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This phase II trial employs a prospective, randomized, parallel-group design to evaluate the efficacy and safety of hypofractionated radiotherapy combined with tislelizumab and surufatinib. Eligible patients are randomly assigned to one of two arms: Experimental Group A receives hypofractionated chemoradiotherapy plus concurrent tislelizumab and surufatinib, followed by consolidation therapy with tislelizumab plus surufatinib; Experimental Group B receives the same hypofractionated chemoradiotherapy plus concurrent tislelizumab alone, followed by tislelizumab consolidation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group A | Experimental | Patients will receive hypofractionated thoracic radiotherapy with concurrent chemotherapy, combined with tislelizumab and surufatinib during radiotherapy. Patients who achieve complete response, partial response, or stable disease after chemoradiotherapy will receive consolidation therapy with tislelizumab and surufatinib for up to one year. |
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| Study group B | Experimental | Patients will receive hypofractionated thoracic radiotherapy with concurrent chemotherapy, combined with tislelizumab during radiotherapy. Patients who achieve complete response, partial response, or stable disease after chemoradiotherapy will receive consolidation therapy with tislelizumab for up to one year. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiotherapy | Radiation | Split-course hypofractionated thoracic radiotherapy |
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| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | The time from randomization to the first documented disease progression or death from any cause, whichever occurs first. | 18-month |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | The time from randomization to death from any cause, censored at the last follow-up date. | 18-month |
| Treatment related toxicity | Graded by CTCAE 5.0 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| DaQuan Wang, MD | Contact | +862087343031 | wangdq@sysucc.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510000 | China |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| C000707970 | tislelizumab |
| C000717729 | surufatinib |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Concurrent chemotherapy | Drug | Weekly nab-paclitaxel and cisplatin during radiotherapy |
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| Tislelizumab | Drug | Tislelizumab 200mg every three weeks during and following radiotherapy |
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| Surufatinib | Drug | Surufatinib during and following radiotherapy |
|
| 18-month |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |