Adapted Guided Stereotactic Body Radiotherapy Combined With Chemotherapy and Enhancement of Novel Drug Ivonescimab for Pancreatic Cancer (ASCEND)

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.

Trial Details

NCT ID
NCT06844422
Phase
PHASE1 / PHASE2
Sponsor
Shandong Cancer Hospital and Institute
Status
RECRUITING
Cancer Type
Pancreatic Cancer
Interventions
  • Ivonescimab
Locations (sample)
  • Jinan, Shandong, China|36.66833,116.99722

Key Eligibility Criteria

  • Pathologically or cytologically confirmed unresectable LAPC, as defined by the 8th edition of the American Joint Committee on Cancer (AJCC);
  • Age between 18 and 80 years;
  • At least one measurable pancreatic cancer lesion, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1;
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;

For full eligibility, visit ClinicalTrials.gov.

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