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

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

Study Overview

• Status: Recruiting
• Conditions: Early-stage; Extranodal NK-T-Cell Lymphoma, Nasal and Nasal-Type
• Intervention / Treatment: Drug: Anti-PD-1 monoclonal antibody

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Shunan Qi, MD; Phone Number: +8610-87788995; Email: medata@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100021
      • Recruiting
      • National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
      • Contact: Shunan Qi, MD; Phone Number: +861087788995; Email: medata@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival rate at year 2 after enrollment, 2y-PFS	From enrollment to any disease progression or death	2-year
Rate of acute toxicity (any and above grade 3)	toxicities according to CTCAE criteria	From enrollment to 3 months after treatment
Overall Survival rate at year 2/5 after enrollment，2y-/5y-OS	From enrollment to death	2-year, 5-year
Quality of Life change, QoL	measurement basing on EORTC-QLQ-HN35 tables	baseline, 1/3/6/12/24 months after treatment
Quality of Life change, QoL	measurement basing on EORTC-QLQ-C30 tables	baseline, 1/3/6/12/24 months after treatment

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Collaborators: Peking University Cancer Hospital & Institute; Affiliated Cancer Hospital & Institute of Guangzhou Medical University; First Affiliated Hospital of Jilin University
• Investigators: Principal Investigator: Ye-Xiong Li, MD, CAMS

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Anticipated): September 30, 2022
• Study Completion (Anticipated): September 30, 2024

Study Registration Dates

• First Submitted: November 6, 2021
• First Submitted That Met QC Criteria: December 7, 2021
• First Posted (Actual): December 8, 2021

Study Record Updates

• Last Update Posted (Actual): December 8, 2021
• Last Update Submitted That Met QC Criteria: December 7, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: radiotherapy; Anti-PD-1 Antibody; NK/T-Cell Lymphoma, Nasal and Nasal-Type
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Lymphoma, Extranodal NK-T-Cell; Physiological Effects of Drugs; Immunologic Factors; Antibodies; Antibodies, Monoclonal
• Other Study ID Numbers: CLCG-NKT-2101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No