Extranodal NK/T-cell LymphomaPhase 2NCT07554482
Selinexor Combined With Reduced-Dose Radiotherapy For Early-Stage Extranodal NK/T-Cell Lymphoma
A Phase 2 study testing Pegaspargase (PEG) Asparaginase, Gemcitabine (GEM) and Oxaliplatin in people with Extranodal NK/T-cell Lymphoma, run by Beijing Tongren Hospital at 1 site in China.
Trial summary
Extranodal NK/T-cell lymphoma (ENKTCL) is an Epstein-Barr virus-associated non-Hodgkin lymphoma with high incidence in Asia and Latin America. Approximately 70% of patients present with early-stage (I-II) disease confined to the upper aerodigestive tract. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Extranodal NK/T-cell Lymphoma
- What is being tested?
- Pegaspargase (PEG) Asparaginase, Gemcitabine (GEM) and Oxaliplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2026to 30 Apr 2029
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 75 years, regardless of gender.
- Pathologically confirmed extranodal NK/T-cell lymphoma (ENKTCL).
- Ann Arbor stage I-II disease with primary lesion located in the nasal cavity or upper aerodigestive tract (UADT).
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
- Treatment-naïve patients with no prior radiotherapy, chemotherapy or targeted therapy.
- Adequate major organ function as follows:
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- Hematopoietic function: absolute neutrophil count (ANC) ≥1.5×10⁹/L, platelet count (PLT) ≥100×10⁹/L, hemoglobin (Hb) ≥90 g/L.
- Hepatic function: total bilirubin (TBIL) ≤1.5×upper limit of normal (ULN), alanine transaminase (ALT) / aspartate transaminase (AST) ≤2.5×ULN.
- Renal function: serum creatinine (Cr) ≤1.5×ULN, or creatinine clearance rate ≥60 mL/min.
- Cardiac function: left ventricular ejection fraction (LVEF) ≥50%.
- Expected overall survival ≥6 months.
- Voluntarily sign the written informed consent form.
Who cannot join
- Non-nasal type ENKTCL, or primary lesions outside the upper aerodigestive tract (UADT), including skin, gastrointestinal tract, lung and other sites.
- Patients with Ann Arbor stage III-IV disease.
- Central nervous system involvement.
- History of prior malignant tumors, excluding non-melanoma skin cancer or cervical carcinoma in situ cured for more than 5 years.
- Active infections, including active hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV) infection.
- Severe complications, such as uncontrolled diabetes mellitus and severe cardiopulmonary diseases.
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- Pregnant or lactating women.
- Hypersensitivity or contraindication to any investigational drugs in this study.
- Concurrent participation in other interventional clinical trials.
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
Beijing Tongren Hospital, Capital Medical University
Beijing, 100730
About this study
Official title: A Prospective, Single-Arm, Multicenter, Phase II Clinical Study of Selinexor Combined With Reduced-Dose Radiotherapy in the Treatment of Early-Stage Extranodal NK/T-Cell Lymphoma
Extranodal NK/T-cell lymphoma (ENKTCL) is an Epstein-Barr virus-associated non-Hodgkin lymphoma with high incidence in Asia and Latin America. Approximately 70% of patients present with early-stage (I-II) disease confined to the upper aerodigestive tract. Radiotherapy at 50-56 Gy is the standard curative treatment, but high-dose radiotherapy causes severe toxicities including oral mucositis and xerostomia, while radiotherapy alone yields high systemic recurrence rates. Previous studies have confirmed the efficacy of P-GEMOX induction chemotherapy, verified the feasibility of reduced-dose radiotherapy in patients achieving complete response after chemotherapy, and demonstrated the radiosensitizing effect of selinexor via inhibiting IRF3-BARD1-BRCA1-mediated DNA damage repair. Moreover, international evidence supports the efficacy of 40 Gy radiotherapy combined with chemotherapy. Accordingly, this study hypothesizes that selinexor combined with 40 Gy reduced-dose radiotherapy following P-GEMOX induction chemotherapy can achieve equivalent efficacy to standard-dose radiotherapy, while markedly decreasing radiotherapy-related toxicities. This trial innovatively applies selinexor as a radiosensitizer in ENKTCL, fulfills the unmet clinical demand for efficacy-preserving toxicity reduction, and is well supported by preliminary data.
