Adapted Guided Stereotactic Body Radiotherapy Combined With Chemotherapy and Enhancement of Novel Drug Ivonescimab for Pancreatic Cancer (ASCEND)
Adapted Guided Stereotactic Body Radiotherapy Combined With Chemotherapy and Enhancement of Novel Drug Ivonescimab for Pancreatic Cancer (ASCEND) -A Single-Arm Phase Ib/II Trial
Sponsor: Shandong Cancer Hospital and Institute
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Maximum Tolerated Dose (MTD)
Time frame: 1 years
Dose-Limiting Toxicity (DLT)
Time frame: 1 years
Recommended Phase 2 Dose (RP2D)
Time frame: 1 years
Progression-Free Survival (PFS)
Time frame: 3 years
Secondary Endpoints
Overall Survival (OS)
Objective remission rate (ORR)
Disease control rate (DCR)
Eligibility Criteria
Inclusion Criteria: 1. Pathologically or cytologically confirmed unresectable LAPC, as defined by the 8th edition of the American Joint Committee on Cancer (AJCC); 2. Age between 18 and 80 years; 3. At least one measurable pancreatic cancer lesion, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1; 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; 5. Life expectancy of at least 3 months; 6. 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 × upper limit of normal (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 × U…
Read full criteria on CT.gov →✦ Analyst Commentary
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