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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | Adebrelimab (PD-L1 inhibitor) 1200 mg on Day 1, every 3 weeks. Radiotherapy (SBRT) with a dose of 24Gy/3 fractions within 3 weeks after the first immunotherapy dose. UDCA 250 mg twice daily, starting 7 days before radiotherapy and continuing for 1 month after radiotherapy completion. |
|
| Control Group | Active Comparator | Adebrelimab 1200 mg on Day 1, every 3 weeks. Radiotherapy (SBRT) with a dose of 24Gy/3 fractions within 3 weeks after the first immunotherapy dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ursodeoxycholic Acid (URSO) | Drug | UDCA 250 mg twice daily, starting 7 days before radiotherapy and continuing for 1 month after completion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) of lesions outside the radiotherapy field, assessed by RECIST 1.1 criteria. | From date of randomization to 4 weeks after completion of radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control Rate (DCR) of lesions outside the radiation field, assessed by RECIST 1.1 criteria | From date of randomization to 4 weeks after completion of radiotherapy | |
| Safety: Incidence of Grade ≥3 toxicities, assessed by CTCAE 5.0 criteria | From first dose of study drug to 30 days post-treatment completion |
| Measure | Description | Time Frame |
|---|---|---|
| Circulating Tumor Cells (CTCs) Enumeration | Within 1 week before radiotherapy, within 1 week after the completion of radiotherapy | |
| Circulating Tumor DNA (ctDNA) | Within 1 week before radiotherapy, within 1 week after the completion of radiotherapy |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Min Deng, Doctor | Contact | 13661135602 | 923791362@qq.com |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D014580 | Ursodeoxycholic Acid |
| D011878 | Radiotherapy |
| D000082082 | Immune Checkpoint Inhibitors |
| ID | Term |
|---|---|
| D003840 | Deoxycholic Acid |
| D002793 | Cholic Acids |
| D001647 | Bile Acids and Salts |
| D013256 | Steroids |
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| Radiotherapy | Radiation | Radiotherapy (SBRT) with a dose of 24Gy/3 fractions within 3 weeks after the first immunotherapy dose. |
|
| Adebrelimab (PD-L1 inhibitor) | Drug | Adebrelimab (PD-L1 inhibitor) 1200 mg on Day 1, every 3 weeks. |
|
| Objective Response Rate (ORR) of lesions within the radiation field, assessed by RECIST 1.1 criteria | 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 | 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 | 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 | From randomization to death from any cause, assessed continuously until all patients have died (up to 5 years post-randomization). |
| Peripheral Blood Mononuclear Cell (PBMC) Immune Composition | Within 1 week before radiotherapy, within 1 week after the completion of radiotherapy |
| Whole Blood Immune Factor Profiling | Within 1 week before radiotherapy, within 1 week after the completion of radiotherapy |
| D017437 |
| Skin and Connective Tissue Diseases |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D002757 | Cholanes |
| D013812 | Therapeutics |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000074322 | Antineoplastic Agents, Immunological |
| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |