🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT06349837
Recruiting Phase 1

Safety and Tolerability of LDRT Plus Concurrent Partial SBRT and Tislelizumab in Patients With Bulky Tumors

NCT06349837 · tracked via the Priya Life Science China tracker
Sponsor
Sichuan University
Phase
Phase 1
Started
2024-04-18
Last updated
2026-05-01

Condition(s) studied

Solid Tumor

Investigational drug(s) / intervention(s)

Tislelizumab →Low Dose RadiotherapyStereotactic Ablative Radiotherapy

Tislelizumab: Patients will receive treatment with Tislelizumab (200 mg, iv, d1), every 3 weeks for a maximum of 48 months.

Low Dose Radiotherapy: LDRT (d1-d3): 6Gy/3f with conventional external beam radiation.

Stereotactic Ablative Radiotherapy: Partial SBRT at dose escalation levels: 24Gy/3f, 30Gy/3f, 45Gy/3f.

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Be willing and able to provide written informed consent/assent for the trial. 2. Be ≥18 years of age on day of signing informed consent. 3. Patients with histologically or cytologically confirmed stage IV solid tumours. 4. Be willing to undergo repeat biopsy of tumor lesions according to the study protocol. 5. Patients who have failed the standard therapy, or who are unsuitable for standard treatment, or refuse chemotherapy. 6. 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. 7. The target lesions (irradiated lesions) are \> 5cm in in diameter 8. ECOG 0-2. 9. Life expectancy of \> 3 months. 10. Subjects should agree to use an adequate method of contraception. Exclusion Criteria: 1. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis and/or spinal cord compression, etc. 2. With oncologic emergencies that require immediate treatment 3. EGFR/ALK/ROS-1 mutation or mutation status unknown. 4. Has evidence of interstitial lung disease or active and/or non-infectious pneumonitis (drug-induced pneumonia, radiation-induced pneumonia, etc.) requiring steroid therapy. 5. History of pulmonary fibrosis, pulmonary hypertension, severe irreversible airway obstruction disease 6. Patients with peripheral neuropathy. 7. Significant heart disease or impairment of cardiac function 8. Fluid accumulating in the third space, such as pericardial effusion, pleural effusion and peritoneal effusion that remains uncontrolled by aspiration or other treatment 9. Known allergy to drugs or excipients, known severe allergic reaction to any of the PD-1 monoclonal antibodies 10. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
West China Hospital, Sichuan University Chengdu Sichuan Recruiting

More Sichuan University trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06349837 on ClinicalTrials.gov ↗ ← All trials in China