synchronous peritoneal metastasis in colorectal cancer
Conditions
Interventions
single arm:FOLFOXIRI, bevacizumab combined with cytoreductive surgery
Sponsors
The Sixth Affiliated Hospital, Sun Yat-Sen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Histological confirmation of colorectal cancer; 2. Imaging CT/PET-CT/MRI diagnosis of tumor peritoneal metastasis; 3. Age 18-70 years; 4. ECOG score (PS): 0-1; 5. Life expectancy exceeds 3 months; 6. Have measurable primary lesions that meet the RECIST standard; 7. The main organs are functioning normally, that is, they meet the following standards: (1) The blood routine examination must meet: ANC >=1.5 x10^9 / L; PLT >= 80x10^9/L. (2) Blood biochemical examination must meet the following standards: BIL 60ml / min (3) Urine test paper (for proteinuria) = 2 +, 24-hour urine must be <= 1g protein; 8. sensitive to the first-line chemotherapy of FOLFOXIRI combined with bevacizumab, the curative effect was evaluated as CR or PR; 9. The subject volunteers to test and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with other primary malignant tumors in the past or at the same time, except for cured skin basal cell carcinoma and cervical carcinoma in situ; 2. First-line treatment with FOLFOXIRI combined with bevacizumab chemotherapy,the curative effect was evaluated as PD; 3. History of inflammatory bowel disease or extensive bowel resection (resection or chronic diarrhea with extensive small bowel resection); 4. Pregnant or lactating women; 5. Patients with central nervous system metastasis (asymptomatic patients do not need to undergo head imaging examination); 6. Active diffuse intravascular coagulation; 7. Clinically important cardiovascular diseases, such as myocardial infarction (=6 before starting treatment Month), unstable angina, NYHA = 2 chronic heart failure (CHF), arrhythmia;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| morbidity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Readmission rate within 30 days;overall survival;Progression-free survival;Response rate;completion rate of cytoreductive surgery; | — |
Countries
China
Contacts
Public ContactJian Cai
The Sixth Affiliated Hospital, Sun Yat-Sen University
Outcome results
None listed