Study to Evaluate the Efficacy and Safety of Toripalimab in Combination With Axitinib Versus Sunitinib Monotherapy in Advanced Renal Cell Cancer

NCT04394975 | Completed Phase 3

• 1 other identifier: JS001-036-Ⅲ-RCC
• Study Type: interventional
• Target: 421
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, open-label, controlled, multicenter, phase III trial to compare the efficacy and safety of Toripalimab in combination with axitinib to sunitinib monotherapy as a first-line therapy for advanced RCC. Eligible patients will be randomized 1:1 to receive the combination therapy of Toripalimab and axitinib or sunitinib monotherapy.

Conditions

Primary Disease: Unresectable or Metastatic Renal Cell Carcinoma Focus of the Study:PFS Assessed by IRC Per RECIST 1.1

Outcome Measures

Primary Outcomes (1)

• PFS assessed by IRC per RECIST 1.1.

  To compare the progression-free survival (PFS) per response evaluation criteria in solid tumors (RECIST) 1.1 as assessed by independent review committee (IRC) in subjects treated with Toripalimab plus axitinib vesus sunitinib monotherapy as a first-line treatment for advanced RCC.

  3 years

Secondary Outcomes (8)

• PFS assessed by investigators per RECIST 1.1;

  3 years

• ORR assessed by investigators and IRC per RECIST 1.1, respectively;

  3 years

• DOR, assessed by investigators and IRC per RECIST 1.1, respectively;

  3 years

• DCR assessed by investigators and IRC per RECIST 1.1, respectively;

  3 years

• overall survival rate assessed by investigators and IRC per RECIST 1.1, respectively;

  3 years

Other Outcomes (1)

• Biomarker

  2 years

Study Arms (2)

Test group

EXPERIMENTAL

Toripalimab+axitinib combination therapy. Participants receive Toripalimab 240mg intravenously every 3 weeks plus axitinib 5mg orraly twice daily.

Combination Product: Biological : Toripalimab Drug: Axitinib

Control group

ACTIVE COMPARATOR

Sunitinib monotherapy. Participants receive sunitinib 50mg orally once daily for 4 weeks and then are off treatent for 2 weeks, or once daily for 2weeks and then are off treatent for 1 week.

Drug: sunitinib

Interventions

Biological : Toripalimab Drug: Axitinib COMBINATION_PRODUCT

Biological: Toripalimab, Intravenous infusion Drug: Axitinib, oral tablet

Test group

sunitinib DRUG

Drug: Sunitinib, oral capsule

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fully understand and be willing to provide written informed consent.
• Male or female with age ≥ 18 years and \<80 years.
• Have received no prior systemic therapy after previous metastasis for RCC, histologically confirmed diagnosis of unresectable, recurrent or metastatic RCC with clear cell component with or without sarcomatoid features,Prior cytokine therapy was allowed.
• The IDMC score was medium to high risk.
• Having at least one measurable disease per RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if re-progression has been demonstrated.
• Provide archival tumor tissues or newly obtained biopsies if patients participate in the exploratory study.
• ECOG PS 0 or 1.
• Adequate function of vital organs:
• Bone marrow function (without blood or blood products transfusion, without hematopoietic stimulating factor or other medication to improve blood cell count within 2 days prior to first dose of study drug):
• Absolute neutrophil count (ANC) ≥ 1.5×109/L. Platelets ≥ 100×109/L. Hemoglobin ≥ 9.0g/dL or ≥ 5.6mmol/L.
• Renal function:
• Serum creatinine ≤ 1.5×ULN
• Hepatic function:
• Serum total bilirubin ≤1.5×ULN or total bilirubin levels \>1.5×ULN with direct bilirubin ≤ ULN. AST and ALT ≤2.5 × ULN, ≤5×ULN in those with hepatic metastasis.
• Endocrine function:

You may not qualify if:

• PriorAnti-PD-1, PD-L1 or CTLA-4 agents ).
• Prior systemic anti-cancer therapy after metastasis (e.g., VEGF/VEGFR or mTOR targeting agents, including (but not limited to) sunitinib, axitinib, sorafenib, pazopanib, cabozantinib, lenvatinib, bevacizumab or everolimus.
• Progression or recurrence during neoadjuvant/adjuvant therapy for renal cell cancer or within 12 months after the last dose treatment.
• Has participated or is currently participating in a trial of investigational agent within 4 weeks prior to the first dose of study treatment, unless observational (non-interventional) clinical study or follow-up period of interventional study.
• Had major surgery (judged by investigators) within 4 weeks prior to the first dose of study treatment or has not recovered from prior surgery.
• Has traditional Chinese medicine or Chinese patent medicine preparation with anti-cancer indication within 2 weeks prior to the first dose of study treatment.
• Requiring corticosteroids (Prednisone \>10 mg/day or equivalent analogue) or other immunosuppressive agents within 2 weeks prior to the first dose of study treatment. Patients without active autoimmune disease using inhaled prednisone \>10 mg/day will not be excluded from the study.
• Has a history of organ transplantation or required long-term treatment with corticosteroids.
• Hypothyroidism, hypoadrenalism or hypopituitarism that can be controlled only with hormone replacement therapy, type I diabetes, psoriasis or leucoderma not requiring systematic treatment.
• Has an additional malignancy that has progressed or required treatment within 5 years prior to randomization (basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ such as breast cancer, prostate cancer are acceptable if they have undergone potentially curative therapy；Remarks: Localized low-risk prostate cancer \[ patietns with stage ≤ T2a, Gleason score ≤ 6 and PSA \< 10ng/mL at the time of diagnosis (as measured) can be included in this study if the subject has received radical therapy and has no evidence for biochemical recurrence(PROSTATE specific antigen,PSA)\].
• Poorly controlled hypertension (systolic blood pressure ≥ 150mmHg and/or diastolic blood pressure ≥ 90mmHg).
• Presence of the following cardiovascular events within 6 months prior to randomization:
• Myocardial infarction
• Unstable angina pectoris
• Cardiac angioplasty or stent

Sponsors & Collaborators

• Shanghai Junshi Bioscience Co., Ltd.: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, China

Location

Related Publications (1)

• Yan XQ, Ye MJ, Zou Q, Chen P, He ZS, Wu B, He DL, He CH, Xue XY, Ji ZG, Chen H, Zhang S, Liu YP, Zhang XD, Fu C, Xu DF, Qiu MX, Lv JJ, Huang J, Ren XB, Cheng Y, Qin WJ, Zhang X, Zhou FJ, Ma LL, Guo JM, Ding DG, Wei SZ, He Y, Guo HQ, Shi BK, Liu L, Liu F, Hu ZQ, Jin XM, Yang L, Zhu SX, Liu JH, Huang YH, Xu T, Liu B, Sun T, Wang ZJ, Jiang HW, Yu DX, Zhou AP, Jiang J, Luan GD, Jin CL, Xu J, Hu JX, Huang YR, Guo J, Zhai W, Sheng XN. Toripalimab plus axitinib versus sunitinib as first-line treatment for advanced renal cell carcinoma: RENOTORCH, a randomized, open-label, phase III study. Ann Oncol. 2024 Feb;35(2):190-199. doi: 10.1016/j.annonc.2023.09.3108. Epub 2023 Oct 21.

  PMID: 37872020 DERIVED

MeSH Terms

Interventions

Sunitinib

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2020
• First Posted: May 20, 2020
• Study Start: August 20, 2020
• Primary Completion: April 2, 2024
• Study Completion: April 2, 2024
• Last Updated: November 28, 2025

Record last verified: 2025-11

Locations

CN (1)