A Phase 2 interventional study of Gemcitabine (GEM) and Etoposide Injection in Natural Killer/T-cell Lymphoma, sponsored by Fudan University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-17.
Sponsored by Fudan University · Phase 2, Interventional, and Treatment
This prospective, multicenter study evaluates a response-adapted treatment strategy for previously untreated patients with early-stage extranodal NK/T-cell lymphoma of the upper aerodigestive tract.
All participants receive two cycles of GELAD induction chemotherapy, followed by early response assessment using positron emission tomography/computed tomography (PET/CT) and plasma Epstein-Barr virus (EBV) DNA. Subsequent treatment is determined by the early response.
Participants with complete metabolic response and negative EBV DNA enter PART A and are randomized 1:1 to standard-dose radiotherapy (50 Gy) or reduced-dose radiotherapy (40 Gy); both groups subsequently receive two additional cycles of GELAD. Participants with partial response and negative EBV DNA enter PART B and receive standard 50 Gy radiotherapy followed by two additional cycles of GELAD. Participants with stable disease, local or regional progressive disease that remains amenable to curative radiotherapy, or partial response with positive EBV DNA enter PART C and receive 50 Gy radiotherapy followed by response-adapted sintilimab consolidation.
The primary objective of PART A is to determine whether reduced-dose radiotherapy is noninferior to standard-dose radiotherapy with respect to the 24-month progression-free survival rate. The primary objective of PART C is to evaluate the 24-month progression-free survival rate with response-adapted sintilimab consolidation in patients with a high-risk early response.
This is an investigator-initiated, prospective, multicenter, response-adapted master protocol for previously untreated patients with stage IE or IIE extranodal NK/T-cell lymphoma of the upper aerodigestive tract.
All enrolled participants first receive two 21-day cycles of GELAD induction chemotherapy consisting of gemcitabine, etoposide, pegaspargase, and dexamethasone. Early response assessment is performed 14 to 21 days after completion of the second GELAD cycle and includes whole-body PET/CT, quantitative plasma EBV DNA, contrast-enhanced MRI or CT of the primary site, and nasal endoscopy.
Participants are subsequently assigned to one of three response-defined modules.
PART A includes participants who achieve complete metabolic response on PET/CT and have negative plasma EBV DNA. These participants are randomized centrally in a 1:1 ratio, stratified by NRI 0-1 versus NRI 2 or higher, to receive either 50 Gy in 25 fractions (A0, standard-dose radiotherapy) or 40 Gy in 20 fractions (A1, reduced-dose radiotherapy). Both groups subsequently receive two additional cycles of GELAD. PART A is designed as a noninferiority comparison. The primary endpoint is the 24-month progression-free survival rate from randomization. The prespecified noninferiority margin for the absolute difference in PFS24 between A1 and A0 is -10 percentage points. A total of 280 participants are planned for randomization in PART A.
PART B includes participants with partial response on PET/CT and negative plasma EBV DNA. These participants are not randomized and receive 50 Gy in 25 fractions followed by two additional cycles of GELAD. PART B serves as a prospective standard-treatment platform cohort and has no formal primary hypothesis test.
PART C includes participants with stable disease, local or regional progressive disease that remains within a field amenable to curative radiotherapy, or partial response with persistent positive plasma EBV DNA after two cycles of GELAD. Participants with distant progression or progression to stage III or IV disease are considered to have induction failure and do not enter PART C. Participants in PART C receive 50 Gy in 25 fractions followed by sintilimab 200 mg intravenously every 3 weeks. Sintilimab is administered for at least 24 weeks. Treatment is discontinued when PET/CT complete metabolic response and plasma EBV DNA negativity have both been sustained for at least 24 weeks according to protocol-defined confirmation criteria. The maximum duration of sintilimab is 24 months or 35 cycles. PART C is a single-arm phase 2 module. Its primary endpoint is the 24-month progression-free survival rate from PART C module registration, evaluated against a prespecified null benchmark of 55%.
