OncoMatch/Clinical Trials/NCT06454448
Phase Ib/II Clinical Study of Adebrelimab in Combination With Decitabine, Albumin-bound Paclitaxel, and Gemcitabine for the First-line Treatment of Metastatic Pancreatic Cancer
Is NCT06454448 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Adebrelimab;decitabine; for adebrelimab (shr-1316).
Treatment: Adebrelimab;decitabine; — Pancreatic cancer is a kind of digestive system tumor with extremely high malignancy and poor prognosis. Although the trend of benefit from immunotherapy in combination with chemotherapy is currently reflected in several exploratory studies, the overall efficacy is still relatively limited. Dysregulation of epigenetic mechanisms, which is common in cancer, leads to down-regulation of genes involved in tumor antigen processing or presentation, resulting in immune evasion and thus affecting the efficacy of immunotherapy. Epigenetic inhibitors may enhance the efficacy of immunotherapy by enhancing antigenicity and presentation of tumor-associated antigens, reprogramming the tumor microenvironment to counteract immunosuppression, and reversing cytotoxic T-cell depletion. Thus, decitabine-promoted immunotherapeutic sensitization is a potential therapeutic avenue for mPDAC patients that warrants further exploration in clinical trials. Taking into account the characteristics of pancreatic cancer immunophenotype, exploring combination therapy regimens that enhance anti-tumor immune response and improve the efficacy of immunotherapy has become an urgent clinical problem. This study is a prospective, single-arm, single-center, phase IB/II clinical study exploring the efficacy and safety of adebrelimab in combination with decitabine, albumin-bound paclitaxel, and gemcitabine in the first-line treatment of metastatic pancreatic cancer. The primary study endpoints are DLT, RP2D and ORR. Secondary study endpoints are OS, PFS, DCR, DoR and safety.
Check if I qualifyExtracted eligibility criteria
Cancer type
Pancreatic Cancer
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anti-tumor therapy
Have not received any anti-tumor therapy (including chemotherapy, targeted, immunotherapy, etc.)
Lab requirements
Blood counts
Neutrophils ≥1.5×10^9/L; platelets ≥80×10^9/L; hemoglobin ≥9g/dl; serum albumin ≥3g/dl
Kidney function
Serum creatinine ≤1.5x ULN, creatinine clearance ≥50ml/min
Liver function
Total bilirubin ≤ 1.5x ULN (biliary obstruction allows biliary drainage); ALT and AST ≤ 3x ULN (≤ 5x ULN with hepatic metastases)
Cardiac function
QTcF ≤450ms (men), ≤470ms (women); LVEF ≥50%
Good major organ function, i.e., the following criteria are met (in the absence of receiving any blood components, cell growth factors within 14 days prior to randomization): Neutrophils ≥1.5×10^9/L; platelets ≥80×10^9/L; hemoglobin ≥9g/dl; serum albumin ≥3g/dl; Total bilirubin ≤ 1.5x ULN (biliary obstruction allows biliary drainage); ALT and AST ≤ 3x ULN (≤ 5x ULN with hepatic metastases); Serum creatinine ≤1.5x ULN, creatinine clearance ≥50ml/min; INR ≤1.5x ULN and APTT ≤1.5x ULN (for the use of a stable dose of anticoagulation therapy, such as low molecular heparin or warfarin, and the INR is within the expected therapeutic range of anticoagulants can be screened); Electrocardiogram: QTcF ≤450ms (men), ≤470ms (women); Cardiac ultrasound: LVEF ≥50%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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