Non-muscle Invasive Bladder CancerPhase 3ASCERTAINNCT04736394
A Phase 3 Study to Evaluate the Safety and Efficacy of APL-1202 as a Single-agent Oral Treatment Versus Intravesical Instillation of Epirubicin Hydrochloride in naïve Intermediate-risk NMIBC Patients
A Phase 3 study testing APL-1202 and Epirubicin Hydrochloride in people with Non-muscle Invasive Bladder Cancer, run by Jiangsu Yahong Meditech Co., Ltd aka Asieris at 1 site in China.
Trial summary
A multi-center, randomized, open-label, parallel-controlled Phase Ⅲ clinical trial to evaluate the clinical safety and efficacy of APL-1202 as a single-agent oral treatment versus intravesical instillation of Epirubicin hydrochloride in naïve intermediate-risk non-muscle invasive bladder cancer (NMIBC) patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-muscle Invasive Bladder Cancer
- What is being tested?
- APL-1202 and Epirubicin Hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- 29 Sep 2021to 31 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients must meet all the following criteria:
- Must be informed of the investigational nature of this study and must provide written informed consent
- Age ≥18 years, male or female
- Non-muscle invasive transitional cell carcinoma of the bladder is histologically confirmed by Independent Pathology Review Committee (IPRC). Diagnosis and classification of intermediate-risk NMIBC is according to 2014 CUA Guideline of Diagnosis and Treatment of Urological Diseases in China:
- Low-risk: Primary, solitary, TaGl (PUNLMP, low-grade urothelial carcinoma), <3cm, no CIS. (Note: the above conditions must be met at the same time as a low-risk NMIBC) Intermediate-risk: All tumours not defined in the two adjacent categories (between the category of low and high risk) High-risk: Any of the following: ① T1 tumour; ②G3(high-grade urothelial carcinoma) tumour;③carcinoma in situ (CIS); ④ Multiple, recurrent and large (> 3 cm) TaG1G2(low-grade urothelial carcinoma) tumours (all features must be present)
- No visible tumor after transurethral resection of bladder tumor (TURBT) on tumor lesion. Some requirements about Re-TURBT are as follows: It is recommended to conduct the secondary TURBT under following situations: incomplete first TURBT; no muscle tissue found in the first TURBT specimen, except Ta G1 (low grade) tumor and CIS only.
Show all 16Show fewer
- The secondary TURBT is recommended 2-6 weeks, but better at 4 weeks, after the first TURBT.
- For subjects undergoing secondary TURBT, they will be enrolled after the second TURBT
- Subjects who never received intravesical instillation (including BCG or intravesical chemotherapy) prior to enrollment, except single, immediate, post-operative intravesical chemotherapy.
- Willing to provide pathological tissue specimen for assessment
- ECOG PS ≤ 1
- Patients, who have not received blood transfusion or colony-stimulating factor treatment within 14 days before the examination, must have normal organ and marrow function within 42 days of study entry (according to normal range in clinical site).
- Absolute neutrophil count >1.5×109/L Platelets > 100 ×109/L Hemoglobin > 9.0 g/dL Alkaline phosphatase < 2.5 ULN GFR (Cockcroft-Gault formula calculated) ≥ 50 mL/min Total bilirubin, alanine aminotransferase or aspartate aminotransferase< 1.5 ULN INR <1.5, except for subjects receiving anticoagulation therapy
- Female should be either surgically sterilized or menopause or agree to use effective contraceptive measures during treatment. Women of reproductive age must have a negative result of pregnancy test during the screening period (pregnancy test will be not required if one of the following situations exists: the subject has undergone sterilization such as hysterectomy and/or bilateral oophorectomy, has no menstruation for 12 months and been diagnosed as menopause based on factors such as age). However, pregnancy tests are required for patients with bilateral fallopian tube ligation.
- Male subjects should be either surgically sterilized or agreed to use effective contraceptive measures. From signing the informed consent, subjects must take continuous measures until 3 months after the end of the treatment of trial. The definition of effective contraceptive measures will be based on the principal investigator(PI) or appointed delegate.
