RecruitingPhase 1Phase 2NCT06844422

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

Enrollment

37 participants

Start Date

Feb 8, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination treatment approach for locally advanced pancreatic cancer (cancer that can't be surgically removed but hasn't spread to distant organs) that combines radiation therapy adapted to tumor changes during treatment ("adapted SBRT"), chemotherapy, and a new immunotherapy drug called ivonescimab. **You may be eligible if...** - You are between 18 and 80 years old with confirmed unresectable locally advanced pancreatic cancer - Your cancer has at least one measurable tumor - You are in good functional health (able to carry out normal activities) - Your blood, kidney, and liver function are adequate **You may NOT be eligible if...** - Your cancer has spread to distant organs (metastatic) - You have prior radiation to the pancreatic area - You have active autoimmune disease - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIvonescimab

1. Phase Ib (Dose Escalation): In this phase, patients will receive Ivonescimab in escalating doses, with the aim of determining the maximum tolerated dose (MTD), dose-limiting toxicity (DLT), and the recommended Phase II dose (RP2D). The dose-escalation process will follow a 3+3 design over a 4-week period to establish the RP2D of Ivonescimab. 2. Phase II (Efficacy Evaluation): After establishing the RP2D, patients will receive Ivonescimab combined with SBRT and modified FOLFIRINOX chemotherapy.


Locations(1)

Shandong Cancer Hospital and Institute

Jinan, Shandong, China

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NCT06844422


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