Status:
RECRUITING
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.
Lead Sponsor:
Shanghai Changzheng Hospital
Conditions:
Advanced Colorectal Cancer in the Third-line Treatment and Beyond
pMMR/MSS Advanced Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Patients with advanced colorectal cancer, particularly those of the pMMR/MSS type, exhibit suboptimal therapeutic responses in the third-line and subsequent treatments. The efficacy of the existing st...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06930118
Start Date
April 10 2025
End Date
September 30 2027
Last Update
April 16 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Medical Oncology, Second Affiliated Hospital of Naval Medical University
Shanghai, China, 200003