Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study aims to investigate the treatment of previously untreated stage I-II Extranodal NK/T Cell Lymphoma with sintilimab, peg-aspargase and anlotinib, "sandwich" with radiotherapy.
The primary endpoint is the complete response rate (CRR) at the end of the treatment, and the second endpoints are CRR after two cycles of the combined regimen (CRR2), overall response rate (ORR) at the end of the treatment, survival time (OS and PFS) and toxicities.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment arm | Experimental | Sintilimab 200mg ivdrip D1 Peg-aspargase 2500U/m2 im D1 Anlotinib 12 mg po D1-14 repeat every three weeks When patients obtained an CR or PR after the second dose of the combined regimen, they woud undergo radiotherapy after the third dose of the combined regimen. Subsequently, another three cycles of the combined regimen would be administered to these patients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sintilimab | Drug | Sintilimab 200mg ivdrip D1 Anlotinib 12mg po D1-14 Peg-aspargase 2500U/m2 im D1 combined with radiotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete response rate at the end of the treatment | Complete response rate at the end of the treatment | 12 weeks after the last dose of the regimen |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | All the adverse events of the patients related will be assessed and graded by NCI CTCAE v4.0 | Up to one year after the start of the study |
| Progression Free Survival (PFS) | PFS was defined as time from study registration to first disease progression or death whichever occurred first, otherwise subject data were censored at time last known disease free. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Zhiming Li | Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-Sen University Cancer Center | Guangzhou | Guangdong | 510060 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C000632826 | sintilimab |
| C000625192 | anlotinib |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Up to three years after the start of the study |
| Overall Survival (OS) | OS was defined as time from study registration to death, and otherwise censored at time last known alive. | Up to three years after the start of the study |
| Complete response rate after two cycles of the combined regimen | Complete response rate after two cycles of the combined regimen | 4 weeks after the second dose of the combined regimen |
| Overall response rate at the end of the treatment | Overall response rate at the end of the treatment | 12 weeks after the last dose of the combined regimen |