Sintilimab With P-GEMOX Versus the P-GEMOX in the Teatment of Advanced-stage Extranodal Natural Killer/T Cell Lymphoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-22

Study Completion Date

2026-08-28

Brief Summary

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Extranodal NK/T-cell lymphoma is a rare and highly aggressive subtype of non-Hodgkin lymphoma. While the overall survival rates have improved for early-stage ENKTL patients, the prognosis for those with advanced disease remains poor, and there is currently no standard treatment. PD-1/PD-L1 inhibitors have demonstrated significant efficacy in various cancers, and recent studies have shown promising results in extranodal NK/T-cell lymphoma as well. Although PD-1 antibodies have exhibited efficacy in relapsed or refractory patients, their effectiveness when combined with chemotherapy as a first-line treatment remains unclear. This study aims to evaluate the efficacy and safety of sintilimab combined with chemotherapy in a randomized controlled trial for newly diagnosed advanced extranodal NK/T-cell lymphoma patients, while also exploring potential biomarkers that may predict treatment outcomes, offering new therapeutic options for extranodal NK/T-cell lymphoma patients.

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Detailed Description

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Conditions

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Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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experimental group

Sintilimab with P-GEMOX Regimen

Group Type EXPERIMENTAL

Sintilimab with P-GEMOX Regimen

Intervention Type DRUG

Sintilimab intravenous drip, Pegaspargase intramuscular injection, gemcitabine intravenous drip, oxaliplatin intravenous drip

control group

P-GEMOX Regimen

Group Type ACTIVE_COMPARATOR

P-GEMOX Regimen

Intervention Type DRUG

Pegaspargase intramuscular injection, gemcitabine intravenous drip, oxaliplatin intravenous drip

Interventions

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Sintilimab with P-GEMOX Regimen

Sintilimab intravenous drip, Pegaspargase intramuscular injection, gemcitabine intravenous drip, oxaliplatin intravenous drip

Intervention Type DRUG

P-GEMOX Regimen

Pegaspargase intramuscular injection, gemcitabine intravenous drip, oxaliplatin intravenous drip

Intervention Type DRUG

Other Intervention Names

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Sintilimab, Pegaspargase, gemcitabine, oxaliplatin Pegaspargase, gemcitabine, oxaliplatin

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No