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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Gossypol Acetate Oral 20mg/day
Primary Endpoint
Objective Response Rate (ORR)
Time frame: up to 16 months
Secondary Endpoints
Progression-Free Survival (PFS)
Time frame: up to 16 months
Secondary Endpoints
Clinical Benefit Rate (CBR)
Time frame: up to 16 months
Secondary Endpoints
Duration of Response (DoR)
Time frame: up to 16 months
Secondary Endpoints
Time to Response (TTR)
Time frame: up to 16 months
Secondary Endpoints
Overall Survival (OS)
Time frame: up to 16 months
Secondary Endpoints
Adverse Events (AE)
Time frame: up to 16 months
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