Health TrialsbyHealthPanel

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

ConditionNatural Killer/T-Cell Lymphoma, Nasal and Nasal-Type
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSun Yat-sen University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pathologically diagnosed with ENKTL.

Advanced stage.

Has at least one measurable or assessable lesion.

Age > 18 years, no gender restrictions, with an expected survival of more than 3 months.

Disqualifiers

Aggressive NK-cell leukemia.

Central nervous system involvement.

Patients with significant dysfunction of vital organs.

History of allergy to the investigational drug, similar drugs, or excipients.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sintilimab with P-GEMOX Regimen

    Drug

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

  • P-GEMOX Regimen

    Drug

    Pegaspargase intramuscular injection, gemcitabine intravenous drip, oxaliplatin intravenous drip

Treatment groups

84 Participants
are divided into 2 treatment groups
Group A: experimental groupExperimental treatment 1 intervention
Group B: control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

PFS

progression free survival

Time frame
Up to 4 years

Secondary outcomes

1

ORR rate

objective response rate

Time frame
Up to 4 years
2

CR rate

complete response rate

Time frame
Up to 4 years
3

OS

overall survival

Time frame
Up to 4 years
4

Adverse events

The incedence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs)

Time frame
Up to 4 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sun Yat-sen University

Lead sponsor

Source ClinicalTrials.gov
Apply now