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New treatment option for Clear Cell Renal Cell Carcinoma
Official title Combination of Toripalimab and JS004 Therapy for ccRCC
ClinicalTrials.gov ID: NCT06690697
What this study is testing
What is JS004?
JS004 is an investigational medicine, being studied as a potential treatment for clear cell renal cell carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- The patient voluntarily participated in this study, signed an informed consent form, and showed good compliance;
- Age ≥ 18 years old;
- Local recurrence or metastatic renal cell carcinoma that has undergone curative surgical resection and has been histologically confirmed;
- Previous treatment history of the subject: patients who have received one type of systemic therapy in the past and have progressed or become...
- Patients are required to provide postoperative tissue wax blocks for research and testing purposes, which should include both renal cancer tissue and...
You likely can't join if
- Patients with any of the following conditions are not eligible for inclusion in this study:
- Known to have allergic reactions to the therapeutic drugs and/or any excipients used in this study;
- Four weeks before the first study medication, receive systemic treatment with other anti-tumor drugs (if it has a half-life of five, it can be...
- Patients who have previously received treatment with anti BTLA or anti HVEM antibodies;
- people with standard second-line treatment and/or contraindications to the use of trastuzumab or JS004;
- people with previous or concurrent malignant tumors (excluding cured cervical cancer, basal or squamous skin cancer);
See the full eligibility criteria
- The patient voluntarily participated in this study, signed an informed consent form, and showed good compliance;
- Age ≥ 18 years old;
- Local recurrence or metastatic renal cell carcinoma that has undergone curative surgical resection and has been histologically confirmed;
- Previous treatment history of the subject: patients who have received one type of systemic therapy in the past and have progressed or become intolerant, as well as patients who have progressed within 6 months after...
- Patients are required to provide postoperative tissue wax blocks for research and testing purposes, which should include both renal cancer tissue and normal kidney tissue adjacent to the cancer. Alternatively, at least...
- Have at least one measurable lesion (RECIST 1.1);
- ECOG score 0-1;
- The main organ functions well, and the laboratory examination indicators meet the following criteria: (1) Blood routine examination:
- Hemoglobin (HB) ≥ 80g/L; ② Absolute neutrophil count (ANC) ≥ 1.5 × 109/L; Total white blood cell count ≥ 3.5 × 109/L; ③ Platelet count (PLT) ≥ 80 × 109/L; (2) Blood biochemistry test:
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (≤ 5 × ULN for liver/bone metastases; ≤ 5 ULN for tumor bone metastases);
- Serum total bilirubin (TBIL) ≤ 1.5 × ULN; ③ Serum creatinine Cr ≤ 1.5 × ULN or creatinine clearance rate ≥ 60 ml/min; (3) Coagulation function test: Activated partial thromboplastin time (APTT), international normalized...
- Patients with any of the following conditions are not eligible for inclusion in this study:
- Known to have allergic reactions to the therapeutic drugs and/or any excipients used in this study;
- Four weeks before the first study medication, receive systemic treatment with other anti-tumor drugs (if it has a half-life of five, it can be included in the group), or receive local anti-tumor treatment, or receive...
- Patients who have previously received treatment with anti BTLA or anti HVEM antibodies;
- people with standard second-line treatment and/or contraindications to the use of trastuzumab or JS004;
- people with previous or concurrent malignant tumors (excluding cured cervical cancer, basal or squamous skin cancer);
- Active autoimmune diseases that require systemic treatment within the past 3 months, or clinically severe autoimmune disease records, or syndromes that require systemic steroids or immunosuppressants;
- Known history of human immunodeficiency virus infection (HIV1/2 antibody positive);
- Female participants who are pregnant, breastfeeding, or planning to become pregnant during the study period;
- Patients with bleeding tendencies (such as active gastrointestinal ulcers) or treated with anticoagulants or vitamin K antagonists such as warfarin, heparin, or their analogues;
- History of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis, symptomatic interstitial lung disease, or any evidence of active pneumonia detected on chest CT scan within 4 weeks...
- According to the researcher's judgment, there are accompanying diseases that pose a serious threat to patient safety or affect the completion of the study.
- There are other serious physical or mental illnesses or laboratory abnormalities that may increase the risk of participating in the study, or interfere with the study results, as well as patients who the researcher...
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.