Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Renal Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Axitinib

Sunitinib

Angiogenesis Inhibitors

Growth Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

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

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.

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

Biological : Toripalimab Drug: Axitinib

sunitinib

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.

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

A Phase III, Randomized, Open-label, Active Controlled, Multicenter Study on Toripalimab Combined With Axitinib Versus Sunitinib Monotheraphy as a First-Line Treatment for Unresectable or Metastatic Renal Cell Carcinoma (RCC)

Correlation between biomarker (PD-L1) and the efficacy of Toripalimab

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.

The treatment effect of with Toripalimab plus axitinib vesus sunitinib monotherapy, will be assessed using RECIST 1.1 to determine tumor response;

The treatment effect of with Toripalimab plus axitinib vesus sunitinib monotherapy, will be assessed using IRC and RECIST 1.1 to determine tumor response;

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study to Evaluate the Efficacy and Safety of Toripalimab in Combination With Axitinib Versus Sunitinib Monotherapy in Advanced Renal Cell Cancer	NCT04394975	Primary Disease...	Biological : To... sunitinib	18 Years - 80 Years	Shanghai Junshi Bioscience Co., Ltd.
Study to Evaluate the Efficacy and Safety of Toripalimab in Combination With Axitinib Versus Sunitinib Monotherapy in Advanced Renal Cell Cancer	NCT04394975	Primary Disease...	Biological : To... sunitinib	18 Years - 80 Years	Shanghai Junshi Bioscience Co., Ltd.

Spots Global Cancer Trial Database for biological : toripalimab drug: axitinib