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

NCT05768464 | Recruiting Phase 2

• 1 other identifier: IUNU-RC-102
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Non-clear Renal Cell Carcinoma

Keywords

toripalimab; axitinib; postoperative adjuvant therapy

Outcome Measures

Primary Outcomes (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.

  2 years

Secondary Outcomes (3)

• OS

  3 years

• DRSS

  3 years

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

  3 years

Study Arms (1)

study group

EXPERIMENTAL

Drug: Toripalimab 240mg, intravenously every 3 weeks Drug: Axitinib 5 mg orraly twice daily

Drug: Toripalimab; Drug: Axitinib

Interventions

Toripalimab DRUG

240mg intravenously every 3 weeks

Also known as: anti-PD-1 monoclonal antibody

study group

Axitinib DRUG

5mg orraly twice daily

Also known as: TKI

study group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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;

You may not qualify if:

• 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;
• 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

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Study Sites (2)

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

Nanjing, Jiangsu, 210000, China

RECRUITING

Hongqian Guo

Nanning, Jiangsu, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 32775427 BACKGROUND

• 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.

  PMID: 35596618 BACKGROUND

• 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.

  PMID: 22698386 BACKGROUND

MeSH Terms

Interventions

toripalimab; spartalizumab; Axitinib

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• hongqian guo

  The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

shun zhang

CONTACT

15050589789; explorershun@126.com

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: December 17, 2022
• First Posted: March 14, 2023
• Study Start: February 1, 2023
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: March 14, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)