colorectal cancer
Conditions
Interventions
Experimental group:Pembrolizumab + DEB-TACE
Sponsors
The First Affiliated Hospital of the Air Force Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients aged >=18 years with colorectal cancer liver metastases (CRC-LM) diagnosed by histological diagnosis or EASL imaging criteria, no gender limit. 2. ECOG score = 1000 /mm^3 (1.0 x 10^9/L); (2) Platelet count (PLT) >= 40,000/mm^3 (40 x 10^9/L); (3) Hemoglobin (Hb) >= 9 g/dL (90 g/L); (4) Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level = 50 ml/min; (6) Left ventricular ejection fraction (LVEF) >=50%; QTc < 450ms for males and < 470ms for females. Note: Blood routine examination [no blood transfusion, no granulocyte colony-stimulating factor (G-CSF), no medication correction within 14 days before screening]; Biochemical tests (no albumin infusion within 14 days prior to screening). 8. Patients with hepatitis B must meet HBV-DNA < 500 IU/mL, and must receive antiviral therapy according to the treatment guidelines; In the case of hepatitis C, HCV-RNA positive patients must receive antiviral therapy according to the guidelines; 9. Female patients of reproductive age must undergo a pregnancy test with negative results within 1 week before starting the study medication and be willing to use a medically approved highly effective contraceptive (e.g., intrauterine device, birth control pill, or condom) during the study period and within 3 months after the last administration of the study medication; Male patients whose partners are women of childbearing age should be surgically sterilized or agree to use an effective method of contraception during the study period and for 3 months after the last study dose. 10. Good compliance is expected and can cooperate with the study according to the protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Combined with the second malignant tumor, and the tumor has been active within 5 years; 2. Lactation patients; 3. A known history or any evidence of central nervous system (CNS) metastases and/or cancerous meningitis; 4. Patients who have received allogeneic tissue/solid organ transplantation; 5. Not suitable for TACE treatment, such as severe arteriovenous leakage; 6. Patients who had gastrointestinal bleeding within 1 month before enrollment, without targeted treatment, and still had high blood risk; 7. Refractory ascites; 8. Known allergy to the study drug or any of its excipients; Or a severe allergic reaction to other monoclonal antibodies; 9. Previously received immunotherapy for PD-1 and PD-L1; 10. Received the following treatments or medications before or currently under study treatment: (1) Use of immunosuppressive agents within 7 days before or currently during the first study drug treatment, excluding intranasal and inhaled corticosteroids or physiological doses of systemic steroid hormones (i.e., other corticosteroids not exceeding 10 mg/ day of prednisone or an equivalent physiological dose); (2) Have received immunoregulatory drugs (such as thymosin, interferon and interleukin) within 3 weeks before the first drug use or currently; (3) Live attenuated vaccine was administered within 28 days before the first study drug treatment or planned to be administered during the study and within 60 days after the end of study drug treatment; 11. Currently participating in other research treatments; Or has participated in any other drug clinical study within 4 weeks prior to the first dose, or has not more than 5 half-lives since the last dose; 12. Suffers from an autoimmune disease that has required systemic treatment for the past two years; Or have a history of autoimmune disease with expected recurrence; 13. Human immunodeficiency virus (HIV) infection, or immunodeficiency; 14. Major organ failure, such as compensatory cardiopulmonary, liver and kidney failure; Severe liver and kidney dysfunction, affecting the normal metabolism of drugs; 15. Patients with myocardial infarction, severe/unstable angina pectoris, NYHA grade 2 or higher cardiac dysfunction, and clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention in the 6 months prior to study entry; Have medically poorly controlled hypertension (systolic blood pressure >=150mmHg or diastolic blood pressure >=100mmHg); 16. Systemic antibiotic use for >= 7 days within 4 weeks before the first dose, or unexplained fever >38.5? during the screening period/before the first dose (tumor-related fever can be included, as judged by the investigator); 17. A clear history of neurological or psychiatric disorders, including epilepsy and dementia; A known history of psychotropic substance abuse or drug use; 18. Patients deemed inappropriate for study participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;progression-free survival;disease control rate;duration of response; | — |
Countries
China
Contacts
Public ContactLi Jipeng
The First Affiliated Hospital of the Air Force Medical University
Outcome results
None listed