Upfront Immune Checkpoint Inhibitors With Deferred Cytoreductive Nephrectomy for Metastatic Renal Cell Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Toripalimab, Cytoreductive Nephrectomy, Axitinib.
- Who it may be relevant to
- Registry conditions: Clear-cell Metastatic Renal Cell Carcinoma, Immune Checkpoint Inhibitors, Cytoreductive Nephrectomy. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Upfront Toripalimab Plus Axitinib Combined With Deferred Cytoreductive Nephrectomy for Metastatic Renal Cell Carcinoma
Overview
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 cells \<10% in the primary tumor after nephrectomy. Study Design: Population: Participants meeting the diagnostic criteria with biopsy-proven clear cell renal cell carcinoma, IMDC score ≤3, or ≤5 metastatic lesions involving ≤3 organs. Sample Size: 20 participants. 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.
Interventions
- Drug Toripalimab
Preoperative Treatment with Toripalimab: Administer 240mg of Toripalimab via intravenous infusion every 3 weeks for a total of 4 cycles. - Procedure Cytoreductive Nephrectomy
Radical Nephrectomy: Complete resection of the tumor and affected kidney within the renal fascia. Partial Nephrectomy: Complete resection of the tumor while preserving maximal kidney function. Lymph Node Dissection: For patients with evident enlargement of retroperitoneal lymph nodes preoperatively, perform lymph node dissection at the renal hilum, along the ipsilateral major vessels, and anterior to the ipsilateral major vessels. Lymph node dissection is not required for patients without evid - Drug Axitinib
Preoperative Treatment with Axitinib: Administer 5mg of axitinib orally twice daily for a duration of 3 months.
Primary outcome measures
- Pathological Major Response (MPR) [Time frame: through study completion, an average of 1 year]
Eligibility criteria
Inclusion criteria
Voluntary consent to participate in this study and signing of an informed consent form.
Male or female participants aged ≥18 years and <80 years. Histologically diagnosed with clear cell carcinoma or predominantly clear cell renal cell carcinoma.
Clinical stage determined by CT or MRI: anyTN1M0 or anyTN0M1; IMDC score ≤3, or ≤5 metastatic lesions involving ≤3 organs; and the primary tumor (unilateral or bilateral) is resectable.
ECOG performance status: 0 or 1. No clinically significant cardiac, bone marrow, hepatic, or renal function abnormalities.
A willingness and ability to comply with testing and follow-up procedures.
Exclusion criteria
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.
Unable to comply with regular follow-up visits due to psychological, social, family, or geographical reasons.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06279403 · IIT-2023-0277