Non-clear cell renal cell carcinoma
Conditions
Interventions
Experimental group:Toripalimab Combined with Lenvatinib
Control group:Active observation or targeted therapy or immunotherapy
Sponsors
The Third Medical Centre, Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. The subjects gave informed consent to this trial before the trial, fully understood the content, process and possible adverse reactions of the trial, voluntarily signed the written informed consent form, had good compliance and cooperated with the follow-up. Male or female individuals aged 18 or above and 85 or below; 3. Histologically confirmed non-clear renal cell carcinoma (excluding clear cell carcinoma, chromophobe cell carcinoma and eosinophilic cell carcinoma), and meeting any of the following subtypes: (1) Papillary renal cell carcinoma: pT>=T3a and ISUP/WHO nuclear grade >=3, any N stage (N any), M0 stage; N1, any pT stage, nuclear grade, M0 stage (2) Collection duct carcinoma, SmarCB1-deficient renal medullary carcinoma, fumarate hydratase-deficient renal cell carcinoma (FH-RCC), any pT stage, ISUP/WHO nuclear grade, N stage, M0 stage; (3) Other non-clear renal cell carcinoma: Excluding the above-mentioned a and b types, including but not limited to TFE3/TFEB translocation renal cell carcinoma or unclassified renal cell carcinoma, any N stage, M0 stage; 4. Patients who have undergone complete resection of the primary tumor (partial or radical nephrectomy), as well as those with no evidence of M1 disease (NED), and have no clinical or imaging gross residual lesions or distant metastases after surgery (M0); 5. Time of renal tumor resection: >=3 weeks but =90g/L, absolute neutrophil value >=1.5×10^9/L, platelet count >=75×10^9/L; (2) Blood biochemistry: When there is no liver metastasis, total bilirubin =45ml/min (Cockcrot-Gault formula), international normalized ratio (INR) =1.5×ULN; (3) Cardiac color Doppler ultrasound: Left ventricular ejection fraction >=50%; 9. Sign a written informed consent form and have the ability and willingness to comply with the research and follow-up procedures;
Exclusion criteria
Exclusion criteria: Patients who meet any of the following conditions will not be eligible for this study: 1. Currently participating in other clinical trials. Other malignant tumors that have progressed or require treatment within 2.5 years (excluding: cured basal/squamous cell carcinoma of the skin, superficial bladder cancer, and carcinoma in situ of the breast/cervix/prostate); 3. Accompanied by central nervous system involvement; 4. Those with a history of immune deficiency, including those who are HIV positive or have other acquired or congenital immune deficiency diseases, or have a history of organ transplantation; 5. Renal failure requires hemodialysis or peritoneal dialysis; 6. Those who are pregnant or breastfeeding or have positive results in blood pregnancy tests; 7. Have a history of other malignant tumors. Patients with cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma or cervical cancer in situ who have received possible curative treatment and have no recurrence of the disease within 5 years after cure are excluded. 8. For subjects who have undergone major surgery or suffered severe trauma, the impact of the surgery or trauma has been eliminated for less than 14 days before enrollment. 9. Severe acute or chronic infections that require systemic treatment; 10. Patients with heart failure (New York Heart Association standard Class III or IV) who, despite receiving appropriate drug treatment, have poorly controlled coronary artery disease or poor arrhythmia, or have a history of myocardial infarction within 6 months prior to screening; 11. The following gastrointestinal diseases exist: Clinically significant gastrointestinal abnormalities: diseases that affect the absorption of oral medications (such as total gastrectomy, malabsorption); Active ulcer within 6 months; Active gastrointestinal bleeding (hematemesis/hematochezia/melena) within 3 months and unhealed by endoscopy; Those with gastrointestinal metastases that may cause bleeding, inflammatory bowel disease, or an increased risk of intestinal perforation; 12. Patients with a history of deep vein thrombosis or pulmonary embolism within the past twelve months; 13. Individuals with any diseases that increase the risk of bleeding, such as acute gastritis or active ulcers with bleeding, clinically significant thrombocytopenia or anemia, as well as those with a history of active pathological bleeding or intracranial hemorrhage; 14. Suffering from mental disorders, including epilepsy, dementia, severe depression, mania, etc. 15. Those who the researchers consider unsuitable to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-Free Survival, DFS;Prognostic Biomarkers - Tumor Histopathological Sections; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival, OS;Disease Recurrence-Specific Survival, DRSS;Adverse Event, AE; | — |
Countries
China
Contacts
Public ContactGu Liangyou
The Third Medical Centre, Chinese PLA General Hospital
Outcome results
None listed