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

NCT06584435 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: TUORA
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

High-risk Renal Cell Carcinoma

Keywords

High-risk Renal Cell Carcinoma; Toripalimab; Adjuvant therapy

Outcome Measures

Primary Outcomes (1)

• Disease-Free Survival (DFS) as Assessed by Investigator

  Disease-Free Survival is defined as the time from enrollment to the first documented occurrence of any of the following events: Local recurrence of renal cell carcinoma (confirmed by imaging) Distant metastasis of renal cell carcinoma (confirmed by imaging) Death from any cause Participants without documented DFS events at the time of analysis will be censored at the date of their last tumor assessment. Tumor assessments will be performed using computed tomography (CT) or magnetic resonance imaging (MRI) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 guidelines.

  From enrollment until the first documented disease recurrence, distant metastasis, or death from any cause (whichever occurs first), assessed up to 60 months

Secondary Outcomes (3)

• Overall Survival (OS)

  From enrollment until death from any cause, assessed up to 120 months

• Incidence and Severity of Adverse Events

  At the following predefined visit time points: first dose (baseline), each subsequent cycle treatment day, and the 90-day safety follow-up visit after the last dose.

• Health-Related Quality of Life Assessment

  Baseline, every 12 weeks during treatment (up to 17 cycles), at treatment discontinuation, and every 12 weeks during follow-up until disease recurrence (up to 60 months).

Study Arms (1)

High risk recurrent renal cell carcinoma patients receiving treatment with Toripalimab

EXPERIMENTAL

Intervention: Toripalimab, a humanized anti-PD-1 monoclonal antibody. Dosage \& Administration: Fixed dose of 240 mg via intravenous infusion every 3 weeks (Q3W). Treatment commences within 4-12 weeks post-nephrectomy. Treatment Duration: Administered for up to 17 cycles (approximately one year), or until disease recurrence, unacceptable toxicity, or meeting other discontinuation criteria. Dose Modification Policy: Dose adjustment is not permitted. Management of specific immune-related adverse events (irAEs) is strictly limited to therapy suspension (with potential resumption after symptom improvement to Grade 0-1) or permanent discontinuation, as per protocol-specified guidelines. Key Assessments: Includes regular tumor imaging (CT/MRI) every 12 weeks, comprehensive safety monitoring, and quality of life evaluations.

Drug: Toripalimab

Interventions

Toripalimab DRUG

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.

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+)

You may qualify if:

• Participants must meet ALL of the following criteria to be eligible for study enrollment:
• Informed Consent Capable of giving signed informed consent； Willing to comply with all study procedures； Signed and dated written informed consent obtained prior to any study-specific procedures.
• Age and Sex Age ≥18 years at time of consent； Male and female participants eligible. 1.3 Disease Characteristics Histologically confirmed renal cell carcinoma with clear cell component; Must have undergone nephrectomy with complete resection; No evidence of residual tumor confirmed by imaging;
• Must meet at least ONE of the following high-risk criteria:
• pT2,with Fuhrman Grade IV or sarcomatoid,N0,M0;pT3/4,N0M0 (any grade);Any T classification with N1,M0;Post nephrectomy(total/partial) plus complete resection of metastasis, M1 NED.
• Brain Metastasis No suspected or confirmed active brain metastases. 1.5 Performance Status Eastern Cooperative Oncology Group (ECOG) performance status 0-1. 1.6 Organ Function (within 14 days prior to enrollment, without transfusion or growth factor support)
• Hematopoietic function:
• Absolute neutrophil count ≥1,500/mm³; Platelet count ≥100,000/mm³; Hemoglobin ≥9.0 g/dL (5.6 mmol/L)
• Hepatic function:
• Total bilirubin ≤1.5 × ULN; AST and ALT ≤1.5 × ULN
• Renal function:
• Serum creatinine ≤1.5 mg/dL; OR creatinine clearance ≥60 mL/min (Cockcroft-Gault formula) 1.7 Contraception Females of childbearing potential must use medically approved contraception during treatment and for 3 months after last dose; Negative serum or urine pregnancy test within 7 days prior to randomization for women of childbearing potential; Non-lactating females; Males with female partners of childbearing potential must use effective contraception during treatment and for 3 months after last dose 1.8 Compliance Voluntarily agrees to participate by signing informed consent; Willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures

You may not qualify if:

