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Combined Treatment of Sintilimab, Peg-aspargase Plus Anlotinib in NK/T Cell Lymphoma

NCT03936452 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2022-06-09

No results posted yet for this study

Summary

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.

Conditions

  • Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type
  • Early Stage
  • Anlotinib
  • Peg-aspargase
  • Sintilimab
  • Phase Two
  • Open
  • Radiotherapy

Interventions

DRUG

Sintilimab

Sintilimab 200mg ivdrip D1 Anlotinib 12mg po D1-14 Peg-aspargase 2500U/m2 im D1 combined with radiotherapy

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Zhiming Li · Sun Yat-sen University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-28
Primary Completion
2021-12-30
Completion
2021-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03936452 on ClinicalTrials.gov