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

NCT ID: NCT06279403

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2029-03-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental

Experimental arm

Group Type: EXPERIMENTAL

Toripalimab

Intervention Type: DRUG

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

Cytoreductive Nephrectomy

Intervention Type: 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.

Axitinib

Intervention Type: DRUG

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

Interventions

Toripalimab

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

Intervention Type: DRUG

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 evident enlargement of retroperitoneal lymph nodes preoperatively.

Intervention Type: PROCEDURE

Axitinib

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

RenJi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

IIT-2023-0277

Identifier Type: -

Identifier Source: org_study_id