jin Xu
Lead sponsor
Fudan University
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options: