pMMR/MSS colorectal cancer
Conditions
Interventions
Experimental group:Olverembatinib 5.0mg/kg, intravenous infusion, D1, repeat every 3 weeks, maximum use for 2 years. TAS-102, 35mg/m^2, oral administration on days 1-5 and 15-19, twice daily, repeat e
Sponsors
Second Affiliated Hospital of Nanchang University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years, no gender limit; 2. Patients with pathologically confirmed, unresectable advanced colorectal cancer liver metastases who have received at least two lines of progression or are intolerant to standard treatment drugs such as oxaliplatin, irinotecan, and fluoropyrimidines for colorectal cancer; 3. Genomic microsatellite molecular typing is microsatellite stable (MSS/pMMR). 4. The number of liver metastases is >=3, and radical resection is not feasible; 5. Child-Pugh score of liver function =12 weeks; 9. Normal major organ function (within 14 days before enrollment), i.e., meet the following criteria: Hematological examination criteria should be met (no blood transfusion or granulocyte colony-stimulating factor treatment within 14 days before enrollment): Hemoglobin (HB) >=90 g/L; Neutrophils (ANC) >=1.0×10^9/L; Platelets (PLT) >=50×10^9/L; No functional organic disease, which must meet the following criteria: Serum total bilirubin =3g/dL; serum creatinine level: Cr =40ml/min and Cr >1.5×ULN; urine protein =2+, then 24-hour urine protein must be <2g, or the urine protein-to-creatinine ratio (UPC) must be <2; international normalized ratio (INR), activated partial thromboplastin time (aPTT): <=1.5×ULN; 10. Women of childbearing age must have already adopted reliable contraceptive measures or have undergone a pregnancy test (serum or urine) within 7 days before enrollment, with negative results, and be willing to use appropriate contraceptive methods during the trial and for 8 weeks after the last administration of the trial drug. For men, they must agree to use appropriate contraceptive methods during the trial and for 8 weeks after the last administration of the trial drug or have undergone surgical sterilization; 11. Subjects voluntarily join this study, sign informed consent forms, adhere well to the protocol, and cooperate with follow-ups.
Exclusion criteria
Exclusion criteria: 1. Clinical effusions requiring drainage, such as pleural effusion, ascites, and pericardial effusion; 2. Previously received PD-1 or CTLA-4 inhibitor treatment before enrollment; 3. Presence of central nervous system metastasis or coexistence of other primary tumors; 4. Patient unable to lie flat or unable to cooperate with lying flat for 10-20 minutes during radiotherapy; 5. Presence of uncontrolled cardiac clinical symptoms or diseases, such as: a. NYHA class II or higher heart failure; b. unstable angina; c. myocardial infarction within the past year; d. clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; 6. Severe or uncontrolled infection; 7. Severe active bleeding, severe arterial or venous thrombotic events, gastrointestinal obstruction or perforation requiring urgent treatment; 8. Received major surgical treatment, incisional biopsy, or significant trauma within 28 days prior to treatment; 9. Individuals requiring immunosuppressive therapy for organ transplantation and those on long-term steroid therapy; 10. Patients with autoimmune diseases; 11. Individuals with a history of allergy to any of the study medication components. 12. According to the researcher's judgment, there are serious accompanying diseases that pose a significant risk to the safety of the subjects or affect their ability to complete the clinical study; 13. According to the researcher's judgment, the subject has other factors that could lead to the premature termination of this study, such as other severe diseases (including mental illnesses) requiring combined treatment, serious laboratory test abnormalities, or family or social factors that could affect the safety of the subjects or the collection of data and samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS, Progression Free Survival;disease control rate, DCR;Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival, OS;Objective response rate, ORR; | — |
Countries
China
Contacts
Public ContactWang Hua
Second Affiliated Hospital of Nanchang University
Outcome results
None listed