NCT06690697

Combination of Toripalimab and JS004 Therapy for ccRCC

A Single Center, Prospective, Randomized Controlled, Second-Line Clinical Study on the Combination of Toripalimab and JS004 in the Treatment for Recurrent and Metastatic Clear Cell Renal Cell Carcinoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a single center, prospective, randomized controlled phase II clinical trial aimed at examining the efficacy and safety of the combination of toripalimab and JS004 versus standard therapy for second-line treatment of recurrent and metastatic clear cell renal cell carcinoma patients. The study population consists of recurrent and metastatic renal cell carcinoma patients who have undergone radical operation and have been histologically confirmed as clear cell subtype. The subjects will receive JS004 combined with toripalimab or standard second-line treatment. The main endpoint of this study is the Overall Response Rate (ORR). In addition, we will explore the ORR, Disease Control Rate (DCR), Progression-Free Survival (PFS), and Overall Survival (OS) of different subgroups of tertiary lymphoid structures (TLSs) presence, location, density, quantity, and maturity in primary tumors. This study is a randomized controlled trial, with a total of 80 participants planned to be included, with regular follow-up for monitoring disease progression and treatment safety. The study will be conducted at Fudan University Cancer Hospital.

Conditions

• Clear Cell Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	JS004	200 mg, ivdrip, D1, Q3W, each 21 days as a treatment cycle
DRUG	Toripalimab	240 mg, ivdrip, D1, Q3W, each 21 days as a treatment cycle
DRUG	Axitinib	5 mg, po, bid, each 21 days as a treatment cycle
DRUG	Sorafenib	0.4 g, po, bid, each 21 days as a treatment cycle

Timeline

• Start date: 2024-06-01
• Primary completion: 2026-06-30
• Completion: 2026-12-31
• First posted: 2024-11-15
• Last updated: 2024-11-15

Locations

1 site across 1 country: China