Observational Study on the Abscopal Efect by Ultra-hypofractionated Radiation Therapyin Combination With Immune Checkpoint Inhibiters for Metastatic Renal Cell Carcinoma
Condition: Renal Cell Cancer Metastatic
Study Type: Observational [Patient Registry]
Clinical Trials Identifier NCT 8-digits: NCT07240610
Sponsor: Zhe Chen
Phase:
Eligibility:
- Age: minimum 18 Years maximum N/A
- Gender: All
Inclusion Criteria:
- Patients aged 18 years and above with metastatic renal cell carcinoma
- Patients currently receiving immune checkpoint inhibitor (ICI) therapy who are assessed as having iCPD or iSD according to iRECIST
- Presence of two or more clinically measurable lesions (assessed by CT, MRI, physical examination, or visual inspection) Note: Osteosclerotic lesions without measurable soft-tissue components are excluded
- Planned to undergo IGU to the target lesion
- Provided written informed consent after receiving sufficient explanation of this study Note: Proxy signature is permitted if the patient is physically unable to sign
Exclusion Criteria:
- 1. Patients with active double cancers (synchronous double cancers or metachronous double cancers with a disease-free interval within 2 years). However, carcinoma in situ or intramucosal carcinoma considered cured by treatment, and the following tumors even if within 2 years of disease-free interval are not excluded: gastric cancer stage 0-II (UICC), prostate cancer stage I-III, colorectal cancer stage 0-II, esophageal cancer stage 0-I, breast cancer stage 0-II, endometrial cancer stage I-II, cervical cancer stage 0-II, and thyroid cancer stage I-III. In addition, any cancer with a disease-free interval greater than 2 years is not excluded regardless of stage. 2. Patients with serious comorbidities, such as:
- severe cardiac disease
- uncontrolled diabetes mellitus despite continuous insulin therapy
- myocardial infarction within 6 months
- uncontrolled hypertension
- active infections (bacterial, viral, or fungal)
- diarrhea (watery stool), paralytic ileus, or bowel obstruction
- autoimmune disease
- any other severe comorbid condition 3. Patients with clear evidence of idiopathic interstitial pneumonia (usual interstitial pneumonia pattern) on chest X-ray or CT 4. Patients with acute-phase pneumonia 5. Patients with psychiatric disorders or psychiatric symptoms judged to make study participation difficult
View trial on ClinicalTrials.gov