OncoMatch/Clinical Trials/NCT06844422
Adapted Guided Stereotactic Body Radiotherapy Combined with Chemotherapy and Enhancement of Novel Drug Ivonescimab for Pancreatic Cancer (ASCEND)
Is NCT06844422 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Ivonescimab for pancreatic cancer.
Treatment: Ivonescimab — This study aims to evaluate the safety and efficacy of Ivonescimab, a bispecific antibody targeting PD-1 and VEGF, in combination with stereotactic body radiotherapy (SBRT) and chemotherapy for treating locally advanced pancreatic cancer (LAPC). The Phase Ib portion is a dose-escalation study to determine the maximum tolerated dose (MTD), dose-limiting toxicity (DLT), and the recommended Phase II dose (RP2D) of Ivonescimab. The Phase II portion will assess the median progression-free survival (mPFS) of patients receiving Ivonescimab with SBRT (25-50Gy/5F) and modified FOLFIRINOX chemotherapy. The study aims to provide critical insights into treatment options for LAPC and inform future therapeutic strategies.
Check if I qualifyExtracted eligibility criteria
Cancer type
Pancreatic Cancer
Disease stage
Required: Stage UNRESECTABLE LOCALLY ADVANCED PANCREATIC CANCER (AJCC 8th edition)
unresectable LAPC, as defined by the 8th edition of the American Joint Committee on Cancer (AJCC)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: drugs targeting other stimulatory or co-inhibitory T-cell receptors
Previous treatment with drugs targeting other stimulatory or co-inhibitory T-cell receptors
Cannot have received: radiation therapy
Prior radiotherapy within 2 weeks before enrollment
Lab requirements
Blood counts
Hemoglobin (Hb) ≥ 90 g/L; ANC ≥ 1.0 × 10^9/L; Platelet count (PLT) ≥ 75 × 10^9/L; INR and aPTT ≤ 1.5 × ULN
Kidney function
Serum creatinine ≤ 1.5 × ULN or calculated creatinine clearance ≥ 40 mL/min if serum creatinine is > 1.5 × ULN; Urine protein < 2+, or if ≥ 2+ on dipstick, 24-hour urine protein must be < 2 g or UPC must be < 2
Liver function
Serum total bilirubin ≤ 1.5 × ULN or direct bilirubin ≤ ULN if total bilirubin > 1.5 × ULN; ALT and AST ≤ 2.5 × ULN; ALP ≤ 2.5 × ULN, or ≤ 2.5 × ULN for the liver fraction if ALP > 2.5 × ULN
Adequate hematological, renal, and hepatic function, as defined by the following criteria (within 14 days prior to enrollment): (1) Hemoglobin (Hb) ≥ 90 g/L; Absolute Neutrophil Count (ANC) ≥ 1.0 × 10^9/L; Platelet count (PLT) ≥ 75 × 10^9/L; (2) No significant organ dysfunction, with the following criteria: Serum total bilirubin ≤ 1.5 × ULN or direct bilirubin ≤ ULN if total bilirubin > 1.5 × ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; Alkaline phosphatase (ALP) ≤ 2.5 × ULN, or ≤ 2.5 × ULN for the liver fraction if ALP > 2.5 × ULN; Serum creatinine ≤ 1.5 × ULN or calculated creatinine clearance (using the MDRD formula) ≥ 40 mL/min if serum creatinine is > 1.5 × ULN; Urine protein < 2+, or if ≥ 2+ on dipstick, 24-hour urine protein must be < 2 g or the urine protein-to-creatinine ratio (UPC) must be < 2; International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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