Combining chemotherapy and radiation for early-stage NK/T-cell lymphoma treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates three treatment strategies for early-stage natural killer/T-cell lymphoma (NKTCL), a common and aggressive cancer in East Asian populations. Patients will be randomly assigned to receive either a combination of Pegaspargase and Sintilimab with radiotherapy, a chemotherapy regimen followed by radiotherapy, or a sandwich approach of chemoradiotherapy. The primary goal is to determine which strategy offers the best progression-free survival over 24 months. The study aims to clarify the optimal sequencing of treatments and improve patient outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.
* 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.

Exclusion Criteria:

* 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.
* 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.

Where it's running

• Cancer Hospital of Fujian Province
  Fuzhou, Fujian, China Recruiting
• Nantong Cancer Hospital
  Nantong, Jiangsu, China Recruiting
• Shanghai Eye Ear Nose and Throat Hospital，Fudan University
  Shanghai, Shanghai Municipality, China Recruiting
• Fudan University Shanghai Cancer Center
  Shanghai, Shanghai Municipality, China Recruiting
• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
  Shanghai, Shanghai Municipality, China Recruiting
• Zhejiang Cancer Hospital
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Rong Tao, MD
• Email: rtao@shca.org.cn
• Phone: 8621-64175590

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Combining sintilimab with chemotherapy for advanced NK/T-cell lymphoma

  This study is testing if adding a new drug called sintilimab to chemotherapy can help people with advanced NK/T-cell lymphoma do better than with chemotherapy alone.

  Recruiting Phase 2 Sun Yat-sen University · Guangzhou, Guangdong · NCT06583083

• Combination treatment for advanced NK/T-cell lymphoma

  This study is testing a new combination treatment for people with advanced NK/T-cell lymphoma to see if it is safe and effective.

  Recruiting Phase 1/2 Beijing Tongren Hospital · Beijing, Beijing Municipality · NCT06376721

• PD-1 antibody therapy combined with radiotherapy for early extranodal NK/T‑cell lymphoma

  This trial will try PD‑1 antibody treatment with concurrent radiotherapy, sometimes adding targeted drugs like chidamide or golidocitinib, to see if it helps adults with previously untreated early-stage nasal-type NK/T-cell lymphoma.

  Recruiting Phase 2 Ruijin Hospital · Shanghai · NCT07380984

• Evaluating a new treatment for relapsed or refractory NK/T-cell lymphoma

  This study is testing a new combination treatment for people with relapsed or hard-to-treat NK/T-cell lymphoma to see if it can help them when other treatments haven't worked.

  Recruiting Phase 1/2 Fudan University · Shanghai, Shangai · NCT06966154

• Combination treatment for relapsed or refractory natural killer T-cell lymphoma

  This study is testing a new combination of two medications to see if they can help people with a type of lymphoma that hasn't responded to previous treatments.

  Recruiting at 2 sites Phase 2 Sun Yat-sen University · Beijing, Beijing Municipality and 1 other locations · NCT06733051

• Combination treatment of sintilimab and linperlisib for relapsed NK/T-cell lymphoma

  This study is testing a new combination of two drugs, sintilimab and linperlisib, to see if it can help people with relapsed NK/T-cell lymphoma who haven't had success with other treatments.

  Recruiting Phase 1 Sun Yat-sen University · Guangzhou, Guangdong · NCT06793956

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.