Predicting Toripalimab Response in High-Risk Recurrent Renal Cell Carcinoma using MRD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective cohort study in high-risk recurrent RCC patients who have undergone radical nephrectomy. MRD testing is performed about 3 weeks after surgery, and Toripalimab is started within 4 weeks. Patients are imaged with CT or MRI from the first dose and followed with imaging every 12 weeks to assess disease-free survival, while overall survival is tracked every 3 months. The goal is to determine if MRD status can predict DFS and OS and help identify which patients may need adjuvant immunotherapy. The study is led by Tianjin Medical University Second Hospital and located in Tianjin, China, enrolling adults with ECOG 0-1 and no residual disease on imaging.

Why it matters

Who can join: the full rules

1. There must be a histological diagnosis of renal cell carcinoma, with or without sarcomatoid features of clear cell components.
2. On the day of signing the informed consent form, both males and females must be at least 18 years old.
3. The participants provide written informed consent for the trial before enrollment.
4. Have high risk or M1 NED renal cell carcinoma as defined by the following pathological tumor-node-metastasis and Fuhrman grading status.

   1. High risk RCC

      * pT4, Any Gr. N0, M0
      * pT Any stage, Any Gr., N+, M0
   2. M1 NED RCC (participants who present not only with the primary kidney tumor but also solid, isolated, soft tissue metastases that can be completely resected at the time of nephrectomy)
5. No previous systemic treatment for advanced RCC (except nephrectomy or pyelectomy) has been performed.
6. Radical nephrectomy (and complete resection of metastatic lesions in M1 NED participants) was performed with a negative surgical margin.
7. It must be evaluated by the investigator as tumor-free and verified by imaging such as CT or MRI. No suspicious brain metastases.
8. Have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
9. Non-surgical sterilization or female participants of childbearing potential who are required to use a medically approved contraceptive method (such as an IUD, contraceptive pill or condom) during the study treatment period and for 3 months after the end of the study treatment period; Serum or urine HCG tests must be negative for women of non-surgical sterilization or childbearing age within 7 days prior to study enrollment; And must be non-lactation period; Non-surgical sterilization or male patients of childbearing age who consent to use a medically approved contraceptive method with their spouse during the study treatment period and for 3 months after the end of the study treatment period.
10. Vital organ function meets the following requirements (excluding use of any blood components and cell growth factors within 14 days) : normal bone marrow reserve function; Absolute neutrophil count (ANC)≥1500/µL, Platelets≥100 000/µL, Hemoglobin ≥5.6 mmol/L (9g/dL); Normal renal function or serum creatinine ≤1.5 mg/d and/or creatinine clearance ≥30 mL/min for participants with creatinine levels \>1.5×institutional ULN; Normal liver function or Total bilirubin ≤1.5xULN, or direct bilirubin≤ULN for participants with total bilirubin levels \>1.5×ULN; AST (SGOT) and ALT (SGPT) ≤2.5×ULN; International normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN.

Where it's running

• Changyi Quan
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Study coordinator: Changyi Quan
• Email: 345920147@qq.com
• Phone: 13388067990

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.