Not Yet RecruitingPhase 1/2

Vorolanib Combined With Cadonilimab in the Treatment of Untreated Advanced RCC Patients

37 participantsStarted 2024-08-31

Plain-language summary

Evaluate the efficacy and safety of vorolanib combined with cadonilimab in the treatment of untreated advanced RCC patients.

Who can participate

Age range18 Years – 75 Years

SexALL

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

✓. Subjects voluntarily participate in this study, willing and able to comply with and sign the informed consent form;
✓. Histologically confirmed clear cell renal cell carcinoma;
✓. Advanced (not suitable for curative surgery or radiation therapy) or metastatic (AJCC Stage IV) RCC;
✓. No prior systemic treatment for RCC, except for the following situations:
✓. Confirmed to have at least one measurable lesion according to RECIST 1.1 criteria;
✓. KPS score ≥ 70;
✓. Expected survival time of more than 3 months;
✓. Aged 18-75 years;

Exclusion criteria

✕. Received any systemic treatment for RCC, unless the investigator can provide evidence that the subject has been randomly assigned to the placebo group;
✕. Central nervous system metastasis;
✕. Active malignant tumor in the past 24 months (except for renal cell carcinoma, skin basal cell carcinoma or squamous cell carcinoma that has been clearly treated, as well as cervical or bladder carcinoma in situ). Participants with a history of localized and low-risk prostate cancer who have received curative treatment and have not had a prostate-specific antigen (PSA) recurrence in the past 5 years may participate in the study;
✕. Received prior radiotherapy within 21 days before the start of study treatment (palliative radiotherapy for bone lesions is allowed, provided it is completed at least 2 weeks before the start of study treatment);
✕. Currently participating in another study or received study drugs within 4 weeks before the start of study treatment.
✕. Receiving live vaccines within 30 days after the planned start of study treatment (first cycle/day 1). Live vaccines include but are not limited to measles, mumps, rubella, varicella/zoster (chickenpox), yellow fever, rabies, BCG, and typhoid vaccines. Injectable seasonal influenza vaccines are generally inactivated virus vaccines and are allowed; however, intranasal influenza vaccines are attenuated live vaccines and are not allowed.
✕. Participants with proteinuria \> 1+ on urine dipstick test will undergo a 24-hour urine collection for quantitative assessment of proteinuria. Participants with urinary protein ≥ 1g/24h will not be eligible.
✕. Fasting total cholesterol \> 300 mg/dL (or 7.75 mmol/L) and/or fasting triglyceride level 2.5 times the upper limit of normal (ULN). Note: These participants can be included after lipid-lowering treatment.

What they're measuring

Objective Response Rate assessed by RECIST 1.1

Timeframe: 12 months

Trial details

NCT IDNCT06577961

SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-08-31

Contact for this trial

xiongjun YE

+86 139 1038 0916 yexiongjun@cicams.ac.cn

View on ClinicalTrials.gov More Kidney Cancer trials