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

NCT07657325 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 110

Last updated 2026-06-18

No results posted yet for this study

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)

Interventions

DRUG

Toripalimab

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.

Sponsors & Collaborators

  • Tianjin Medical University Second Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2028-02-01
Completion
2028-02-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07657325 on ClinicalTrials.gov