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Non-clear Renal Cell CarcinomaPhase 2IUNU-RCNCT05768464

Postoperative Adjuvant Therapy for Non-clear Renal Cell Carcinoma With High-risk Recurrence Factors

A Phase 2 study testing Toripalimab and Axitinib in people with Non-clear Renal Cell Carcinoma, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The goal of this prospective, multicenter, single-arm clinical study is to evaluate the efficacy and safety of toripalimab in combination with axitinib for postoperative adjuvant therapy for non-clear renal cell carcinoma with high-risk recurrence factors. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Non-clear Renal Cell Carcinoma
What is being tested?
Toripalimab and Axitinib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
2 sitesChina
Study dates
1 Feb 2023to 30 Dec 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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18-75 years old
  • Participants with histologically confirmed non-clear renal cell carcinoma except clear cell RCC, chromophobe RCC and eosinophilic RCC, and must meet any of the following conditions:
  • histologically confirmed Papillary RCC, pT≥T1b and ISUP/WHO ≥3, N (any), M0;
  • Collecting duct carcinoma, SMARCB1-deficient renal medullary carcinoma, fumarate hydratase deficiency renal cell carcinoma (FH-RCC), pT (any), ISUP/WHO (any), N (any), M0.
  • Non-clear renal cell carcinoma except Organizational Credits Type a and b, including but not limited to TFE3/TFEB translocated RCC or unclassified RCC, pT (any), ISUP/WHO ≥ grade 3, N (any), M0;
  • Patients who have completely resected the primary tumor (partial or radical nephrectomy), and M1 NED patients who have completely resected solid, isolated soft tissue metastases.
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  • Patients who have completely removed the renal tumor. The nephrectomy must be performed ≥ 3 weeks but ≤ 12 weeks before randomization. Partial nephrectomy and renal tumor enucleation are permitted;
  • Patients must have no clinical or radiographic evidence of macroscopic residual lesions or distant metastasis (M0) after surgery. M1 participants must have no evidence of disease (M1 NED);
  • ECOG performance status 0-1 ;
  • Patients must have not received systemic therapy for renal tumors;
  • Adequate hematopoiesis and organ function:
  • Hematopoietic function: Absolute neutrophil count (ANC) ≥1.5×109/L; platelets≥ 100×109/L; Hemoglobin≥ 9.0g/dL;
  • Renal function: serum creatinine ≤ 1.5 times ULN, or creatinine clearance > 50 mL/min;
  • Liver function: total bilirubin ≤1.5×ULN or total bilirubin >1.5×ULN but direct bilirubin normal; AST and ALT≤2.5×ULN;
  • Coagulation function: international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5×ULN, and activated partial thromboplastin time (aPTT) ≤1.5×ULN;
  • Left ventricular ejection fraction (LVEF) ≥ 50%;
  • Signed informed consent form;
  • Patients and/or their partner are willing to use highly effective forms of contraception and to continue its use 3 months after the last dose of drugs.
  • Ability and capacity to comply with study and follow-up procedures.

Who cannot join

  • Clear cell RCC, chromophobe RCC and eosinophilic RCC;
  • Previous anti-tumor immunotherapy, including but not limited to cytokines (IL-2, IFN-α, etc.) and antibody drugs (anti-PD-1, PD-L1, or CTLA-4 antibodies, etc.)
  • Previous drug therapy targeting VEGF, VEGFR, or mTOR;
  • Have participated in or are currently participating in an investigational drug trial within 4 weeks; major surgery performed within 4 weeks prior to randomization;
  • Receive traditional Chinese medicines or proprietary Chinese medicine, adrenocortical hormone or other immunosuppressant systemic therapy within 2 weeks before enrollment; People who > 10 mg of prednisone or equivalent inhalers daily but have no active autoimmune disease may participate in this study;
  • Toxicity has not been relieved after previous antineoplastic therapy; Irreversible toxicities (e.g., hearing loss) that are reasonably expected not to be aggravated by the study drug may participate in this study;
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  • Other malignancies that have progressed or require treatment in 5 years (excluding adequately treated basal cell carcinoma of the skin, cutaneous squamous cell carcinoma, superficial bladder cancer, breast, cervix, or prostate carcinoma in situ);
  • History of central nervous system (CNS) metastases or CNS metastases on baseline imaging (MRI or CT) within 30 days prior to the first trial administration;
  • Hypertension that cannot be controlled by medications (blood pressure 150/100 mmHg despite optimal medical therapy)
  • Evidence of following cardiovascular disease within 6 months:
  • Myocardial infarction
  • Unstable angina
  • Cardiac angioplasty or stenting
  • Coronary/peripheral artery bypass grafting
  • Class III or IV congestive heart failure as prescribed by the New York Heart Association
  • Cerebrovascular accident or transient ischemic attack
  • QT interval (QTc) corrected with heart rate ≥500 msec (Bazett's formula)
  • History of active or other severe bleeding within 30 days, and have haemoptysis within 6 weeks prior to randomization;
  • Deep vein thrombosis or pulmonary embolism within 6 months;
  • Clinically significant gastrointestinal (GI) abnormalities, including:
  • malabsorption, total gastrectomy or any condition that may affect the absorption of oral medications;
  • active ulcers treated within the past 6 months;
  • active gastrointestinal bleeding (e.g., hematemesis, hematochezia, or melena) within the past 3 months with no evidence of healing endoscopic or colonoscopy;
  • Metastatic lesions of the gastrointestinal tract suspected of bleeding, inflammatory bowel disease, ulcerative colitis, perforation of the digestive tract or other gastrointestinal diseases that increase the risk of perforation;
  • History of organ transplantation may require long-term adrenocortical hormone therapy;
  • Previous or current presence of (noninfectious) pneumonia/interstitial lung disease requiring adrenocortical hormone therapy
  • Active infection requiring systemic treatment, human immunodeficiency virus (HIV) infection (known HIV antibody positive), active HBV or HCV infection;
  • Have received a live vaccine within 30 days prior to enrollment;
  • History of severe drug allergy;
  • Known history of psychiatric illness or substance abuse;
  • The presence of unhealed wounds;
  • Taken within 7 days prior to enrollment or expected to take concomitant treatment with potent CYP3A4/5 inhibitors and CYP3A4/5 inducers ;
  • Subject has a history or current evidence of any disease, treatment, or laboratory abnormality that may confound the trial results, interfere with the subject's participation in the full trial, or is not in the best interest of the subject to participate in the trial, in the judgment of the investigator.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

