The Aim of This Study is to Assess the Efficacy and Safety of Chidamide, Regorafenib in Combination With Iparomlimab and Tuvonralimab for the Treatment of Advanced Colorectal Cancer in Third-line Therapy and Subsequent Lines.

Launched by SHANGHAI CHANGZHENG HOSPITAL · Apr 8, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with advanced colorectal cancer who have not responded well to previous therapies. The researchers want to find out if a combination of three drugs—chidamide, regorafenib, and two immune therapy agents called iparomlimab and tuvonralimab—can help improve outcomes for patients in what is known as "third-line" treatment and beyond. This is important because current treatment options for advanced colorectal cancer often have limited effectiveness.

To be eligible for this trial, participants must be adults (18 years and older) with confirmed advanced colorectal cancer that has continued to progress after receiving at least two standard treatments. They should have at least one measurable tumor and a good performance status, meaning they can carry out daily activities with minimal issues. Participants can expect to receive the study drugs at Shanghai Changzheng Hospital and will be monitored closely for safety and effectiveness. It’s important to note that women of childbearing age are required to take precautions to avoid pregnancy during the study. Overall, this trial aims to explore new possibilities for patients who have run out of effective treatment options.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients with advanced colorectal adenocarcinoma confirmed by histology or cytology;
• • Those who have experienced disease progression or are intolerant to treatment after receiving ≥ 2 lines of systemic standard therapy;
• • Patients must have at least one measurable lesion (according to RECIST 1.1 criteria);
• • Patients who have received local radiotherapy at least 3 weeks before the first drug treatment are eligible for inclusion; however, the lesions evaluated by RECIST must not be within the radiotherapy field;
• • Patients must be at least 18 years old;
• • Performance status ECOG score of 0-1;
• • Expected survival ≥ 12 weeks;
• • Patients must have the ability to understand and voluntarily sign the written informed consent form;
• • Women of childbearing age must have a negative pregnancy test within 7 days before the start of treatment. During the study period, both the patient and the patient's spouse must take contraceptive measures.
• Exclusion Criteria:
• • Patients who have undergone major surgery or suffered severe trauma within 4 weeks prior to the first dose of the study drug;
• • Patients with hypersensitivity to any component of the study protocol;
• • Patients planning to conceive or who are pregnant;
• • Patients with brain metastases and an inability to accurately describe their condition;
• • Patients who have experienced any of the following diseases within 6 months prior to the start of the study treatment: myocardial infarction, severe/unstable angina pectoris, NYHA class 2 or higher congestive heart failure, uncontrolled arrhythmia, etc.;
• * Abnormal laboratory tests:
• • Absolute neutrophil count (ANC) \< 1,500/mm3; Platelet count \< 75,000/mm3; Total bilirubin \> 1.5 times the upper limit of normal; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \> 2.5 times the upper limit of normal (for patients with liver metastases \> 5 times the upper limit of normal); Creatinine \> 1.5 times the upper limit of normal;
• • Patients who have had other cancers (except advanced colorectal cancer) within 5 years prior to the start of this study treatment. Cervical carcinoma in situ, cured basal cell carcinoma and bladder epithelial tumors are excluded;
• • Patients with a history of drug abuse, drug addiction, or alcohol dependence;
• • Patients without legal capacity or with limited civil capacity;
• • Other conditions that the investigator deems inappropriate for inclusion in the study.