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Natural Killer/T-Cell Lymphoma, Nasal and Nasal-TypePhase 2NCT06314334

Screening Study of Combined Sequential Chemotherapy and Radiation Therapy for Early-stage NK/T-cell Lymphoma

A Phase 2 study testing Sintilimab+Pegaspargase, P-GemOx and GELAD in people with Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type, run by Fudan University at 7 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Extranodal NK/T-cell lymphoma, nasal type (NKTCL) is a common malignant tumor in East Asian populations, often starting in the nasal cavity and spreading to other organs. Associated with EBV infection, NKTCL is aggressive. Early-stage patients typically receive chemo and radiotherapy, with promising outcomes. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Sintilimab+Pegaspargase, P-GemOx and GELAD
Could I receive a placebo?
No, everyone receives an active treatment
How many people
210 participants
Where
7 sitesChina
Study dates
4 Mar 2024to 30 Dec 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients who meet the diagnostic criteria for NKTCL (WHO-2016) based on pathological examination.
  • Primary lesions located in the upper respiratory and digestive tract such as the nasal cavity, sinuses, nasopharynx, oropharynx, or oral cavity, with clinical staging of IE/IIE based on PET/CT and bone marrow examination according to the Lugano 2014 criteria.
  • Evaluated for lymphoma response according to the Lugano 2014 criteria, with at least one measurable lesion or lesion assessable by PET/CT.
  • No prior treatment with chemotherapy, radiotherapy, immunotherapy, or biological therapy for lymphoma.
  • Age between 18 and 75 years, both genders.
  • Eastern Cooperative Oncology Group performance status (ECOG) score of 0-2.
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  • Must have adequate organ and bone marrow function, defined as follows:
  • Hematology: Absolute neutrophil count (ANC) ≥1.0×10^9/L, platelet count (PLT) ≥75×10^9/L, hemoglobin (Hb) ≥90g/L; no administration of granulocyte colony-stimulating factor, platelet transfusion, or red blood cell transfusion in the previous 14 days.
  • Liver function: Total bilirubin (TBIL) ≤1.5 times the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2×ULN.
  • Renal function: Serum creatinine (Cr) ≤1.5×ULN. Coagulation function: Plasma fibrinogen ≥1.5g/L. Cardiac function: Left ventricular ejection fraction (LVEF) ≥50%, no acute myocardial infarction, arrhythmia, or atrioventricular conduction block of grade I or above on electrocardiogram.
  • Willing to comply with the study protocol, follow-up plan, and laboratory and ancillary investigations.

Who cannot join

  • Patients co-infected with HCV, HIV, or HBV with plasma HBV-DNA >10^3/ml.
  • Patients with a history of pancreatitis.
  • Patients with acute or systemic infections requiring intravenous antibiotic therapy.
  • Patients with severe complications such as hemophagocytic syndrome, DIC, etc.
  • Significant organ dysfunction: such as respiratory failure, chronic congestive heart failure with NYHA class ≥2, decompensated liver or renal dysfunction, uncontrolled hypertension and diabetes despite aggressive treatment, and cardiovascular thrombotic or hemorrhagic events in the past 6 months.
  • Patients with a history of autoimmune diseases who are not suitable for treatment with immune checkpoint inhibitors.
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  • Pregnant and lactating women.
  • Patients with psychiatric disorders.
  • Known allergies to drugs in the chemotherapy regimen.
  • Patients with concomitant other tumors requiring surgery or chemotherapy within the past 6 months.
  • Currently using other experimental drugs.

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Rong Tao, MD contact

8621-64175590

rtao@shca.org.cn

Chuanxu Liu, MD contact

021-64175590

liuchuanxu@shca.org.cn

7 sites in 1 country

China7 sites, 7 recruiting

  • Cancer Hospital of Fujian Province

    Fuzhou, Fujian, 350003

    Jiesong Wang, MD, 0086591-83660063, 349697291@qq.com

    Jiesong Wang, MD

    Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

    Cong Li, MD, 0086571-8812-2222, licong@zjcc.org.cn

    Recruiting

  • Nantong Cancer Hospital

    Nantong, Jiangsu, 226006

    Xiaohong Xu, MD, 0086513-86712049, xhx107@163.com

    Xiaohong Xu, MD

    Recruiting

  • People's Hospital of Ningbo University

    Ningbo, Zhejiang

    Dong Chen, MD, 0086574-87016888, shanying0626@163.com

    Dong Chen, MD

    Recruiting

  • Shanghai Eye Ear Nose and Throat Hospital，Fudan University

    Shanghai, Shanghai Municipality, 200000

    Hao Ding, MD, 008621-64377134, eentding@163.com

    Hao Ding, MD

    Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

    Rong Tao, MD, 8621-64175590, rtao@shca.org.cn

    Chuanxu Liu, MD, 8621-64175590, liuchuanxu@shca.org.cn

    Recruiting

  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200092

    Jiangbo Wan, MD, 008621-25077607, wangjiangbo@xinhuamed.com.cn

    Jiangbo Wan, MD

    Recruiting

Other trials in China

About this study

Official title: A Multicenter, Randomized, Controlled Phase II Screening Study of Combined Sequential Chemotherapy and Radiation Therapies for Early-stage Natural Killer/T-cell Lymphoma (IE/IIE)

Extranodal NK/T-cell lymphoma, nasal type (NKTCL) is a common malignant tumor in East Asian populations, often starting in the nasal cavity and spreading to other organs. Associated with EBV infection, NKTCL is aggressive. Early-stage patients typically receive chemo and radiotherapy, with promising outcomes. Recent studies show the potential of immune checkpoint inhibitors in NKTCL treatment. However, optimal treatment sequencing and efficacy remain unclear. This study aims to compare three strategies: (A) Pegaspargase with Sintilimab and radiotherapy; (B) chemo then radiotherapy (PGemOx); (C) sandwich chemoradiotherapy (GELAD). The goal is to identify the best treatment based on 24-month progression-free survival.

Read the detailed description

Extranodal NK/T-cell lymphoma, nasal type (NKTCL) is a malignant hematological tumor that is common in East Asian populations. The disease typically manifests in the nasal cavity in its early stages and can later involve multiple organs throughout the body. Highly associated with EBV infection, NKTCL is known for its aggressive nature. Currently, early-stage patients usually undergo combined treatment with chemotherapy and radiotherapy. Recent studies have shown that combining chemotherapy and radiotherapy containing asparaginase can achieve a complete remission rate (CR) of over 80%, with long-term survival rates exceeding 70% for patients. In recent years, researchers have found that immune checkpoint inhibitors demonstrate high activity in NKTCL, becoming an important therapeutic option. However, it is worth noting that the optimal sequence of chemotherapy and radiotherapy, as well as the effectiveness of combining radiotherapy with immunotherapy, have not been defined. Studies on different treatment strategies have shown variations in treatment-related adverse reactions and compliance with regimens among patients. However, there is currently no prospective randomized controlled study comparing the efficacy and safety of different strategies. Therefore, it is necessary to identify a treatment strategy with good efficacy and tolerability for patients. This study will stratify early-stage NKTCL patients using the NRI scoring system and randomly assign them to three different treatment strategies: (A) asparaginase combined with Sintilimab and synchronous radiotherapy; (B) sequential chemotherapy (PGemOx) followed by radiotherapy ; (C) chemotherapy (GELAD) with sandwiched chemoradiotherapy, to identify the best or worst treatment strategy based on the 24-month progression-free survival rate.

Being tested
Sintilimab+Pegaspargase, P-GemOx, GELAD, IMRT
Keywords
Chemotherapy, Radiation therapy, Immune checkpoint inhibitor, Pegaspargase

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sintilimab+PegaspargaseDrug

    1. Sintilimab, 200mg intravenous drip, on day 1;
    2. pegaspargase, 2000U/m^2, capped at 3750U, intramuscular, day 1;

  • P-GemOxDrug

    1. pegaspargase 2000U/m^2, capped at 3750U on day 1, intramuscular;
    2. gemcitabine 1.0g/m^2 on day 1 and day 8, intravenous drip;
    3. oxaliplatin 130mg/m^2 on day 1, intravenous drip

  • GELADDrug

    1. gemcitabine 1.0g/m^2 on day 1, intravenous drip;
    2. etoposide 60mg/m^2 on day 1-3, intravenous drip;
    3. pegaspargase 2000U/m^2, capped at 3750U on day 1,intramuscular;
    4. dexamethasone 20mg on day 1-4, intravenous drip.

  • IMRTRadiation

    Intensity modulated radiotherapy (50-56Gy)

Study groups in NCT06314334
Study groupRoleWhat they receive
Group A (synchronous treatment group)ExperimentalPatients received 4 cycles of Sintilimab combined with pegaspargase therapy, with each cycle lasting 3 weeks, for a total of 4 cycles. Concurrently, they received radiotherapy treatment (IMRT, 50-56Gy, starting within 21 days after the first Sintilimab treatment).
Receives: Drug: Sintilimab+Pegaspargase; Radiation: IMRT
Group B (sequential treatment group)ExperimentalPatients received 4 cycles of the PGEMOX regimen chemotherapy. Each cycle lasted 3 weeks, with sequential radiotherapy (IMRT, 50-56Gy) administered within 4 weeks after the last chemotherapy cycle.
Receives: Drug: P-GemOx; Radiation: IMRT
Group C (sandwiched radiotherapy group)ExperimentalPatients received 2 cycles of the GELAD regimen chemotherapy initially, with each cycle lasting 3 weeks. After the second cycle of chemotherapy, radiotherapy (IMRT, 50-56Gy) was administered within 4 weeks. Following the completion of radiotherapy, they received an additional 2 cycles of the GELAD regimen chemotherapy.
Receives: Drug: GELAD; Radiation: IMRT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PFS24

    Rate of patients with 24-month progression-free survival

    Measured: From date of randomization until the date of first documented progression, assessed up to 24 months by the Lugano 2014 response criteria.

Secondary outcomes (4)

  1. ORR

    Overall response rate

    Measured: response rate at 24th week

  2. OS

    Overall survival

    Measured: From the time of patient randomization to the end of study, assessed up to 60 months

  3. EFS

    Event-free survival

    Measured: From the time of patient randomization to the end of study, assessed up to 60 months

  4. TRAE

    Treatment-related adverse event related to the study drug or intervention

    Measured: From the time of patient randomization to the end of study, assessed up to 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2024
  2. Study start4 Mar 2024
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion30 Dec 2028 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Model description
Participants were stratified according to the NRI prognostic index obtained from the baseline assessment (NRI \<2, NRI ≥2) and randomly assigned to three groups receiving different experimental treatments. Group A (synchronous treatment group) received 4 cycles of Sintilimab combined with pegaspargase therapy. Concurrently, they received radiotherapy treatment. Group B (sequential treatment group) received 4 cycles of the PGEMOX regimen chemotherapy with sequential radiotherapy. Group C (sandwiched radiotherapy group) received 2 cycles of the GELAD regimen chemotherapy initially, followed by radiotherapy and another two cycles GELAD chemotherapy.
Masking
None (open label)
Enrolment
210 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06314334
Sponsor's protocol ID
SHCA-NKT-202301
Status last verified
Apr 2026
First submitted
8 Mar 2024
Last updated
9 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zhu Y, Tian S, Xu L, Ma Y, Zhang W, Wang L, Jin L, Liu C, Zhu C, Li Z, Hao S, Zhong H, Ding H, Tao R. GELAD chemotherapy with sandwiched radiotherapy for patients with newly diagnosed stage IE/IIE natural killer/T-cell lymphoma: a prospective multicentre study. Br J Haematol. 2022 Feb;196(4):939-946. doi: 10.1111/bjh.17960. Epub 2021 Nov 21.

    PubMed 34806163

  • Zhang Y, Ma S, Cai J, Yang Y, Jing H, Shuang Y, Peng Z, Li B, Liu P, Xia Z, Xia Y, Gao Y, Chen D, Lin J, Li Q, Xu S, Xu Q, Zhang H, Huang H, Cai Q. Sequential P-GEMOX and radiotherapy for early-stage extranodal natural killer/T-cell lymphoma: A multicenter study. Am J Hematol. 2021 Nov 1;96(11):1481-1490. doi: 10.1002/ajh.26335. Epub 2021 Sep 13.

    PubMed 34449095

  • Wang H, Wang L, Li C, Wuxiao Z, Chen G, Luo W, Lu Y. Pegaspargase Combined with Concurrent Radiotherapy for Early-Stage Extranodal Natural Killer/T-Cell Lymphoma, Nasal Type: A Two-Center Phase II Study. Oncologist. 2020 Nov;25(11):e1725-e1731. doi: 10.1634/theoncologist.2020-0144. Epub 2020 Jul 29.

    PubMed 32627928

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sintilimab+Pegaspargase, P-GemOx and GELAD in people with Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type, run by Fudan University at 7 sites 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 11 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Rong Tao, MD (8621-64175590, rtao@shca.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS24 (time frame: From date of randomization until the date of first documented progression, assessed up to 24 months by the Lugano 2014 response criteria.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06314334, which also lists 3 linked publications.

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 9 Apr 2026.

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