Skip to main content
OpenTrials
Completed

NCT Number: NCT05254899

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Extranodal NK-T-Cell Lymphoma Early-stage High-Risk Cancer Lymphoma Lymphoma, Extranodal NK-T-Cell Lymphoma, Non-Hodgkin Lymphoma, T-Cell Neoplasms Neoplasms by Histologic Type

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, 100021, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anti-PD-1 monoclonal antibody

Drug

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

pegaspargase

Drug

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

Gemcitabine

Drug

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

Oxaliplatin

Drug

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

Involved site radiotherapy

Radiation

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

Primary outcomes

  1. Complete Response rate after 3 cycles of Anti-PD-1 antibody and P-GEMOX therapy

    Time frame: 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 outcomes

  1. Progression-free survival rate at year 2 after enrollment, 2y-PFS

    Time frame: 2 year

    From enrollment to disease progression or any death

  2. Overall Survival rate at year 2/5 after enrollment，2y-/5y-OS

    Time frame: 2-year, 5-year

    From enrollment to death

  3. acute toxicity

    Time frame: From enrollment to 3 months after treatment

    evaluated according to the CTCAE criteria

  4. Quality of Life，QoL

    Time frame: baseline, 1/3/6/12/24 months after treatment

    evaluated according to EORTC-QLQ-HN35

  5. Quality of Life，QoL

    Time frame: baseline, 1/3/6/12/24 months after treatment

    evaluated according to EORTC-QLQ-C30

Other outcomes

  1. biomarkers (single cell transcriptomics)

    Time frame: baseline, 2 years

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Collaborators

  • People's Hospital of Ningxia Hui Autonomous Region
  • The Affiliated Hospital Of Guizhou Medical University
  • The First Affiliated Hospital of Dalian Medical University
  • The First Hospital of Jilin University

Registry information

Official study title

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

Acronym: CLCG-2102

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Feb 24, 2022
Registry last updated
Aug 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.