Read the detailed description
Extranodal NK/T-cell lymphoma (ENKTCL) is a distinct subtype of Epstein-Barr virus (EBV)-associated non-Hodgkin lymphoma, which shows a prominent geographical predilection with high incidence in Asia and Latin America. Clinically, around 70% of patients are diagnosed with early-stage (stage I-II) disease, and most lesions are localized to the nasal cavity and upper aerodigestive tract (UADT). Radiotherapy at a standard dose of 50-56 Gy is recommended as the curative first-line treatment for early ENKTCL in international guidelines. Nevertheless, high-dose radiotherapy inevitably induces severe adverse events, including oral mucositis, xerostomia, hypothyroidism and dysphagia, which severely impair patients' long-term quality of life. In addition, radiotherapy alone remains unsatisfactory due to a high risk of systemic recurrence, which is the leading cause of treatment failure.
Accumulating preliminary evidence supports rational treatment de-escalation for early ENKTCL. Previous research has validated the favorable efficacy and safety of the P-GEMOX chemotherapy regimen. A multicenter retrospective study including 202 early ENKTCL patients demonstrated that 4-6 cycles of P-GEMOX followed by standard-dose radiotherapy achieved an 83.2% complete response (CR) rate, with 3-year progression-free survival (PFS) of 74.6% and overall survival (OS) of 85.2%. Another retrospective cohort of 144 post-chemotherapy CR patients further confirmed the feasibility of reduced-dose radiotherapy: no significant differences in PFS and OS were observed between ≤50 Gy and >50 Gy groups, while grade 3-4 mucositis was markedly reduced. Recent international data also verified the long-term efficacy of 40 Gy chemoradiotherapy.
Our team previously identified the radiosensitizing effect of selinexor in vitro. Experiments on SNK-6 and YT cell lines showed that selinexor significantly enhances radiosensitivity by inhibiting the IRF3-BARD1-BRCA1 DNA damage repair pathway and inducing dsRNA accumulation. Based on these foundations, we hypothesize that selinexor combined with 40 Gy reduced-dose radiotherapy after P-GEMOX induction chemotherapy can achieve non-inferior efficacy compared with conventional 50-56 Gy radiotherapy, while substantially alleviating radiotherapy toxicity. This study innovatively applies XPO1 inhibitor selinexor as a radiosensitizer in ENKTCL for the first time, establishes a precision dose-reduction strategy targeting DNA damage repair, addresses the unmet clinical need of toxicity reduction without compromising efficacy, and is highly feasible with solid preclinical and clinical supporting data.
- Conditions
- Extranodal NK/T-cell Lymphoma
- Being tested
- Pegaspargase (PEG) Asparaginase, Gemcitabine (GEM), Oxaliplatin, Selinexor, radiotherapy
- Keywords
- extranodal NK/T-cell lymphoma, selinexor, XPO1 inhibitor, radiotherapy, reduced-dose radiotherapy
- Medical subject headings
- Lymphoma, Extranodal NK-T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegaspargase (PEG) AsparaginaseDrug
Pegaspargase at a dose of 2500 IU/m² (maximum dose not exceeding 3750 IU) is administered via intramuscular injection on Day 1 of each 21-day cycle for a total of 4 cycles.
Gemcitabine (GEM)Drug
Gemcitabine 1000 mg/m² is given by intravenous infusion on Day 1 and Day 8 of each 21-day cycle for a total of 4 cycles.
OxaliplatinDrug
Oxaliplatin 130 mg/m² is administered intravenously on Day 1 of each 21-day cycle for a total of 4 cycles.
