Pancreatic Cancer Metastatic, Pancreatic Cancer Non-resectable
Conditions
Keywords
pancreatic cancer
Brief summary
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.
Interventions
DRUGAdebrelimab
Adebrelimab: 1200mg，iv，d1，q3w；
DRUGAG
Gemcitabine: 1000 mg/m² ，iv，d1、d8，q3w； Nab-paclitaxel: 125 mg/m² ，iv，d1、d8，q3w；
Sponsors
Jin Xu
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Adebrelimab Combined with AG
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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； * Disease progression after prior treatment with at least one systemic therapy; * No previous immunotherapy; * No previous gemcitabine-based chemotherapy; * Have at least one measurable lesion (according to RECIST 1.1 criteria); * ECOG 0\ 1； * The estimated survival time is greater than 3 months; * Adequate Organ Function (within 28 days prior to first dose): Hematology: White blood cell count (WBC) ≥3.0×10⁹/L Absolute neutrophil count (ANC) ≥1.5×10⁹/L Platelets (PLT) ≥100×10⁹/L Hemoglobin (HGB) ≥90 g/L Liver Function: Aspartate aminotransferase (AST) ≤2.5×ULN Alanine aminotransferase (ALT) ≤2.5×ULN Total bilirubin (TBIL) ≤1.5×ULN Renal Function: Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (CrCl) ≥60 mL/min (calculated via Cockcroft-Gault formula). Coagulation: International normalized ratio (INR) ≤1.5 Activated partial thromboplastin time (APTT) ≤1.5×ULN Cardiac Function: No clinically significant abnormalities on electrocardiogram (ECG)； * Male subjects and females of childbearing potential must agree to use effective contraceptive measures from the first dose until 3 months after the last dose of the study drug.
Exclusion criteria
* 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; * Subjects have other malignancies requiring treatment; * Clinically significant cardiovascular disorders； * Prior allogeneic organ transplantation or hematopoietic stem cell transplantation； * Serologically confirmed HIV infection； * Active hepatitis B (HBsAg-positive with HBV-DNA ≥10³ copies/mL). Active hepatitis C (HCV antibody-positive with detectable HCV RNA and requiring antiviral therapy)； * Known hypersensitivity to monoclonal antibodies or any component of adebrelimab； * History of severe allergic reactions to gemcitabine or nab-paclitaxel； * Any situation that the investigator believes may compromise the validity of the trial or patient safety.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR | up to 20 weeks | Objective response rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS | up to 20 weeks | Progression-free survival |
| OS | 1 year | Overall survival |
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | through study completion, an average of 1 year | 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. |
Countries
China
Contacts
Primary ContactJin Xu
Outcome results
None listed