colorectal cancer
Conditions
Interventions
Group A:TAS-102 plus Fruquintinib in combination with Chidamide and Serplulimab
Group B:TAS-102 plus Fruquintinib
Sponsors
The First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Pathologically confirmed colorectal cancer. 2. Male or female, aged >= 18 years. 3. Life expectancy >= 3 months. 4. ECOG performance status of 0 or 1. 5. At least one measurable lesion as defined by RECIST 1.1 criteria. 6. Third-line and beyond treatment, with no prior treatment with PD-1 monoclonal antibody, TAS-102, or Fruquintinib. 7. Adequate organ function, meeting the following laboratory parameters within 14 days prior to treatment: Absolute neutrophil count (ANC) >= 1.5 × 10^9/L without granulocyte colony-stimulating factor support within 14 days. Platelet count >= 100 × 10^9/L without transfusion within 14 days. Hemoglobin >90 g/L without transfusion or erythropoietin use within 14 days. Total bilirubin ULN with direct bilirubin = 60 mL/min. 8. Written informed consent must be obtained prior to any trial-related procedures, and family members agree to cooperate with survival follow-up.
Exclusion criteria
Exclusion criteria: 1. Diagnosis of any malignancy other than pancreatic cancer within 5 years prior to the first dose (excluding adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, and/or carcinoma in situ that has undergone radical resection); 2. Current participation in an interventional clinical study, or treatment with other investigational drugs or use of investigational devices within 4 weeks prior to the first dose. 3. Diagnosis of central nervous system (CNS) metastasis or a history of CNS metastasis before enrollment. For patients clinically suspected of having CNS metastasis, a CT or MRI examination must be conducted within 28 days before enrollment to exclude CNS metastasis; 4. Individuals with a history of unstable angina pectoris; Newly diagnosed with angina pectoris within 3 months prior to screening or experienced a myocardial infarction within 6 months prior to screening; individuals with arrhythmias (including QTcF: >=450 ms for males and >=470 ms for females) requiring long-term antiarrhythmic medication, and with New York Heart Association functional classification of >=II heart dysfunction; 5. Urine routine test indicates that the urine protein is >=++ and the 24-hour urine protein quantitation is confirmed to be >1.0 g; 6. For female subjects: they should be patients who have undergone surgical sterilization, have gone through menopause, or agree to adopt a medically approved contraceptive measure during and within 6 months after the completion of the study treatment period; their serum or urine pregnancy test must be negative within 7 days before enrollment in the study, and they must not be breastfeeding. For male subjects: they should be patients who have undergone surgical sterilization, or agree to adopt a medically approved contraceptive measure during and within 6 months after the completion of the study treatment period; 7. Having a history of immune deficiency, or suffering from other acquired or congenital immune deficiency diseases, or having undergone organ transplantation. 8. Patients with infectious pneumonia, non-infectious pneumonia, interstitial pneumonia, and others requiring the use of corticosteroids. 9. Individuals with a history of chronic autoimmune diseases such as systemic lupus erythematosus; those with a history of inflammatory bowel diseases such as ulcerative enteritis and Crohn's disease; individuals with a history of chronic diarrhea diseases such as irritable bowel syndrome; those with a history of sarcoidosis or tuberculosis; individuals with active hepatitis B, hepatitis C, and HIV infection. 10. Patients with hypersensitivity reactions to human or mouse monoclonal antibodies. 11. Patients with a history of abuse of psychoactive drugs and unable to quit, or those with mental disorders. 12. Pleural effusion or ascites with clinical symptoms requiring clinical intervention. 13. According to the researchers' judgment, there are concomitant diseases that pose serious threats to patient safety or affect patients' ability to complete the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety;Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 6 months OS rate;12 months OS rate;progression-free survival;QoL;6 months PFS rate;12 months PFS rate;disease control rate;overall survival; | — |
Countries
China
Contacts
Public ContactLi Wei
The First Affiliated Hospital of Soochow University
Outcome results
None listed