SelinexorDrug
Following induction chemotherapy, patients will receive consolidation therapy consisting of selinexor combined with reduced-dose radiotherapy. Selinexor 40 mg will be administered orally twice weekly (Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Selinexor will be given concurrently with radiotherapy for a total of 8 doses.
radiotherapyRadiation
ollowing induction chemotherapy, patients will receive consolidation therapy consisting of selinexor combined with reduced-dose radiotherapy. Radiotherapy will be delivered at a total dose of 40 Gy in 20 fractions (2 Gy per fraction), once daily, 5 fractions per week, over 4 weeks. Radiation therapy will be performed using intensity-modulated radiation therapy (IMRT) or volumetric modulated arc therapy (VMAT). The target volume includes the gross tumor volume (GTV) of the primary lesion before chemotherapy, with a clinical target volume (CTV) margin expansion of 1-2 cm.
| Study group | Role | What they receive |
|---|---|---|
| treatment arm | Experimental | Patients will first receive 4 cycles of P-GEMOX induction chemotherapy. Pegaspargase at a dose of 2500 IU/m² (maximum dose not exceeding 3750 IU) is administered via intramuscular injection on Day 1 of each 21-day cycle. Gemcitabine 1000 mg/m² is given by intravenous infusion on Day 1 and Day 8 of each 21-day cycle. Oxaliplatin 130 mg/m² is administered intravenously on Day 1 of each 21-day cycle. A total of 4 cycles will be completed.
Following induction chemotherapy, patients will receive consolidation therapy consisting of selinexor combined with reduced-dose radiotherapy. Radiotherapy will be delivered at a total dose of 40 Gy in 20 fractions (2 Gy per fraction), once daily, 5 fractions per week, over 4 weeks. Radiation therapy will be performed using intensity-modulated radiation therapy (IMRT) or volumetric modulated arc therapy (VMAT). The target volume includes the gross tumor volume (GTV) of the primary lesion before chemotherapy, with a clinical target volume (CTV) margin ex Receives: Drug: Pegaspargase (PEG) Asparaginase; Drug: Gemcitabine (GEM); Drug: Oxaliplatin; Drug: Selinexor; Radiation: radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response (CR) rate
CR was defined as complete response evaluated using MRI scan and PET-CT scan according to Lugano criteria.
Measured: From the day of initiation of treatment to 8 weeks after completion of radiotherapy.
Secondary outcomes (5)
Overall Response Rate (ORR)
Overall response rate means sum of complete response rate and partial response rate.
Measured: From the day of initiation of treatment to 8 weeks after completion of radiotherapy.
two-year PFS rate
PFS was defined from the date of initiation of treatment to the date fo confirmed disease progression or death of any reason
Measured: From the day of treatment as of 24 months
two-year OS rate
OS was defined from the date of initiation of treatment to the date fo death
Measured: From the day of initiation of treatment as of 24 months
two-year local control rate (LCR)
local control was defined as no local disease relapse or progression
Measured: From the day of initiation of treatment as of 24 months
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
measured using CTCAE version 5.0
Measured: From the day of initiation of treatment as of 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study start15 May 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extranodal NK/T-cell LymphomaStudies of the same condition, open and under way.
- More trials run by Beijing Tongren HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LIANG WANG, Beijing Tongren Hospital
- Investigators
- Liang Wang, Principal investigator, Beijing Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07554482
- Sponsor's protocol ID
- TRhos-NKTCL-XPO1
- Status last verified
- Apr 2026
- First submitted
- 21 Apr 2026
- Last updated
- 28 Apr 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 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Arm, Multicenter, Phase II Clinical Study of Selinexor Combined With Reduced-Dose Radiotherapy in the Treatment of Early-Stage Extranodal NK/T-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT07554482
- Acronym / sponsor ID
- TRhos-NKTCL-XPO1
- Conditions
- Extranodal NK/T-cell Lymphoma
- Keywords
- extranodal NK/T-cell lymphoma, selinexor, XPO1 inhibitor, radiotherapy, reduced-dose radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- 15 May 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 28 Apr 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.
