Natural Killer/T-Cell Lymphoma, Nasal and Nasal-TypeNCT04366128
Camrelizumab, Pegaspargase and Apatinib With Radiation Therapy for Stage IE/IIE ENKTL
A study testing CAPA indution immunotherapy in people with Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type, run by Rong Tao at 3 sites in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of camrelizumab, apatinib, pegaspargase (CAPA) and as an intruction immunotherapy with radiotherapy as first-line treatment in patients with de novo stage IE/IIE extranodal natural killer/T-cell lymphoma, nasal type. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type
- What is being tested?
- CAPA indution immunotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 3 sitesChina
- Study dates
- 25 Apr 2020to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who meet the WHO 2016 diagnostic criteria for NK/T-cell lymphoma by biopsy histopathology, immunohistochemistry and EBER.
- The primary site is in the nasal cavity or upper gastrointestinal tract. The de novo diagnosed patient has at least one objective and evaluable lesion.
- Stage IE / IIE disease according to Lugano 2014 lymphoma staging system.
- ECOG score 0-3.
- The laboratory examination within 1 week before entering the group meets the following conditions:
- Blood routine test: neutrophil count≥1.0 × 10^9/L, Hemoglobin≥80g/L, Platelet≥50 × 10^9/L.
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- Coagulation routine: plasma fibrinogen ≥ 1.0g / L.
- Liver function: Alanine aminotransferase, aspartate aminotransferase and total bilirubin ≤ 2 times the upper limit of normal value.
- Renal function: Creatinine is normal.
- Refers to oxygen saturation> 93%.
- Cardiac function: Left ventricular ejection fraction ≥50%, electrocardiogram does not suggest any acute myocardial infarction, arrhythmia or atrioventricular block above 1 degree
- Signed informed consent.
- Voluntarily follow the research protocol, follow-up plan, laboratory and auxiliary examinations.
Who cannot join
- accompanied with HCV or HIV infection, HBV-infected patients who also receive antiviral treatment are not excluded.
- Severe infection requires ICU treatment.
- Serious complications such as hemophagocytic syndrome, DIC, etc.
- Impairment of important organ functions: such as respiratory failure, chronic congestive heart failure with NYHA grade ≥3, decompensated liver or kidney dysfunction, hypertension and diabetes that cannot be controlled despite active treatment.
- Have a history of autoimmune diseases, have disease activity in the last 6 months, and are still taking oral immunosuppressive therapy within the past three months, with a daily dose of oral prednisone greater than 10 mg.
- Pregnant and lactating women.
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- Those who are known to be allergic to drugs in the CAPA regimen.
- Patients with other tumors who need surgery or chemotherapy within 6 months.
- Other experimental drugs are being used.
- The investigators believe that other clinical conditions (including medical history or the presence of comorbidities) of the patient will significantly increase the risk of the subject when using the study treatment drugs.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Sun Yat-sen University
Guangzhou, Guangdong, 510060
Shanghai Eye Ear Nose and Throat Hospital, Fudan University
Shanghai, Shanghai Municipality, 200000
Department of Hematology, Xinhua hospital
Shanghai, Shanghai Municipality, 200092
About this study
Official title: Camrelizumab, Pegaspargase and Apatinib With Radiation Therapy for Stage IE/IIE Natural Killer /T-cell Lymphoma
The purpose of this study is to evaluate the efficacy and safety of camrelizumab, apatinib, pegaspargase (CAPA) and as an intruction immunotherapy with radiotherapy as first-line treatment in patients with de novo stage IE/IIE extranodal natural killer/T-cell lymphoma, nasal type.
Read the detailed description
Extranodal natural killer/T-cell lymphoma (ENKTCL), nasal type, is a rare subtype of non-Hodgkin lymphoma (NHL) with relatively high incidence in China. Radiotherapy alone for stage IE/IIE diseases has good response rate but with high relapse rates, ranging from 20-50%. The combination of chemotherapy and radiotherapy improved the long-term survival for patients with stage IE/IIE diseases. But the optimal treatment schedule has not been established. This study is designed with four cycles CAPA induction immunotherapy, followed by 50-56Gy radiotherapy as an approach for stage IE/IIE ENKTCL. The efficacy and safety of this treatment will be measured.
- Being tested
- CAPA indution immunotherapy
- Keywords
- camrelizumab, apatinib, pegaspargase, radiotherapy, natural killer/T-cell lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAPA indution immunotherapyDrug
Also called Radiotherapy
- Camelirumab 200mg Intravenous injection on day 1.
- Apatinib 250mg taken orally once daily.
