Colorectal Cancer
Conditions
Interventions
Experimental group:Cetuximab:500mg/m2,d1,q2w Camrelizumab:200mg, d1, q2w
Sponsors
Medical Oncology Fujian Medical University Union Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: A.Age 18-75 years old, gender is not limited; B.Colon or rectal adenocarcinoma diagnosed by histology; C.Combined with metastatic lesions (unable to undergo radical resection); D. The previous standard treatment regimen containing cetuximab failed, and the curative effect of the cetuximab combined regimen reached SD or above, and progress occurred after stopping cetuximab for at least 3 months; E. The KRAS, NRAS, and BRAF genes of the primary tumor or metastatic tumor tissue are all wild-type, and microsatellite stable MSS or pMMR; F. Confirmed by CT or MRI, there is at least one measurable lesion (non-radiotherapy field) that meets the RECIST 1.1 standard; G. Physical condition score ECOG 0-2; H. The estimated survival period is more than 3 months, and the place of residence is convenient for follow-up; I. Subjects with reproductive potential must accept effective medical contraceptive measures (regardless of male or female subjects, until 90 days after the last drug administration); J. Recovered from previous treatment-related toxicity before study enrollment; K. Voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: A.The organ function level shows the following conditions: Bone marrow: white blood cells (WBC) 1.5*ULN; ALT and AST>2.5*ULN (without liver metastasis) or>5*ULN (for patients with liver metastasis); Kidney: Serum creatinine (Cr) > 1.5*ULN or creatinine clearance < 50ml/min; B.Known hypersensitivity or allergic reaction to any component of the study treatment; C.Previous history of organ transplantation, autologous/allogeneic stem cell transplantation; D. Other accompanying anti-tumor therapy; E. Symptomatic brain and/or leptomeningeal metastases; F. In the past 5 years, history of other malignant tumors except CRC, cured carcinoma in situ of the cervix, except skin basal carcinoma or squamous cell carcinoma; G. Participate in clinical trials of other anti-tumor drugs within 30 days before enrollment; H. Are receiving hormone therapy other than chronic systemic immunotherapy or physiological replacement therapy; I. Any unstable systemic disease: Active infection, uncontrolled hypertension, unstable angina, angina pectoris that started within the last 3 months, congestive failure (New York Heart Association [NYHA] = class II), within 6 months before enrollment Myocardial infarction, severe arrhythmia requiring drug treatment, liver, kidney or metabolic disease; J. History of acute or subacute intestinal obstruction, or inflammatory bowel disease; K. Subjects with severe bone marrow failure; L. Any disease, metabolic disorder, or physical examination or laboratory suspicion that the patient has contraindications to the study drug or has high-risk factors for treatment complications; M. Known or self-reported human immunodeficiency virus (HIV) infection; N. HBV-DNA positive (copy number greater than 103) O. Pregnancy or lactation; P. Subjects who are known to be addicted to alcohol or drugs, or who, in the opinion of the researchers, may have other adverse health conditions or mental states that may affect protocol compliance and evaluation of test indicators, are not suitable for participating in the study; Q. Lack of legal capacity or limited legal capacity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Disease control rate;Overall survival; | — |
Countries
China
Contacts
Public ContactXiaoyan Lin
Fujian Medical University Union Hospital
Outcome results
None listed