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:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-25 @ 2:15 AM
NCT ID:
NCT07047560
Brief Summary:
This is an investigator-initiated, prospective, multicenter, single-arm phase II clinical study. It aims to evaluate the efficacy and safety of fractionated liposomal irinotecan (II)-based combination chemotherapy (FOLFIRInali-3) plus bevacizumab (Bev) as second-line treatment for advanced colorectal cancer, with the primary endpoint being objective response rate (ORR).
Eligible subjects will receive second-line treatment with the FOLFIRInali-3 （Liposomal irinotecan (II) fractionated dosing combined with 5-FU/LV） plus bevacizumab (Bev) 。Treatment will be discontinued upon occurrence of any of the following: Disease progression (radiologically confirmed)，intolerable toxicity (unmanageable after dose modification)， initiation of new antitumor therapy, withdrawal of informed consent or investigator's discretion (based on clinical judgment). Patients received regular and periodic reviews, with imaging evaluations every 6 weeks.
Detailed Description:
This is an investigator-initiated, prospective, multicenter, single-arm phase II clinical study. It aims to evaluate the efficacy and safety of fractionated liposomal irinotecan (II)-based combination chemotherapy (FOLFIRInali-3) plus bevacizumab (Bev) as second-line treatment for advanced colorectal cancer, with the primary endpoint being objective response rate (ORR).
Prospective participants must undergo screening assessments within 28 days before randomization to determine eligibility. Eligible subjects will receive second-line treatment with the FOLFIRInali-3 plus bevacizumab (Bev) regimen as follows:
1. Liposomal irinotecan (II): 30 mg/m² IV on D1 and D3
2. Fluorouracil (5-FU):
* 400 mg/m² IV bolus on D1
* Followed by 2400 mg/m² continuous IV infusion over 46-48 hours
3. Leucovorin (LV): 400 mg/m² IV infusion on D1
4. Bevacizumab: 5 mg/kg IV infusion on D1。
Treatment will be discontinued upon occurrence of any of the following:
1. Disease progression (radiologically confirmed)
2. Intolerable toxicity (unmanageable after dose modification)
3. Initiation of new antitumor therapy
4. Withdrawal of informed consent
5. Investigator's discretion (based on clinical judgment)
Patients received regular and periodic reviews, with imaging evaluations every 6 weeks.
Study:
NCT07047560
Study Brief:
Protocol Section:
NCT07047560