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Anti-PD-1 Antibody and P-GEMOX Chemotherapy Combined With Radiotherapy in High-risk Early-Stage ENKTL

NCT05254899 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2022-02-24

No results posted yet for this study

Summary

The current study is a phase II multi-center single arm trial to evaluate the efficacy and safety of inductive Anti-PD-1+P-GEMOX treatment followed by radiotherapy and concurrent Anti-PD-1 antibody in early-stage high-risk extranodal NK/T cell lymphoma, nasal type

Conditions

  • Extranodal NK-T-Cell Lymphoma, Nasal and Nasal-Type
  • Early-stage
  • High-Risk Cancer

Interventions

DRUG

Anti-PD-1 monoclonal antibody

200mg iv on Day 1 of each 14-day cycle for 3 cycles in induction treatment; 200mg iv on Day 1,15, 29 during RT treatment

DRUG

Pegaspargase

3000 U/m2 im on Day 2 of each 14-day cycle for 3 cycles in induction treatment

DRUG

Gemcitabine

1g/m2 iv on Day 2 of each 14-day cycle for 3 cycles in induction treatment

DRUG

Oxaliplatin

1g/m2 iv on Day 2 of each 14-day cycle for 3 cycles in induction treatment

RADIATION

Involved site radiotherapy

Involved site radiotherapy according to the ILROG guideline with primary tumor dose of 50-56Gy 14-28 days after inductive therapy

Sponsors & Collaborators

  • Peking University Cancer Hospital & Institute

    collaborator OTHER

  • The Affiliated Hospital Of Guizhou Medical University

    collaborator OTHER

  • The First Hospital of Jilin University

    collaborator OTHER

  • Chinese Academy of Medical Sciences

    lead OTHER

Principal Investigators

  • Shunan M Qi, MD · Chinese Academy of Medical Sciences

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
2021-10-01
Primary Completion
2022-09-30
Completion
2024-09-30

Countries

  • China

Study Locations

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Entities

Drugs

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 NCT05254899 on ClinicalTrials.gov