Colorectal cancer
Conditions
Interventions
Case series:RACS assistant chemotherapy
Sponsors
Shanghai Jiao Tong University affiliated Sixth people's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. patients with unresectable stage IV (AJCC 8) colorectal cancer and the second-line chemotherapy efficacy idendified as PD; 2. The expected survival time was more than 12 weeks; 3. According to the RECIST 1.1 standard, at least one measurable lesion; 4. aged 18-75 years old; 5. ECOG score 0-2; 6. The organ function level must conform to the following requirements: Hematology Index: neutrophils count was more than 2.5 x 109/L. Platelet count was more than 80 x 109/L. Hemoglobin was more than 90 g/L (could be maintained through blood transfusion). Liver function: total bilirubin was less than 1.5 times the upper limit of normal value. ALT and AST were less than 2.5 times the upper limit of normal value. If intrahepatic metastasis, ALT and AST were less than 5 times the upper limit of normal value. Renal function: creatinine was less than 1.25 times the upper limit of normal value, and creatinine clearance rate was more than 60ml/min; 7. Women of childbearing age not in the lactation period must be tested in the urine pregnancy test within 7 days before the beginning of the treatment and the result is negative. The male must be agree to adopt appropriate methods of contraception or surgical sterilization within 8 weeks after the trial and during the trial; 8. Patients could comply with the research and follow-up procedures; 9. Patients have the ability to understand and voluntarily sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients unable to obtain fresh tissue specimens; 2. Patients with symptomatic central nervous system metastases or spinal cord compression; 3. Previously suffering from interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis requiring hormone therapy or any active interstitial lung disease with clinical evidence; 4. Large pleural effusion or pericardial effusion; 5. Any unstable systemic disease (including active infection, poorly controlled hypertension, unstable angina, congestive heart failure, liver, kidney or metabolic disease); 6. Any significant eye abnormalities, especially severe dry eye syndrome, dry keratoconjunctivitis, etc.; 7. Patients who cannot receive oral administration, require intravenous high-energy nutrition, surgery that has previously undergone absorption, active peptic ulcer, or chronic diarrhea; 8. Any clinical evidence suggesting moderate-severe chronic obstructive pulmonary disease - COPD and other active lung diseases as determined by the investigator; 9. Allergies to related treatments.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival;Objective Response Rate;Disease control rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overallsurvival; | — |
Countries
China
Contacts
Public ContactZhigang Wang
Shanghai Jiao Tong University affiliated Sixth people's Hospital
Outcome results
None listed