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

NCT07175480 | Recruiting Phase 2

• 1 other identifier: 2025DZKY-069-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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)

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS) rate

  Proportion of participants alive and without disease progression at 24 months will be assessed according to PERCIST 1.0 criteria.

  24 months from treatment initiation

Secondary Outcomes (12)

• Duration of response (DoR)

  From treatment interruption until disease progression or death, assessed up to 24 months

• Overall survival (OS)

  From treatment initiation until death from any cause, assessed up to 5 years

• Progression free survival (PFS)

  From treatment initiation until disease progression or death from any cause, assessed up to 5 years

• Overall safety profile

  From the date of the first study drugs administration up to 90 days after the last dose of study drugs administration

• Patient-reported outcome (PRO) - Health-related quality of life measured by NCCN FKSI-19

  24 months from treatment initiation

Other Outcomes (2)

• Metabolic response assessed by serial PET/CT

  Baseline to 24 months from treatment initiation

• Biobanking for future research

  Baseline to 24 months from treatment initiation

Study Arms (1)

Treatment pause

EXPERIMENTAL

Patients achieving complete metabolic response (CMR) or partial metabolic response (PMR) on PET/CT within 24 months discontinue combination regimens with the possibility to restart initial treatment at progression.

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

Interventions

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

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.

Also known as: Treatment pause

Treatment pause

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects aged ≥ 18 years at time of signing informed consent
• Locally advanced (not amenable to curative surgery or radiation therapy) or metastatic RCC (American Joint Committee on Cancer \[AJCC\] Stage IV)
• Favorable or intermediate risk as per International Metastatic RCC Database Consortium (IMDC) criteria
• Eastern Cooperative Oncology Group performance status 0 or 1
• Karnofsky Performance Status (KPS) grade ≥ 70%
• Adequate organ and bone marrow function meeting all laboratory criteria:
• Ⅰ. Absolute neutrophil count (ANC) ≥ 1.5 × 10³/μL (≥ 1.5 GI/L); Platelet count ≥ 100 × 10³/μL (≥ 100 GI/L); Hemoglobin ≥ 9 g/dL (≥ 90 g/L)
• Ⅱ. Alanine aminotransferase (ALT) and aspartate aminotransferase (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)
• Ⅲ. Serum creatinine ≤ 2.0 × upper limit of normal or calculated creatinine clearance ≥ 30 mL/min using the Cockroft-Gault formula.
• Capacity to comprehend and comply with protocol requirements, with documented informed consent signed
• Contraception agreement for sexually active fertile participants and partners to use of medically accepted methods during study and continue for 5 months after last treatment
• Negative pregnancy status at screening for women of childbearing potential

You may not qualify if:

• Highly malignant pathology
• Prior systemic therapy for advanced RCC
• Poor risk as per International Metastatic RCC Database Consortium (IMDC) criteria
• ECOG performance status \>1
• Karnofsky Performance Status (KPS) \<70%
• Inadequate organ and bone marrow function
• Bulky or symptomatic disease or hepatic metastases
• Active brain metastases or leptomeningeal disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 3 months before the start of treatment.
• Concurrent or prior invasive malignancies that could confound efficacy assessment, except adequately treated non-melanoma skin cancer, superficial bladder cancer or carcinoma in situ of the cervix/breast with curative therapy \>3 years ago.
• Uncontrolled hypertension (\>150/100 mmHg despite optimal therapy)
• Uncontrolled comorbidities within 6 months including but not limited to: clinically significant cardiovascular disorders, gastrointestinal disorders with high risk of perforation or fistula formation, significant hematuria, hematemesis, hemoptysis, or major bleeding history, severe infections, severe autoimmune diseases (e.g., systemic lupus erythematosus, immune pneumonitis), active HIV, HBV, or HCV infections.
• Major surgery within 4 weeks with unhealed wounds or planned surgery during study
• Concomitant use of drugs or substances affecting activity or pharmacokinetics of investigational products
• Hypersensitivity to any component of study drugs
• Chronic or concurrent immunosuppressive therapy, except Inhaled/topical steroids

Sponsors & Collaborators

• Jinling Hospital, China: lead

Study Sites (1)

Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China

Nanjing, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Le Qu

  Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China

  STUDY CHAIR

Central Study Contacts

Le Qu, M.D

CONTACT

+86 15720625951; septsoul@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate chief urologist

Study Record Dates

• First Submitted: August 30, 2025
• First Posted: September 16, 2025
• Study Start: January 24, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2030
• Last Updated: September 16, 2025

Record last verified: 2025-08

Locations

CN (1)