Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2025-12-24 @ 4:58 PM
NCT ID:
NCT07021950
Brief Summary:
This study is a multicenter, open-label phase II trial conducted to assess the safety and antitumor activity of Ivonescimab (AK112) plus FOLFIRI versus bevacizumab plus FOLFIRI as second-line treatment in subjects with MSS/pMMR metastatic colorectal cancer who have experienced intolerance to oxaliplatin-containing first-line therapy or disease progression, or recurrence within 6 months after oxaliplatin adjuvant therapy.
Detailed Description:
After obtaining informed consent, the experimental group receives AK112 at 20 mg/kg via intravenous infusion on day 1 of each cycle (Q2W) combined with FOLFIRI chemotherapy (Q2W), while the control group receives bevacizumab at 5 mg/kg via intravenous infusion on day 1 of each cycle (Q2W) in combination with FOLFIRI (Q2W). Treatment continues until disease progression, death, intolerable toxicity, withdrawal of consent, initiation of new antitumor therapy, or other protocol-specified reasons for discontinuation. The maximum treatment duration is 24 months.
Study:
NCT07021950
Study Brief:
Protocol Section:
NCT07021950