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

Sponsor

Chinese Academy of Medical Sciences (Other)

Overall Status

Recruiting

CT.gov ID

NCT05254899

Collaborator

Peking University Cancer Hospital & Institute (Other), The Affiliated Hospital Of Guizhou Medical University (Other), First Affiliated Hospital of Jilin University (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Extranodal NK-T-Cell Lymphoma, Nasal and Nasal-Type Early-stage High-Risk Cancer	Drug: Anti-PD-1 monoclonal antibody Drug: Pegaspargase Drug: Gemcitabine Drug: Oxaliplatin Radiation: Involved site radiotherapy	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

54 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Anti-PD-1 Antibody and P-GEMOX Chemotherapy Combined With Radiotherapy in High-risk Early-Stage Extranodal NK/T Cell Lymphoma, Nasal Type: A Multi-center Phase II Study

Actual Study Start Date :

Oct 1, 2021

Anticipated Primary Completion Date :

Sep 30, 2022

Anticipated Study Completion Date :

Sep 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: 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 Other Names: Tislelizumab Drug: Pegaspargase 3000 U/m2 im on Day 2 of each 14-day cycle for 3 cycles in induction treatment Drug: Gemcitabine 1g/m2 iv on Day 2 of each 14-day cycle for 3 cycles in induction treatment Drug: Oxaliplatin 1g/m2 iv on Day 2 of each 14-day cycle for 3 cycles in induction treatment Radiation: Involved site radiotherapy Involved site radiotherapy according to the ILROG guideline with primary tumor dose of 50-56Gy 14-28 days after inductive therapy

Arm

Intervention/Treatment

Experimental: 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.

Drug: 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

Other Names:

Tislelizumab

Drug: Pegaspargase

3000 U/m2 im on Day 2 of each 14-day cycle for 3 cycles in induction treatment

Drug: Gemcitabine

1g/m2 iv on Day 2 of each 14-day cycle for 3 cycles in induction treatment

Drug: Oxaliplatin

1g/m2 iv on Day 2 of each 14-day cycle for 3 cycles in induction treatment

Radiation: Involved site radiotherapy

Involved site radiotherapy according to the ILROG guideline with primary tumor dose of 50-56Gy 14-28 days after inductive therapy

Outcome Measures

Primary Outcome Measures

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

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-HN35
Quality of Life，QoL [baseline, 1/3/6/12/24 months after treatment]
evaluated according to EORTC-QLQ-C30

Other Outcome Measures

biomarkers (single cell transcriptomics) [baseline, 2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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