Anti-PD-1 Antibody and P-GEMOX Chemotherapy Combined With Radiotherapy in High-risk Early-Stage ENKTL

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Enrolling; Phase 2

Conditions: Early-stage; Extranodal NK-T-Cell Lymphoma, Nasal and Nasal-Type; High-Risk Cancer

Treatments: Drug: Oxaliplatin; Drug: Pegaspargase; Radiation: Involved site radiotherapy; Drug: Gemcitabine; Drug: Anti-PD-1 monoclonal antibody

Study type: Interventional

Funder types: Other

Identifiers

NCT05254899

CLCG-NKT-2102

Details and patient eligibility

About

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 high-risk extranodal NK/T cell lymphoma, nasal type

Enrollment: 54 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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54 participants in 1 patient group

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

Experimental group

Description:

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.

Treatment:

Drug: Anti-PD-1 monoclonal antibody

Drug: Oxaliplatin

Drug: Gemcitabine

Radiation: Involved site radiotherapy

Drug: Pegaspargase