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A Study of Toripalimab in Adjuvant Therapy After Resection of High-risk Renal Cancer

NCT06584435 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-12-19

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if the drug toripalimab (an anti-PD-1 antibody) works to prevent cancer recurrence in patients with high-risk renal cell carcinoma after they have had surgery to remove the kidney (nephrectomy). The study will also learn about the safety of toripalimab in this setting.The main questions the study aims to answer are:

1. Does treatment with toripalimab after nephrectomy increase the time patients live without their cancer returning (disease-free survival) compared to what would be expected without this treatment?
2. What medical problems (side effects) do participants have when receiving toripalimab? This is a single-arm study, meaning all participants in the trial will receive the study drug, toripalimab.. Researchers will monitor participants over time to see if the outcomes with toripalizumab are better than what is historically known for similar patients who only had surgery.

Participants in this study will:

1. Receive toripalimab by intravenous (IV) infusion once every 3 weeks for up to about one year ( 17 doses).
2. Visit the clinic regularly for check-ups, which will include:

Imaging scans (like CT or MRI) of the chest, abdomen, and pelvis every 12 weeks to check for cancer recurrence.

Blood and urine tests to monitor safety. Questionnaires about their quality of life and symptoms. Be followed for a long period after treatment ends to track overall survival and long-term health.

Conditions

  • High-risk Renal Cell Carcinoma

Interventions

DRUG

Toripalimab

Drug Profile: Toripalimab , a humanized IgG4 anti-PD-1 monoclonal antibody with unique structural features. Key Differentiators: Dosing Protocol: Fixed 240mg Q3W regimen (not weight-based) Administration: 30-minute IV infusion with mandatory 0.2μm filtration Dose Policy: Strictly no dose adjustment permitted - only suspension/discontinuation allowed for toxicity management Unique Features: Binding Specificity: Toripalimab targets a unique conformational epitope on the PD-1 receptor's CC' loop, differentiated from pembrolizumab (binding FG loop) and nivolumab (binding BC loop). This results in varied steric hindrance effects and potentially distinct immune activation kinetics.The specific binding interface may influence receptor internalization dynamics and duration of pathway blockade, contributing to toripalimab's characteristic clinical activity and safety profile observed in prior studies.

Sponsors & Collaborators

  • Tianjin Medical University Second Hospital

    lead OTHER

Principal Investigators

  • Changyi Changyi, MD,PhD · Tianjin Medical University Second Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-10
Primary Completion
2025-11-01
Completion
2027-11-01

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 NCT06584435 on ClinicalTrials.gov