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

Phase 2

Recruiting

• Conditions: Extranodal NK-T-Cell Lymphoma, Nasal and Nasal-Type; Early-stage
• Interventions: Drug: Anti-PD-1 monoclonal antibody

• Registration Number: NCT05149170
• Lead Sponsor: Chinese Academy of Medical Sciences

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-01
• Study First Submitted: 2021-11-06
• Status Verified: 2021-12
• Study First Submitted QC: 2021-12-07
• Last Update Submitted: 2021-12-07
• Study First Posted: 2021-12-08
• Last Update Posted: 2021-12-08
• Primary Completion: 2022-09-30
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Inductive and concurrent anti-PD-1 antibody combined with radiotherapy	Anti-PD-1 monoclonal antibody	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Overall Survival rate at year 2/5 after enrollment，2y-/5y-OS	2-year, 5-year	From enrollment to death
Progression-free survival rate at year 2 after enrollment, 2y-PFS	2-year	From enrollment to any disease progression or death
Quality of Life change, QoL	baseline, 1/3/6/12/24 months after treatment	measurement basing on EORTC-QLQ-C30 tables
Rate of acute toxicity (any and above grade 3)	From enrollment to 3 months after treatment	toxicities according to CTCAE criteria

Trial Locations

Locations (1)

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College; 🇨🇳 Beijing, Beijing, China