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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05149170

Enrollment

Registered

2021-12-08

Start date

2021-10-01

Completion date

2024-09-30

Last updated

2021-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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

Interventions

DRUGAnti-PD-1 monoclonal antibody

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Rate of Complete response after inductive therapy	2-4 weeks after inductive anti-PD-1 antibody	complete resolution of disease in imaging and biopsy after inductive therapy

Secondary

Measure	Time frame	Description
Progression-free survival rate at year 2 after enrollment, 2y-PFS	2-year	From enrollment to any disease progression or death
Overall Survival rate at year 2/5 after enrollment，2y-/5y-OS	2-year, 5-year	From enrollment to death
Rate of acute toxicity (any and above grade 3)	From enrollment to 3 months after treatment	toxicities according to CTCAE criteria
Quality of Life change, QoL	baseline, 1/3/6/12/24 months after treatment	measurement basing on EORTC-QLQ-HN35 tables

Other

Measure	Time frame	Description
Biomarkers to predict anti-PD-1 antibody efficacy and 2y-PFS	baseline	potential biomarkers in baseline tumor samples and blood samples

Countries

China

Contacts

Primary ContactShunan Qi, MD

medata@163.com+8610-87788995

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026