Colorectal cancer
Conditions
Interventions
Test group:Camrelizumab + Cetuximab + Chemotherapy
Sponsors
Harbin Medical University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients with liver metastases/lung metastases of colorectal cancer confirmed by imaging or histological/cytology; 2. Must have CT or MRI examination in the past 3 months; 3. Measurable metastatic lesions in addition to ablation lesions (spiral CT scan = 10mm, meeting RECIST 1.1 criteria); 4. Expected survival> 3 months; 5. Have not previously received systematic treatment for colorectal cancer; 6. The damage caused by the subject receiving other treatments has been restored; 7. Patients whose RAS and BRAF gene states are known to be wild-type; 8. Immunohistochemistry (IHC) showed that the mismatch repair status was proficient in mismatch repair (pMMR) or the microsatellite state was microsatellite stable (MSS) ; 9. Age: 18-75 years old, male or female; 10. ECOG PS: 0-2 points; 11. The function of important organs meets the following requirements: 1) absolute neutrophil count= 1.5×109/L, platelet = 100×109/L, hemoglobin =9 g/dL; 2) bilirubin = 1.5 times ULN (patients drained by retrograde technique can include); ALT and AST =5 times ULN; 3) creatinine 60 mL/min; 12. Women of childbearing age must take a negative pregnancy test (ßHCG) before starting treatment, and women and men of childbearing age (who have sexual relations with women of childbearing age) must agree to the uninterrupted use of effective contraception during treatment and 6 months after the last therapeutic dose is administered. 13. Signature of patient information and informed consent form.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women, or those who are fertile but refuse to take contraceptive measures; 2.Suffering from other malignant tumors within 5 years, except cervical carcinoma in situ or skin squamous cell carcinoma that has been adequately treated, or skin basal cell carcinoma that has been basically controlled; 3. Patients with uncontrolled, symptomatic brain metastases or a history of uncontrollable mental illness or severe intellectual or cognitive impairment; 4. Pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia and severe impairment of lung function; 5. Subjects with active, known or suspected autoimmune diseases, hypothyroidism who only need hormone replacement therapy, and skin diseases (such as vitiligo, psoriasis or alopecia) that do not require systemic treatment Can be selected; 6. Congestive heart failure, uncontrollable arrhythmia, myocardial infarction, unstable angina, stroke or transient ischemic attack within 6 months; 7. Serious active infection requiring intravenous antibiotic treatment occurred during enrollment; 8. Those who are allergic to the experimental drugs; 9. Have been vaccinated or will be vaccinated with live vaccines within 30 days before camrelizumab administration; 10. Known history of HIV infection; 11. Patients who cannot comply with the trial protocol or cannot cooperate with follow-up; 12. The researchers think that it is not suitable to participate in this experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the PFS rate of 12 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Disease control rate;Progression-free survival;Overall survival;Safety;Efficacy predictive biomarker analysis, ctDNA dynamic monitoring; | — |
Countries
China
Contacts
Public ContactZhiwei Li
Harbin Medical University Cancer Hospital
Outcome results
None listed