Actively Recruiting
Combination of Toripalimab and JS004 Therapy for ccRCC
Led by Fudan University · Updated on 2024-11-15
80
Participants Needed
1
Research Sites
134 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Combination of Toripalimab and JS004 Therapy for ccRCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient voluntarily agrees to participate and signs informed consent with good compliance
- Age 18 years or older
- Diagnosed with local recurrence or metastatic clear cell renal cell carcinoma confirmed by histology after surgery
- Previous systemic therapy received with disease progression or intolerance, or progression within 6 months after adjuvant/neoadjuvant therapy
- Able to provide postoperative tissue samples including cancer and adjacent normal kidney tissue for research
- At least one measurable lesion according to RECIST 1.1 criteria
- ECOG performance status score of 0 or 1
- Adequate major organ function and laboratory test results meeting specified thresholds for blood counts, liver enzymes, bilirubin, creatinine, coagulation, and thyroid function
- Women of childbearing potential must confirm non-pregnancy and all participants agree to use contraception during treatment and for 4 weeks after
- Willing and able to comply with study follow-up requirements
You will not qualify if you...
- Known allergies to study drugs or their components
- Received other systemic anti-tumor treatments or local anti-tumor treatments within 4 weeks before study drug
- Prior treatment with anti-BTLA or anti-HVEM antibodies
- Contraindications to standard second-line treatments including trastuzumab or JS004
- History of other cancers except cured cervical, basal, or squamous skin cancer
- Active or severe autoimmune disease needing systemic treatment within past 3 months
- Known HIV infection
- Pregnant, breastfeeding, or planning pregnancy during study
- Bleeding disorders or use of anticoagulants like warfarin or heparin
- History or evidence of interstitial lung disease or active pneumonia within 4 weeks before treatment
- Serious medical or mental conditions that pose safety risks or interfere with study participation
- Any other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
D
Dingwei Ye, MD
CONTACT
W
Wenhao Xu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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