Colorectal cancer
Conditions
Interventions
Sponsors
Chongqing Qianjiang Central Hospital (Chongqing University Affiliated Qianjiang Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients voluntarily participate in this study, have good compliance, can cooperate with the requirements of the trial to complete observation and follow-up, and sign the informed consent form; 2. Age>=18 years old (when signing the informed consent form); 3. Histologically definitively diagnosed adenocarcinoma of the colon or rectum; 4. Metastatic lesions (no radical resection is possible); 5. Wild-type RAS/BRAF gene was determined by genetic testing; 6. Physical status score ECOG 0~1; 7. Expected survival >=12 weeks; 8. Recovered from toxicities related to prior therapy prior to study enrollment; 9. At least one measurable lesion (non-radiotherapy field) according to RECIST 1.1 criteria confirmed by CT or MRI; 10. Subjects of childbearing potential must use an appropriate method of contraception during this study and for 120 days after the end of the study, have a negative serum pregnancy test within 7 days prior to study enrollment, and must be non-lactating subjects.
Exclusion criteria
Exclusion criteria: Patients with any of the following conditions are not eligible to be included in this study: 1. Radiotherapy or surgery within 30 days prior to treatment (except for diagnostic biopsies); 2. The following organ function levels: bone marrow: white blood cells (WBC) 1.5 times the upper limit of the normal reference value; alanine aminotransferase and aspartate aminotransferase (ALT and AST) > 2.5 times the upper limit of the normal reference value (for those without liver metastasis) or > 5 times the upper limit of the normal reference value (for those with liver metastasis); kidneys: serum creatinine (Cr) > 1.5 times the upper limit of the normal reference value or creatinine clearance rate < 50ml/min; 3. Previously received adjuvant chemotherapy for CRC, and the time from the end of adjuvant chemotherapy to the discovery of disease recurrence or metastasis is less than 12 months; 4. Previously received anti-EGFR monoclonal antibody, EGFR tyrosine kinase inhibitor or other EGFR-targeted therapy (such as cetuximab, nivolumab, panitumumab, etc.); 5. Known hypersensitivity or allergic reaction to any component of the study treatment; 6. Previous history of organ transplantation or autologous/allo-organ stem cell transplantation; 7. Other concomitant anti-tumor treatment; 8. Symptomatic brain and/or meningeal metastasis; 9. History of other malignant tumors except CRC, which have been cured, including cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma of the skin; 10. Participated in other anti-tumor drug clinical trials within 30 days before enrollment; 11. Undergoing chronic systemic immunotherapy or hormone therapy other than physiological replacement therapy; 12. Any unstable systemic diseases: including active infection, uncontrolled hypertension, unstable angina pectoris, recent onset angina pectoris within 3 months, congestive heart failure (NYHA = II), myocardial infarction within 6 months before enrollment, severe arrhythmia requiring drug treatment, liver, kidney or metabolic diseases; 13. Acute or subacute intestinal obstruction, or history of inflammatory bowel disease; 14. Severe bone marrow failure patients; 15. Any disease, metabolic disorder, or physical examination or laboratory findings suggesting that the patient has contraindications to the study drug or has high-risk factors for treatment complications; 16. Known or self-reported human immunodeficiency virus (HIV) infection; 17. HBV-DNA positive (copy number greater than 103); 18. Pregnant or lactating; 19. Known to have alcohol or drug addiction, or the investigator believes that there are other adverse health conditions or mental states that may affect the compliance with the protocol and the assessment of trial indicators, and is not suitable for participation in the study; 20. Lack of legal capacity or limited legal capacity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Disease control rate;Duration of relief;safety;overall survival; | — |
Countries
China
Contacts
Public ContactWang Dong
Chongqing Qianjiang Central Hospital (Chongqing University Affiliated Qianjiang Hospital)
Outcome results
None listed