Spots Global Cancer Trial Database for Safety and Tolerability of LDRT Plus Concurrent Partial SBRT and Tislelizumab in Patients With Bulky Tumors

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Trial Identification

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

Official Title: Safety and Tolerability of Low Dose Radiotherapy Plus Concurrent Partial Stereotactic Ablative Radiotherapy (Eclipse-RT) and Tislelizumab in Patients With Bulky Tumors

Study ID: NCT06349837

Conditions

Solid Tumor

Interventions

Tislelizumab

Low Dose Radiotherapy

Stereotactic Ablative Radiotherapy

Study Description

Brief 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.

Detailed Description: This is 3+3 escalation phase I study which will be conducted in West China Hospital. 3 patients per cohort (a total of 9 patients) will be enrolled to observe the dose-limiting toxicity (DLT) and recommended dose for expansion (RDE) for lung LDRT and partial SBRT. All eligible patients will receive LDRT + partial SBRT and Tislelizumab at different dose levels (decried as below). Tislelizumab will be given at 200mg as recommended in the instruction manual every 3 weeks until disease progression, unacceptable toxicities, the patient withdraws informed consent, or Tislelizumab reaches a maximum of up to 24 months. Patients in the dose escalation will receive LDRT + partial SBRT at 3 cohorts with increasing dose levels: 6 Gy (2 Gy/f) + 24 Gy (8 Gy/f); 6 Gy (2 Gy/f) + 30 Gy (10 Gy/f); 6 Gy (2 Gy/f) + 45 Gy (15 Gy/f).