Efficacy and Safety of Tislelizumab Combined With Gemcitabine and Peraspartase in the Treatment o… (NCT07450040) | Clinical Trial Compass
By InvitationNot Applicable
Efficacy and Safety of Tislelizumab Combined With Gemcitabine and Peraspartase in the Treatment of Patients With Primary Stage I-II NK/T Cell Lymphoma
China60 participantsStarted 2024-09-12
Plain-language 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. 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.