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To investigate the objective response rate (ORR) of stereotactic body radiotherapy (SBRT) combined with anlotinib and beromuzumab in locally advanced/metastatic renal cell carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SBRT combined with Anlotinib and Bemarituzumab | Experimental | Interventions:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic Body Radiation Therapy (SBRT) | Radiation | Dose fractionation: 39-48Gy/3f or 40-50Gy/5f, alternative 20-50Gy/5f if OAR dose-limited. Dose adjusted per radiation toxicities during treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Assessed at baseline, before the second/fourth cycle of targeted-immunotherapy and at regular intervals during consolidation therapy follow-up throughout the study, from enrollment to 36 month. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months | |
| Disease Control Rate (DCR) | Assessed at baseline, before the second/fourth cycle of targeted-immunotherapy and regular follow-up during consolidation therapy, from enrollment to 36 month. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jinluan Li, MD | Contact | +86-15159628678 | lijinluan@fjmu.edu.cn | |
| Shushang Chen, MD | Contact | +86-18960939103 | 121257401@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Jiunluan Li, MD | Fujian Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Cancer Hospital | Fuzhou | Fujian | 350014 | China |
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| C000625192 | anlotinib |
| C000714767 | bemarituzumab |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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| Anlotinib | Drug | Oral anti-angiogenic agent, 12 mg qd fasting, 21d/cycle (2w on/1w off) |
|
| Bemarituzumab | Drug | Intravenous PD-1 inhibitor, 1200 mg q3w, 60min infusion |
|
| Overall Survival (OS) | Followed up for the entire study period until patient death or study conclusion, from enrollment to 36 month. |
| Objective Response Rate in the Field of Irradiation | Assessed at baseline, post-SBRT (before the 2nd cycle of targeted-immunotherapy) and regular follow-up during consolidation therapy, from enrollment to 36 month.. |
| Objective response rate (ORR) of irradiated versus non-irradiated lesions assessed by RECIST v1.1 | Baseline, before cycle 2 and cycle 4 of immunotherapy (each cycle is 21 days), and up to 36 months. |
| Incidence of treatment-related adverse events (TRAEs) assessed by CTCAE v5.0 | From baseline through study treatment period, up to 2 years. |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |