Anti-PD-1 Antibody and P-GEMOX Chemotherapy Combined With Radiotherapy in High-risk Early-Stage ENKTL
NCT ID: NCT05254899
Last Updated: 2022-02-24
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
54 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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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 chemo-radiotherapy
All the enrolled patients receive 3 cycles of anti-PD-1 antibody (Tislelizumab 200mg d1) + P-GEMOX (Pegaspargase 3000u d2, Gemcitabine 1g/m2 d2, Oxaliplatin 85mg/m2 d2) systemic treatment every 14 days, followed by involved-site radiotherapy with concurrent anti-PD-1 antibody (Tislelizumab 200mg) every two weeks.
Anti-PD-1 monoclonal antibody
200mg iv on Day 1 of each 14-day cycle for 3 cycles in induction treatment; 200mg iv on Day 1,15, 29 during RT treatment
Pegaspargase
3000 U/m2 im on Day 2 of each 14-day cycle for 3 cycles in induction treatment
Gemcitabine
1g/m2 iv on Day 2 of each 14-day cycle for 3 cycles in induction treatment
Oxaliplatin
1g/m2 iv on Day 2 of each 14-day cycle for 3 cycles in induction treatment
Involved site radiotherapy
Involved site radiotherapy according to the ILROG guideline with primary tumor dose of 50-56Gy 14-28 days after inductive therapy
Interventions
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Anti-PD-1 monoclonal antibody
200mg iv on Day 1 of each 14-day cycle for 3 cycles in induction treatment; 200mg iv on Day 1,15, 29 during RT treatment
Pegaspargase
3000 U/m2 im on Day 2 of each 14-day cycle for 3 cycles in induction treatment
Gemcitabine
1g/m2 iv on Day 2 of each 14-day cycle for 3 cycles in induction treatment
Oxaliplatin
1g/m2 iv on Day 2 of each 14-day cycle for 3 cycles in induction treatment
Involved site radiotherapy
Involved site radiotherapy according to the ILROG guideline with primary tumor dose of 50-56Gy 14-28 days after inductive therapy
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-II
* Have at lest one following risk factor: Elevated serum LDH level; PTI+; stage II
* 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 Affiliated Hospital Of Guizhou Medical University
OTHER
The First Hospital of Jilin 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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Shunan M Qi, MD
Role: PRINCIPAL_INVESTIGATOR
Chinese Academy of Medical Sciences
Locations
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National Cancer Center/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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Other Identifiers
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CLCG-NKT-2102
Identifier Type: -
Identifier Source: org_study_id
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