A Study of Tislelizumab, Chemotherapy, and Radiation Therapy for Early-Stage High-Risk ENKTCL (CLCG-2102) (CLCG-2102)

Tislelizumab Plus Dose-Dense P-GemOx and Radiation Therapy for Early-Stage Intermediate/High-Risk Extranodal NK/T-Cell Lymphoma: A Multicenter Phase II Trial

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

Study Overview

• Status: Completed
• Conditions: High-Risk Cancer; Extranodal NK-T-Cell Lymphoma; Early-stage
• Intervention / Treatment: Drug: Anti-PD-1 monoclonal antibody; Drug: Gemcitabine; Drug: Pegaspargase; Drug: Oxaliplatin; Radiation: Involved site radiotherapy

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100021
      • National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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: Gemcitabine; 1g/m2 iv on Day 2 of each 14-day cycle for 3 cycles in induction treatment; Drug: Pegaspargase; 3000 IU im on Day 2 of each 14-day cycle for 3 cycles in induction treatment; Drug: Oxaliplatin; 85 mg/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 50Gy 14-28 days after inductive therapy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival rate at year 2 after enrollment, 2y-PFS	From enrollment to disease progression or any death	2 year
Overall Survival rate at year 2/5 after enrollment，2y-/5y-OS	From enrollment to death	2-year, 5-year
acute toxicity	evaluated according to the CTCAE criteria	From enrollment to 3 months after treatment
Quality of Life，QoL	evaluated according to EORTC-QLQ-HN35	baseline, 1/3/6/12/24 months after treatment
Quality of Life，QoL	evaluated according to EORTC-QLQ-C30	baseline, 1/3/6/12/24 months after treatment

Other Outcome Measures

Outcome Measure	Time Frame
biomarkers (single cell transcriptomics)	baseline, 2 years

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Collaborators: The First Hospital of Jilin University; The Affiliated Hospital Of Guizhou Medical University; The First Affiliated Hospital of Dalian Medical University; People's Hospital of Ningxia Hui Autonomous Region
• Investigators: Principal Investigator: Shunan Qi, MD, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2021
• Primary Completion (Actual): August 30, 2025
• Study Completion (Actual): March 31, 2026

Study Registration Dates

• First Submitted: November 7, 2021
• First Submitted That Met QC Criteria: February 23, 2022
• First Posted (Actual): February 24, 2022

Study Record Updates

• Last Update Posted (Actual): August 20, 2026
• Last Update Submitted That Met QC Criteria: August 18, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: chemotherapy; radiotherapy; Pegaspargase; anti-PD-1 antibody; NK/T-Cell Lymphoma, Nasal and Nasal-Type
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, T-Cell; Lymphoma, Extranodal NK-T-Cell; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Coordination Complexes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Oxaliplatin; Gemcitabine; pegaspargase; spartalizumab; tislelizumab
• Other Study ID Numbers: CLCG-NKT-2102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual participant data underlying the results reported in this article, together with the study protocol, statistical analysis plan, and data dictionary, will be made available to qualified researchers whose proposed use has been approved by the investigators and is consistent with participants' consent.
• IPD Sharing Time Frame: Data will be available beginning 6 months and ending 5 years after publication.
• IPD Sharing Access Criteria: Proposals should be directed to qis@cicams.pumc.edu.cn. Data requestors will be required to sign a data access agreement. Analysis code will be available upon reasonable request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No