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

Phase 2

Recruiting

• Conditions: Extranodal NK-T-Cell Lymphoma, Nasal and Nasal-Type; Early-stage; High-Risk Cancer
• Interventions: Drug: Anti-PD-1 monoclonal antibody; Drug: Pegaspargase; Drug: Gemcitabine; Drug: Oxaliplatin; Radiation: Involved site radiotherapy

• Registration Number: NCT05254899
• Lead Sponsor: Chinese Academy of Medical Sciences

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-01
• Study First Submitted: 2021-11-07
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-23
• Last Update Submitted: 2022-02-23
• Study First Posted: 2022-02-24
• Last Update Posted: 2022-02-24
• Primary Completion: 2022-09-30
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Inductive and concurrent anti-PD-1 antibody combined with chemo-radiotherapy	Anti-PD-1 monoclonal antibody	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.
Inductive and concurrent anti-PD-1 antibody combined with chemo-radiotherapy	Involved site 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.
Inductive and concurrent anti-PD-1 antibody combined with chemo-radiotherapy	Gemcitabine	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.
Inductive and concurrent anti-PD-1 antibody combined with chemo-radiotherapy	Pegaspargase	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.
Inductive and concurrent anti-PD-1 antibody combined with chemo-radiotherapy	Oxaliplatin	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.

Primary Outcome Measures

Name	Time	Method
Complete Response rate after 3 cycles of Anti-PD-1 antibody and P-GEMOX therapy	At the end of Cycle 3 (each cycle is 14 days)	To evaluate the complete response (CR) rate after 3 cycles of Anti-PD-1 antibody and P-GEMOX therapy according to Lyric 2016 criteria

Secondary Outcome Measures

Name	Time	Method
Progression-free survival rate at year 2 after enrollment, 2y-PFS	2 year	From enrollment to disease progression or any death
Overall Survival rate at year 2/5 after enrollment，2y-/5y-OS	2-year, 5-year	From enrollment to death
acute toxicity	From enrollment to 3 months after treatment	evaluated according to the CTCAE criteria
Quality of Life，QoL	baseline, 1/3/6/12/24 months after treatment	evaluated according to EORTC-QLQ-C30

Trial Locations

Locations (1)

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College; 🇨🇳 Beijing, Beijing, China