OncoMatch/Clinical Trials/NCT06690697
Combination of Toripalimab and JS004 Therapy for ccRCC
Is NCT06690697 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including JS004 and Toripalimab for clear cell renal cell carcinoma.
Treatment: JS004 · Toripalimab · Axitinib · Sorafenib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Renal Cell Carcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic therapy
patients who have received one type of systemic therapy in the past and have progressed or become intolerant
Must have received: adjuvant or neoadjuvant therapy — adjuvant or neoadjuvant
patients who have progressed within 6 months after previous adjuvant or neoadjuvant therapy
Cannot have received: anti BTLA antibody
Patients who have previously received treatment with anti BTLA or anti HVEM antibodies
Cannot have received: anti HVEM antibody
Patients who have previously received treatment with anti BTLA or anti HVEM antibodies
Lab requirements
Blood counts
Hemoglobin (HB) ≥ 80g/L; ANC ≥ 1.5 × 10^9/L; WBC ≥ 3.5 × 10^9/L; Platelet count (PLT) ≥ 80 × 10^9/L
Kidney function
Serum creatinine Cr ≤ 1.5 × ULN or creatinine clearance rate ≥ 60 ml/min
Liver function
ALT and AST ≤ 2.5 × ULN (≤ 5 × ULN for liver/bone metastases); Serum total bilirubin (TBIL) ≤ 1.5 × ULN
The main organ functions well, and the laboratory examination indicators meet the following criteria: ... (see above for details)
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