Clinical trial · Interventional
A CpG-methylation-based Assay for Stratifying Stage III Clear Cell Renal Cell Carcinoma of Receiving Adjuvant Treatment
A Multi-site, Open, Perspective Study of Prognostic Value and Benefit From Adjuvant Targeted Therapy of Stage III Clear Cell Renal Cell Carcinoma Based on a CpG-methylation-based Assay
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Renal Neoplasms | Kidney Neoplasm | ALIAS | 0.90 |
| Targeted Molecular Therapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| sunitinib | Drug | Sunitinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A (Intervention group,sunitinib)
- description
- Beginning 4-12 weeks following radical nephrectomy, patients receive sunitinib malate PO QD for 4 weeks
- interventionNames
- Drug: sunitinib
- type
- NO_INTERVENTION
- label
- B(observation group)
- description
- Patients with radical nephrectomy are observed without intervention
Primary outcomes (1)
- measure
- Disease free survival
- timeFrame
- From the date of registration to up to10 years
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * The informed consent has been obtained from the patient. * With confirmed diagnosis of stage III clear cell renal cell carcinoma * With moderate/good ECOG health rating (PS): 0-1 score. * The patient receive no anti-cancer treatment before primary surgery. * The patient receive radical operation for renal cancer with negative margin. Exclusion Criteria: * With severe comorbidities, such as cardiovascular disease, chronic obstructive pulmonary disease, diabetes mellitus, and chronic renal dysfunction. * With bad compliance or contraindication to enrollment. * Pregnant woman or lactating woman. * With contraindication to receive adjuvant targeted therapy.
References
Publications (0)
Data not yet available