Renal cell carcinoma
Conditions
Interventions
Experimental Group:Vorolanib monotherapy
Sponsors
Chongqing University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Aged between 18 and 80 years old (including 18 and 80 years old), both and females; 2.Histologically or cytologically confirmed clear cell renal cell carcinoma; 3.Enrollment subjects were confirmed as: Intermediate-high risk of recurrence: pT2, nuclear grade 4 or with sarcomatoid, N0, M0; pT3, any nuclear grade, N0, M0; High risk of recurrence: pT4, any nuclear grade, N0,0, any pT, any nuclear grade, N , M0, M1 NED: M1 stage, but no evidence of residual tumor after oligometastases removed by surgery at the same time or within 1 year after nephrectomy; 4.Expected survival >=12 months; 5.Patients could not have received any systemic therapy for RCC previously; 6.The patient had not received antiangiogenic therapy; 7.ECOG performance status 0-1. 8.Main organ functions are normal without severe hemat, cardiac, pulmonary, hepatic, and renal dysfunction. The specific laboratory index requirements are as follows: Absolute neutrophil count >=1.5×10^9/L; Platelets >=100×10^9/L; Hemoglobin >=100 g/L Bilirubin =45 mL/min; 9.Able and willing to comply with the study and follow-up procedures; 10.Pregnant men and must agree to use adequate contraception during the entire study period and for 6 months after the end of treatment; 11.Capable of understanding and willing to sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Subjects who have undergone a major surgery or chemotherapy within 4 weeks before the first dose of the study drug; 2.Sub with active bleeding, ulcers, intestinal perforation, intestinal obstruction, and uncontrolled hypertension (Controlled hypertension is defined as blood pressure <=140/90 mmHg and stable during the screening period); 3.Patients with symptoms, disseminated to the internal organs, and at risk of life-threatening complications in the short term (including those with uncontrolled massive eff [pleural, pericardial, peritoneal], pulmonary lymphangitis, and more than 30% of the liver involved; 4.patients with a history of other malignant tumors within five years; 5.Patients who are participating in other inter studies or standard anticancer medications; 6.Subjects who are allergic to the ingredients of the study drug; 7.Subjects with active infection; 8.jects at risk of bleeding; 9.Patients with systemic diseases such as cardiac or pulmonary insufficiency who cannot tolerate general anesthesia for partial nephrectomy or radicalphrectomy; 10.Pregnant and lactating patients; Other conditions that the investigator considers unsuitable for enrollment. 11.Other conditions considered by other investigators to be exclusion from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year Disease Free Survival Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Free Survival;Safety;Overall Survival; | — |
Countries
China
Contacts
Public ContactLiu Nan
Chongqing University Cancer Hospital
Outcome results
None listed