Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 2:33 AM
Study NCT ID:
NCT07337551
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-13
First Post:
2025-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gossypol Acetate + FOLFIRI + Bev in mCRC With TP53-Mutant and LRPPRC Positive
Sponsor:
Guiying Wang
Organization:
Study Overview
Official Title:
Gossypol Acetate Combined With Bevacizumab and FOLFIRI as Second-Line Therapy for Metastatic Colorectal Cancer With TP53 Mutation and LRPPRC Positivity: A Single-Center, Single-Arm Clinical Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a single-center, single-arm clinical trial involving patients with TP53-mutated and LRPPRC-positive metastatic colorectal cancer. It aims to evaluate the efficacy and safety of gossypol acetate tablets combined with bevacizumab and the FOLFIRI regimen as a second-line treatment. The study is based on a key scientific finding: LRPPRC is a critical protein mediating chemotherapy resistance induced by TP53 mutation, and gossypol acetate-an existing drug-can specifically degrade LRPPRC. Preclinical studies have demonstrated its potential to effectively reverse drug resistance.
Patients who have experienced failure of first-line oxaliplatin-based therapy are planned to be enrolled. All eligible subjects will receive the same combined treatment regimen until disease progression or unacceptable toxicity occurs. The primary endpoint is objective response rate (ORR), and secondary endpoints include progression-free survival (PFS), overall survival (OS), and safety. Throughout the treatment period, patients will undergo regular tumor imaging evaluations and safety monitoring. Statistical analyses will be performed using both the full analysis set and the per-protocol set.
This study strictly adheres to ethical standards and aims to explore a new potential treatment strategy for this specific refractory patient population.
Patients who have experienced failure of first-line oxaliplatin-based therapy are planned to be enrolled. All eligible subjects will receive the same combined treatment regimen until disease progression or unacceptable toxicity occurs. The primary endpoint is objective response rate (ORR), and secondary endpoints include progression-free survival (PFS), overall survival (OS), and safety. Throughout the treatment period, patients will undergo regular tumor imaging evaluations and safety monitoring. Statistical analyses will be performed using both the full analysis set and the per-protocol set.
This study strictly adheres to ethical standards and aims to explore a new potential treatment strategy for this specific refractory patient population.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: