Extranodal NK-T-Cell LymphomaPhase 2CLCG-2102NCT05254899
A Study of Tislelizumab, Chemotherapy, and Radiation Therapy for Early-Stage High-Risk ENKTCL (CLCG-2102)
A Phase 2 study testing Anti-PD-1 monoclonal antibody, Pegaspargase and Gemcitabine in people with Extranodal NK-T-Cell Lymphoma and Early-stage, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial 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 Intermediate/High-Risk extranodal NK/T cell lymphoma Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Extranodal NK-T-Cell Lymphoma, Early-stage, High-Risk Cancer
- What is being tested?
- Anti-PD-1 monoclonal antibody, Pegaspargase and Gemcitabine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteChina
- Study dates
- 10 Nov 2021to 31 Mar 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 100021
About this study
Official 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
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
- Conditions
- Extranodal NK-T-Cell Lymphoma, Early-stage, High-Risk Cancer
- Being tested
- Anti-PD-1 monoclonal antibody, Pegaspargase, Gemcitabine, Oxaliplatin, Involved site radiotherapy
- Keywords
- NK/T-Cell Lymphoma, Nasal and Nasal-Type, anti-PD-1 antibody, radiotherapy, chemotherapy, Pegaspargase
- Medical subject headings
- Lymphoma, Extranodal NK-T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-PD-1 monoclonal antibodyDrug
Also called Tislelizumab
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
PegaspargaseDrug
3000 IU im on Day 2 of each 14-day cycle for 3 cycles in induction treatment
GemcitabineDrug
1g/m2 iv on Day 2 of each 14-day cycle for 3 cycles in induction treatment
OxaliplatinDrug
85 mg/m2 iv on Day 2 of each 14-day cycle for 3 cycles in induction treatment
Involved site radiotherapyRadiation
Involved site radiotherapy according to the ILROG guideline with primary tumor dose of 50Gy 14-28 days after inductive therapy
| Study group | Role | What they receive |
|---|---|---|
| Inductive and concurrent anti-PD-1 antibody combined with chemo-radiotherapy | Experimental | 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. Receives: Drug: Anti-PD-1 monoclonal antibody; Drug: Pegaspargase; Drug: Gemcitabine; Drug: Oxaliplatin; Radiation: Involved site radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At the end of Cycle 3 (each cycle is 14 days)
Secondary outcomes (5)
Progression-free survival rate at year 2 after enrollment, 2y-PFS
From enrollment to disease progression or any death
Measured: 2 year
Overall Survival rate at year 2/5 after enrollment，2y-/5y-OS
From enrollment to death
Measured: 2-year, 5-year
acute toxicity
evaluated according to the CTCAE criteria
Measured: From enrollment to 3 months after treatment
Quality of Life，QoL
evaluated according to EORTC-QLQ-HN35
Measured: baseline, 1/3/6/12/24 months after treatment
Quality of Life，QoL
evaluated according to EORTC-QLQ-C30
Measured: baseline, 1/3/6/12/24 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start10 Nov 2021
- Primary completion30 Aug 2025
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extranodal NK-T-Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The Affiliated Hospital Of Guizhou Medical University, The First Hospital of Jilin University, People's Hospital of Ningxia Hui Autonomous Region, The First Affiliated Hospital of Dalian Medical University
- Responsible party
- Principal investigator, Shunan Qi, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Investigators
- Shunan Qi, MD, Principal investigator, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05254899
- Sponsor's protocol ID
- CLCG-NKT-2102
- Acronym
- CLCG-2102
- Status last verified
- Aug 2026
- First submitted
- 7 Nov 2021
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05254899
- Acronym / sponsor ID
- CLCG-2102 / CLCG-NKT-2102
- Conditions
- Extranodal NK-T-Cell Lymphoma, Early-stage, High-Risk Cancer
- Keywords
- NK/T-Cell Lymphoma, Nasal and Nasal-Type, anti-PD-1 antibody, radiotherapy, chemotherapy, Pegaspargase
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- The Affiliated Hospital Of Guizhou Medical University, The First Hospital of Jilin University, People's Hospital of Ningxia Hui Autonomous Region, The First Affiliated Hospital of Dalian Medical University
- Study start
- 10 Nov 2021 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 24 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inductive and concurrent anti-PD-1 antibody combined with chemo-radiotherapy | Experimental | Drug: Anti-PD-1 monoclonal antibody, Drug: Pegaspargase, Drug: Gemcitabine, Drug: Oxaliplatin, Radiation: Involved site radiotherapyAll 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti-PD-1 monoclonal antibodyAlso: Tislelizumab200mg 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 | Drug | Inductive and concurrent anti-PD-1 antibody combined with chemo-radiotherapy |
| Pegaspargase3000 IU im on Day 2 of each 14-day cycle for 3 cycles in induction treatment | Drug | Inductive and concurrent anti-PD-1 antibody combined with chemo-radiotherapy |
| Gemcitabine1g/m2 iv on Day 2 of each 14-day cycle for 3 cycles in induction treatment | Drug | Inductive and concurrent anti-PD-1 antibody combined with chemo-radiotherapy |
| Oxaliplatin85 mg/m2 iv on Day 2 of each 14-day cycle for 3 cycles in induction treatment | Drug | Inductive and concurrent anti-PD-1 antibody combined with chemo-radiotherapy |
| Involved site radiotherapyInvolved site radiotherapy according to the ILROG guideline with primary tumor dose of 50Gy 14-28 days after inductive therapy | Radiation | Inductive and concurrent anti-PD-1 antibody combined with chemo-radiotherapy |
Primary outcome
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
5 secondary outcomes
Progression-free survival rate at year 2 after enrollment, 2y-PFS
Time frame: 2 year
Overall Survival rate at year 2/5 after enrollment，2y-/5y-OS
Time frame: 2-year, 5-year
acute toxicity
Time frame: From enrollment to 3 months after treatment
Quality of Life，QoL
Time frame: baseline, 1/3/6/12/24 months after treatment
Quality of Life，QoL
Time frame: baseline, 1/3/6/12/24 months after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shunan Qi, MD principal investigator
Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anti-PD-1 monoclonal antibody, Pegaspargase and Gemcitabine in people with Extranodal NK-T-Cell Lymphoma and Early-stage, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.