NCT06146777Not yet recruitingPhase 3
Multi-classifier System for Stratifying Stage III Papillary Renal Cell Carcinoma of Receiving Adjuvant Therapy
A Multicenter, Open, Prospective Study of Prognostic Value and Benefit From Adjuvant Immunotherapy of Stage III Papillary Renal Cell Carcinoma Based on Multi-classifier System
Source: ClinicalTrials.gov · Last updated 29 Nov 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The goal of this trial is to test whether patients with stage III papillary renal cell carcinoma (pRCC) could benefit from adjuvant therapy or not. The investigators invented a multi-classifier system that was successfully categorise patients with stage III pRCC into high-risk and low-risk groups. Here the investigators randomly assign classifier-defined high risk patients of stage III pRCC into adjuvant pembrolizumab group placebo group. Disease-free survival and overall survival are the end points of observation.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 468 (estimated)
- First submitted
- 20 Nov 2023
- Start date
- 1 Dec 2023
- Primary completion date
- 1 Dec 2030
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen University
- Diseases
- Kidney cancer
- NCT number
- NCT06146777
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 468
- From 1 Dec 2023 to the primary completion date, 1 Dec 2030
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previously received neoadjuvant therapy
- With contraindication to receive pembrolizumab, such as had a prior solid organ transplant, has a known history of human immunodeficiency virus infection.
Other illness
- With severe comorbidities, such as cardiovascular disease, chronic obstructive pulmonary disease, diabetes mellitus, and chronic renal dysfunction.
Other
- Patients with Transcription factor enhancer 3(TFE3) or transcription factor EB (TFEB) translocation proven by cytogenetic analysis or by fluorescence in situ hybridization (FISH)
- With bad compliance or contraindication to enrollment.
- Pregnant woman or lactating woman.
Who the study is looking for
- Histological confirmation of pRCC
- With confirmed diagnosis of stage III pRCC
- Classified as high-risk by multi-classifier system
- With moderate/good Eastern Cooperative Oncology Group (ECOG) health rating (PS): 0-1 score.
- Receive radical operation for renal cancer with negative margin.
- Receive no anti-cancer treatment before primary surgery.
- The informed consent has been obtained from the patient.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.