CD70-Targeted Immuno-PET/CT-Directed Free of Therapy Used for mccRCC Patients With IMDC Favorable or Intermediate Risk

NCT07615348 | Recruiting Phase 2

• 1 other identifier: 2026DZKY-086-01
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this study is to evaluate the safety and feasibility of a treatment holiday strategy directed by CD70-targeted immuno-PET/CT in patients with metastatic clear cell renal cell carcinoma (mccRCC). Specifically, the study aims to assess whether patients who achieve both anatomical disease control and metabolic response after 12 months of first-line PD-1/PD-L1 ICI + VEGFR-TKI combination therapy can safely pause their treatment, improve quality of life without compromising therapeutic efficacy.

Conditions

Metastatic Clear Cell Renal Cell Carcinoma

Keywords

Metastatic Clear Cell Renal Cell Carcinoma; CD70-Targeted Immuno-PET/CT; Treatment Holiday

Outcome Measures

Primary Outcomes (1)

• Treatment-free survival (TFS) rate

  Defined as the proportion of patients who are alive without having restarted the original therapy at 12 months following discontinuation of the combination therapy.

  12 months after treatment discontinuation

Secondary Outcomes (13)

• Overall survival (OS)

  From treatment initiation until 3 years of follow-up

• Progression free survival (PFS)

  From treatment initiation until 3 years of follow-up

• Overall safety profile

  From treatment initiation until 3 years of follow-up

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

  From treatment initiation until 2 years of follow-up

• Patient-reported outcome (PRO) - Health-related quality of life measured by EORTC QLQ-C30

  From treatment initiation until 2 years of follow-up

Study Arms (1)

Treatment Holiday Strategy

EXPERIMENTAL

Patients with mccRCC who complete 12 months of first-line PD-1/PD-L1 inhibitor plus VEGFR-TKI combination therapy AND achieve the predefined composite response (anatomical CR/PR/SD per RECIST 1.1 AND metabolic CMR/PMR per PERCIST on CD70 immuno-PET/CT) will enter a treatment holiday. Systemic therapy will be suspended, and patients will undergo active surveillance.

Drug: PD-1/PD-L1 ICI + VEGFR-TKI; Other: Treatment pause

Interventions

Treatment pause OTHER

Patients who achieve the predefined criteria after 12 months of treatment will discontinue both drugs and enter a closely monitored treatment holiday. Upon radiographic or clinical progression, the previous systemic therapy will be reintroduced according to the protocol and investigator's discretion.

Treatment Holiday Strategy

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

All participants will receive first-line PD-1/PD-L1 inhibitor + VEGFR-TKI combination therapy for 12 months (±1 month).

Treatment Holiday Strategy

Eligibility Criteria

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

You may qualify if:

• STEP0: At Treatment Initiation
• Male or female subjects aged ≥ 18 years
• Locally advanced (not amenable to curative surgery or radiation therapy) or metastatic RCC (American Joint Committee on Cancer \[AJCC\] Stage IV)
• Histologically or cytologically confirmed advanced RCC with predominantly clear-cell subtype
• Favorable or intermediate risk as per International Metastatic RCC Database Consortium (IMDC) criteria
• Karnofsky Performance Status (KPS) grade ≥ 70%
• At least one measurable lesion on CT per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
• At least one high-uptake target lesion on CD70-targeted immuno-PET/CT per Positron Emission Tomography Response Criteria in Solid Tumors (PERCIST) version 1.0
• If CD70-negative lesions (visible on CT but lacking CD70 avidity on PET/CT) are present at baseline, they must meet ALL the following conditions: cannot be target lesions, cannot be located in major involved organs, must be ≤ 3 in number, and must account for ≤ 30% of the total tumor burden
• Adequate organ and bone marrow function meeting all laboratory criteria:
• Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L; Platelet count ≥ 100 × 10\^9/L; Hemoglobin ≥90 g/L
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 2.5 × upper limit of normal(ULN) (or ≤ 5 × ULN if hepatic metastases are present). Total bilirubin ≤ 1.5 × ULN (≤ 3 mg/dL if Gilbert's syndrome)
• Serum creatinine ≤ 2.0 × ULN or estimated glomerular filtration rate (eGFR) ≥ 30 mL/min using the Cockcroft-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 medically accepted methods during the study and continue for 5 months after last treatment

You may not qualify if:

• STEP0: At Treatment Initiation
• Prior systemic therapy for advanced RCC
• Poor risk as per International Metastatic RCC Database Consortium (IMDC) criteria
• Karnofsky Performance Status (KPS) \<70%
• Inadequate organ and bone marrow function
• Active brain metastases or leptomeningeal disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) who are clinically stable without progression prior to treatment
• Concurrent or prior invasive malignancies within the past 5 years, except adequately treated in situ/superficial cancers (e.g., non-melanoma skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix/breast)
• Presence of uncontrolled major comorbidities or recent severe illnesses within 6 months, including but not limited to: uncontrolled hypertension, clinically significant cardiovascular disease, GI disorders with high risk of perforation/fistula, significant hematuria, hematemesis, hemoptysis, major bleeding history, severe active infections (including active HIV, HBV, or HCV), or severe autoimmune diseases (e.g., systemic lupus erythematosus, immune pneumonitis)
• Life expectancy \< 6 months
• Known allergy or hypersensitivity to the CD70 imaging agent or any of its excipients
• Severe hepatic or renal insufficiency, or inability to tolerate PET/CT examination
• Medical/psychiatric/social conditions compromising protocol compliance
• Pregnancy, lactation, or refusal of contraception during and for 5 months post-treatment
• STEP1: At 12-Month Evaluation
• Failure to complete 12 months(±1m) of first-line PD-1/PD-L1 + VEGFR-TKI therapy due to unmanageable toxicity or disease progression

Sponsors & Collaborators

• Jinling Hospital, China: lead

Study Sites (5)

Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University

Nanjing, Jiangsu, 210000, China

RECRUITING

Nanjing First Hospital, Nanjing Medical University

Nanjing, Jiangsu, 210006, China

RECRUITING

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

RECRUITING

Sir Run Run Hospital, Nanjing Medical University

Nanjing, Jiangsu, 211100, China

RECRUITING

Wuxi No.2 People's Hospital (Jiangnan University Medical Center)

Wuxi, Jiangsu, 214002, China

RECRUITING

MeSH Terms

Conditions

Clear-cell metastatic renal cell carcinoma

Study Officials

• Le Qu, Ph.D.

  Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Le Qu, Ph.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: May 22, 2026
• First Posted: May 29, 2026
• Study Start: June 16, 2026
• Primary Completion (Estimated): August 10, 2028
• Study Completion (Estimated): August 10, 2029
• Last Updated: July 23, 2026

Record last verified: 2026-05

Locations

CN (5)