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Completed
NCT05254899
A Study of Tislelizumab, Chemotherapy, and Radiation Therapy for Early-Stage High-Risk ENKTCL (CLCG-2102)
Conditions: Extranodal NK-T-Cell Lymphoma, Early-stage, High-Risk Cancer
Sex: All
Ages: 18 Years – 70 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 54
Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Location: National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College Beijing Beijing Municipality
Summary
The current study is a phase II multi-center single arm trial to evaluate the efficacy and safety of inductive Anti-PD-1+P-GEMOX treatment followed by radiotherapy and concurrent Anti-PD-1 antibody in early-stage Intermediate/High-Risk extranodal NK/T cell lymphoma
Eligibility Criteria
Inclusion Criteria:
* Biopsy proved extranodal NK/T cell lymphoma
* 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:
* 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
Source: ClinicalTrials.gov (NCT05254899). StuddyBuddy aggregates publicly available trial information.