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High-risk Renal Cell CarcinomaPhase 2TUORANCT06584435

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

A Phase 2 study testing Toripalimab in people with High-risk Renal Cell Carcinoma, run by Tianjin Medical University Second Hospital at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
High-risk Renal Cell Carcinoma
What is being tested?
Toripalimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteChina
Study dates
10 Oct 2022to 1 Nov 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult
  1. INCLUSION CRITERIA Participants must meet ALL of the following criteria to be eligible for study enrollment: 1.1 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. 1.2 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. 1.4 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
  2. EXCLUSION CRITERIA Participants meeting ANY of the following criteria will be excluded from study participation: 2.1 Prior Therapy Previous radiotherapy, chemotherapy, targeted therapy, long-term or high-dose hormone therapy, or any immune checkpoint inhibitor treatment. 2.2 Concurrent Malignancy History of or current concurrent malignancy (except adequately treated basal cell carcinoma of skin, carcinoma in situ of cervix, etc.). 2.3 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. 2.4 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. 2.5 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. 2.6 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. 2.10 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
  3. WITHDRAWAL CRITERIA

Participants will be withdrawn from study treatment if ANY of the following occurs:

3.1 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Changyi Quan

    Tianjin, Tianjin Municipality, 300211

Other trials in China

About this study

Official title: A Single-arm Study of Toripalimab in Adjuvant Therapy After Resection of High-risk Renal Cancer

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.
Read more

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.

Read the detailed description
  1. Study Background and Rationale Renal cell carcinoma (RCC) carries a substantial risk of recurrence post-nephrectomy, particularly in patients with intermediate-high risk, high risk, or M1 no evidence of disease (NED) status following metastasectomy. The phase III KEYNOTE-564 clinical trial demonstrated that adjuvant therapy with pembrolizumab, an anti-PD-1 antibody, significantly improved disease-free survival (DFS) compared to placebo in this patient population, establishing a new therapeutic standard. Building upon this landmark finding, the present study aims to investigate the efficacy and safety of toripalimab, another anti-PD-1 monoclonal antibody, within a similar clinical context. This single-arm, phase II trial seeks to evaluate whether toripalimab can provide comparable clinical benefits, including reduced recurrence risk and improved survival outcomes, for patients with high-risk RCC following complete surgical resection, while thoroughly assessing its safety profile.
  2. Study Objectives Primary Objectives: To evaluate the efficacy of adjuvant toripalimab as measured by investigator-assessed Disease-Free Survival (DFS) and Overall Survival (OS). Secondary Objectives: To assess the safety and tolerability profile of adjuvant toripalimab and patient-reported outcomes (PROs) using quality of life questionnaires..
  3. Trial Design and Methodology This is a single-center, prospective, single-arm, Phase II clinical trial. The design leverages the positive signal observed in the KEYNOTE-564 trial to explore the potential of a similar immunotherapeutic agent, toripalimab, in a real-world setting at a major academic center. The study will enroll patients who have undergone nephrectomy and are within the 4 to 12-week postoperative window. Treatment involves intravenous administration of toripalimab at a fixed dose of 240 mg every three weeks, for a planned treatment duration of approximately one year (17 cycles), mirroring the treatment schedule found effective in the precedent trial. Treatment will continue until disease recurrence, unacceptable toxicity, or other protocol-defined discontinuation criteria are met. The single-arm design is chosen to efficiently characterize the activity and safety of toripalimab in this specific adjuvant setting, with outcomes referenced against historical controls and the results of prior pivotal studies.
  4. Study Procedures and Assessments The assessment schedule is structured to closely monitor for efficacy and safety signals, consistent with the standards set by recent practice-changing trials. Key procedures include: Screening Period (Within 4 weeks prior to treatment initiation):
  • Informed consent process.
  • Confirmation of diagnosis and high-risk status via central pathology review .
  • Tumor imaging via CT or MRI of the chest, abdomen, and pelvis to confirm no evidence of disease post-surgery.
  • Collection of archival tumor tissue from nephrectomy/metastasectomy.
  • Physical examination, vital signs, ECOG performance status assessment.
  • Clinical laboratory tests: hematology, serum chemistry, thyroid function, coagulation profile, urinalysis.
  • Viral serology testing (HBV, HCV, HIV).
  • Pregnancy test for women of childbearing potential (WOCBP).
  • Baseline quality of life assessments (EORTC QLQ-C30 and FKSI-15). Treatment Period (Each cycle is 3 weeks):
  • Pre-dose assessments (Day 1 of each cycle): Vital signs, directed physical exam, assessment of adverse events (AEs) and concomitant medications.
  • Toripalimab administration: IV infusion on Day 1 of each cycle.
  • Laboratory tests: Hematology and serum chemistry at every cycle; urinalysis and thyroid function tests periodically as specified in the protocol.
  • Tumor imaging: CT/MRI scans of chest, abdomen, and pelvis will be performed every 12 weeks (± 7 days) from the date of treatment to assess for disease recurrence.
  • Quality of Life (QoL) assessments: EORTC QLQ-C30 and FKSI-15 questionnaires will be administered at predefined cycles and at the end of treatment. Post-Treatment Follow-up Period:
  • Safety Follow-up Visit: Occurs 30 days (± 7 days) after the last dose of toripalimab for ongoing AE monitoring.
  • Efficacy Follow-up: After treatment discontinuation (without disease recurrence), patients will continue tumor imaging assessments every 12 weeks (Year 1-3), then every 24 weeks (Years 4+) until disease recurrence, start of new anticancer therapy, or study end.
  • Survival Follow-up: Overall survival status will be assessed via telephone or clinic visit every 12 weeks (± 7 days) until death, withdrawal of consent, or the end of the study.
  1. Endpoints The endpoints are selected to align with the established efficacy parameters in adjuvant RCC immunotherapy trials, facilitating a meaningful evaluation of toripalimab's benefit-risk profile. Primary Endpoint:
  • Disease-Free Survival (DFS) , defined as the time from randomization to the first documented local or distant recurrence or death from any cause.
  • Overall Survival (OS): Defined as the time from randomization to death from any cause. Secondary Endpoints: Include incidence and severity of adverse events (AEs/SAEs) graded by CTCAE v5.0, and changes from baseline in PRO scores.
  1. Statistical Considerations The sample size is planned to be 40-100 participants. The analysis will be primarily descriptive for this single-arm study. Efficacy analyses (DFS, OS) will be performed on the Full Analysis Set (FAS) using Kaplan-Meier methodology. Safety analyses will be conducted on the Safety Set (SS). The results will be contextualized with reference to existing data from the adjuvant RCC treatment landscape, including findings from the KEYNOTE-564 trial.
Being tested
Toripalimab
Keywords
High-risk Renal Cell Carcinoma, Toripalimab, Adjuvant therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ToripalimabDrug

    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.

Study groups in NCT06584435
Study groupRoleWhat they receive
High risk recurrent renal cell carcinoma patients receiving treatment with ToripalimabExperimentalIntervention: 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.
Receives: Drug: Toripalimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. Overall Survival (OS)

    Overall Survival is defined as the time from enrollment to death from any cause. Participants who are alive at the time of analysis will be censored at the last known alive date. Survival status will be collected through regular follow-up contacts every 12 weeks (± 7 days) until death, withdrawal of consent, or the end of the study, whichever occurs first.

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

  2. Incidence and Severity of Adverse Events

    Safety and tolerability will be assessed through:

    • Incidence, severity, and relationship to study treatment of all adverse events (AEs)
    • Serious adverse events (SAEs) and adverse events leading to treatment discontinuation
    • Laboratory abnormalities (hematology, clinical chemistry, urinalysis)
    • Vital signs measurements and physical examination findings
    • Electrocardiogram (ECG) parameters
    • All AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. Immune-related adverse events (irAEs) will be specifically monitored and managed according to protocol-specified guidelines.

    Measured: 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.

  3. Health-Related Quality of Life Assessment

    Quality of life will be evaluated using validated patient-reported outcome (PRO) instruments:

    EORTC QLQ-C30: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 items FKSI-DRS: Functional Assessment of Cancer Therapy-Kidney Symptom Index-Disease-Related Symptoms The EORTC QLQ-C30 assesses global health status and quality of life across multiple domains including physical, role, emotional, cognitive, and social functioning. The FKSI-DRS specifically measures disease-related symptoms in renal cell carcinoma patients. Changes from baseline in scale scores will be analyzed.

