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Trial Title:
Upfront Immune Checkpoint Inhibitors With Deferred Cytoreductive Nephrectomy for Metastatic Renal Cell Carcinoma
NCT ID:
NCT06279403
Condition:
Clear-cell Metastatic Renal Cell Carcinoma
Immune Checkpoint Inhibitors
Cytoreductive Nephrectomy
Conditions: Official terms:
Carcinoma
Carcinoma, Renal Cell
Axitinib
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Toripalimab
Description:
Preoperative Treatment with Toripalimab: Administer 240mg of Toripalimab via intravenous
infusion every 3 weeks for a total of 4 cycles.
Arm group label:
Experimental
Intervention type:
Procedure
Intervention name:
Cytoreductive Nephrectomy
Description:
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 evident enlargement of retroperitoneal
lymph nodes preoperatively.
Arm group label:
Experimental
Intervention type:
Drug
Intervention name:
Axitinib
Description:
Preoperative Treatment with Axitinib: Administer 5mg of axitinib orally twice daily for a
duration of 3 months.
Arm group label:
Experimental
Summary:
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
Accepts Healthy Volunteers
Start date:
March 1, 2024
Completion date:
March 1, 2029
Lead sponsor:
Agency:
RenJi Hospital
Agency class:
Other
Source:
RenJi Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06279403
