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Adjuvant therapy of Immune checkpoint inhibitors for m0i + renal cell carcinoma

Adjuvant therapy of Immune checkpoint inhibitors for m0i + renal cell carcinoma

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035535
Enrollment
Unknown
Registered
2020-08-13
Start date
2020-08-10
Completion date
Unknown
Last updated
2020-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Cancer

Interventions

experimental group:immunocheckpoint inhibitors
control group:Nil

Sponsors

The Second Affiliated Hospital of Xi'an Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. 18 year-old 6 months; 7. Adequate organ function, defined as following criteria: a. Platelets 75 x 109/L, Hemoglobin 10.0 g/L, Absolute Neutrophils(ANC) >= 1.5x10^9/L; b. Serum bilirubin = 30 ml/min. 8. Left ventricular ejection fraction (LVEF) >= lower limit of normal (LLN) as assessed by multigated acquisition (MUGA) scan or echocardiography; 9. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

Exclusion criteria

Exclusion criteria: 1. Histologically diagnosed as undifferentiated carcinoma, sarcoma, collecting duct carcinoma and lymphoma; 2. NCICTCAE Grade 3 bleeding in 4 weeks before inclusion; 3. Diagnosed as any second primary malignant tumor in 5 years before inclusion, except for basal cell carcinoma, Squamous cell carcinoma of the skin, or cervical carcinoma in situ without evidence of recurrence for at least 12 months through adequate treatment; 4. Pregnancy or breastfeeding. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) within 7 days before randomization and at first day of every cycle on visit; 5. Other severe acute or chronic physiologicalor psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study; 6. Current treatment on another clinical trial. Supportive care or non-therapeutic clinical trials are allowed.

Design outcomes

Primary

MeasureTime frame
circulating tumor cells in peripheral blood;recurrence-free survival ;

Secondary

MeasureTime frame
Overall survival (OS);

Countries

China

Contacts

Public ContactWang Zhenlong

The Second Affiliated Hospital of Xi'an Jiaotong University

zhenlongw2001@xjtu.edu.cn+86 13572272931

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026