Upfront Immune Checkpoint Inhibitors With Deferred Cytoreductive Nephrectomy for Metastatic Renal Cell Carcinoma

Phase 2

Not yet recruiting

• Conditions: Clear-cell Metastatic Renal Cell Carcinoma; Immune Checkpoint Inhibitors; Cytoreductive Nephrectomy
• Interventions: Drug: Toripalimab; Procedure: Cytoreductive Nephrectomy; Drug: Axitinib

• Registration Number: NCT06279403
• Lead Sponsor: RenJi Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-29
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-25
• Last Update Submitted: 2024-02-25
• Study First Posted: 2024-02-28
• Last Update Posted: 2024-02-28
• Study Start: 2024-03-01
• Primary Completion: 2026-03-01
• Study Completion: 2029-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	Cytoreductive Nephrectomy	Experimental arm
Experimental	Toripalimab	Experimental arm
Experimental	Axitinib	Experimental arm

Primary Outcome Measures

Name	Time	Method
Pathological Major Response (MPR)	through study completion, an average of 1 year	The percentage of residual tumor cells in the primary tumor after surgery, with MPR defined as less than 10% of residual tumor cells in the pathology report.