drugset / Trial / NCT02688491
A CpG-methylation-based Assay for Stratifying Stage III Clear Cell Renal Cell Carcinoma of Receiving Adjuvant Treatment
Not yet recruiting
300 enrolled
First Affiliated Hospital, Sun Yat-Sen University
Sun Yat-sen University · collabXi'an Jiaotong University · collabYantai Yuhuangding Hospital · collab
RandomizedParallel-groupOpen-label
Summary
Whether patients with stage III clear cell renal cell carcinoma(ccRCC) should receive adjuvant targeted therapy or not is still on debate. The investigators invented a assay consisting of 5 CpGs: cg00396667（PITX1）, cg18815943 （FOXE3）, cg03890877（TWF2）, cg07611000 （EHBP1L1）and cg14391855（RIN1）that was successfully categorise patients with stage III clear cell renal cell carcinoma into high-risk and low-risk groups with Harzard Ratio(HR) of 4.93. Here the investigators randomly assign assay-defined high risk patients of locally advanced ccRCC into adjuvant targeted therapy group and observation group.Disease free survival and overall survival are the end points of observation.
Timeline
- Start
- 2016-07
- Primary completion
- 2026-07
- Completion
- 2026-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sunitinib | Small molecule | — | Oral |