SABR Combined with Targeted Therapy and Anti-PD-1 for Recurrent or Metastatic Renal Cancer

Launched by PEKING UNIVERSITY FIRST HOSPITAL · Sep 1, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with recurrent or metastatic renal cancer, which is a type of kidney cancer that has returned or spread. The researchers are exploring the combination of a precise form of radiation therapy called Stereotactic Ablative Radiotherapy (SABR) with targeted therapy and immunotherapy (a type of treatment that helps your body's immune system fight cancer). The goal is to see if this combination can improve survival rates and control the cancer better than current treatments.

To participate in this trial, patients need to be at least 18 years old, have confirmed kidney cancer that has returned or spread, and have at least one tumor that can be treated with radiation. They should also be undergoing or planning to undergo treatment with targeted therapy and immunotherapy. Participants will receive regular check-ups and care throughout the study to monitor their health and the effectiveness of the treatment. This trial is currently open for enrollment, and those who join will be contributing to important research that may lead to better options for kidney cancer patients in the future.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Patients with histologically confirmed renal cancer; diagnosed with recurrent or metastatic renal cancer via PET/CT or other whole-body imaging.
• • Evaluated by the radiation oncology and imaging departments as having at least one lesion amenable to radiation therapy.
• • Planning to undergo or currently receiving first-line or second-line targeted therapy combined with immunotherapy.
• • Voluntarily agrees to participate in the study and signs an informed consent form.
• • Male or female, aged ≥18 years (inclusive).
• • Expected survival of ≥12 weeks.
• • At least one measurable lesion as per the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
• • European Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• • Adequate cardiac, bone marrow, liver, and renal function.
• • Willing and able to comply with the study procedures and follow-up schedule.
• Exclusion Criteria:
• • Extensive, multiple metastases;
• • Presence of central nervous system metastases and/or carcinomatous meningitis.
• • Toxicity from previous treatments not yet recovered to grade 0-1 (excluding grade 2 alopecia);
• • Other severe, uncontrollable co-morbid conditions that could affect protocol compliance or confound interpretation of results, including active opportunistic or severe progressive infections, uncontrolled diabetes, uncontrolled hypertension, cardiovascular diseases (defined as New York Heart Association Class III or IV heart failure, second-degree or higher heart block, myocardial infarction within the last 12 months, unstable arrhythmias or angina, stroke within the last 6 months), or pulmonary diseases (interstitial pneumonia, obstructive pulmonary disease, and symptomatic bronchospasm history), deep vein thrombosis or pulmonary embolism within the last 6 months;
• * Diagnosed with other malignancies within 5 years prior to enrollment, except:
• • Localized low-risk prostate cancer (defined as stage ≤T2b, Gleason score ≤7, and PSA ≤20ng/mL at diagnosis, who have undergone curative treatment with no recurrence of prostate-specific antigen);
• • Malignancies treated with a curative intent that are considered cured, including but not limited to adequately treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer, or ductal carcinoma in situ of the breast treated with surgery;
• • Pregnant or breastfeeding women;
• • Positive HIV test result;
• • Active hepatitis B or C infection;
• • Active tuberculosis;
• • Any other conditions, metabolic abnormalities, physical examination or laboratory findings that in the investigator's judgment might indicate an unsuitability for the study drug, could interfere with the interpretation of study results, or place the patient at high risk if they participate in the study;
• • Estimated insufficient compliance with the clinical study.