Phase Ib/II Clinical Study of SHR-8068 Combined Anti-tumor Drugs in the Treatment of Advanced Ren… (NCT07239596) | Clinical Trial Compass
RecruitingPhase 1/2
Phase Ib/II Clinical Study of SHR-8068 Combined Anti-tumor Drugs in the Treatment of Advanced Renal Cell Carcinom
China92 participantsStarted 2026-01-06
Plain-language summary
This study evaluated the safety and efficacy of SHR-8068 in combination anti-tumor drugs in the treatment of advanced renal cell carcinoma
Who can participate
Age range
18 Years – 75 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
. Age 18 to 75 years old (including boundary values)
. Volunteer to participate in this clinical study and sign informed consent;
. ECOG score 0-1;
. Expected survival ≥3 months;
. Patients with locally advanced unresectable or metastatic clear cell renal cell carcinoma confirmed by histology or cytology;
. Tumor tissue samples must be provided for testing
. There is at least one measurable or evaluable lesion that meets the RECIST 1.1 criteria;
. Adequate bone marrow and organ function.
Exclusion criteria
. Have previously used or are currently using HIF inhibitors.
. Had received chemotherapy, immunotherapy, targeted therapy, anti-tumor traditional Chinese medicine or other clinical research drugs within 4 weeks prior to the first administration of the study; Palliative radiotherapy was received within 2 weeks before the first administration.
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.
What they're measuring
1
Dose-limiting toxicity (DLT)
Timeframe: 21days after the first administration of each subject
2
Overall response rate(ORR)
Timeframe: from first dose to disease progression or death, whichever comes first, up to 3 years
. Live attenuated vaccines are used within a certain period of time before the first medication as stipulated in the plan, or it is expected that such vaccines will be needed during the treatment period.
. Undergoing major surgical treatment within a certain period of time after the first administration of medication (excluding diagnosis) or expecting major surgical treatment during the study period.
. There are severe gastrointestinal function abnormalities in clinical practice, which may affect the intake, transportation or absorption of drugs.
. Suffering from other active malignant tumors within 3 years or at the same time.
. Patients who have received organ transplants in the past (excluding corneal transplants).
. A clinically significant thrombotic or embolic event occurred within 6 months prior to the first administration of the drug.