Non-squamous Non-small Cell Lung CancerPhase 3NCT03992885
Clinical Study of Combination Therapy With Ectiecinib, Pemetrexed and Platinum in Patients With Metastatic Non-squamous Non-small Cell Lung Cancer With EGFR Mutations.
A Phase 3 study testing Icotinib in people with Non-squamous Non-small Cell Lung Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This single-arm, open, multicenter clinical study is going to evaluate the efficacy and safety of combination therapy with ectiecinib, pemetrexed and platinum in patients with metastatic non-squamous non-small cell lung cancer with EGFR mutations who did not progress after pemetrexed in combination with platinum-based… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-squamous Non-small Cell Lung Cancer
- What is being tested?
- Icotinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2019to 1 Aug 2025
- Phase
- Phase 3
- 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
- Age 18-75;
- Expected survival is at least 12 weeks;
- Metastatic non-squamous non-small cell lung cancer with EGFR mutations confirmed by histological or cytological examination;
- Received two cycles of pemetrexed/platinum chemotherapy with no progress (efficacy was evaluated as SD or PR);
- Tumor specimens must be provided before patients receive ectinib combined chemotherapy to complete the EGFR gene test. There is no need to clarify the EGFR mutation status before the initial pemetrexed/platinum chemotherapy;
- Volunteers who participate in exploratory studies need provide tumor samples for the laboratory to complete the study on anti-tumor drug sensitivity of microfluidic chip technology;
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- Volunteers who participate in exploratory studies need provide blood samples to complete the analysis of blood biomarkers and disease progression/anti-tumor efficacy, tolerance and safety of drugs;
- 0-1 ECOG score;
- Patients may have a history of brain parenchymal metastasis, and local treatment (surgery and/or radiotherapy) is required for good control of symptoms, and hormone maintenance therapy is not required;
- According to RECIST criteria 1.1, there is at least one measurable lesion that has not been irradiated:1) if there is at least one measurable lesion, and if there is only one lesion, the nature of new organisms at the lesion site must be confirmed by cytology or histology;2) for patients with at least one lesion diameter that can be accurately measured by any of the following methods, computed tomography (CT) or magnetic resonance (MRI) of chest or abdomen, the diameter of which should be at least 20mm by conventional methods or at least 10mm by spiral CT;
- The level of organ function must meet the following requirements:1) bone marrow: median granulocyte absolute count (ANC) ≥1.5×109/L, platelet ≥100×109/L, hemoglobin ≥9 g/dL;2) liver: serum bilirubin ≤1.5 times the upper limit of normal value, aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤2.5 times the upper limit of normal value (ALT ≤ 5 times the upper limit of normal value if there is liver metastasis);3) upper limit of serum creatinine <1.5 times normal value;Creatinine clearance ≥50 mL/min (calculated by cockroft-gault10 formula) for patients with low body weight or patients with significantly different values calculated by the two formulas, it is recommended to measure creatinine clearance by other methods, such as EDTA method, inulin clearance method, or 24-hour urinalysis.4) international standardized ratio of prothrombin time (INR) ≤1.5 and partial thrombin time (APTT) ≤1.5 upper limit of normal value in patients who have not received anticoagulation therapy.Patients receiving full or parenteral anticoagulant therapy can enter the clinical trial as long as the dose of anticoagulant is stable for at least 2 weeks before entering the clinical study and the results of coagulation test are within the limits of local treatment.
- Women of reproductive age must have negative serum pregnancy test results within 7 days prior to treatment;All enrolled patients (male or female) should take adequate barrier contraception during and within 4 weeks after treatment;
- Patients must be able to understand and sign informed consent voluntarily, prior to any trial procedures.
Who cannot join
- Previous EGFR-TKIs targeted drug therapy;
- Allergic history or hypersensitivity history of patients to active ingredients or non-active excipients of experimental drugs, drugs with chemical structure similar to experimental drugs, or similar drugs of experimental drugs;
- Known CYP inhibitors or inducers, such as phenytoin, carbamazepine, rifampicin, barbiturate, or st. John's wort, are currently being used (or cannot be discontinued within 1 week prior to the first administration);
- Patient's organs and systems:1) patients with brain/meningeal metastasis (except those who do not need hormone maintenance therapy after local treatment for brain parenchymal metastasis is controlled);2) having had interstitial lung disease, drug-induced interstitial disease, radiation pneumonia requiring hormone therapy, or any active interstitial lung disease with clinical evidence, and having had idiopathic pulmonary fibrosis on CT scan at baseline;Uncontrolled massive pleural or pericardial effusion;3) evidence of serious or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, heart, liver or kidney disease), as determined by the investigator;4) any unstable systemic disease (including active >CTCAE grade 2 clinical severe infection, grade 4 hypertension, unstable angina pectoris, congestive heart failure, human immunodeficiency virus (HIV) infection, liver, kidney or metabolic disease);5) any other malignancy (other than fully cured cervical carcinoma in situ or basal or squamous cell skin cancer) within 5 years;6) a clear history of neurological or psychiatric disorders, including epilepsy or dementia;7) patients with a history of allogeneic organ transplantation;Patients who underwent major surgery or suffered severe trauma within 4 weeks prior to first administration;8) more than 30% of the experimental drugs received extensive radiotherapy or bone marrow radiotherapy within 4 weeks before the first administration;
- Any conditions that affect the swallowing or absorption of medications, such as refractory nausea and vomiting, inability to swallow test medications, history of any type of gastrointestinal tract resection or surgery;
- Pregnant or lactating females (males and females participating in this study must take adequate barrier contraceptive measures during and within 4 weeks after the end of the study);
- Existing substance abuse and medical, psychological or social conditions that may interfere with patients participating in or evaluating research results;
- Any unstable or potentially compromising patient safety and compliance with the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Pulmonary Medical Oncology, Tianjin Medical University Cancer Hospital
Tianjin, Tianjin Municipality, 300060
Peng Chen, M.D., +86-22-23340123 ext. 3201, chenpengdoc@sina.com
Peng Chen, M.D.
About this study
Official title: Combination Therapy With Ectiecinib, Pemetrexed and Platinum in Patients With Metastatic Non-squamous Non-small Cell Lung Cancer With EGFR Mutations Who Did Not Progress After Pemetrexed in Combination With Platinum-based Chemotherapy:a Single-arm, Open, Multicenter Clinical Study.
This single-arm, open, multicenter clinical study is going to evaluate the efficacy and safety of combination therapy with ectiecinib, pemetrexed and platinum in patients with metastatic non-squamous non-small cell lung cancer with EGFR mutations who did not progress after pemetrexed in combination with platinum-based chemotherapy.
Read the detailed description
The positive rate of EGFR mutations in lung adenocarcinoma patients is about 50% in both Asian population and China.Domestic and international clinical studies have found that targeted therapy combination chemotherapy can prolong the overall survival of patients with EGFR mutations, and a large number of class 2A evidences have been recommended.The 2018 CSCO lung cancer guidelines recommend EGFR-TKIs combined with chemotherapy for first-line treatment of advanced EGFR mutant NSCLC (grade II recommended).The independently developed ectinib in China, belong to EGFR-TKIs as gefitinib and erlotinib . The results of phase III clinical trial (ICOGEN) showed that the efficacy of ectinib and gefitinib was similar, but in terms of safety, the adverse reactions of the ectinib group were significantly lower than that of the gefitinib group, and the difference between the two groups was statistically significant.Targeted combination chemotherapy has relatively large side effects, which will increase chemotherapy-related side effects, mainly hematological toxicity. Foreign studies suggest that combination therapy may be more suitable for patients with good basic state.Based on previous studies, this study is going to use the strategy of short-term induction chemotherapy and drug sensitivity platform to find the most suitable patients for combined therapy.
This single-arm, open, multicenter clinical study is going to evaluate the efficacy and safety of combination therapy with ectiecinib, pemetrexed and platinum in patients with metastatic non-squamous non-small cell lung cancer with EGFR mutations who did not progress after pemetrexed in combination with platinum-based chemotherapy.
Patients received two cycles of chemotherapy with pemetrexed/platinum before enrolling, followed by ectinib: ectinib 125mg/ tablet, one tablet at a time, three times a day, take orally, until disease progression;Pemetrexed 500mg/m2, intravenously administered on day 1;Carboplatin AUC6/ Cisplatin 75mg/m2,intravenously on day 1,21 days for a cycle, a total of 6 cycles.Maintenance therapy: ectinib: ectinib 125mg/ tablet, one tablet at a time, three times a day, take orally, pemetrexed 500mg/m2, intravenously on day 1,21 days for a cycle, until disease progression.Make detailed records of toxic and side effects during medication.The efficacy was evaluated using RESIST standard after every 2 cycles of the treatment, the regimen will continue until the disease progression or the appearance of not tolerable toxicity.
- Conditions
- Non-squamous Non-small Cell Lung Cancer
- Being tested
- Icotinib
- Keywords
- the combination therapy of targeted therapy and chemotherapy, metastatic non-squamous non-small cell lung cancer with EGFR mutations, ectiecinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IcotinibDrug
Also called Pemetrexed, platinum
Intervention: Drug: Icotinib Ectinib 125mg/ tablet, one tablet at a time, three times a day, take orally
Intervention: Drug: Carboplatin/ Cisplatin Pemetrexed 500mg/m2, intravenous infusion, day 1;Carboplatin AUC6/ Cisplatin 75mg/m2,intravenous infusion, day 1,21 days for a cycle
| Study group | Role | What they receive |
|---|---|---|
| combination therapy with ectiecinib, pemetrexed and platinum | Experimental | ectinib 125mg/ tablet, one tablet at a time, three times a day, take orally;Pemetrexed 500mg/m2, intravenous infusion, day 1;Carboplatin AUC6/ Cisplatin 75mg/m2,intravenous infusion, day 1,21 days for a cycle, a total of 6 cycles.Maintenance therapy: ectinib: ectinib 125mg/ tablet, one tablet at a time, three times a day, take orally, pemetrexed 500mg/m2,d intravenous infusion, day 1,21 days for a cycle Receives: Drug: Icotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progress free survival
PFS was defined as the length of time from the date of randomization to the date of disease progression was first observed (as determined by imaging), and the number of days from the date of randomization to death if the patient died of other causes before the disease progression.
Measured: 5 years
Overall survival
OS was defined as the length of time from the date of randomization to death from any cause.Patients who are alive as of the date of analysis will have their last contact as the cut-off date.
Measured: 5 years
Secondary outcomes (2)
Objective response rate
Objective response rate was defined as the percentage of patients whose tumor shrinkage has reached a certain point and remains there for a certain period of time, including cases of complete response and partial response.
Measured: 5 years
Adverse Events
Adverse events are unforeseeable medical conditions or deterioration of pre-existing medical conditions that occur during or after the use of a drug, regardless of whether it is related to the drug in question.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2019
- Study start1 Jul 2019 (estimated)
- Primary completion1 Jul 2020 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Non-squamous Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- EGFR-positive patients with metastatic non-squamous non-small cell lung cancer who did not progress after pemetrexed combined with platinum chemotherapy
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peng Chen, M.D., Principal investigator, Department of Pulmonary Medical Oncology, Tianjin Medical University Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03992885
- Sponsor's protocol ID
- E2019161
- Status last verified
- Jun 2019
- First submitted
- 19 Jun 2019
- Last updated
- 20 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mehic B, Duranovic Rayan L, Bilalovic N, Dohranovic Tafro D, Pilav I. Lung adenocarcinoma mimicking pulmonary fibrosis-a case report. BMC Cancer. 2016 Sep 13;16(1):729. doi: 10.1186/s12885-016-2763-6.
PubMed 27619516Inoue A, Kobayashi K, Maemondo M, Sugawara S, Oizumi S, Isobe H, Gemma A, Harada M, Yoshizawa H, Kinoshita I, Fujita Y, Okinaga S, Hirano H, Yoshimori K, Harada T, Saijo Y, Hagiwara K, Morita S, Nukiwa T; North-East Japan Study Group. Updated overall survival results from a randomized phase III trial comparing gefitinib with carboplatin-paclitaxel for chemo-naive non-small cell lung cancer with sensitive EGFR gene mutations (NEJ002). Ann Oncol. 2013 Jan;24(1):54-9. doi: 10.1093/annonc/mds214. Epub 2012 Sep 11.
PubMed 22967997
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination Therapy With Ectiecinib, Pemetrexed and Platinum in Patients With Metastatic Non-squamous Non-small Cell Lung Cancer With EGFR Mutations Who Did Not Progress After Pemetrexed in Combination With Platinum-based Chemotherapy:a Single-arm, Open, Multicenter Clinical Study.
- ClinicalTrials.gov ID
- NCT03992885
- Acronym / sponsor ID
- E2019161
- Conditions
- Non-squamous Non-small Cell Lung Cancer
- Keywords
- the combination therapy of targeted therapy and chemotherapy, metastatic non-squamous non-small cell lung cancer with EGFR mutations, ectiecinib
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 1 Jul 2019 (estimated)
- Primary completion
- 1 Jul 2020 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 20 Jun 2019 (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.
This single-arm, open, multicenter clinical study is going to evaluate the efficacy and safety of combination therapy with ectiecinib, pemetrexed and platinum in patients with metastatic non-squamous non-small cell lung cancer with EGFR mutations who did not progress after pemetrexed in combination with platinum-based chemotherapy.
Detailed description
The positive rate of EGFR mutations in lung adenocarcinoma patients is about 50% in both Asian population and China.Domestic and international clinical studies have found that targeted therapy combination chemotherapy can prolong the overall survival of patients with EGFR mutations, and a large number of class 2A evidences have been recommended.The 2018 CSCO lung cancer guidelines recommend EGFR-TKIs combined with chemotherapy for first-line treatment of advanced EGFR mutant NSCLC (grade II recommended).The independently developed ectinib in China, belong to EGFR-TKIs as gefitinib and erlotinib . The results of phase III clinical trial (ICOGEN) showed that the efficacy of ectinib and gefitinib was similar, but in terms of safety, the adverse reactions of the ectinib group were significantly lower than that of the gefitinib group, and the difference between the two groups was statistically significant.Targeted combination chemotherapy has relatively large side effects, which will increase chemotherapy-related side effects, mainly hematological toxicity. Foreign studies suggest that combination therapy may be more suitable for patients with good basic state.Based on previous studies, this study is going to use the strategy of short-term induction chemotherapy and drug sensitivity platform to find the most suitable patients for combined therapy.
This single-arm, open, multicenter clinical study is going to evaluate the efficacy and safety of combination therapy with ectiecinib, pemetrexed and platinum in patients with metastatic non-squamous non-small cell lung cancer with EGFR mutations who did not progress after pemetrexed in combination with platinum-based chemotherapy.
Patients received two cycles of chemotherapy with pemetrexed/platinum before enrolling, followed by ectinib: ectinib 125mg/ tablet, one tablet at a time, three times a day, take orally, until disease progression;Pemetrexed 500mg/m2, intravenously administered on day 1;Carboplatin AUC6/ Cisplatin 75mg/m2,intravenously on day 1,21 days for a cycle, a total of 6 cycles.Maintenance therapy: ectinib: ectinib 125mg/ tablet, one tablet at a time, three times a day, take orally, pemetrexed 500mg/m2, intravenously on day 1,21 days for a cycle, until disease progression.Make detailed records of toxic and side effects during medication.The efficacy was evaluated using RESIST standard after every 2 cycles of the treatment, the regimen will continue until the disease progression or the appearance of not tolerable toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- EGFR-positive patients with metastatic non-squamous non-small cell lung cancer who did not progress after pemetrexed combined with platinum chemotherapy
| Arm | Type | Receives |
|---|---|---|
| combination therapy with ectiecinib, pemetrexed and platinum | Experimental | Drug: Icotinibectinib 125mg/ tablet, one tablet at a time, three times a day, take orally;Pemetrexed 500mg/m2, intravenous infusion, day 1;Carboplatin AUC6/ Cisplatin 75mg/m2,intravenous infusion, day 1,21 days for a cycle, a total of 6 cycles.Maintenance therapy: ectinib: ectinib 125mg/ tablet, one tablet at a time, three times a day, take orally, pemetrexed 500mg/m2,d intravenous infusion, day 1,21 days for a cycle |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age 18-75;
- Expected survival is at least 12 weeks;
- Metastatic non-squamous non-small cell lung cancer with EGFR mutations confirmed by histological or cytological examination;
- Received two cycles of pemetrexed/platinum chemotherapy with no progress (efficacy was evaluated as SD or PR);
- Tumor specimens must be provided before patients receive ectinib combined chemotherapy to complete the EGFR gene test. There is no need to clarify the EGFR mutation status before the initial pemetrexed/platinum chemotherapy;
Key exclusion criteria (8 listed)
- Previous EGFR-TKIs targeted drug therapy;
- Allergic history or hypersensitivity history of patients to active ingredients or non-active excipients of experimental drugs, drugs with chemical structure similar to experimental drugs, or similar drugs of experimental drugs;
- Known CYP inhibitors or inducers, such as phenytoin, carbamazepine, rifampicin, barbiturate, or st. John's wort, are currently being used (or cannot be discontinued within 1 week prior to the first administration);
- Patient's organs and systems:1) patients with brain/meningeal metastasis (except those who do not need hormone maintenance therapy after local treatment for brain parenchymal metastasis is controlled);2) having had interstitial lung disease, drug-induced interstitial disease, radiation pneumonia requiring hormone therapy, or any active interstitial lung disease with clinical evidence, and having had idiopathic pulmonary fibrosis on CT scan at baseline;Uncontrolled massive pleural or pericardial effusion;3) evidence of serious or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, heart, liver or kidney disease), as determined by the investigator;4) any unstable systemic disease (including active >CTCAE grade 2 clinical severe infection, grade 4 hypertension, unstable angina pectoris, congestive heart failure, human immunodeficiency virus (HIV) infection, liver, kidney or metabolic disease);5) any other malignancy (other than fully cured cervical carcinoma in situ or basal or squamous cell skin cancer) within 5 years;6) a clear history of neurological or psychiatric disorders, including epilepsy or dementia;7) patients with a history of allogeneic organ transplantation;Patients who underwent major surgery or suffered severe trauma within 4 weeks prior to first administration;8) more than 30% of the experimental drugs received extensive radiotherapy or bone marrow radiotherapy within 4 weeks before the first administration;
- Any conditions that affect the swallowing or absorption of medications, such as refractory nausea and vomiting, inability to swallow test medications, history of any type of gastrointestinal tract resection or surgery;
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 |
|---|---|---|
| IcotinibAlso: Pemetrexed, platinumIntervention: Drug: Icotinib Ectinib 125mg/ tablet, one tablet at a time, three times a day, take orally Intervention: Drug: Carboplatin/ Cisplatin Pemetrexed 500mg/m2, intravenous infusion, day 1;Carboplatin AUC6/ Cisplatin 75mg/m2,intravenous infusion, day 1,21 days for a cycle | Drug | combination therapy with ectiecinib, pemetrexed and platinum |
Primary outcome
Progress free survival
Time frame: 5 years
PFS was defined as the length of time from the date of randomization to the date of disease progression was first observed (as determined by imaging), and the number of days from the date of randomization to death if the patient died of other causes before the disease progression.
Overall survival
Time frame: 5 years
OS was defined as the length of time from the date of randomization to death from any cause.Patients who are alive as of the date of analysis will have their last contact as the cut-off date.
2 secondary outcomes
Objective response rate
Time frame: 5 years
Adverse Events
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2019.
- Results publication: PubMed 27619516Mehic B, Duranovic Rayan L, Bilalovic N, Dohranovic Tafro D, Pilav I. Lung adenocarcinoma mimicking pulmonary fibrosis-a case report. BMC Cancer. 2016 Sep 13;16(1):729. doi: 10.1186/s12885-016-2763-6.
- Results publication: PubMed 22967997Inoue A, Kobayashi K, Maemondo M, Sugawara S, Oizumi S, Isobe H, Gemma A, Harada M, Yoshizawa H, Kinoshita I, Fujita Y, Okinaga S, Hirano H, Yoshimori K, Harada T, Saijo Y, Hagiwara K, Morita S, Nukiwa T; North-East Japan Study Group. Updated overall survival results from a randomized phase III trial comparing gefitinib with carboplatin-paclitaxel for chemo-naive non-small cell lung cancer with sensitive EGFR gene mutations (NEJ002). Ann Oncol. 2013 Jan;24(1):54-9. doi: 10.1093/annonc/mds214. Epub 2012 Sep 11.
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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.
Peng Chen, M.D. principal investigator
Department of Pulmonary Medical Oncology, Tianjin Medical University Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Icotinib in people with Non-squamous Non-small Cell Lung Cancer, run by Tianjin Medical University Cancer Institute and 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 13 inclusion and 8 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 20 Jun 2019. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Peng Chen, M.D. (+86-18622221220, chenpengdoc@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progress free survival (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03992885, which also lists 2 linked publications.
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 20 Jun 2019.