MSS type advanced colorectal cancer with liver metastasis
Conditions
Interventions
one:Interventional protocol: regorafenib and PD-1/PD-L1 treatment within 1 week before liver c-TACE, intraoperative administration: raltitrexed 4mg.
Sponsors
The First Affiliated Hospital of University of Science and Technology of China
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria: 1. Patients voluntarily participate in the research of this topic, have good compliance, can cooperate with the requirements of the experiment to complete observation and follow-up, and sign informed consent; 2. Age >= 18 years old, male or female; 3. Genetic testing is clearly MSS or pMMR type; 4. Patients with colorectal cancer diagnosed by histopathological examination; 5. Imaging diagnosis of liver metastasis, which can be accompanied by metastasis in other parts; 6. After evaluation, about 80% of the volume of metastases is in the liver, but 60% of the affected liver is normal tissue; or those who are deemed unsuitable for surgery after multidisciplinary discussion, or the patient refuses surgical treatment; 7. Failure of treatment with at least 2 previous regimens; 8. Estimated survival time >= 3 months; 9. Have at least 1 measurable lesion according to mRECIST/RECIST1.1 criteria; 10. For female subjects: should be surgically sterilized, postmenopausal patients, or agree to use a medically recognized method of contraception (e.g., IUD, pill, or condom) during study treatment and within 6 months of the end of study treatment period; A blood pregnancy test must be negative within 7 days prior to study administration and must be non-lactating. For male subjects: should be surgically sterilized or agree to use a medically recognized contraceptive method during study treatment and within 6 months of the end of study treatment period; 11. Able to understand the test requirements, willing and able to follow the test and follow-up procedures. 12. Sufficient organ function, subjects need to meet the following laboratory indicators: (1) Absolute value (ANC) of neutrophils >= 1.5x10^9/L; (2) Platelet >= 90×10^9/L; (3) Hemoglobin> 9g/dL; (4) Total bilirubin ULN but direct bilirubin = 60 ml/min; (6) Good coagulation function, defined as the international normalized ratio (INR) or prothrombin time (PT) <= 1.5 times ULN; (7) Thyroid function is normal, defined as thyroid-stimulating hormone (TSH) within the normal range. If baseline TSH is outside the normal range, participants may also be enrolled if total T3 (or FT3) and FT4 are within the normal range; Myocardial enzyme profiles within the normal range (if the investigator comprehensively judges that simple laboratory abnormalities are not clinically significant, enrollment is also allowed).
Exclusion criteria
Exclusion criteria: Patients with any of the following were not enrolled in this study: 1. Diagnosed immunodeficiency or being receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 14 days prior to the first administration of the study, allowing the use of physiologic doses of glucocorticoids (= 150mmHg or diastolic blood pressure >=100mmHg); (2) Patients with grade >=2 myocardial ischemia or myocardial infarction, arrhythmia (QTc >=470ms) and grade >=2 congestive heart failure (New York Heart Association [NYHA] grade); (3) Active or uncontrolled severe infection (>= CTCAE grade 2 infection); (4) Cirrhosis, active hepatitis*; *Active hepatitis (hepatitis B reference: HBsAg positive and HBV DNA test above the upper limit of normal; Hepatitis C reference: positive HCV antibody and HCV virus titer above the upper limit of normal); Note: Subjects who meet the enrollment conditions, positive hepatitis B surface antigen or core antibody, and patients with hepatitis C need continuous antiviral therapy to prevent virus activation. (5) Those with active syphilis; (6) Renal failure requiring hemodialysis or peritoneal dialysis; (7) Have a history of immunodeficiency, including HIV-positive or other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation; 3. Have received a live vaccine within 30 days before the first dose (cycle 1, day 1); 4. Female patients who are pregnant, lactating, and have childbearing potential and do not take contraception; 5. Medical history or disease evidence, abnormal treatment or laboratory test values that may interfere with the test results, prevent the subject from participating in the research throughout the study, or other situations that the investigator believes are not suitable for enrollment, and the investigator believes that there are other potential risks and is not suitable for participating in this study; Those who are known to be allergic to active ingredients such as drugs or excipients in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival, PFS;Disease Control Rate, DCR;Duration of Response, DOR;Overall Survival, OS; | — |
Countries
China
Contacts
Public ContactHe Yifu
The First Affiliated Hospital of University of Science and Technology of China
Outcome results
None listed