Colorecal cancer
Conditions
Interventions
Sponsors
Sun Yat-Sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects voluntarily join the study, sign informed consent, and cooperate with follow-up; 2. Aged 18 to 75 years old; 3. Colorectal adenocarcinoma confirmed by histopathological examination; 4. Genetically tested as RAS mutant type; 5. Failed from standard first-line FOLFOX/CAPEOX+/-bevacizumab treatment; 6. Patients who progress within 6 months after the adjuvant treatment ends; 7. According to the RECIST 1.1 standard, there is at least one measurable lesion with CT scan >=10mm; routine clinical examination equipment >=10mm, chest X-ray >= 20mm; malignant lymph nodes: pathologically enlarged and measurable, single lymph node CT scan short diameter >=15mm (the thickness of CT scan is not more than 5mm); 8. The ECOG systemic state score is 0-1; 9. The organ function is basically normal; 10. From the planned first administration time, the life expectancy >=3 months; 11. The subject has undergone surgery for >=8 weeks, and the wound has healed completely; 12. No history of other malignant tumors (except for cured cervical carcinoma in situ, skin basal carcinoma and squamous cell carcinoma); 13. Women of childbearing age must take a pregnancy test (serum or urine) within 7 days before enrollment, and the result is negative, and are willing to use appropriate methods of contraception during the trial and 8 weeks after the last trial drug administration. Men should be surgically sterilized or agree to use appropriate methods of contraception during the trial period and 8 weeks after the last trial drug administration.
Exclusion criteria
Exclusion criteria: 1. The researcher's judgment that the patient is not suitable for this study includes (but is not limited to) the following: - other malignant tumors have occurred in the past 5 years, except for cervical carcinoma in situ or non melanoma skin cancer after proper treatment; - patients with symptomatic brain metastases (confirmed or suspected); - patients diagnosed with diabetes; - patients with a history of heart disease, such as myocardial infarction, severe unstable angina, congestive heart failure, or congenital heart disease; - patients with hypertension who cannot be reduced to normal range by antihypertensive drugs (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); - patients with severe complications, including intestinal paralysis, intestinal obstruction, gastrointestinal perforation, fistula, interstitial pneumonia, pulmonary fibrosis, chronic obstructive pulmonary disease, renal insufficiency and liver cirrhosis; - patients with chronic nausea, vomiting or diarrhea (more than or equal to 4 times a day, or watery stool); - patients with large amount of proteinuria (24h urinary protein quantity > 2G / 24h); - patients with hemorrhagic diseases, including intracranial hemorrhage, pulmonary hemorrhage, hemoptysis, gastrointestinal bleeding, urinary tract bleeding, vaginal bleeding, skin mucosal bleeding, acquired coagulation disease, etc., except for NCI-CTC grade 1 epistaxis; - patients with thrombus / tumor thrombus embolism; - patients known to have HIV or AIDS; - patients with mental illness; - patients with known neuropathy with grade 2 or higher severity; - infectious disease or uncontrollable active infection, body temperature >= 38 degrees C; 2. Patients who are known to be allergic to any of the drugs in the study; 3. Patients who are in use or have participated in clinical trials of other drugs within 4 weeks; 4. According to the judgment of the researcher, there are concomitant diseases that seriously endanger the safety of patients or affect patients to complete the study. Conclusion: there are concomitant diseases that seriously endanger the safety of patients or affect patients to complete the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effect;toxicity;Quality of Life; | — |
Countries
China
Contacts
Public ContactLiangping Xia
Sun Yat-Sen University Cancer Center
Outcome results
None listed