Actively Recruiting
Adapted Guided Stereotactic Body Radiotherapy Combined With Chemotherapy and Enhancement of Novel Drug Ivonescimab for Pancreatic Cancer (ASCEND)
Led by Shandong Cancer Hospital and Institute · Updated on 2026-04-28
37
Participants Needed
1
Research Sites
157 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Adapted Guided Stereotactic Body Radiotherapy Combined With Chemotherapy and Enhancement of Novel Drug Ivonescimab for Pancreatic Cancer (ASCEND)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically or cytologically confirmed unresectable locally advanced pancreatic cancer (LAPC) as defined by AJCC 8th edition
- Age between 18 and 80 years
- At least one measurable pancreatic cancer lesion defined by RECIST 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Life expectancy of at least 3 months
- Adequate blood counts and organ function within 14 days before enrollment
- Ability to provide tissue and blood samples for research
- Ability to understand study details and give written informed consent
You will not qualify if you...
- History of any malignant tumors within the past 5 years except cured localized tumors
- Uncontrolled infections or systemic diseases, poorly controlled hypertension or diabetes, or severe comorbidities within 6 months
- Previous treatment with drugs targeting other T-cell receptors
- Radiotherapy within 2 weeks before enrollment
- Known allergy to Ivonescimab or its ingredients
- Pregnancy or breastfeeding
- Use of strong CYP3A4/5 or CYP1A2 inducers or inhibitors
- Need for oral vitamin K antagonists for anticoagulation except low-dose warfarin or low-molecular-weight heparin
- Conditions affecting oral medication such as recent gastrointestinal perforation, fistula, obstruction, extensive bowel surgery, Crohn's disease, ulcerative colitis, or chronic diarrhea
AI-Screening
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Trial Site Locations
Total: 1 location
1
Shandong Cancer Hospital and Institute
Jinan, Shandong, China, 0531
Actively Recruiting
Research Team
J
Jinbo Yue, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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