Study on MRD Prediction of Efficacy of Toripalimab in the Treatment of High-risk Recurrent Renal Carcinoma

NCT07657325 | Recruiting DMC

• 1 other identifier: MRD-RCC
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective cohort study aimed at clarifying the predictive value of MRD for postoperative DFS and OS in high-risk recurrent renal cell carcinoma patients who have undergone radical nephrectomy and received adjuvant treatment with Toripalimab. Further differentiating patients who need adjuvant immunotherapy.

Conditions

Renal Cell Carcinoma (RCC)

Keywords

Minimal Residual Disease; Toripalimab; Renal Cell Carcinoma; Disease Free Survival

Outcome Measures

Primary Outcomes (1)

• Effect on the disease-free survival in the trial patients.

  The sample size was calculated based on the objective response rate reported in the previous literature, and the target assumption was that the recurrence rate was 30% at 2 years and that adjuvant therapy with Toripalimab would prevent 50% of relapses.

  Imaging (CT, MRI) was evaluated at 12 weeks after the first dose of Toripalimab and every 12 weeks. Until the tumor recurred or could not tolerate the side effects or the drug for 1 year.

Secondary Outcomes (1)

• Effect on the overall survival in the trial patients.

  Imaging (CT, MRI) was evaluated 12 weeks after initial dosing and every 12 weeks until the tumor recurred or could not tolerate side effects or drugs for 1 year, and survival was recorded every 3 months.

Study Arms (1)

High risk recurrent renal cell carcinoma patients receiving treatment with Toripalimab

High risk recurrence renal cell carcinoma patients who have undergone radical surgery will begin receiving treatment with Toripalimab within 4 weeks after surgery.Toripalimab is administered intravenously once every 3 weeks for a maximum of 17 cycles (approximately 1 year) or until disease recurrence, unacceptable toxic effects, intercurrent illness preventing further administration of Toripalimab, decision by the investigator, a new cancer resulting in active treatment, pregnancy, or nonadherence to the protocol. Imaging (CT, MRI) tests will be performed 12 weeks after the initial dosing and every 12 weeks for 2 years.Definition of High risk of recurrence ：tumor stage 2 with nuclear grade 4 or sarcomatoid differentiation, tumor stage 3 or higher, regional lymph-node metastasis, regional lymph-node metastasis, or stage M1 with NED (M1 with no evidence of disease) (M1 NED, defined as resection of the primary tumor and solid, isolated, soft-tissue metastases).

Drug: Toripalimab

Interventions

Toripalimab DRUG

Toripalimab is a newly developed recombinant humanized (with a degree of 97%) anti-PD-1 monoclonal antibody (Chinese patent authorization number CN104250302B, PCT patent publication number (WO2014/206107A1)), belonging to the human IgG4/Kappa subtype. A point mutation of proline (S228P) has been introduced at the serine protein site 228 in the IgG4 hinge region to increase antibody stability and reduce possible IgG4 Fab chain substitutions. It can specifically bind to PD-1 and effectively block the interaction between PD-1 and its ligands PD-L1 (i.e. B7-H1) and PD-L2 (i.e. B7-DC), thereby activating cytotoxic T lymphocytes, increasing lymphocyte proliferation, and cytokine secretion, especially IFN - γ. To achieve the goal of using the immune system to kill tumors.

High risk recurrent renal cell carcinoma patients receiving treatment with Toripalimab

Eligibility Criteria

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

Study Population

Participants with high-risk recurrent renal cell carcinoma after radical nephrectomy who are older than 18 years of age must have a clear pathological diagnosis and meet all enrollment criteria. The subjects voluntarily join the study and have good compliance with safety and survival follow-up.

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Tianjin Medical University Second Hospital: lead

Study Sites (1)

Changyi Quan

Tianjin, Tianjin Municipality, 300211, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

10ml blood with EDTA

MeSH Terms

Conditions

Carcinoma, Renal Cell; Neoplasm, Residual

Interventions

toripalimab

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; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Changyi Quan

CONTACT

13388067990; 345920147@qq.com

Shimiao Zhu

CONTACT

13752436539; zhushimiao1@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: June 18, 2026
• Study Start: April 1, 2024
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: June 18, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)