ORRNCT07450040
Efficacy and Safety of Tislelizumab Combined With Gemcitabine and Peraspartase in the Treatment of Patients With Primary Stage I-II NK/T Cell Lymphoma
An observational study of ORR and OS, run by Eye & ENT Hospital of Fudan University at 1 site in China.
Trial summary
In the past 10 years, there have been many effective explorations on the treatment of NK/TCL at home and abroad, which has innovated the treatment mode. Since ENKTCL-NT cells are sensitive to radiotherapy, radiotherapy is considered to be the most reliable treatment for ENKTCL-NT. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 12 Sep 2024to 31 Dec 2027
- How long will I take part?
- 3 Years
- Phase
- Observational
- 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 to 70 years
- All sexes
- Adult, Older adult
Study population: This study was conducted in patients with primary stage I-II NK/ T-cell lymphoma (subjects must have a measurable tumor lesion at baseline).
Who may be able to join
- Clinical diagnosis of NK/T cell lymphoma .
- Stage I/II patients .
- Age 18-70.
- ECOG score 0-2 points.
- Sign informed consent.
- Voluntary compliance with research protocols, follow-up plans, laboratory and auxiliary examinations.
Who cannot join
- Patients with HCV or HIV infection and HBV infection receiving antiviral therapy at the same time are not excluded.
- Complicated with severe infection requires ICU treatment.
- There are serious complications such as hemophagic syndrome, DIC, etc.
- Functional impairment of major organs.
- A history of autoimmune disease.
- Pregnant or lactating women.
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- Patients with a history of psychotropic drug abuse who cannot abstain or have mental disorders.
- Patients who are known to be allergic to drugs used in chemotherapy regimens.
- Patients with other tumors requiring surgery or chemotherapy within 6 months.
- Patients who have participated in other clinical trials within 4 weeks prior to the trial;
- Patients who are taking other investigational drugs.
- Patients with severe allergic history or allergic constitution.
- The target lesion has received radiation therapy or surgery (except biopsy);
- Previously used chemotherapy, immunotherapy or biological targeted therapy for the primary tumor.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Study on the Efficacy and Safety of Tislelizumab in Combination With Gemcitabine and Sequential Pemetrexed Radiotherapy for Patients With Primary Stage I-II NK/T-Cell Lymphoma
In the past 10 years, there have been many effective explorations on the treatment of NK/TCL at home and abroad, which has innovated the treatment mode. Since ENKTCL-NT cells are sensitive to radiotherapy, radiotherapy is considered to be the most reliable treatment for ENKTCL-NT. Although patients with radiotherapy alone have excellent short-term efficacy and can achieve CR in 70-97% of patients, the 5-year PFS is only 30.5-61%, with a higher recurrence rate 5,6. The combination of chemotherapy and radiotherapy significantly improved the survival of patients compared with historical controls. Recent studies have shown that the advantage of radiotherapy combined with chemotherapy is that it can significantly reduce the later recurrence of patients with radiotherapy alone. However, the traditional synchronous chemotherapy and radiotherapy have many and serious adverse reactions and poor tolerance in patients, so it cannot be widely applied.
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Objective Response Rate; The proportion of patients who achieved pre-specified tumor volume reduction and maintained the minimum time frame required by accepted response evaluation criteria, such as Solid Tumor RECIST Version 1.1.
Measured: At 14 weeks after treatment initiation
Secondary outcomes (1)
PFS
progression free survival; It refers to the time between the start of treatment and the onset of disease progression or death from any cause
Measured: up to 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start12 Sep 2024
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ORRStudies of the same condition, open and under way.
- More trials run by Eye & ENT Hospital of Fudan 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07450040
- Sponsor's protocol ID
- 2024071
- Status last verified
- Feb 2026
- First submitted
- 13 Sep 2024
- Last updated
- 4 Mar 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Efficacy and Safety of Tislelizumab in Combination With Gemcitabine and Sequential Pemetrexed Radiotherapy for Patients With Primary Stage I-II NK/T-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT07450040
- Acronym / sponsor ID
- 2024071
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 12 Sep 2024 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 4 Mar 2026 (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.
In the past 10 years, there have been many effective explorations on the treatment of NK/TCL at home and abroad, which has innovated the treatment mode. Since ENKTCL-NT cells are sensitive to radiotherapy, radiotherapy is considered to be the most reliable treatment for ENKTCL-NT. Although patients with radiotherapy alone have excellent short-term efficacy and can achieve CR in 70-97% of patients, the 5-year PFS is only 30.5-61%, with a higher recurrence rate 5,6. The combination of chemotherapy and radiotherapy significantly improved the survival of patients compared with historical controls. Recent studies have shown that the advantage of radiotherapy combined with chemotherapy is that it can significantly reduce the later recurrence of patients with radiotherapy alone. However, the traditional synchronous chemotherapy and radiotherapy have many and serious adverse reactions and poor tolerance in patients, so it cannot be widely applied.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This study was conducted in patients with primary stage I-II NK/ T-cell lymphoma (subjects must have a measurable tumor lesion at baseline).
Key inclusion criteria (6 listed)
- Clinical diagnosis of NK/T cell lymphoma .
- Stage I/II patients .
- Age 18-70.
- ECOG score 0-2 points.
- Sign informed consent.
Key exclusion criteria (14 listed)
- Patients with HCV or HIV infection and HBV infection receiving antiviral therapy at the same time are not excluded.
- Complicated with severe infection requires ICU treatment.
- There are serious complications such as hemophagic syndrome, DIC, etc.
- Functional impairment of major organs.
- A history of autoimmune disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ORR
Time frame: At 14 weeks after treatment initiation
Objective Response Rate; The proportion of patients who achieved pre-specified tumor volume reduction and maintained the minimum time frame required by accepted response evaluation criteria, such as Solid Tumor RECIST Version 1.1.
1 secondary outcome
PFS
Time frame: up to 5 year
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 4 Mar 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ORR and OS, run by Eye & ENT Hospital of Fudan 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 14 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: enrolling by invitation, as of the sponsor's last update on 4 Mar 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: At 14 weeks after treatment initiation). 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 4 Mar 2026.