shun zhang contact

15050589789

explorershun@126.com

China2 sites, 2 recruiting

  • Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University

    Nanjing, Jiangsu, 210000

    Shun Zhang, 15050589789 ext. 15050589789, explorershun@126.com

    Recruiting

  • Hongqian Guo

    Nanning, Jiangsu

    Hongqian Guo, PhD

    Recruiting

Other trials in China

About this study

Official title: A Prospective, Multicenter, Single-arm Clinical Study of the Efficacy and Safety of Toripalimab in Combination With Axitinib for Postoperative Adjuvant Therapy for Non-clear Renal Cell Carcinoma With High-risk Recurrence Factors

The goal of this prospective, multicenter, single-arm clinical study is to evaluate the efficacy and safety of toripalimab in combination with axitinib for postoperative adjuvant therapy for non-clear renal cell carcinoma with high-risk recurrence factors.

Being tested
Toripalimab, Axitinib
Keywords
toripalimab, axitinib, postoperative adjuvant therapy

What participants receive

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

  • ToripalimabDrug

    Also called anti-PD-1 monoclonal antibody

    240mg intravenously every 3 weeks

  • AxitinibDrug

    Also called TKI

    5mg orraly twice daily

Study groups in NCT05768464
Study groupRoleWhat they receive
study groupExperimentalDrug: Toripalimab 240mg, intravenously every 3 weeks Drug: Axitinib 5 mg orraly twice daily
Receives: Drug: Toripalimab; Drug: Axitinib

What is being measured

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

  1. DFS

    DFS is defined as time interval from the date of randomization to first date of recurrence/relapse (distant or local recurrence of [RCC] or occurrence of a secondary malignancy {occurrence of a second primary cancer other than RCC} or death). For participants with no DFS event, DFS was censored at date of last scan prior to time of analyses. Participants alive who did not have post-baseline disease assessments, DFS was censored at randomization. Participants who received further anti-tumor therapy prior to recurrence or occurrence of a secondary malignancy or death, DFS was censored on date of last scan prior to taking anti-tumor medication. Participants who missed 2 or more consecutive tumor scans immediately followed by an event were censored at date of last objective tumor assessment prior to missing/not readable scan.

    Measured: 2 years

Secondary outcomes (3)

  1. OS

    OS defined as the time from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time was censored at the last date the participant was known to be alive. Participants lacking data beyond randomization had their survival times censored at randomization.

    Measured: 3 years

  2. DRSS

    Localised disease recurrence-specific survival

    Measured: 3 years

  3. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Incidence and grade of AEs and SAEs per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0, incidence of ≥ grade 3 AE

    Measured: 3 years

Timeline

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

  1. First posted14 Mar 2023
  2. Study start1 Feb 2023
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion30 Dec 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
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05768464
Sponsor's protocol ID
IUNU-RC-102
Acronym
IUNU-RC
Status last verified
Dec 2022
First submitted
17 Dec 2022
Last updated
14 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Liu T, Zhang M, Sun D. Immune Cell Infiltration and Identifying Genes of Prognostic Value in the Papillary Renal Cell Carcinoma Microenvironment by Bioinformatics Analysis. Biomed Res Int. 2020 Jul 25;2020:5019746. doi: 10.1155/2020/5019746. eCollection 2020.

    PubMed 32775427

  • Lobo J, Ohashi R, Amin MB, Berney DM, Comperat EM, Cree IA, Gill AJ, Hartmann A, Menon S, Netto GJ, Raspollini MR, Rubin MA, Tan PH, Tickoo SK, Tsuzuki T, Turajlic S, Zhou M, Srigley JR, Moch H. WHO 2022 landscape of papillary and chromophobe renal cell carcinoma. Histopathology. 2022 Oct;81(4):426-438. doi: 10.1111/his.14700. Epub 2022 Jun 10.

    PubMed 35596618

  • Steffens S, Janssen M, Roos FC, Becker F, Schumacher S, Seidel C, Wegener G, Thuroff JW, Hofmann R, Stockle M, Siemer S, Schrader M, Hartmann A, Kuczyk MA, Junker K, Schrader AJ. Incidence and long-term prognosis of papillary compared to clear cell renal cell carcinoma--a multicentre study. Eur J Cancer. 2012 Oct;48(15):2347-52. doi: 10.1016/j.ejca.2012.05.002. Epub 2012 Jun 13.

    PubMed 22698386

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Toripalimab and Axitinib in people with Non-clear Renal Cell Carcinoma, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 2 sites in China.

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

Who may be eligible to take part?

The sponsor lists 19 inclusion and 33 exclusion criteria. 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: looking for participants now, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Contact shun zhang (15050589789, explorershun@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DFS (time frame: 2 years). 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 NCT05768464, which also lists 3 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 14 Mar 2023.

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