Experimental Group Adebrelimab (PD-L1 inhibitor) 1200 mg on Day 1, every 3 weeks. Radiotherapy (Stereotactic Body Radiation Therapy, SBRT) with a dose of 24 Gy/3 fractions within 3 weeks after the first immunotherapy dose. Ursodeoxycholic Acid (UDCA) 250 mg twice daily, starting 7 days before radiotherapy and continuing for 1 month after radiotherapy completion. Control Group Adebrelimab 1200 mg on Day 1, every 3 weeks. SBRT with a dose of 24 Gy/3 fractions within 3 weeks after the first immunotherapy dose. Chemotherapy is permitted during the study in both groups. The decision to use chemotherapy will be made by the treating physician based on the patient's individual condition and prior treatment history. Primary Endpoint Objective Response Rate (ORR) of lesions outside the radiotherapy field, assessed by RECIST 1.1 criteria. Secondary Endpoints Disease Control Rate (DCR) of lesions outside the radiotherapy field. Safety profile (≥3 toxicities). ORR of lesions within the radiotherapy field. Distant metastasis rate outside the radiotherapy field. Progression-Free Survival (PFS) and Overall Survival (OS). Safety Monitoring Adverse events and serious adverse events (SAE) will be closely monitored and reported according to the protocol. Treatment will be discontinued if predefined criteria for stopping are met. Study Duration The study will include a screening period, a treatment period, and a follow-up period with regular assessments every 2 cycles of immunotherapy until death occurs.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
UDCA 250 mg twice daily, starting 7 days before radiotherapy and continuing for 1 month after completion.
Radiotherapy (SBRT) with a dose of 24Gy/3 fractions within 3 weeks after the first immunotherapy dose.
Adebrelimab (PD-L1 inhibitor) 1200 mg on Day 1, every 3 weeks.
Objective Response Rate (ORR) of lesions outside the radiotherapy field, assessed by RECIST 1.1 criteria.
Time frame: From date of randomization to 4 weeks after completion of radiotherapy
Disease Control Rate (DCR) of lesions outside the radiation field, assessed by RECIST 1.1 criteria
Time frame: From date of randomization to 4 weeks after completion of radiotherapy
Safety: Incidence of Grade ≥3 toxicities, assessed by CTCAE 5.0 criteria
Time frame: From first dose of study drug to 30 days post-treatment completion
Objective Response Rate (ORR) of lesions within the radiation field, assessed by RECIST 1.1 criteria
Time frame: From date of randomization to 4 weeks after completion of radiotherapy
Overall response assessment of lesions both within and outside the radiation field, assessed by mRECIST criteria
Time frame: From date of randomization to 4 weeks after completion of radiotherapy
Progression-Free Survival (PFS): Time from randomization to the first documented progression or death, whichever occurs first
Time frame: From randomization to the first documented progression or death, whichever occurs first, assessed every 6 weeks up to 48 weeks post-randomization.
Overall Survival (OS): time from randomization to death from any cause
Time frame: From randomization to death from any cause, assessed continuously until all patients have died (up to 5 years post-randomization).
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