Colorectal cancer with liver metastasis/lung metastasis
Conditions
Interventions
Experimental group:Microwave ablation + camrelizumab + chemotherapy
Sponsors
Affiliated Cancer Hospital of Harbin Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients with colorectal cancer liver metastases/lung metastases confirmed by two types of imaging or histology/cytology; 2. Must have CT or MRI examination within the past 3 months; 3. In addition to ablation lesions, there are measurable metastatic lesions (spiral CT scan >=10mm, meeting mRECIST 1.1 criteria); 4. Expected survival period > 3 months; 5. Patients who have failed at least one systemic therapy; 6. The damage caused by the subject receiving other treatments has recovered; 7. Known KRAS, NRAS, BRAF and HER2 gene status; 8. Aged 18 to 70 years; 9. ECOG PS 0-2 points; 10. The functions of vital organs meet the following requirements: (1) Absolute neutrophil count >=1.5x10^9/L, platelets >=100x10^9/L, hemoglobin >=9g/dL; (2) Bilirubin 60 mL/min; 11. Women of childbearing age must have a negative pregnancy test (ßHCG) before starting treatment, women of childbearing age and men (who have sex with women of childbearing age) must agree to use effective contraception without interruption during treatment and for 6 months after the last therapeutic dose; 12. With signature of patient information and informed consent.
Exclusion criteria
Exclusion criteria: 1. Breastfeeding subjects; 2. Suffering from other malignant tumors within 5 years, except for fully treated cervical carcinoma in situ or skin squamous cell carcinoma, or skin basal cell carcinoma that has been basically controlled; 3. Those with uncontrolled, symptomatic brain metastases or with a history of uncontrollable mental illness or severe intellectual or cognitive dysfunction; 4. Suffering from active, known or suspected autoimmune disease, subjects with hypothyroidism who only receive hormone replacement therapy, and skin diseases that do not require systemic therapy (such as vitiligo, psoriasis, or alopecia) can be enrolled; 5. Active hepatitis B or C, chronically infected subjects with hepatitis B virus (HBV) or hepatitis C virus (HCV) with viral load below 500 IU/mL are allowed to participate in the study, but need to continue or start full standard antiviral therapy during the study period; 6. Congestive heart failure, uncontrollable arrhythmia, myocardial infarction, unstable angina pectoris, stroke or transient ischemic attack within 6 months; or other subjects who cannot tolerate surgery; 7. Serious active infection requiring intravenous antibiotic treatment occurred during enrollment; 8. Those who are allergic to the test drug; 9. Have been vaccinated or will be vaccinated with live vaccines within 30 days before the administration of camrelizumab; 10. Subjects who cannot comply with the trial protocol or cannot cooperate with follow-up; 11. The researchers believe that it is not suitable to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 12-month progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Disease control rate;Progression-free survival;Overall survival;Safety; | — |
Countries
China
Contacts
Public ContactLi Zhiwei
Affiliated Cancer Hospital of Harbin Medical University
Outcome results
None listed