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PET/CT-Directed Free of Therapy for Metastatic RCC Patients With IMDC Favorable or Intermediate Risk

NCT07175480 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-09-16

No results posted yet for this study

Summary

This phase 2 trial aims to test the feasibility and efficiency of PET/CT-directed treatment interruption strategy in metastatic renal cell carcinoma patients with IMDC favorable/intermediate risk who achieve complete (CMR) or partial metabolic response (PMR) after ≥12 months of first-line PD-1/PD-L1 Immune checkpoint inhibitor (ICI)+ VEGFR-tyrosine kinase inhibitor (TKI) therapy. It helps figure out whether PET/CT can safely direct treatment pause as well as explores a new individualized treatment option based on metabolic imaging for RCC patients.

Conditions

  • Renal Cell Carcinoma (RCC)
  • Metastatic Renal Cell Carcinoma (mRCC)

Interventions

DRUG

Intermittent PD-1/PD-L1 ICI + VEGFR-TKI

Any PD-1/PD-L1 inhibitor or VEGFR-TKI that is commercially marketed, regulatory-approved and reimbursed under public health plans.Dose as recommended by the manufacturer.

Sponsors & Collaborators

  • Jinling Hospital, China

    lead OTHER

Principal Investigators

  • Le Qu · Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-24
Primary Completion
2027-08-31
Completion
2030-08-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07175480 on ClinicalTrials.gov