Natural Killer/T-Cell Lymphoma, Nasal and Nasal-TypePhase 2SPIRIT-02NCT06583083
Sintilimab With P-GEMOX Versus the P-GEMOX in the Teatment of Advanced-stage Extranodal Natural Killer/T Cell Lymphoma
A Phase 2 study testing Sintilimab with P-GEMOX Regimen and P-GEMOX Regimen in people with Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type, run by Sun Yat-sen University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type
- What is being tested?
- Sintilimab with P-GEMOX Regimen and P-GEMOX Regimen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 22 Oct 2024to 28 Aug 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Willing to participate in the clinical study; fully informed and has signed a written informed consent form.
- Adequate organ and bone marrow function.
Who cannot join
- 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.
- Less than 6 weeks since major organ surgery (excluding surgery for biopsy purposes).
- Pregnant or breastfeeding women, and women of childbearing potential who are unwilling to use contraception.
- Active infection, excluding fever related to tumor-associated B symptoms.
- Known history of human immunodeficiency virus (HIV) infection and/or acquired immunodeficiency syndrome (AIDS).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen Universitiy Cancer Center
Guangzhou, Guangdong, 510060
Cai Qingqing
About this study
Official title: A Multicenter, Phase 2, Randomized Trial of Sintilimab (PD-1 Antibody) With P-GEMOX Versus the P-GEMOX Regimen in the Teatment of Newly Diagnosed Advanced-stage Extranodal Natural Killer/T Cell Lymphoma (ENKTL) (SPIRIT-02)
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.
- Being tested
- Sintilimab with P-GEMOX Regimen, P-GEMOX Regimen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sintilimab with P-GEMOX RegimenDrug
Also called Sintilimab, Pegaspargase, gemcitabine, oxaliplatin
Sintilimab intravenous drip, Pegaspargase intramuscular injection, gemcitabine intravenous drip, oxaliplatin intravenous drip
P-GEMOX RegimenDrug
Also called Pegaspargase, gemcitabine, oxaliplatin
Pegaspargase intramuscular injection, gemcitabine intravenous drip, oxaliplatin intravenous drip
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Sintilimab with P-GEMOX Regimen Receives: Drug: Sintilimab with P-GEMOX Regimen |
| control group | Active comparator | P-GEMOX Regimen Receives: Drug: P-GEMOX Regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
progression free survival
Measured: Up to 4 years
Secondary outcomes (4)
ORR rate
objective response rate
Measured: Up to 4 years
CR rate
complete response rate
Measured: Up to 4 years
OS
overall survival
Measured: Up to 4 years
Adverse events
The incedence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs)
Measured: Up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start22 Oct 2024
- Primary completion28 Aug 2026 (estimated)
- Study completion28 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Natural Killer/T-Cell Lymphoma, Nasal and Nasal-TypeStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qingqing Cai, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06583083
- Sponsor's protocol ID
- B2024-475-01
- Acronym
- SPIRIT-02
- Status last verified
- Apr 2026
- First submitted
- 28 Aug 2024
- Last updated
- 14 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Phase 2, Randomized Trial of Sintilimab (PD-1 Antibody) With P-GEMOX Versus the P-GEMOX Regimen in the Teatment of Newly Diagnosed Advanced-stage Extranodal Natural Killer/T Cell Lymphoma (ENKTL) (SPIRIT-02)
- ClinicalTrials.gov ID
- NCT06583083
- Acronym / sponsor ID
- SPIRIT-02 / B2024-475-01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 22 Oct 2024 (actual)
- Primary completion
- 28 Aug 2026 (estimated)
- Study completion
- 28 Aug 2026 (estimated)
- First posted
- 3 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Drug: Sintilimab with P-GEMOX RegimenSintilimab with P-GEMOX Regimen |
| control group | Active comparator | Drug: P-GEMOX RegimenP-GEMOX Regimen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- Willing to participate in the clinical study; fully informed and has signed a written informed consent form.
Key exclusion criteria (8 listed)
- 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.
- Less than 6 weeks since major organ surgery (excluding surgery for biopsy purposes).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sintilimab with P-GEMOX RegimenAlso: Sintilimab, Pegaspargase, gemcitabine, oxaliplatinSintilimab intravenous drip, Pegaspargase intramuscular injection, gemcitabine intravenous drip, oxaliplatin intravenous drip | Drug | experimental group |
| P-GEMOX RegimenAlso: Pegaspargase, gemcitabine, oxaliplatinPegaspargase intramuscular injection, gemcitabine intravenous drip, oxaliplatin intravenous drip | Drug | control group |
Primary outcome
PFS
Time frame: Up to 4 years
progression free survival
4 secondary outcomes
ORR rate
Time frame: Up to 4 years
CR rate
Time frame: Up to 4 years
OS
Time frame: Up to 4 years
Adverse events
Time frame: Up to 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sintilimab with P-GEMOX Regimen and P-GEMOX Regimen in people with Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type, run by Sun Yat-sen University at 1 site 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 6 inclusion and 8 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 14 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 1 site 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 Cai Qingqing, MD.PhD ((020)87342823, caiqq@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: Up to 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Apr 2026.