    Measured: 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2024
  2. Study start10 Oct 2022
  3. Primary completion1 Nov 2025
  4. Study completion1 Nov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06584435
Sponsor's protocol ID
TUORA
Acronym
TUORA
Status last verified
Nov 2025
First submitted
2 Sep 2024
Last updated
19 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 1. Data Scope De-identified individual participant data (IPD) Clinical study report protocols 2. Data Specifications Clinical Datasets: Demographic/ efficacy (response, survival)/ safety (adverse events) data Documentation: Informed consent templates and complete study protocols Standards: CDISC SDTM/ADaM formatted datasets 3. Access Process Timeline: Available within 18 months after trial completion Platform: Access via designated data sharing portal Review: Scientific review committee approval required 4. Usage Terms Purpose: Academic non-commercial research use only Requirements: Signed data sharing agreements mandatory Restrictions: No commercial use or re-identification attempts 5. Technical Details Format: Analysis-ready datasets with metadata Support: Provided documentation and limited technical support

Publications

  • Chen J, Ji T, Zhao J, Li G, Zhang J, Jin R, Liu J, Liu X, Liang X, Huang D, Xie A, Lin H, Cang Y, Cai X. Sorafenib-resistant hepatocellular carcinoma stratified by phosphorylated ERK activates PD-1 immune checkpoint. Oncotarget. 2016 Jul 5;7(27):41274-41284. doi: 10.18632/oncotarget.8978.

    PubMed 27129180

  • Fukuda T, Kamai T, Masuda A, Nukui A, Abe H, Arai K, Yoshida K. Higher preoperative serum levels of PD-L1 and B7-H4 are associated with invasive and metastatic potential and predictable for poor response to VEGF-targeted therapy and unfavorable prognosis of renal cell carcinoma. Cancer Med. 2016 Aug;5(8):1810-20. doi: 10.1002/cam4.754. Epub 2016 Jun 12.

    PubMed 27292320

  • Chen Y, Ramjiawan RR, Reiberger T, Ng MR, Hato T, Huang Y, Ochiai H, Kitahara S, Unan EC, Reddy TP, Fan C, Huang P, Bardeesy N, Zhu AX, Jain RK, Duda DG. CXCR4 inhibition in tumor microenvironment facilitates anti-programmed death receptor-1 immunotherapy in sorafenib-treated hepatocellular carcinoma in mice. Hepatology. 2015 May;61(5):1591-602. doi: 10.1002/hep.27665. Epub 2015 Mar 20.

    PubMed 25529917

  • Choueiri TK, Figueroa DJ, Fay AP, Signoretti S, Liu Y, Gagnon R, Deen K, Carpenter C, Benson P, Ho TH, Pandite L, de Souza P, Powles T, Motzer RJ. Correlation of PD-L1 tumor expression and treatment outcomes in patients with renal cell carcinoma receiving sunitinib or pazopanib: results from COMPARZ, a randomized controlled trial. Clin Cancer Res. 2015 Mar 1;21(5):1071-7. doi: 10.1158/1078-0432.CCR-14-1993. Epub 2014 Dec 23.

    PubMed 25538263

  • Hughes PE, Caenepeel S, Wu LC. Targeted Therapy and Checkpoint Immunotherapy Combinations for the Treatment of Cancer. Trends Immunol. 2016 Jul;37(7):462-476. doi: 10.1016/j.it.2016.04.010. Epub 2016 May 20.

    PubMed 27216414

  • Voron T, Colussi O, Marcheteau E, Pernot S, Nizard M, Pointet AL, Latreche S, Bergaya S, Benhamouda N, Tanchot C, Stockmann C, Combe P, Berger A, Zinzindohoue F, Yagita H, Tartour E, Taieb J, Terme M. VEGF-A modulates expression of inhibitory checkpoints on CD8+ T cells in tumors. J Exp Med. 2015 Feb 9;212(2):139-48. doi: 10.1084/jem.20140559. Epub 2015 Jan 19.

    PubMed 25601652

  • Hato T, Zhu AX, Duda DG. Rationally combining anti-VEGF therapy with checkpoint inhibitors in hepatocellular carcinoma. Immunotherapy. 2016;8(3):299-313. doi: 10.2217/imt.15.126. Epub 2016 Feb 11.

    PubMed 26865127

  • Abdel-Wahab N, Shah M, Suarez-Almazor ME. Adverse Events Associated with Immune Checkpoint Blockade in Patients with Cancer: A Systematic Review of Case Reports. PLoS One. 2016 Jul 29;11(7):e0160221. doi: 10.1371/journal.pone.0160221. eCollection 2016.

    PubMed 27472273

  • Boutros C, Tarhini A, Routier E, Lambotte O, Ladurie FL, Carbonnel F, Izzeddine H, Marabelle A, Champiat S, Berdelou A, Lanoy E, Texier M, Libenciuc C, Eggermont AM, Soria JC, Mateus C, Robert C. Safety profiles of anti-CTLA-4 and anti-PD-1 antibodies alone and in combination. Nat Rev Clin Oncol. 2016 Aug;13(8):473-86. doi: 10.1038/nrclinonc.2016.58. Epub 2016 May 4.

    PubMed 27141885

  • Wu C, Zhu Y, Jiang J, Zhao J, Zhang XG, Xu N. Immunohistochemical localization of programmed death-1 ligand-1 (PD-L1) in gastric carcinoma and its clinical significance. Acta Histochem. 2006;108(1):19-24. doi: 10.1016/j.acthis.2006.01.003. Epub 2006 Mar 13.

    PubMed 16530813

  • Gao Q, Wang XY, Qiu SJ, Yamato I, Sho M, Nakajima Y, Zhou J, Li BZ, Shi YH, Xiao YS, Xu Y, Fan J. Overexpression of PD-L1 significantly associates with tumor aggressiveness and postoperative recurrence in human hepatocellular carcinoma. Clin Cancer Res. 2009 Feb 1;15(3):971-9. doi: 10.1158/1078-0432.CCR-08-1608.

    PubMed 19188168

  • Mu CY, Huang JA, Chen Y, Chen C, Zhang XG. High expression of PD-L1 in lung cancer may contribute to poor prognosis and tumor cells immune escape through suppressing tumor infiltrating dendritic cells maturation. Med Oncol. 2011 Sep;28(3):682-8. doi: 10.1007/s12032-010-9515-2. Epub 2010 Apr 6.

    PubMed 20373055

  • Robert C, Ribas A, Wolchok JD, Hodi FS, Hamid O, Kefford R, Weber JS, Joshua AM, Hwu WJ, Gangadhar TC, Patnaik A, Dronca R, Zarour H, Joseph RW, Boasberg P, Chmielowski B, Mateus C, Postow MA, Gergich K, Elassaiss-Schaap J, Li XN, Iannone R, Ebbinghaus SW, Kang SP, Daud A. Anti-programmed-death-receptor-1 treatment with pembrolizumab in ipilimumab-refractory advanced melanoma: a randomised dose-comparison cohort of a phase 1 trial. Lancet. 2014 Sep 20;384(9948):1109-17. doi: 10.1016/S0140-6736(14)60958-2. Epub 2014 Jul 15.

    PubMed 25034862

  • Davies M. New modalities of cancer treatment for NSCLC: focus on immunotherapy. Cancer Manag Res. 2014 Feb 3;6:63-75. doi: 10.2147/CMAR.S57550. eCollection 2014.

    PubMed 24520205

  • Hamid O, Carvajal RD. Anti-programmed death-1 and anti-programmed death-ligand 1 antibodies in cancer therapy. Expert Opin Biol Ther. 2013 Jun;13(6):847-61. doi: 10.1517/14712598.2013.770836. Epub 2013 Feb 19.

    PubMed 23421934

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Toripalimab in people with High-risk Renal Cell Carcinoma, run by Tianjin Medical University Second Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-Free Survival (DFS) as Assessed by Investigator (time frame: From enrollment until the first documented disease recurrence, distant metastasis, or death from any cause (whichever occurs first), assessed up to 60 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06584435, which also lists 29 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.

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