Extranodal NK/T-cell lymphoma (ENKTCL) is an Epstein-Barr virus-associated non-Hodgkin lymphoma with high incidence in Asia and Latin America. Approximately 70% of patients present with early-stage (I-II) disease confined to the upper aerodigestive tract. Radiotherapy at 50-56 Gy is the standard curative treatment, but high-dose radiotherapy causes severe toxicities including oral mucositis and xerostomia, while radiotherapy alone yields high systemic recurrence rates. Previous studies have confirmed the efficacy of P-GEMOX induction chemotherapy, verified the feasibility of reduced-dose radiotherapy in patients achieving complete response after chemotherapy, and demonstrated the radiosensitizing effect of selinexor via inhibiting IRF3-BARD1-BRCA1-mediated DNA damage repair. Moreover, international evidence supports the efficacy of 40 Gy radiotherapy combined with chemotherapy. Accordingly, this study hypothesizes that selinexor combined with 40 Gy reduced-dose radiotherapy following P-GEMOX induction chemotherapy can achieve equivalent efficacy to standard-dose radiotherapy, while markedly decreasing radiotherapy-related toxicities. This trial innovatively applies selinexor as a radiosensitizer in ENKTCL, fulfills the unmet clinical demand for efficacy-preserving toxicity reduction, and is well supported by preliminary data.
Detailed description
Extranodal NK/T-cell lymphoma (ENKTCL) is a distinct subtype of Epstein-Barr virus (EBV)-associated non-Hodgkin lymphoma, which shows a prominent geographical predilection with high incidence in Asia and Latin America. Clinically, around 70% of patients are diagnosed with early-stage (stage I-II) disease, and most lesions are localized to the nasal cavity and upper aerodigestive tract (UADT). Radiotherapy at a standard dose of 50-56 Gy is recommended as the curative first-line treatment for early ENKTCL in international guidelines. Nevertheless, high-dose radiotherapy inevitably induces severe adverse events, including oral mucositis, xerostomia, hypothyroidism and dysphagia, which severely impair patients' long-term quality of life. In addition, radiotherapy alone remains unsatisfactory due to a high risk of systemic recurrence, which is the leading cause of treatment failure.
Accumulating preliminary evidence supports rational treatment de-escalation for early ENKTCL. Previous research has validated the favorable efficacy and safety of the P-GEMOX chemotherapy regimen. A multicenter retrospective study including 202 early ENKTCL patients demonstrated that 4-6 cycles of P-GEMOX followed by standard-dose radiotherapy achieved an 83.2% complete response (CR) rate, with 3-year progression-free survival (PFS) of 74.6% and overall survival (OS) of 85.2%. Another retrospective cohort of 144 post-chemotherapy CR patients further confirmed the feasibility of reduced-dose radiotherapy: no significant differences in PFS and OS were observed between ≤50 Gy and >50 Gy groups, while grade 3-4 mucositis was markedly reduced. Recent international data also verified the long-term efficacy of 40 Gy chemoradiotherapy.
Our team previously identified the radiosensitizing effect of selinexor in vitro. Experiments on SNK-6 and YT cell lines showed that selinexor significantly enhances radiosensitivity by inhibiting the IRF3-BARD1-BRCA1 DNA damage repair pathway and inducing dsRNA accumulation. Based on these foundations, we hypothesize that selinexor combined with 40 Gy reduced-dose radiotherapy after P-GEMOX induction chemotherapy can achieve non-inferior efficacy compared with conventional 50-56 Gy radiotherapy, while substantially alleviating radiotherapy toxicity. This study innovatively applies XPO1 inhibitor selinexor as a radiosensitizer in ENKTCL for the first time, establishes a precision dose-reduction strategy targeting DNA damage repair, addresses the unmet clinical need of toxicity reduction without compromising efficacy, and is highly feasible with solid preclinical and clinical supporting data.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment arm | Experimental | Drug: Pegaspargase (PEG) Asparaginase, Drug: Gemcitabine (GEM), Drug: Oxaliplatin, Drug: Selinexor, Radiation: radiotherapyPatients will first receive 4 cycles of P-GEMOX induction chemotherapy. Pegaspargase at a dose of 2500 IU/m² (maximum dose not exceeding 3750 IU) is administered via intramuscular injection on Day 1 of each 21-day cycle. Gemcitabine 1000 mg/m² is given by intravenous infusion on Day 1 and Day 8 of each 21-day cycle. Oxaliplatin 130 mg/m² is administered intravenously on Day 1 of each 21-day cycle. A total of 4 cycles will be completed. Following induction chemotherapy, patients will receive consolidation therapy consisting of selinexor combined with reduced-dose radiotherapy. Radiotherapy will be delivered at a total dose of 40 Gy in 20 fractions (2 Gy per fraction), once daily, 5 fractions per week, over 4 weeks. Radiation therapy will be performed using intensity-modulated radiation therapy (IMRT) or volumetric modulated arc therapy (VMAT). The target volume includes the gross tumor volume (GTV) of the primary lesion before chemotherapy, with a clinical target volume (CTV) margin ex |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Aged 18 to 75 years, regardless of gender.
- Pathologically confirmed extranodal NK/T-cell lymphoma (ENKTCL).
- Ann Arbor stage I-II disease with primary lesion located in the nasal cavity or upper aerodigestive tract (UADT).
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
- Treatment-naïve patients with no prior radiotherapy, chemotherapy or targeted therapy.
Key exclusion criteria (9 listed)
- Non-nasal type ENKTCL, or primary lesions outside the upper aerodigestive tract (UADT), including skin, gastrointestinal tract, lung and other sites.
- Patients with Ann Arbor stage III-IV disease.
- Central nervous system involvement.
- History of prior malignant tumors, excluding non-melanoma skin cancer or cervical carcinoma in situ cured for more than 5 years.
- Active infections, including active hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV) infection.
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 |
|---|---|---|
| Pegaspargase (PEG) AsparaginasePegaspargase at a dose of 2500 IU/m² (maximum dose not exceeding 3750 IU) is administered via intramuscular injection on Day 1 of each 21-day cycle for a total of 4 cycles. | Drug | treatment arm |
| Gemcitabine (GEM)Gemcitabine 1000 mg/m² is given by intravenous infusion on Day 1 and Day 8 of each 21-day cycle for a total of 4 cycles. | Drug | treatment arm |
| OxaliplatinOxaliplatin 130 mg/m² is administered intravenously on Day 1 of each 21-day cycle for a total of 4 cycles. | Drug | treatment arm |
| SelinexorFollowing induction chemotherapy, patients will receive consolidation therapy consisting of selinexor combined with reduced-dose radiotherapy. Selinexor 40 mg will be administered orally twice weekly (Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Selinexor will be given concurrently with radiotherapy for a total of 8 doses. | Drug | treatment arm |
| radiotherapyollowing induction chemotherapy, patients will receive consolidation therapy consisting of selinexor combined with reduced-dose radiotherapy. Radiotherapy will be delivered at a total dose of 40 Gy in 20 fractions (2 Gy per fraction), once daily, 5 fractions per week, over 4 weeks. Radiation therapy will be performed using intensity-modulated radiation therapy (IMRT) or volumetric modulated arc therapy (VMAT). The target volume includes the gross tumor volume (GTV) of the primary lesion before chemotherapy, with a clinical target volume (CTV) margin expansion of 1-2 cm. | Radiation | treatment arm |
Primary outcome
Complete response (CR) rate
Time frame: From the day of initiation of treatment to 8 weeks after completion of radiotherapy.
CR was defined as complete response evaluated using MRI scan and PET-CT scan according to Lugano criteria.
5 secondary outcomes
Overall Response Rate (ORR)
Time frame: From the day of initiation of treatment to 8 weeks after completion of radiotherapy.
two-year PFS rate
Time frame: From the day of treatment as of 24 months
two-year OS rate
Time frame: From the day of initiation of treatment as of 24 months
two-year local control rate (LCR)
Time frame: From the day of initiation of treatment as of 24 months
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: From the day of initiation of treatment as of 24 months
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 28 Apr 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.
Liang Wang principal investigator
Beijing Tongren Hospital
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 Pegaspargase (PEG) Asparaginase, Gemcitabine (GEM) and Oxaliplatin in people with Extranodal NK/T-cell Lymphoma, run by Beijing Tongren Hospital 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 12 inclusion and 9 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: opening soon, as of the sponsor's last update on 28 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 Liang Wang, M.D. (+861058266633, wangliangtrhos@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response (CR) rate (time frame: From the day of initiation of treatment to 8 weeks after completion of radiotherapy.). 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 28 Apr 2026.