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

NCT ID: NCT05149170

Last Updated: 2021-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2024-09-30

Brief Summary

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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

Detailed Description

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Conditions

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

Keywords

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NK/T-Cell Lymphoma, Nasal and Nasal-Type radiotherapy Anti-PD-1 Antibody

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

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.

Group Type EXPERIMENTAL

Anti-PD-1 monoclonal antibody

Intervention Type DRUG

inductive Anti-PD-1 antibody + concurrent Anti-PD-1 antibody with RT

Interventions

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Anti-PD-1 monoclonal antibody

inductive Anti-PD-1 antibody + concurrent Anti-PD-1 antibody with RT

Intervention Type DRUG

Other Intervention Names

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radiotherapy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University Cancer Hospital & Institute

OTHER

Sponsor Role collaborator

The First Hospital of Jilin University

OTHER

Sponsor Role collaborator

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

OTHER

Sponsor Role collaborator

Chinese Academy of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Shunan Qi

Associated Prof. in the radiation oncology department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ye-Xiong Li, MD

Role: PRINCIPAL_INVESTIGATOR

CAMS

Locations

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

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shunan Qi, MD

Role: CONTACT

Phone: +8610-87788995

Email: [email protected]

Facility Contacts

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Shunan Qi, MD

Role: primary

References

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Li JY, Qi SN, Hu C, Liu X, Yang Y, Wu T, Zheng R, Feng XL, Ni XG, Jin FY, Song YQ, Liu WP, Zhou SY, Li YX. Tislelizumab and radiation therapy in low-risk early-stage extranodal natural killer/T-cell lymphoma, nasal type: a phase II study protocol. Future Oncol. 2024 Feb;20(5):245-256. doi: 10.2217/fon-2023-0065. Epub 2023 Nov 29.

Reference Type DERIVED
PMID: 38018460 (View on PubMed)

Other Identifiers

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CLCG-NKT-2101

Identifier Type: -

Identifier Source: org_study_id