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

Sponsor

Chinese Academy of Medical Sciences (Other)

Overall Status

Recruiting

CT.gov ID

NCT05149170

Collaborator

Peking University Cancer Hospital & Institute (Other), First Affiliated Hospital of Jilin University (Other), Affiliated Cancer Hospital & Institute of Guangzhou Medical University (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Early-stage Extranodal NK-T-Cell Lymphoma, Nasal and Nasal-Type	Drug: Anti-PD-1 monoclonal antibody	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Oct 1, 2021

Anticipated Primary Completion Date :

Sep 30, 2022

Anticipated Study Completion Date :

Sep 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Anti-PD-1 monoclonal antibody inductive Anti-PD-1 antibody + concurrent Anti-PD-1 antibody with RT Other Names: radiotherapy

Arm

Intervention/Treatment

Experimental: 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.

Drug: Anti-PD-1 monoclonal antibody

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

Other Names:

radiotherapy

Outcome Measures

Primary Outcome Measures

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

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
Quality of Life change, QoL [baseline, 1/3/6/12/24 months after treatment]
measurement basing on EORTC-QLQ-C30 tables

Other Outcome Measures

Biomarkers to predict anti-PD-1 antibody efficacy and 2y-PFS [baseline]
potential biomarkers in baseline tumor samples and blood samples

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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	100021