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

NCT06279403 | Not Yet Recruiting Phase 2

• 1 other identifier: IIT-2023-0277
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Clear-cell Metastatic Renal Cell Carcinoma; Immune Checkpoint Inhibitors; Cytoreductive Nephrectomy

Outcome Measures

Primary Outcomes (1)

• Pathological Major Response (MPR)

  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.

  through study completion, an average of 1 year

Study Arms (1)

Experimental

EXPERIMENTAL

Experimental arm

Drug: Toripalimab; Procedure: Cytoreductive Nephrectomy; Drug: Axitinib

Interventions

Toripalimab DRUG

Preoperative Treatment with Toripalimab: Administer 240mg of Toripalimab via intravenous infusion every 3 weeks for a total of 4 cycles.

Experimental

Cytoreductive Nephrectomy PROCEDURE

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.

Experimental

Axitinib DRUG

Preoperative Treatment with Axitinib: Administer 5mg of axitinib orally twice daily for a duration of 3 months.

Experimental

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• RenJi Hospital: lead

MeSH Terms

Conditions

Clear-cell metastatic renal cell carcinoma

Interventions

toripalimab; Axitinib

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: February 28, 2024
• Study Start: March 1, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): March 1, 2029
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share