Approximately 620 participants are expected to be registered in the master protocol. Enrollment may be increased, based only on a blinded feasibility review of actual module-assignment proportions, to a maximum of 660 participants. Participants are followed every 3 months during the first 2 years after completion or discontinuation of protocol treatment, every 6 months during years 3 through 5, and annually thereafter.
270 studies on the registry are indexed under Lymphoma, Extranodal NK-T-Cell; 36 are open to participants now.
This study's planned enrollment of 620 is above the median of 33 across 225 interventional studies indexed under Lymphoma, Extranodal NK-T-Cell.
Browse Lymphoma, Extranodal NK-T-Cell studies →Fudan University is the lead sponsor of 1,315 studies on the registry; 643 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Adequate organ function, including:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants who achieve complete metabolic response on PET/CT and negative plasma EBV DNA after two cycles of GELAD are randomized to standard-dose intensity-modulated radiotherapy (IMRT), 50 Gy in 25 fractions, followed by two additional 21-day cycles of GELAD.
Drug: Gemcitabine (GEM) · Drug: Etoposide Injection · Drug: Dexamethasone · Drug: pegaspargase · Radiation: IMRT 50 Gy
Participants who achieve complete metabolic response on PET/CT and negative plasma EBV DNA after two cycles of GELAD are randomized to reduced-dose IMRT, 40 Gy in 20 fractions, followed by two additional 21-day cycles of GELAD.
Drug: Gemcitabine (GEM) · Drug: Etoposide Injection · Drug: Dexamethasone · Drug: pegaspargase · Radiation: IMRT 40 Gy
Participants with partial response on PET/CT and negative plasma EBV DNA after two cycles of GELAD receive IMRT, 50 Gy in 25 fractions, followed by two additional 21-day cycles of GELAD.
Drug: Gemcitabine (GEM) · Drug: Etoposide Injection · Drug: Dexamethasone · Drug: pegaspargase · Radiation: IMRT 50 Gy
Participants with stable disease, local or regional progressive disease that remains amenable to curative radiotherapy, or partial response with positive plasma EBV DNA after two cycles of GELAD receive IMRT, 50 Gy in 25 fractions, followed by sintilimab 200 mg intravenously every 3 weeks. Sintilimab is administered for at least 24 weeks and is discontinued after complete metabolic response and EBV DNA negativity have both been sustained for at least 24 weeks. The maximum duration is 24 months or 35 cycles.
Drug: Gemcitabine (GEM) · Drug: Etoposide Injection · Drug: Dexamethasone · Drug: pegaspargase · Radiation: IMRT 50 Gy · Drug: Sintilimab
Gemcitabine 1.0 g/m\^2 is administered intravenously on Day 1 of each 21-day GELAD cycle. All participants receive two induction cycles. Participants in PART A A0, PART A A1, and PART B receive two additional GELAD cycles after radiotherapy.
Etoposide 60 mg/m\^2 is administered intravenously on Days 1 through 3 of each 21-day GELAD cycle.
Dexamethasone 20 mg per day is administered intravenously on Days 1 through 4 of each 21-day GELAD cycle.
Pegaspargase 2000 U/m\^2, capped at 3750 U per dose, is administered intramuscularly on Day 1 of each 21-day GELAD cycle.
Intensity-modulated radiotherapy is delivered at a total dose of 50 Gy in 25 fractions, 2.0 Gy per fraction, 5 fractions per week.
Intensity-modulated radiotherapy is delivered at a total dose of 40 Gy in 20 fractions, 2.0 Gy per fraction, 5 fractions per week.
Sintilimab 200 mg is administered intravenously every 3 weeks after completion of radiotherapy in PART C. Treatment continues for at least 24 weeks. Sintilimab is discontinued when PET/CT complete metabolic response and plasma EBV DNA negativity have both been sustained for at least 24 weeks according to protocol-defined confirmation criteria. The maximum treatment duration is 24 months or 35 cycles.
24-Month Progression-Free Survival Rate in PART A
Progression-free survival (PFS) is measured from the date of PART A randomization to the first documented disease progression, relapse, or death from any cause, whichever occurs first. Participants without a PFS event are censored at the date of the last adequate disease assessment. The 24-month PFS rate will be estimated using the Kaplan-Meier method. The primary treatment effect is the absolute difference in PFS24 between A1 (40 Gy) and A0 (50 Gy), calculated as A1 minus A0. Noninferiority is concluded if the lower bound of the two-sided 95% confidence interval for this difference is greater than -10 percentage points.
Time frame: From PART A randomization through 24 months
24-Month Progression-Free Survival Rate in PART C
Progression-free survival (PFS) is measured from the date of PART C module registration, which occurs before radiotherapy, to the first documented disease progression, relapse, or death from any cause, whichever occurs first. Participants without a PFS event are censored at the date of the last adequate disease assessment. The 24-month PFS rate will be estimated using the Kaplan-Meier method and evaluated against the prespecified null benchmark of 55%.
Time frame: From PART C module registration through 24 months
Percentage of Participants With Complete Response at the End of Treatment
Complete response is assessed according to the Lugano 2014 response criteria. Participants who are not evaluable at the protocol-defined end-of-treatment assessment are considered not to have achieved complete response in the primary analysis.
Time frame: At the protocol-defined end-of-treatment assessment, approximately 6 weeks plus or minus 2 weeks after the final protocol treatment
Percentage of Participants With an Overall Response at the End of Treatment
Overall response is defined as complete response or partial response according to the Lugano 2014 response criteria.
Time frame: At the protocol-defined end-of-treatment assessment, approximately 6 weeks plus or minus 2 weeks after the final protocol treatment
Overall Survival
Overall survival is defined as the time from the first GELAD dose to death from any cause. Participants who are alive are censored at the date they were last known to be alive.
Time frame: From the first GELAD dose through 60 months
Locoregional Control Rate at 12, 24, and 36 Months
Description: Locoregional failure is defined as recurrence or progression within the primary radiotherapy region, involved cervical nodal region, or adjacent locoregional region. Locoregional control rates will be estimated at prespecified time points.
Time frame: At 12, 24, and 36 months after module assignment
Percentage of Baseline EBV DNA-Positive Participants Achieving Confirmed Plasma EBV DNA Clearance
Plasma EBV DNA below 500 copies/mL is defined as negative. Confirmed clearance is defined as conversion from positive to negative plasma EBV DNA with at least two consecutive negative measurements separated by at least 2 weeks.
Time frame: From the first GELAD dose through 24 months
Number of Participants With Adverse Events as Assessed by CTCAE Version 5.0
Adverse events, serious adverse events, grade 3 or higher adverse events, treatment-related adverse events, treatment discontinuations due to toxicity, and treatment-related deaths will be collected. Radiation-related acute and late toxicities and immune-related adverse events in PART C will be specifically evaluated.
Time frame: From the first study treatment through the protocol-defined safety follow-up after the final study treatment, up to approximately 26 months
Percentage of PART C Participants in Treatment-Free Remission at 24 Months
Treatment-free remission at 24 months is defined as being alive and progression-free at 24 months after PART C module registration, having discontinued sintilimab for at least 6 months, and having received no additional anticancer therapy after discontinuation.
Time frame: 24 months after PART C module registration
Plan to share: Undecided — De-identified individual participant data underlying the published study results may be made available to qualified researchers following submission and approval of a scientifically justified research proposal and execution of an appropriate data-use agreement.
Start is estimated for Sep 2026; primary completion for Jun 2033, 81 months later.
Of 39 phase 2 interventional studies under Lymphoma, Extranodal NK-T-Cell, half reached primary completion within 64 months of starting (the median), counting those still running; a quarter within 45 and three quarters within 99. This study's planned 81 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Sintilimab
Lymphoma, Extranodal NK-T-Cell →