Status:
UNKNOWN
Anti-PD-1 Antibody and Pegaspargase Combined With Radiotherapy in Early-Stage ENKTL
Lead Sponsor:
Sun Yat-sen University
Conditions:
Extranodal NK/T-cell Lymphoma, Nasal Type
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
Aim of the trial is to evaluate the safety and efficacy of sintilimab and pegaspargase in combination with pegaspargase for the initial treatment of previously untreated patients with limited stage NK...
Detailed Description
This is a multicentre, open-label, single-arm, phase II clinical study to evaluate the safety and efficacy of sintilimab and pegaspargase in combination with pegaspargase for the initial treatment of ...
Eligibility Criteria
Inclusion
- newly diagnosed ENKTL
- age:18-80years
- Ann Arbor stage IE,or stage IIE
- at lease one measurable lesion
- receive no chemotherapy or radiotherapy before
- Eastern CooperativeOncology Group performance status of 0 to 2.
- Adequate hematologic function (eg, white blood cell ≥ 3×10e9/l,neutrophils count ≥1.5×10e9/L, and platelet count≥ 100×10e9/L),renal function (eg, serum creatinine≤1.5 mg/dL and creatinine clearance ≥50 mL minute), and hepatic function (e.g, total bilirubin≤ 2 times the upper limit of normal and aspartate and alanine transaminase levels ≤ 3 times the upper limit of normal)
Exclusion
- mismatch the inclusion criteria
- non-nasal type disease
- systematic central nervous system involvement
- previous or concomitant malignancies and any coexisting medical problems that could cause poor compliance with the study protocol.
Key Trial Info
Start Date :
September 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04676789
Start Date
September 1 2021
End Date
December 31 2024
Last Update
December 21 2020
Active Locations (1)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Please Select, China, 510060