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

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 clinical trial evaluates the efficacy and safety of sintilimab, a PD-1 inhibitor, combined with the P-GEMOX chemotherapy regimen in patients with newly diagnosed advanced-stage extranodal NK/T-cell lymphoma. The study aims to determine if this combination can improve treatment outcomes compared to chemotherapy alone. Additionally, it will explore potential biomarkers that may predict patient responses to the treatment. The trial is designed as a randomized controlled trial to provide robust data on the effectiveness of this approach.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Pathologically diagnosed with ENKTL.
2. Advanced stage.
3. Has at least one measurable or assessable lesion.
4. Age \> 18 years, no gender restrictions, with an expected survival of more than 3 months.
5. Willing to participate in the clinical study; fully informed and has signed a written informed consent form.
6. Adequate organ and bone marrow function.

Exclusion Criteria:

1. Aggressive NK-cell leukemia.
2. Central nervous system involvement.
3. Patients with significant dysfunction of vital organs.
4. History of allergy to the investigational drug, similar drugs, or excipients.
5. Less than 6 weeks since major organ surgery (excluding surgery for biopsy purposes).
6. Pregnant or breastfeeding women, and women of childbearing potential who are unwilling to use contraception.
7. Active infection, excluding fever related to tumor-associated B symptoms.
8. Known history of human immunodeficiency virus (HIV) infection and/or acquired immunodeficiency syndrome (AIDS).

Where it's running

• Sun Yat-sen Universitiy Cancer Center
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Cai Qingqing, MD.PhD
• Email: caiqq@sysucc.org.cn
• Phone: (020)87342823

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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.