NCT06279403Active, not recruitingPhase 2
Upfront Immune Checkpoint Inhibitors With Deferred Cytoreductive Nephrectomy for Metastatic Renal Cell Carcinoma
Upfront Toripalimab Plus Axitinib Combined With Deferred Cytoreductive Nephrectomy for Metastatic Renal Cell Carcinoma
Source: ClinicalTrials.gov · Last updated 27 Oct 2026
Brief summary (registry, in English)
Study Objective: To determine the efficacy of upfront immune checkpoint inhibitors combined with deferred cytoreductive nephrectomy in treating metastatic renal cell carcinoma. Primary Endpoint: Pathological Major Response (MPR), defined as the percentage of residual tumor ≦10% in the primary tumor after nephrectomy. Study Design: Population: Participants meeting the diagnostic criteria with biopsy-proven clear cell renal cell carcinoma. Clinical staging by CT or MRI demonstrating either any T, N1, M0 disease or any T, any N, M1 disease, together with at least one of the following: an IMDC score ≤3; or ≤5 metastatic lesions involving ≤3 organs. Patient Grouping: Non-randomized. Interventions: Eligible participants will receive upfront treatment with a combination of Axitinib and Toripalimab for 4 cycles. After 2 cycles of treatment, radiological assessment will be conducted using RECIST 1.1 criteria. If disease progression is observed, the clinical trial will be terminated, and second-line treatment will be initiated according to guidelines. If disease progression is not observed, treatment will continue for 2 additional cycles followed by repeat radiological assessment before undergoing surgery.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 21 (actual)
- First submitted
- 29 Jan 2024
- Start date
- 1 Mar 2024
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- RenJi Hospital
- Diseases
- Kidney cancer
- NCT number
- NCT06279403
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 21
- From 1 Mar 2024 to the primary completion date, 30 Jun 2026
- 1 site in 1 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.
Other illness
- Non-clear cell carcinoma. Severe liver or kidney dysfunction, or other severe diseases. Immune deficiency, organ transplantation, or autoimmune diseases. Severe central nervous system diseases. Other malignant tumors within the past 5 years, except for cured basal cell carcinoma of the skin and cervical carcinoma in situ.
Other
- Unable to comply with regular follow-up visits due to psychological, social, family, or geographical reasons.
Who the study is looking for
- Willingness to participate in the study and provision of written informed consent.
- Male or female participants aged ≥18 years and \<80 years. Histologically confirmed clear cell renal cell carcinoma or renal cell carcinoma with a predominant clear cell component.
- Clinical staging by CT or MRI demonstrating either any T, N1, M0 disease or any T, any N, M1 disease, together with at least one of the following: an IMDC score ≤3; or ≤5 metastatic lesions involving ≤3 organs.
- A primary renal tumor, whether unilateral or bilateral, considered resectable. ECOG performance status of 0 or 1. No clinically significant abnormalities in cardiac, bone marrow, hepatic, or renal function.
- Willingness and ability to comply with study assessments and follow-up procedures.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| RENJI Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.