colorectal cancer
Conditions
Interventions
Sponsors
Peking University Shenzhen Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosis of colorectal cancer; 2. Diagnosis of metastatic cancer by pathology laboratory; 3. The subjects experienced postoperative recurrence or disease progression after 2 cycles of two standard or conventional first-line protocols, and continued use of the existing treatment could not benefit the patients better; 4. The subject receives at least one first-line treatment and the disease progresses, and the subject cannot tolerate or refuses to receive other conventional treatments; 5. Exclude subjects with brain metastases; 6. The subject of radiochemical therapy must be clinically stable one month after treatment to meet the needs of the subject; 7. Aged 18-70 years; 8. Clinical manifestations ECOG 0, 1, 2; 9. Serological test: seronegative of HIV antibodies (experimental treatment in this protocol depends on the integrity of the immune system. Hiv-seropositive subjects have reduced immune capacity and poor response to experimental treatment); Sera negative for hepatitis B antigen, sera negative for hepatitis C antibody; Serum ALT/AST is less than or equal to 2.5 times the upper limit of normal, serum creatinine is less than or equal to 1.6 mg/dl, and total bilirubin is less than or equal to 1.5 mg/dl, but subjects with Gilbert syndrome must have total bilirubin below 3.0 mg/dl; 10. Hematology: Without the support of granulocyte colony stimulating factor, absolute neutrophil count >= 1 x 10^9 /L, white blood cell count >= 3 x 10^9/L, platelet count >= 100 x 10^9/L, hemoglobin > 8.0 g/dl, CD4+ cell count > 200/µL; 11. By the time the patient receives the vaccine, the subject's other therapeutic drug toxicity must have returned to grade 1 or less (except for toxicity such as baldness or vitiligo). Note: The patient may have undergone minor surgical procedures in the past 3 weeks, as long as all toxic reactions return to grade 1 or less; 12. Presurvival >= 6 months; 13. Able to understand and willing to sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Primary immunodeficiency in any form (e.g., severe combined immunodeficiency disease); 2. Concurrent opportunistic infection. Immunocompromised subjects were slow to respond to experimental treatments; 3. Active systemic infection (e.g. need anti-infective treatment), blood clotting disorder or any other serious disease; 4. Poor general condition (ECOG >= 2), estimated to be unable to tolerate short-term chemotherapy and immune cell therapy; 5. Is receiving systemic glucocorticoid therapy; 6. Unstable angina pectoris, symptomatic congestive heart failure, severe arrhythmia, myocardial infarction in the past 6 months, prolonged QT interval (> 450 ms); 7. Malignant tumors of other sites have appeared within the last 5 years; Subjects cannot be followed up or are participating in other clinical trials; 8. The investigator determined that the subjects were not suitable for participating in the study for other reasons.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| PFS, Progression-Free Survival;Tumor indicators (AFP, abnormal prothrombin, CA199, CEA, CA724, etc.);PCR was used to detect the survival of neoantigen personalized DC cells; | — |
Primary
| Measure | Time frame |
|---|---|
| The incidence and severity of treatment-related adverse events;Treatment response rate;Overall survival; | — |
Countries
China
Contacts
Public ContactGuoqing Lv
Peking University Shenzhen Hospital
Outcome results
None listed