Combination of Toripalimab and JS004 Therapy for ccRCC (NCT06690697) | Clinical Trial Compass
RecruitingPhase 2
Combination of Toripalimab and JS004 Therapy for ccRCC
China80 participantsStarted 2024-06-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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 previous adjuvant or neoadjuvant therapy;
. 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 20 slices of previous surgical specimens should be provided for HE/IHC/spatial omics testing; The criteria for detecting TLS positivity are: detecting at least one CD3+/CD20+lymphocyte aggregate containing\>700 cells in the tumor;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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:
Exclusion criteria
. 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 clinical investigational drug or device treatment;
. Patients who have previously received treatment with anti BTLA or anti HVEM antibodies;
. Subjects with standard second-line treatment and/or contraindications to the use of trastuzumab or JS004;
. Subjects 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;