Safety and Tolerability of LDRT Plus Concurrent Partial SBRT and Tislelizumab in Patients With Bulky Tumors
ConditionSolid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorSichuan University
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Tislelizumab
- Low Dose Radiotherapy
- Stereotactic Ablative Radiotherapy
Treatment groups
24 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov