Safety and EfficacyPhase 2NCT05008666
Induction Chemotherapy Sequential Sintilimab Combined With Dual Epigenetic Drugs for ENKTL-HLH
A Phase 2 study testing Sintilimab, Chidamide and Azacitidine in people with Safety and Efficacy, run by Sun Yat-sen University at 1 site in China.
Trial summary
ENKTL is a highly aggressive non-Hodgkin lymphoma closely related to EBV infection，and advanced patients often suffer from hemophagocytic lymphohistiocytosis (HLH). ENKTL-HLH lacks standard treatment and experiences a extremely poor prognosis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Safety and Efficacy
- What is being tested?
- Sintilimab, Chidamide and Azacitidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2021to 30 Apr 2023
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Volunteer to participate in clinical research; fully understand and know the research and sign the Informed Consent Form (ICF); willing to follow and have the ability to complete all trial procedures.
- The age at the time of signing the ICF is ≥18 years old and ≤75 years old.
- ENKTL confirmed by the research center histopathology and HLH conformed by the HLH-2004 diagnostic criteria.
- Available tumor tissue samples (10-15 unstained, fresh-frozen, paraffin-embedded [FFPE] glass slides) obtained from past or fresh coarse needle puncture or excision.
- Newly treated or refractory or relapsed ENKTL that has failed treatment with asparaginase-based chemotherapy or radiochemotherapy.
- HLH occurred for the first time.
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- Eastern cooperative oncology group score:0-2.
- Estimated survival≥3 months.
- There must be at least 1 evaluable or measurable lesion that meets the RECIL 2017 lymphoma standard [evaluable lesion: 18FDG/PET examination Shows increased local uptake in lymph nodes or extranodal areas (higher than liver) and PET and/or Computed Tomography (CT) features are consistent with lymphoma manifestations; measurable lesions: nodular lesions longer than 15mm or extranodal lesions longer diameter >10mm (if the only measurable lesion has received radiotherapy in the past, there must be evidence of imaging progression after radiotherapy) and accompanied by increased 18FDG uptake]. No measurable lesion and the diffuse increased 18FDG uptake in the liver would be excluded.
- Sufficient organ function, no serious heart, lung, kidney, thyroid dysfunction and immune deficiency:
- Hemoglobin ≥6 g/dL (no growth factor support or blood transfusion was used within 7 days before platelet measurement);
- Platelets ≥60×109/L (no growth factor support or blood transfusion was used within 7 days before platelet measurement);
- Serum creatinine ≤1.5 times the upper limit of normal (Upper Limit Normal, ULN), or creatinine clearance ≥40mL/min (estimated according to the Cockcroft-Gault formula);
- Serum total bilirubin ≤ 5 times ULN (unless it is confirmed to have Gilbert syndrome);
- Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) ≤10 times ULN;
- Coagulation function: International Normalized Ratio (INR)≤1.5 times ULN; Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT)≤1.5 times ULN; Fiber Fibrinogen (Fbg)>1.0g/L. (Unless the subject is receiving anticoagulant therapy and PT and APTT are within the expected range of anticoagulant therapy at the time of screening).
- Thyroid stimulating hormone (TSH) or free thyroxine (FT4) or free triiodothyronine (FT3) are within ±10% of the normal value.
- There is no evidence that the subject has difficulty breathing at rest, and the pulse oximetry value at rest is> 92%.
- The subject must pass a pulmonary function test (PFT) to confirm that the forced expiratory volume (FEV1)/forced vital capacity (FVC) in the first second is greater than 60%; the diffusion volume of carbon monoxide (DLCO), FEV1 and FVC are all exceeding the predicted value by 50 % Above; all PFT results must be obtained within 4 weeks before the first dose.
- Subjects who have received anti-tumor therapy in the past should return to the Common Terminology Criteria for Adverse Events (CTCAE) v4.03 rating score ≤ level 1 or baseline level after the toxicity of the previous treatment has been restored Entry into the group; The irreversible grade 2 toxicity (such as thrombocytopenia, anemia, neurotoxicity, hair loss and hearing loss) caused by previous anti-tumor treatments and is not expected to worsen during the study treatment period requires the consent of the investigator to be included in the group.
- Women of Childbearing Potential (WOBCP) must have a serum pregnancy test within 7 days before the first medication, and the result is negative; WOBCP or men and their WOBCP partners should agree from signing the ICF to the last dose Take effective contraceptive measures within 6 months after the study drug.
Who cannot join
- Invasive natural killer cell leukemia.
- Primary central nervous system lymphoma or secondary central nervous system involvement.
- Have received other anti-tumor therapy (including chemotherapy, immunotherapy, targeted therapy, and allowed to receive L-DEP or HLH-94/04 regimen for HLH).
- Have received allogeneic organ transplantation.
- Received allogeneic hematopoietic stem cell transplantation (allo-HSCT) within 3 years before study drug administration (Patients who have received allo-HSCT more than 3 years before study drug administration and currently have no graft-versus-host reaction can be included in the group).
- Participating in other clinical studies, or planning to start the treatment of this study is less than 4 weeks from the end of the previous clinical study.
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- An autologous hematopoietic stem cell transplantation(ASCT) was performed within 90 days.
- Received immune checkpoint inhibitors (anti-PD-1/PD-L1/CTLA-4 antibodies and other drugs) within half a year.
- Have received histone deacetylase inhibitor or DNA methyltransferase inhibitor treatment within 1 year before the study drug administration.
- Suffer from active autoimmune diseases that require systemic treatment in the past two years (glucocorticoid replacement therapy is not considered systemic treatment, such as type I diabetes, hypothyroidism that requires only thyroxine replacement therapy, only Patients with low adrenal function or hypopituitarism who need to receive physiological doses of glucocorticoid replacement therapy); patients with autoimmune diseases who do not require systemic treatment in the past two years can be included in the group.
- Subjects who need to receive systemic glucocorticoid therapy or other immunosuppressive therapy due to certain conditions within 14 days before starting the research treatment [Subjects are allowed to use topical, ocular, intra-articular, intranasal and inhaled types glucocorticoid therapy (very low systemic absorption); high-dose intravenous or oral glucocorticoid therapy for HLH is allowed; short-term (≤ 7 days) use of glucocorticoid for preventive treatment (such as contrast agent allergy) or for the treatment of non-autoimmune diseases (for example, delayed-type hypersensitivity reactions caused by contact allergens)].
- Suffered from other malignant tumors in the past 5 years, except for skin basal cell carcinoma, skin squamous cell carcinoma, breast carcinoma in situ and cervical carcinoma in situ that have undergone radical treatment.
- Received systemic anti-tumor therapy within 28 days before starting the study drug treatment, including chemotherapy, immunotherapy, biological therapy (tumor vaccine, cytokines, or growth factors), etc. [L-DEP or HLH-94/04 based regimens are allowed for HLH; G-CSF,IL-11, TPO, EPO therapy are allowed.
- Received major surgery within 28 days or radiation therapy within 90 days.
- Received traditional Chinese medicine or Chinese patent medicine treatment within 7 days.
- Vaccine live vaccines (except influenza attenuated vaccine) within 28 days.
- Human immunodeficiency virus (HIV) infection and/or acquired immunodeficiency syndrome.
- Patients with active chronic hepatitis B or active hepatitis C. In the screening period, patients who are positive for Hepatits B Surface Antigen (HBsAg) or Hepatitis C Virus (HCV) antibodies must pass the Hepatitis B Virus (HBV) DNA titer test (not allowed Higher than 2500 copies/mL or 500 IU/mL) and HCV RNA testing (not exceeding the lower limit of detection of the assay). After excluding the active hepatitis B or C infection that requires treatment, the test can be included . Carriers of hepatitis B virus, hepatitis B (DNA titer shall not be higher than 2500 copies/mL or 500 IU/mL) after drug treatment, and hepatitis C patients who have been cured can be included in the group.
- Active tuberculosis.
- Active fungal, bacterial and/or viral infections that require systemic treatment.
- Women who are pregnant or breastfeeding.
- People with a history of alcohol or drug abuse.
- Suffer from uncontrollable comorbid diseases, including but not limited to symptomatic congestive heart failure, acute and chronic liver failure, uncontrollable hypertension, unstable angina, active peptic ulcer or bleeding disorders.
- A history of interstitial lung disease or non-infectious pneumonia within 3 months before the start of the study treatment. Subjects who have previously had drug-induced or radioactive non-infectious pneumonia but asymptomatic are allowed to join the group.
- QTcF interval> 450 msec, unless it is secondary to bundle branch block.
- People with a history of mental illness; those who are incapacitated or restricted.
- According to the judgment of the investigator, the patient's basic condition may increase the risk of receiving study drug treatment, or cause confusion about the toxic reaction and its judgment.
- The investigator assessed that the patient was not suitable for participating in the study due to other conditions.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Medical Oncology,Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Huiqiang Huang, Professor, +86 020 87343350, huanghq@sysucc.org.cn
Huiqiang Huang
About this study
Official title: Induction Chemotherapy Sequential Sintilimab Combined With Dual Epigenetic Drugs (Chidamide and Azacitidine) in ENKTL-HLH: A Single-arm, Multi-center, Phase II, Exploratory Clinical Study
ENKTL is a highly aggressive non-Hodgkin lymphoma closely related to EBV infection，and advanced patients often suffer from hemophagocytic lymphohistiocytosis (HLH). ENKTL-HLH lacks standard treatment and experiences a extremely poor prognosis. Anti-PD-1 antibody has shown good anti-tumor activity in ENKTL and play a potential role in EBV-HLH. Epigenetic drugs have been confirmed to exert synergistic anti-tumor activity with anti-PD-1 antibody. We next further explore the efficacy and safety of Sintilimab sequential combination of epigenetic drugs in ENKTL-HLH.
- Conditions
- Safety and Efficacy
- Being tested
- Sintilimab, Chidamide, Azacitidine, L-DEP
- Keywords
- sintilimab, chidamide, azacitidine, Extranodal NK/T cell lymphoma, hemophagocytic lymphohistiocytosis
- Medical subject headings
- Lymphoma, Extranodal NK-T-Cell, Lymphohistiocytosis, Hemophagocytic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SintilimabDrug
- To evaluate the short-term objective efficacy of sintilimab Sequential combined with chidamide and azacitidine in the treatment of ENKTL-HLH patients.
- To evaluate the long-term efficacy and safety of sintilimab Sequential combined with chidamide and azacitidine in the treatment of ENKTL-HLH patients.
- Exploring biomarkers that may have predictive effects.
ChidamideDrug
- To evaluate the short-term objective efficacy of sintilimab Sequential combined with chidamide and azacitidine in the treatment of ENKTL-HLH patients.
- To evaluate the long-term efficacy and safety of sintilimab Sequential combined with chidamide and azacitidine in the treatment of ENKTL-HLH patients.
- Exploring biomarkers that may have predictive effects.
AzacitidineDrug
- To evaluate the short-term objective efficacy of sintilimab Sequential combined with chidamide and azacitidine in the treatment of ENKTL-HLH patients.
- To evaluate the long-term efficacy and safety of sintilimab Sequential combined with chidamide and azacitidine in the treatment of ENKTL-HLH patients.
- Exploring biomarkers that may have predictive effects.
L-DEPDrug
L-DEP
| Study group | Role | What they receive |
|---|---|---|
| L-DEP, Sintinimab+Chidamide, Sintinimab+Azacitidine | Experimental | 【L-DEP】
L-asparaginase: 2000U/m2 d5, im
Doxorubicin liposome: 25mg/m2 d1, ivd
Etoposide: 100mg/m2 d1, d8, d15, ivd
Methylprednisolone: 15mg/kg/day d1-3, 0.75mg/kg/day, d4-7, 0.25mg/kg/day, d8-14, ivd
【Sintinimab+Chidamide】
Sintinimab: 200mg，d1,ivd,q21d Chidamide：30mg biw, continued oral
【Sintinimab+Azacitidine】
Sintinimab:200mg，d1, ivd, q21d Azacitidine:75mg/m2, d1-d7, ih, q28d Receives: Drug: Sintilimab; Drug: Chidamide; Drug: Azacitidine; Drug: L-DEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR) after end of treatment
Assessed by the lymphoma response to immunomodulatory therapy criteria (LYRIC)
Measured: [Time Frame: up to 24 months]
Complete response rate (CRR) after end of treatment
Assessed by the lymphoma response to immunomodulatory therapy criteria (LYRIC)
Measured: [Time Frame: up to 24 months]
Partial response rate (PRR) after end of treatment
Assessed by the lymphoma response to immunomodulatory therapy criteria (LYRIC)
Measured: [Time Frame: up to 24 months]
Secondary outcomes (6)
Progression-Free Survival (PFS)
PFS is defined as the time from the treatment date to the date of disease progression per the RECIL 2017 Response Criteria for Malignant Lymphoma or death regardless of cause.
Measured: [Time Frame: Time Frame: up to 36 months]
Overall Survival (OS)
OS is defined as the time from treatment to the date of death.
Measured: [Time Frame: up to 36 months]
Duration of Response (DOR)
Among participants who experience an objective response, DOR is defined as the date of their first objective response (which is subsequently confirmed) to disease progression per the the lymphoma response to immunomodulatory therapy criteria (LYRIC) or death regardless of cause.
Measured: [Time Frame: up to 36 months]
Time to disease response (TTR)
Among participants who experience an objective response, TTR is defined as the date of their first administration to the day of their first objective response (which is subsequently confirmed) per the RECIL 2017 Response Criteria for Malignant Lymphoma.
Measured: [Time Frame: up to 36 months]
Time to progression (TTP)
Among all participants, TTP is defined as the date of their first administration to the day of disease progression per the RECIL 2017 Response Criteria for Malignant Lymphoma or death regardless of cause.
Measured: [Time Frame: Up to 36 months]
The frequency of adverse events (adverse events, AEs) and serious adverse events (SAEs)
An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAE were defined as AEs with onset during the treatment period or that are a consequence of a pre-existing condition that has worsened since baseline.
Measured: [Time Frame: Up to 36 months]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2021
- Study start1 Dec 2021 (estimated)
- Primary completion30 Nov 2022 (estimated)
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety and EfficacyStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huiqiang Huang, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05008666
- Sponsor's protocol ID
- SELEN
- Status last verified
- Aug 2021
- First submitted
- 14 Aug 2021
- Last updated
- 17 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induction Chemotherapy Sequential Sintilimab Combined With Dual Epigenetic Drugs (Chidamide and Azacitidine) in ENKTL-HLH: A Single-arm, Multi-center, Phase II, Exploratory Clinical Study
- ClinicalTrials.gov ID
- NCT05008666
- Acronym / sponsor ID
- SELEN
- Conditions
- Safety and Efficacy
- Keywords
- sintilimab, chidamide, azacitidine, Extranodal NK/T cell lymphoma, hemophagocytic lymphohistiocytosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 17 Aug 2021 (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.
ENKTL is a highly aggressive non-Hodgkin lymphoma closely related to EBV infection，and advanced patients often suffer from hemophagocytic lymphohistiocytosis (HLH). ENKTL-HLH lacks standard treatment and experiences a extremely poor prognosis. Anti-PD-1 antibody has shown good anti-tumor activity in ENKTL and play a potential role in EBV-HLH. Epigenetic drugs have been confirmed to exert synergistic anti-tumor activity with anti-PD-1 antibody. We next further explore the efficacy and safety of Sintilimab sequential combination of epigenetic drugs in ENKTL-HLH.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| L-DEP, Sintinimab+Chidamide, Sintinimab+Azacitidine | Experimental | Drug: Sintilimab, Drug: Chidamide, Drug: Azacitidine, Drug: L-DEP【L-DEP】 L-asparaginase: 2000U/m2 d5, im Doxorubicin liposome: 25mg/m2 d1, ivd Etoposide: 100mg/m2 d1, d8, d15, ivd Methylprednisolone: 15mg/kg/day d1-3, 0.75mg/kg/day, d4-7, 0.25mg/kg/day, d8-14, ivd 【Sintinimab+Chidamide】 Sintinimab: 200mg，d1,ivd,q21d Chidamide：30mg biw, continued oral 【Sintinimab+Azacitidine】 Sintinimab:200mg，d1, ivd, q21d Azacitidine:75mg/m2, d1-d7, ih, q28d |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Volunteer to participate in clinical research; fully understand and know the research and sign the Informed Consent Form (ICF); willing to follow and have the ability to complete all trial procedures.
- The age at the time of signing the ICF is ≥18 years old and ≤75 years old.
- ENKTL confirmed by the research center histopathology and HLH conformed by the HLH-2004 diagnostic criteria.
- Available tumor tissue samples (10-15 unstained, fresh-frozen, paraffin-embedded [FFPE] glass slides) obtained from past or fresh coarse needle puncture or excision.
- Newly treated or refractory or relapsed ENKTL that has failed treatment with asparaginase-based chemotherapy or radiochemotherapy.
Key exclusion criteria (28 listed)
- Invasive natural killer cell leukemia.
- Primary central nervous system lymphoma or secondary central nervous system involvement.
- Have received other anti-tumor therapy (including chemotherapy, immunotherapy, targeted therapy, and allowed to receive L-DEP or HLH-94/04 regimen for HLH).
- Have received allogeneic organ transplantation.
- Received allogeneic hematopoietic stem cell transplantation (allo-HSCT) within 3 years before study drug administration (Patients who have received allo-HSCT more than 3 years before study drug administration and currently have no graft-versus-host reaction can be included in the group).
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 |
|---|---|---|
| Sintilimab1. To evaluate the short-term objective efficacy of sintilimab Sequential combined with chidamide and azacitidine in the treatment of ENKTL-HLH patients. 2. To evaluate the long-term efficacy and safety of sintilimab Sequential combined with chidamide and azacitidine in the treatment of ENKTL-HLH patients. 3. Exploring biomarkers that may have predictive effects. | Drug | L-DEP, Sintinimab+Chidamide, Sintinimab+Azacitidine |
| Chidamide1. To evaluate the short-term objective efficacy of sintilimab Sequential combined with chidamide and azacitidine in the treatment of ENKTL-HLH patients. 2. To evaluate the long-term efficacy and safety of sintilimab Sequential combined with chidamide and azacitidine in the treatment of ENKTL-HLH patients. 3. Exploring biomarkers that may have predictive effects. | Drug | L-DEP, Sintinimab+Chidamide, Sintinimab+Azacitidine |
| Azacitidine1. To evaluate the short-term objective efficacy of sintilimab Sequential combined with chidamide and azacitidine in the treatment of ENKTL-HLH patients. 2. To evaluate the long-term efficacy and safety of sintilimab Sequential combined with chidamide and azacitidine in the treatment of ENKTL-HLH patients. 3. Exploring biomarkers that may have predictive effects. | Drug | L-DEP, Sintinimab+Chidamide, Sintinimab+Azacitidine |
| L-DEPL-DEP | Drug | L-DEP, Sintinimab+Chidamide, Sintinimab+Azacitidine |
Primary outcome
Objective response rate (ORR) after end of treatment
Time frame: [Time Frame: up to 24 months]
Assessed by the lymphoma response to immunomodulatory therapy criteria (LYRIC)
Complete response rate (CRR) after end of treatment
Time frame: [Time Frame: up to 24 months]
Assessed by the lymphoma response to immunomodulatory therapy criteria (LYRIC)
Partial response rate (PRR) after end of treatment
Time frame: [Time Frame: up to 24 months]
Assessed by the lymphoma response to immunomodulatory therapy criteria (LYRIC)
6 secondary outcomes
Progression-Free Survival (PFS)
Time frame: [Time Frame: Time Frame: up to 36 months]
Overall Survival (OS)
Time frame: [Time Frame: up to 36 months]
Duration of Response (DOR)
Time frame: [Time Frame: up to 36 months]
Time to disease response (TTR)
Time frame: [Time Frame: up to 36 months]
Time to progression (TTP)
Time frame: [Time Frame: Up to 36 months]
The frequency of adverse events (adverse events, AEs) and serious adverse events (SAEs)
Time frame: [Time Frame: Up to 36 months]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2021.
- Individual participant dataSharing planned: Undecided
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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.
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 Sintilimab, Chidamide and Azacitidine in people with Safety and Efficacy, run by Sun Yat-sen 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 21 inclusion and 28 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: status not confirmed, as of the sponsor's last update on 17 Aug 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huiqiang Huang, Professor (+86 020 87343350, huanghq@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) after end of treatment (time frame: [Time Frame: up to 24 months]). The study lists 3 primary outcomes in all. 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 17 Aug 2021.