Safety and Tolerability of LDRT Plus Concurrent Partial SBRT and Tislelizumab in Patients With Bulky Tumors
Safety and Tolerability of Low Dose Radiotherapy Plus Concurrent Partial Stereotactic Ablative Radiotherapy (Eclipse-RT) and Tislelizumab in Patients With Bulky Tumors
Sichuan University
24 participants
Apr 18, 2024
INTERVENTIONAL
Conditions
Summary
This is a 3+3 dose escalation phase I study which aims to evaluate the safety and tolerability of low dose radiotherapy (LDRT) plus concurrent partial Stereotactic Ablative Radiotherapy (SBRT) and Tislelizumab in Patients with bulky tumors who have failed standard therapy. At least 9 participants will be enrolled in this study.
Eligibility
Inclusion Criteria10
- Be willing and able to provide written informed consent/assent for the trial.
- Be ≥18 years of age on day of signing informed consent.
- Patients with histologically or cytologically confirmed stage IV solid tumours.
- Be willing to undergo repeat biopsy of tumor lesions according to the study protocol.
- Patients who have failed the standard therapy, or who are unsuitable for standard treatment, or refuse chemotherapy.
- At least one measurable lesion according to RECIST 1.1. A lesion that has previously received radiotherapy can be considered a target lesion only if this lesion is clearly progressed after radiotherapy.
- The target lesions (irradiated lesions) are > 5cm in in diameter
- ECOG 0-2.
- Life expectancy of > 3 months.
- Subjects should agree to use an adequate method of contraception.
Exclusion Criteria10
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis and/or spinal cord compression, etc.
- With oncologic emergencies that require immediate treatment
- EGFR/ALK/ROS-1 mutation or mutation status unknown.
- Has evidence of interstitial lung disease or active and/or non-infectious pneumonitis (drug-induced pneumonia, radiation-induced pneumonia, etc.) requiring steroid therapy.
- History of pulmonary fibrosis, pulmonary hypertension, severe irreversible airway obstruction disease
- Patients with peripheral neuropathy.
- Significant heart disease or impairment of cardiac function
- Fluid accumulating in the third space, such as pericardial effusion, pleural effusion and peritoneal effusion that remains uncontrolled by aspiration or other treatment
- Known allergy to drugs or excipients, known severe allergic reaction to any of the PD-1 monoclonal antibodies
- Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation.
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Interventions
Patients will receive treatment with Tislelizumab (200 mg, iv, d1), every 3 weeks for a maximum of 48 months.
LDRT (d1-d3): 6Gy/3f with conventional external beam radiation.
Partial SBRT at dose escalation levels: 24Gy/3f, 30Gy/3f, 45Gy/3f.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06349837