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NCT06844422PHASE1, PHASE2RECRUITING

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

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Key Facts

Study type
INTERVENTIONAL
Conditions
Pancreatic Cancer
Interventions
Ivonescimab
Enrollment
37 participants
Primary completion
Feb 2028
Study completion
Feb 2028
First posted
Feb 2025
Last updated
Apr 2026

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

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✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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Source

Open on ClinicalTrials.gov