Combining targeted therapy and immunotherapy with radiation for advanced kidney cancer

Cohort Study of SABR Combined With Targeted Therapy and Anti-PD-1 Versus Targeted Therapy and Anti-PD-1 for Recurrent or Metastatic Renal Cell Carcinoma Patients

This study is testing if combining targeted therapy and immunotherapy with a specific type of radiation can help people with advanced kidney cancer live longer without their disease getting worse.

Quick facts

• Study type: Observational
• Enrollment: 300 (estimated)
• Ages: 18 Years to 85 Years
• Sex: Male
• Sponsor: Peking University First Hospital (Academic / other)
• Drugs / interventions: immunotherapy, radiation
• Locations: 2 sites (Beijing, Beijing Municipality and 1 other locations)
• Trial ID: NCT06583070 on ClinicalTrials.gov

What this trial studies

This observational study focuses on patients with recurrent or metastatic renal cancer, aiming to enhance local control of tumors through the combination of Stereotactic Ablative Radiotherapy (SABR) and systemic treatments like targeted therapy and anti-PD-1 immunotherapy. The study evaluates patients who have at least one lesion suitable for radiation therapy and are undergoing or planning to receive systemic therapy. By leveraging SABR's ability to precisely ablate tumors and potentially activate the immune response, the study seeks to improve progression-free survival rates beyond two years. The research is conducted at Peking University First Hospital and Peking University Third Hospital in Beijing.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed recurrent or metastatic renal cancer and at least one measurable lesion suitable for radiation therapy.

Not a fit: Patients with extensive metastases or central nervous system involvement may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve survival rates for patients with advanced renal cancer.

How similar studies have performed: Preliminary research has shown promising results with similar approaches, indicating potential for success.

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.

Where this trial is running

Beijing, Beijing Municipality and 1 other locations

• Peking University First Hospital — Beijing, Beijing Municipality, China (Recruiting)
• Peking University Third Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Mingwei Ma, M.D.

Conditions Radiation Therapy; Metastatic Renal Cancer; Recurrent Renal Cell Cancer; SBRT