colorectal cancer
Conditions
Interventions
therapy group:Individualized and precise immunotherapy for colorectal cancer based on high-throughput tumor antigen polypeptides screening
Sponsors
The First Medical Center of Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years, males and females; 2. Abdominal CT examination confirmed that the primary colon cancer is located in the right hemicolon (ileocecal part to splenic flexure of colon); 3. The primary lesion of the colon was diagnosed as colon adenocarcinoma by endoscopic biopsy histopathology, including papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, signet ring cell carcinoma, and undifferentiated carcinoma. 4. The diagnosis of simultaneous liver metastasis by abdominal CT or MRI examination, according to the RECIST 1.1 standard at least one measurable focus (CT or MR scan diameter >= 10 mm); 5. Clinical evaluation of patients can not obtain radical resection (to meet any of the following points: colorectal cancer primary focus can not obtain radical resection; there is an unresectable extrahepatic metastasis; estimated postoperative residual liver volume is not enough; the patient's systemic condition can not tolerate surgery); 6. No previous chemotherapy, systemic targeted therapy or immune checkpoint inhibitor therapy; 7. Life expectancy >= 3 months; 8. ECOG physical status score 0 or 2; 9. Within seven days before the start of treatment, Laboratory examination confirmed adequate bone marrow function, liver function, renal function, cardiac function: total bilirubin (TBI)= 30 mL/min/1.73 m2, INR =1.5x10^9/ L, Platelets (PLT) >= 75 x 10^9/ L, hemoglobin (HGB)>=90 g/L, Electrocardiogram is basically normal; 10. Male and female subjects with potential fertility must agree to use efficient contraceptive methods throughout the study period and at least 3 months after the last treatment; 11. The participants should volunteer to participate in this clinical study and sign the informed consents.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; 2. Other malignancies within five years; 3. Concurrent infectious diseases requiring systematic treatment (AIDS, hepatitis B, hepatitis C and syphilis); 4. Severe mental illness; 5. Severe respiratory diseases; 6. Severe liver and kidney dysfunction; 7. History of unstable angina or myocardial infarction within six months; 8. History of cerebral infarction or cerebral hemorrhage within six months; 9. Continuous use of glucocorticoids for one month (except for local applications); 10. Complications of severe colon cancer (massive bleeding, perforation and complete obstruction); 11. Patients have participated in or are participating in other clinical studies (within six months); 12. Other circumstances in which the researchers do not believe they should participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events;Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 resection rate;Objective remission rate;Disease control rate;Overall survival;Time to tumor progression; | — |
Countries
China
Contacts
Public ContactXia Shaoyou
The First Medical Center of Chinese PLA General Hospital
Outcome results
None listed