Safety and Tolerability of LDRT Plus Concurrent Partial SBRT and Tislelizumab in Patients With Bulky Tumors
- Conditions
- Solid Tumor
- Registration Number
- NCT06349837
- Lead Sponsor
- Sichuan University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 9
Inclusion Criteria:<br><br> 1. Be willing and able to provide written informed consent/assent for the trial.<br><br> 2. Be =18 years of age on day of signing informed consent.<br><br> 3. Patients with histologically or cytologically confirmed stage IV NSCLC.<br><br> 4. Be willing to undergo repeat biopsy of tumor lesions according to the study<br> protocol.<br><br> 5. Patients who have failed the standard therapy, or who are unsuitable for standard<br> treatment, or refuse chemotherapy.<br><br> 6. At least one measurable lesion according to RECIST 1.1. A lesion that has previously<br> received radiotherapy can be considered a target lesion only if this lesion is<br> clearly progressed after radiotherapy.<br><br> 7. The target lesions (irradiated lesions) are > 5cm in in diameter<br><br> 8. ECOG 0-2.<br><br> 9. Life expectancy of > 3 months.<br><br> 10. Subjects should agree to use an adequate method of contraception.<br><br>Exclusion Criteria:<br><br> 1. Has known active central nervous system (CNS) metastases and/or carcinomatous<br> meningitis and/or spinal cord compression, etc.<br><br> 2. With oncologic emergencies that require immediate treatment<br><br> 3. EGFR/ALK/ROS-1 mutation or mutation status unknown.<br><br> 4. Has evidence of interstitial lung disease or active and/or non-infectious<br> pneumonitis (drug-induced pneumonia, radiation-induced pneumonia, etc.) requiring<br> steroid therapy.<br><br> 5. History of pulmonary fibrosis, pulmonary hypertension, severe irreversible airway<br> obstruction disease<br><br> 6. Patients with peripheral neuropathy.<br><br> 7. Significant heart disease or impairment of cardiac function<br><br> 8. Fluid accumulating in the third space, such as pericardial effusion, pleural<br> effusion and peritoneal effusion that remains uncontrolled by aspiration or other<br> treatment<br><br> 9. Known allergy to drugs or excipients, known severe allergic reaction to any of the<br> PD-1 monoclonal antibodies<br><br> 10. Known allogeneic organ transplantation (except corneal transplantation) or<br> allogeneic hematopoietic stem cell transplantation.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Dose Limiting Toxicities
- Secondary Outcome Measures
Name Time Method Objective Response Rate (ORR);Progression Free Survival (PFS);Overall Survival (OS)