Trials Sponsors Conditions Drugs Pricing

Conditions

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

Keywords

NK/T-Cell Lymphoma, Nasal and Nasal-TyperadiotherapyAnti-PD-1 Antibody

Outcome Measures

Primary Outcomes (1)

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 Outcomes (5)

Progression-free survival rate at year 2 after enrollment, 2y-PFS
2-year
Overall Survival rate at year 2/5 after enrollment，2y-/5y-OS
2-year, 5-year
Rate of acute toxicity (any and above grade 3)
From enrollment to 3 months after treatment
Quality of Life change, QoL
baseline, 1/3/6/12/24 months after treatment
Quality of Life change, QoL
baseline, 1/3/6/12/24 months after treatment

Other Outcomes (1)

Biomarkers to predict anti-PD-1 antibody efficacy and 2y-PFS
baseline

Study Arms (1)

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

EXPERIMENTAL

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

Interventions

Anti-PD-1 monoclonal antibodyDrug

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

Also known as: radiotherapy

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Biopsy proved extranodal NK/T cell lymphoma
No previous anti-cancer treatment

Sponsors & Collaborators

Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Othercollaborator
Chinese Academy of Medical Sciences
Otherlead

Study Sites (1)

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

Beijing, Beijing Municipality, 100021, China

RECRUITING

Shunan Qi, MDCONTACT+861087788995 medata@163.com

Related Publications (1)

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.
PMID: 38018460DERIVED

MeSH Terms

Conditions

Lymphoma, Extranodal NK-T-Cell

Interventions

spartalizumabRadiotherapy

Condition Hierarchy (Ancestors)

Lymphoma, T-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

Ye-Xiong Li, MD
CAMS
PRINCIPAL INVESTIGATOR

Central Study Contacts

Shunan Qi, MD

CONTACT

+8610-87788995 medata@163.com

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Associated Prof. in the radiation oncology department

Study Record Dates

First Submitted

November 6, 2021

First Posted

December 8, 2021

Study Start

October 1, 2021

Actual (reported)

Primary Completion

September 30, 2022

Estimated (date passed)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Other Outcomes (1)

Study Arms (1)

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

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Other Outcomes (1)

Study Arms (1)

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

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations