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OncoMatch/Clinical Trials/NCT07175480

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

Is NCT07175480 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Intermittent PD-1/PD-L1 ICI + VEGFR-TKI for renal cell carcinoma (rcc).

Phase 2RecruitingJinling Hospital, ChinaNCT07175480Data as of May 2026

Treatment: Intermittent PD-1/PD-L1 ICI + VEGFR-TKIThis 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.

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Extracted eligibility criteria

Cancer type

Renal Cell Carcinoma

Disease stage

Required: Stage IV

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Max 1 prior line
Min 1 prior line

Must have received: anti-PD-1 therapy — first-line

Patient must receive≥12 months of first line treatment with the combination of PD-1/PD-L1 ICI and VEGFR-TKI, and have not experienced a toxicity that prevents them from continuing on therapy.

Must have received: anti-PD-L1 therapy — first-line

Patient must receive≥12 months of first line treatment with the combination of PD-1/PD-L1 ICI and VEGFR-TKI, and have not experienced a toxicity that prevents them from continuing on therapy.

Must have received: VEGFR inhibitor — first-line

Patient must receive≥12 months of first line treatment with the combination of PD-1/PD-L1 ICI and VEGFR-TKI, and have not experienced a toxicity that prevents them from continuing on therapy.

Cannot have received: systemic therapy

Prior systemic therapy for advanced RCC

Lab requirements

Blood counts

anc ≥ 1.5 × 10³/μl (≥ 1.5 gi/l); platelet count ≥ 100 × 10³/μl (≥ 100 gi/l); hemoglobin ≥ 9 g/dl (≥ 90 g/l)

Kidney function

serum creatinine ≤ 2.0 × upper limit of normal or calculated creatinine clearance ≥ 30 ml/min using the cockroft-gault formula

Liver function

alt and ast < 2.5 × upper limit of normal. total bilirubin ≤ 1.5 × the upper limit of normal (≤ 3 mg/dl [≤ 51.3 μmol/l] if gilbert's syndrome)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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