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RECRUITING
NCT07657325

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

Sponsor: Tianjin Medical University Second Hospital

View on ClinicalTrials.gov

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.

Official title: Predictive Value of Minimal Residual Disease for Efficacy of Toripalimab in High-risk Recurrent Renal Cell Carcinoma Following Nephrectomy: A Prospective Single-arm Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

110

Start Date

2024-04-01

Completion Date

2028-02-01

Last Updated

2026-06-18

Healthy Volunteers

No

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.

Locations (1)

Changyi Quan

Tianjin, Tianjin Municipality, China