metastatic clear cell renal cell carcinoma
Conditions
Interventions
experimental group:DC Vaccine combined with PD1 Inhibitors
control group: DC Vaccine Monodrug
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
15 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) sign a written informed consent form; 2) histopathologically confirmed mccRCC; 3) appropriate storage of tumor tissue that can be used to produce lysates of at least three vaccine preparations; 4) 18-75 years old, regardless of gender; 5) patients must be at least 4 weeks from their last treatment (tyrosine kinase inhibitors, immunotherapy, radiotherapy, surgery); 6) life expectancy > 3 months; 7) ECOG score 0 or 1. 8) the function of important organs is good; 9) there are no concomitant diseases that seriously endanger the survival of patients for less than 5 years; 10) fertile subjects must accept effective medical contraception.
Exclusion criteria
Exclusion criteria: 1) the patient has been treated with anti-PD-1 or PD-L1 antibody in the past; 2) the patient is using immunosuppressant or systemic hormone therapy to achieve the purpose of immunosuppression (dose > 10mg/ prednisone or other therapeutic hormone) and continues to use it within 2 weeks before the first administration; 3) patients with active autoimmune disease or history of intractable autoimmune disease. 4) more than 20% weight loss in the past 2 months; 5) uncontrollable pleural effusion, pericardial effusion or ascites; 6) Peripheral neuropathy NCI CTC AE evaluation greater than grade 1, except for patients with loss of deep tendon reflex; 7) previous history of organ transplantation, autologous / allogeneic stem cell transplantation. 8) History of malignant tumors other than renal cell carcinoma in this study in the past 5 years, except basal cell carcinoma of the skin, superficial bladder cancer or cervical carcinoma in situ; 9) those who participated in other clinical trials or took other research drugs within the past 30 days; 10) history of lung diseases: pulmonary interstitial disease, non-infectious pneumonia, pulmonary fibrosis, acute lung disease. 11) clinically severe heart, brain, liver, kidney and other important organ dysfunction; 12) severe chronic or active infections, such as HIV infection or a history of chronic hepatitis B or C; 13) known hypersensitivity or allergic reactions to any drug ingredient studied and treated; 14) pregnancy or breastfeeding; 15) there are certain medical or mental abnormalities that prevent subjects from completing or signing informed consent. 16) there are other serious diseases that make researchers think that subjects cannot be enrolled in the group; 17) those who lack legal capacity or legal capacity are limited.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events; | — |
Countries
China
Contacts
Public ContactQu Yuanyuan
Fudan University Shanghai Cancer Center
Outcome results
None listed