- Expected life expectancy is more than 48 months
Who cannot join
- The presence of any of the following will exclude a patient from study enrollment:
- Low-risk: Primary, solitary, TaGl (PUNLMP, low-grade urothelial carcinoma), <3cm, no CIS. (PS: the above conditions must be met at the same time as a low-risk NMIBC)
- High-risk: Any of the following: ① T1 tumour; ②G3(high-grade urothelial carcinoma) tumour;③carcinoma in situ (CIS); ④ Multiple, recurrent and large (> 3 cm) TaG1G2(low-grade urothelial carcinoma) tumours (all features must be present)
- Tumors of T2 stage or more serious
- The histological types are mainly non-urothelial carcinomas such as squamous cell carcinoma and adenocarcinoma
- Urothelial carcinoma outside the bladder (renal pelvis, ureter or urethra)
Show all 24Show fewer
- Received intravesical therapy in last TURBT/cystoscopy prior to treatment period, but not including immediate intravesical therapy once (the subjects who received the immediate intravesical therapy need to be recorded in e-CRF)
- Received surgery (not includes TURBT/cystoscopy), radiation therapy, or systemic therapy within 6 weeks before enrollment
- Malignancies within 2 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in-situ' of the cervix
- Grade 3 (according to the NCI CTCAE 5.0) hemorrhage in any part of body within 6 weeks before starting the treatment of trial
- Any of the following within 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism
- Hypertension that cannot be controlled by medications (systolic blood pressure≥140 mmHg and/or diastolic blood pressure≥90mmHg)
- Uncontrolled active infections before starting the treatment of trial, such as acute pneumonia, active hepatitis B, etc.
- Dysphagia or known drug absorption disorders
- Anuria
- One week prior to enrollment, having gross hematuria
- Active duodenal ulcers, ulcerative colitis and other gastrointestinal diseases or other conditions that the investigator may determine to cause gastrointestinal bleeding or perforation
- The risk of participation or administration may increase, judged by investigator, or other severe acute or chronic medical conditions may interfere with the interpretation and judgment of results
- or optic nerve disorders
- Subjects have optic nerve disorders and cataracts, or other related medical history
- Pregnancy or breastfeeding. Female patients with reproductive potential have a positive pregnancy test prior to enrollment
- Psychological or mental abnormality, subjects are estimated to have insufficient adherence to this clinical study
- Four weeks prior to enrollment, participate in other clinical trials
- Patients who had previously received anthracycline for systemic chemotherapy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 201203
Dingwei Ye, MD,PhD, +8602164175590
Dingwei Ye, MD,PhD
About this study
Official title: A Multi-center, Randomized, Open-label, Parallel-controlled Phase 3 Clinical Trial to Evaluate the Clinical Safety and Efficacy of APL-1202 as a Single-agent Oral Treatment Versus Intravesical Instillation of Epirubicin Hydrochloride in naïve Intermediate-risk Non-muscle Invasive Bladder Cancer (NMIBC) Patients
A multi-center, randomized, open-label, parallel-controlled Phase Ⅲ clinical trial to evaluate the clinical safety and efficacy of APL-1202 as a single-agent oral treatment versus intravesical instillation of Epirubicin hydrochloride in naïve intermediate-risk non-muscle invasive bladder cancer (NMIBC) patients
Read the detailed description
A multi-center, randomized, open-label, placebo controlled Phase Ⅲ trial. The subjects must be histopathologically diagnosed, naïve intermediate-risk NMIBC patient. The screening period is 6 weeks prior to treatment.
The trial including 2 stages:
- First stages: The subjects are randomly assigned to receive APL-1202 single-agent oral treatment or intravesical instillation of Epirubicin hydrochloride at a ratio of 1:1. At this stage, an interim analysis will be performed after the first 100 subjects enrolled completing the 6-month visit (completing the second cystoscopy), and the Independent Data Monitoring Committee (IDMC) conducted a preliminary evaluation of the safety. If approved by the IDMC after the safety evaluation, the trial will proceed to the second stage. Before the result of the interim analysis are obtained, subjects receiving APL-1202 will continue to be given continuous administration if they have completed the 6-month visit (V4). After the interim analysis, if the safety of continuous administration is as expected, subjects receiving APL-1202 will continue to do the same, otherwise it will be adjusted to the administration of APL-1202 at every 3-month interval which is proven to be safe and tolerable.
- Second stage: After the interim analysis of the first stage, the subjects of the second stage will be enrolled, and the subjects were randomly assigned to receive APL-1202 single-agent oral treatment or intravesical instillation of Epirubicin hydrochloride at a ratio of 1:1. For treatment, according to the results of the interim analysis, if the safety of continuous administration reaches the expected level, subjects receiving APL-1202 will continue to do the same, otherwise it will be adjusted to the administration of APL-1202 at every 3-month interval which is proven to be safe and tolerable.
In this trial, the APL-1202 dosing regimen will continue until subjects exit the trial early for any reason, complete 24 months' treatment or the trial is terminated early.
