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Radiotherapy and Anti-PD-1 in Low-risk ES-ENKTCL

Primary Purpose

Early-stage, Extranodal NK-T-Cell Lymphoma, Nasal and Nasal-Type

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Anti-PD-1 monoclonal antibody
Sponsored by
Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Early-stage focused on measuring NK/T-Cell Lymphoma, Nasal and Nasal-Type, radiotherapy, Anti-PD-1 Antibody

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Biopsy proved extranodal NK/T cell lymphoma
  • No previous anti-cancer treatment
  • Measurable lesion on baseline PET/CT and MRI
  • Stage I
  • Normal serum LDH level
  • Primary tumor invasion (PTI) absence
  • ECOG PS 0-1
  • Sufficient organ functions

Exclusion Criteria:

  • Other mature T- or NK- lymphoma
  • Hemophagocytic lymphohistiocytosis
  • Primary CNS lymphoma or CNS-involved lymphoma
  • History of malignancy except for cutaneous basal-/squamous- cell carcinoma or cervical carcinoma in situ 3 years prior to study treatment

Sites / Locations

  • National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical CollegeRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Inductive and concurrent anti-PD-1 antibody combined with radiotherapy

Arm Description

All the enrolled patients receive 2 doses of inductive anti-PD-1 antibody (Tislelizumab 200mg) every two weeks, and then Involved-site radiotherapy (50±6-10 Gy) with concurrent anti-PD-1 antibody (Tislelizumab 200mg) every two weeks.

Outcomes

Primary Outcome Measures

Rate of Complete response after inductive therapy
complete resolution of disease in imaging and biopsy after inductive therapy

Secondary Outcome Measures

Progression-free survival rate at year 2 after enrollment, 2y-PFS
From enrollment to any disease progression or death
Overall Survival rate at year 2/5 after enrollment，2y-/5y-OS
From enrollment to death
Rate of acute toxicity (any and above grade 3)
toxicities according to CTCAE criteria
Quality of Life change, QoL
measurement basing on EORTC-QLQ-HN35 tables
Quality of Life change, QoL
measurement basing on EORTC-QLQ-C30 tables

Full Information

First Posted
November 6, 2021
Last Updated
December 7, 2021
Sponsor
Chinese Academy of Medical Sciences
Collaborators
Peking University Cancer Hospital & Institute, First Affiliated Hospital of Jilin University, Affiliated Cancer Hospital & Institute of Guangzhou Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05149170
Brief Title
Radiotherapy and Anti-PD-1 in Low-risk ES-ENKTCL
Official Title
Radiotherapy With Inductive and Concurrent Anti-PD-1 Antibody in Early-stage Low-risk Extranodal NK/T Cell Lymphoma, Nasal Type: A Multi-center Phase II Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences
Collaborators
Peking University Cancer Hospital & Institute, First Affiliated Hospital of Jilin University, Affiliated Cancer Hospital & Institute of Guangzhou Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The current study is a phase II multi-center single arm trial to evaluate the efficacy and safety of adding Anti-PD-1 antibody in an inductive and concurrent way to radiotherapy in early-stage low-risk extranodal NK/T cell lymphoma, nasal type

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early-stage, Extranodal NK-T-Cell Lymphoma, Nasal and Nasal-Type
Keywords
NK/T-Cell Lymphoma, Nasal and Nasal-Type, radiotherapy, Anti-PD-1 Antibody

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Inductive and concurrent anti-PD-1 antibody combined with radiotherapy
Arm Type
Experimental
Arm Description
All the enrolled patients receive 2 doses of inductive anti-PD-1 antibody (Tislelizumab 200mg) every two weeks, and then Involved-site radiotherapy (50±6-10 Gy) with concurrent anti-PD-1 antibody (Tislelizumab 200mg) every two weeks.
Intervention Type
Drug
Intervention Name(s)
Anti-PD-1 monoclonal antibody
Other Intervention Name(s)
radiotherapy
Intervention Description
inductive Anti-PD-1 antibody + concurrent Anti-PD-1 antibody with RT
Primary Outcome Measure Information:
Title
Rate of Complete response after inductive therapy
Description
complete resolution of disease in imaging and biopsy after inductive therapy
Time Frame
2-4 weeks after inductive anti-PD-1 antibody
Secondary Outcome Measure Information:
Title
Progression-free survival rate at year 2 after enrollment, 2y-PFS
Description
From enrollment to any disease progression or death
Time Frame
2-year
Title
Overall Survival rate at year 2/5 after enrollment，2y-/5y-OS
Description
From enrollment to death
Time Frame
2-year, 5-year
Title
Rate of acute toxicity (any and above grade 3)
Description
toxicities according to CTCAE criteria
Time Frame
From enrollment to 3 months after treatment
Title
Quality of Life change, QoL
Description
measurement basing on EORTC-QLQ-HN35 tables
Time Frame
baseline, 1/3/6/12/24 months after treatment
Title
Quality of Life change, QoL
Description
measurement basing on EORTC-QLQ-C30 tables
Time Frame
baseline, 1/3/6/12/24 months after treatment
Other Pre-specified Outcome Measures:
Title
Biomarkers to predict anti-PD-1 antibody efficacy and 2y-PFS
Description
potential biomarkers in baseline tumor samples and blood samples
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Biopsy proved extranodal NK/T cell lymphoma No previous anti-cancer treatment Measurable lesion on baseline PET/CT and MRI Stage I Normal serum LDH level Primary tumor invasion (PTI) absence ECOG PS 0-1 Sufficient organ functions Exclusion Criteria: Other mature T- or NK- lymphoma Hemophagocytic lymphohistiocytosis Primary CNS lymphoma or CNS-involved lymphoma History of malignancy except for cutaneous basal-/squamous- cell carcinoma or cervical carcinoma in situ 3 years prior to study treatment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shunan Qi, MD
Phone
+8610-87788995
Email
medata@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ye-Xiong Li, MD
Organizational Affiliation
CAMS
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shunan Qi, MD
Phone
+861087788995
Email
medata@163.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All IPD that underlie results in a publication
IPD Sharing Time Frame
From: 6 months after publication. To: 5 years after publication
IPD Sharing Access Criteria
Will share data with the PIs who had specific study plan in immunotherapy area and biomarker area

Learn more about this trial

Radiotherapy and Anti-PD-1 in Low-risk ES-ENKTCL

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