- Pegaspargase 2000U/m2 Intramuscular injection on day 1.
| Study group | Role | What they receive |
|---|---|---|
| CAPA indution immunotherapy | Experimental | CAPA regimen, repeat every 3 week for 4 cycles. Receives: Drug: CAPA indution immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of complete response at week 24
Rate of patients with complete response (CR) at week 24 evaluate by Lugano 2014 criteria
Measured: 24 weeks
Secondary outcomes (4)
Rate of overall response rate at week 24
Rate of patients with complete response and partial response (ORR) at week 24 evaluate by Lugano 2014 criteria
Measured: 24 weeks
Rate of overall survival at 2 years
overall survival rate (OS) of patients at 2 years
Measured: 2 years
Rate of progression free survival at 2 years
progression free survival rate (PFS) of patients at 2 years
Measured: 2 years
percent of adverse events
adverse events graded by NCI CTCAE Ver4.03
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start25 Apr 2020
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Camrelizumab, apatinib and pegaspargase
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rong Tao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rong Tao, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Rong Tao, MD, Principal investigator, Xinhua Hospital, Shanghai Jiaotong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04366128
- Sponsor's protocol ID
- XHLSG-NK-1902
- Status last verified
- Jul 2026
- First submitted
- 25 Apr 2020
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Camrelizumab, Pegaspargase and Apatinib With Radiation Therapy for Stage IE/IIE Natural Killer /T-cell Lymphoma
- ClinicalTrials.gov ID
- NCT04366128
- Acronym / sponsor ID
- XHLSG-NK-1902
- Keywords
- camrelizumab, apatinib, pegaspargase, radiotherapy, natural killer/T-cell lymphoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Rong TaoUniversity, hospital or other
- Study start
- 25 Apr 2020 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 28 Apr 2020 (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.
The purpose of this study is to evaluate the efficacy and safety of camrelizumab, apatinib, pegaspargase (CAPA) and as an intruction immunotherapy with radiotherapy as first-line treatment in patients with de novo stage IE/IIE extranodal natural killer/T-cell lymphoma, nasal type.
Detailed description
Extranodal natural killer/T-cell lymphoma (ENKTCL), nasal type, is a rare subtype of non-Hodgkin lymphoma (NHL) with relatively high incidence in China. Radiotherapy alone for stage IE/IIE diseases has good response rate but with high relapse rates, ranging from 20-50%. The combination of chemotherapy and radiotherapy improved the long-term survival for patients with stage IE/IIE diseases. But the optimal treatment schedule has not been established. This study is designed with four cycles CAPA induction immunotherapy, followed by 50-56Gy radiotherapy as an approach for stage IE/IIE ENKTCL. The efficacy and safety of this treatment will be measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Camrelizumab, apatinib and pegaspargase
| Arm | Type | Receives |
|---|---|---|
| CAPA indution immunotherapy | Experimental | Drug: CAPA indution immunotherapyCAPA regimen, repeat every 3 week for 4 cycles. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients who meet the WHO 2016 diagnostic criteria for NK/T-cell lymphoma by biopsy histopathology, immunohistochemistry and EBER.
- The primary site is in the nasal cavity or upper gastrointestinal tract. The de novo diagnosed patient has at least one objective and evaluable lesion.
- Stage IE / IIE disease according to Lugano 2014 lymphoma staging system.
- ECOG score 0-3.
- The laboratory examination within 1 week before entering the group meets the following conditions:
Key exclusion criteria (10 listed)
- accompanied with HCV or HIV infection, HBV-infected patients who also receive antiviral treatment are not excluded.
- Severe infection requires ICU treatment.
- Serious complications such as hemophagocytic syndrome, DIC, etc.
- Impairment of important organ functions: such as respiratory failure, chronic congestive heart failure with NYHA grade ≥3, decompensated liver or kidney dysfunction, hypertension and diabetes that cannot be controlled despite active treatment.
- Have a history of autoimmune diseases, have disease activity in the last 6 months, and are still taking oral immunosuppressive therapy within the past three months, with a daily dose of oral prednisone greater than 10 mg.
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 |
|---|---|---|
| CAPA indution immunotherapyAlso: Radiotherapy1. Camelirumab 200mg Intravenous injection on day 1. 2. Apatinib 250mg taken orally once daily. 3. Pegaspargase 2000U/m2 Intramuscular injection on day 1. | Drug | CAPA indution immunotherapy |
Primary outcome
Rate of complete response at week 24
Time frame: 24 weeks
Rate of patients with complete response (CR) at week 24 evaluate by Lugano 2014 criteria
4 secondary outcomes
Rate of overall response rate at week 24
Time frame: 24 weeks
Rate of overall survival at 2 years
Time frame: 2 years
Rate of progression free survival at 2 years
Time frame: 2 years
percent of adverse events
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Rong Tao, MD principal investigator
Xinhua Hospital, Shanghai Jiaotong University School of Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAPA indution immunotherapy in people with Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type, run by Rong Tao at 3 sites 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 13 inclusion and 10 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: finished, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of complete response at week 24 (time frame: 24 weeks). 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 3 Aug 2026.