• Participants meeting ANY of the following criteria will be excluded from study participation:
• Prior Therapy Previous radiotherapy, chemotherapy, targeted therapy, long-term or high-dose hormone therapy, or any immune checkpoint inhibitor treatment.
• Concurrent Malignancy History of or current concurrent malignancy (except adequately treated basal cell carcinoma of skin, carcinoma in situ of cervix, etc.).
• Allergy and Prior Immunotherapy Previous treatment with other PD-1/PD-L1 inhibitors; Known hypersensitivity to macromolecular protein preparations or any PD-1 inhibitor components.
• Autoimmune Disease Active autoimmune disease or history of autoimmune disease; Exceptions:Controlled type 1 diabetes, hypothyroidism requiring only hormone replacement, skin diseases not requiring systemic treatment (vitiligo, psoriasis), or childhood asthma in complete remission without intervention in adulthood.
• Immunosuppressive Therapy Current use of immunosuppressants (e.g., systemic corticosteroids \>10 mg/day prednisone equivalent) for immunosuppressive purposes, continued within 2 weeks prior to enrollment.
• Cardiovascular Disease
• Poorly controlled cardiac clinical symptoms or diseases, including:
• NYHA Class II or higher heart failure; Unstable angina pectoris; Myocardial infarction within 1 year; Clinically significant arrhythmias requiring treatment 2.7 Coagulation Function Abnormal coagulation function with bleeding tendency; Current thrombolytic or anticoagulant therapy; 2.8 Gastrointestinal Disease
• Current active gastrointestinal diseases including:
• Esophageal varices; Active ulcers; Inflammatory bowel disease; Risk of perforation or bleeding; 2.9 Hemorrhage and Thrombosis Events History of or current severe hemorrhage, hemoptysis, or thrombotic events within 12 months.
• Infection Active infection requiring systemic therapy; Unexplained fever \>38.5°C during screening or before first dose; Congenital or acquired immunodeficiency, including HIV infection or active hepatitis 2.11 Other Medical Conditions History of severe pulmonary fibrosis, interstitial pneumonia, radiation pneumonia; Live vaccination within 4 weeks prior to study treatment; History of psychotropic drug abuse, alcoholism, or drug addiction 2.12 Administrative Reasons Participation in another clinical study or within 1 month after completion of previous clinical study; Any condition that, in the investigator's judgment, may lead to early study termination affecting participant safety or data quality
• WITHDRAWAL CRITERIA
• Participants will be withdrawn from study treatment if ANY of the following occurs:
• Participant Request Participant or legal representative requests withdrawal 3.2 Disease Progression Confirmed disease progression 3.3 Intolerable Toxicity Occurrence of intolerable toxicities 3.4 Investigator Judgment Investigator determines continued participation may harm the participant 3.5 Protocol Violations Pregnancy Loss to follow-up Major protocol violation 3.6 Treatment Delay Any cause leading to treatment delay \>2 weeks.

Sponsors & Collaborators

• Tianjin Medical University Second Hospital: lead

Study Sites (1)

Changyi Quan

Tianjin, Tianjin Municipality, 300211, China

Location

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MeSH Terms

Interventions

toripalimab

Study Officials

• Changyi Changyi, MD,PhD

  Tianjin Medical University Second Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2024
• First Posted: September 4, 2024
• Study Start: October 10, 2022
• Primary Completion: November 1, 2025
• Study Completion (Estimated): November 1, 2027
• Last Updated: December 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Availability Start Date: Individual participant data and supporting documents will become available for sharing 24 months after the primary results publication of the main trial outcomes. Data Availability Period: The data will remain accessible for a period of 5 years from the initial sharing date. During this timeframe, qualified researchers may submit requests and access the data through the designated platform. Extension Policy: After the initial 5-year period, the availability of the data will be re-evaluated annually. Data may remain accessible beyond this period based on continued scientific interest, resource availability, and platform sustainability. Data Updates: The shared datasets represent the final, locked database from the completed clinical trial. No additional updates or amendments to the core dataset are anticipated. However, corrected versions may be released if critical errors are identified, with clear version control maintained.
• Access Criteria: 1. Eligible Data Requestors Academic researchers from accredited institutions Regulatory and government health authorities Pharmaceutical company researchers (for non-commercial research) Other qualified scientific researchers with legitimate research inquiries 2. Accessible Data and Documents De-identified individual participant data Study protocol and statistical analysis plan Annotated case report forms Clinical study report (sanitized) Data dictionaries and metadata documentation 3. Data Access Process 3.1 Application Requirements Submission of research proposal through designated portal Detailed statistical analysis plan required Proof of institutional review board approval Signed data sharing agreement 3.2 Review and Approval Independent review by scientific committee 60-day standard review period Evaluation based on scientific merit and feasibility Approval notification with access credentials 4. Permitted Research Uses Conducting meta-analyses

Locations

CN (1)