Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
30 participants
INTERVENTIONAL
2021-10-01
2024-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Anti-PD-1 monoclonal antibody
inductive Anti-PD-1 antibody + concurrent Anti-PD-1 antibody with RT
Interventions
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Anti-PD-1 monoclonal antibody
inductive Anti-PD-1 antibody + concurrent Anti-PD-1 antibody with RT
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Peking University Cancer Hospital & Institute
OTHER
The First Hospital of Jilin University
OTHER
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
OTHER
Chinese Academy of Medical Sciences
OTHER
Responsible Party
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Shunan Qi
Associated Prof. in the radiation oncology department
Principal Investigators
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Ye-Xiong Li, MD
Role: PRINCIPAL_INVESTIGATOR
CAMS
Locations
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National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Shunan Qi, MD
Role: primary
References
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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.
Other Identifiers
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CLCG-NKT-2101
Identifier Type: -
Identifier Source: org_study_id