Cystoscopy will be performed every 3 months in the enrolled subjects. If there is no recurrence in the enrolled subject during the treatment period (2 years after enrollment), cystoscopy will be performed every 6 months during the follow-up period until recurrence or the end of the clinical trial.
Safety assessment will be performed every 3 months during the treatment period.
- Conditions
- Non-muscle Invasive Bladder Cancer
- Being tested
- APL-1202, Epirubicin Hydrochloride
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APL-1202Drug
APL-1202 single-agent oral treatment
Epirubicin HydrochlorideDrug
Epirubicin hydrochloride
| Study group | Role | What they receive |
|---|---|---|
| Epirubicin hydrochloride group | Active comparator | intravesical instillation of Epirubicin hydrochloride Receives: Drug: Epirubicin Hydrochloride |
| APL-1202 group | Experimental | receive APL-1202 single-agent oral treatment Receives: Drug: APL-1202 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free survival (EFS)
Event-free survival (EFS) based on the assessment of pathological report from the Independent Pathology Review Committee (IPRC)
Measured: Up to 48 months
Secondary outcomes (7)
Event-free survival (EFS) based on the assessment of pathological report from each site
Event-free survival (EFS) based on the assessment of pathological report from each site
Measured: Up to 48 months
Overall survival (OS)
Overall survival (OS)
Measured: Up to 48 months
Recurrence-free rate
Recurrence-free rate at 12,18, and 24 months after enrollment
Measured: Up to 48 months
Progression-free rate
Progression-free rate at 12,18, and 24 months after enrollment
Measured: Up to 48 months
Clinical benefit rates
Clinical benefit rates at 12,18, 24 months after enrollment (clinical benefits are defined as the pathological improvement of the recurrence, no high-risk recurrence, progression-free recurrence, no radical therapy and no death)
Measured: Up to 48 months
Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life Total Score
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall outcome
Measured: Up to 48 months
Change from Baseline in EORTC-QLQ-Non-muscle Invasive Bladder Cancer Module 24 (NMIBC24) Total Score
The EORTC-QLQ-NMIBC24 is a 24-item questionnaire developed to supplement the EORTC QLQ-C30 in high-risk NMIBC patients. Each item is scored out of 4 total points (1=Not at All to 4=Very Much). All responses are transformed from 0 to 100, with a high score indicating more symptoms or problems. The change from baseline in EORTC-QLQ-NMIBC24 total score will be presented.
Measured: Up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start29 Sep 2021
- Primary completion1 Mar 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-muscle Invasive Bladder CancerStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Yahong Meditech Co., Ltd aka Asieris
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04736394
- Sponsor's protocol ID
- YHCT-NIT-R2
- Acronym
- ASCERTAIN
- Status last verified
- Feb 2022
- First submitted
- 29 Jan 2021
- Last updated
- 22 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Open-label, Parallel-controlled Phase 3 Clinical Trial to Evaluate the Clinical Safety and Efficacy of APL-1202 as a Single-agent Oral Treatment Versus Intravesical Instillation of Epirubicin Hydrochloride in naïve Intermediate-risk Non-muscle Invasive Bladder Cancer (NMIBC) Patients
- ClinicalTrials.gov ID
- NCT04736394
- Acronym / sponsor ID
- ASCERTAIN / YHCT-NIT-R2
- Conditions
- Non-muscle Invasive Bladder Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Jiangsu Yahong Meditech Co., Ltd aka AsierisIndustry (pharma, biotech, devices)
- Study start
- 29 Sep 2021 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 3 Feb 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.
A multi-center, randomized, open-label, parallel-controlled Phase Ⅲ clinical trial to evaluate the clinical safety and efficacy of APL-1202 as a single-agent oral treatment versus intravesical instillation of Epirubicin hydrochloride in naïve intermediate-risk non-muscle invasive bladder cancer (NMIBC) patients
Detailed description
A multi-center, randomized, open-label, placebo controlled Phase Ⅲ trial. The subjects must be histopathologically diagnosed, naïve intermediate-risk NMIBC patient. The screening period is 6 weeks prior to treatment.
The trial including 2 stages:
- First stages: The subjects are randomly assigned to receive APL-1202 single-agent oral treatment or intravesical instillation of Epirubicin hydrochloride at a ratio of 1:1. At this stage, an interim analysis will be performed after the first 100 subjects enrolled completing the 6-month visit (completing the second cystoscopy), and the Independent Data Monitoring Committee (IDMC) conducted a preliminary evaluation of the safety. If approved by the IDMC after the safety evaluation, the trial will proceed to the second stage. Before the result of the interim analysis are obtained, subjects receiving APL-1202 will continue to be given continuous administration if they have completed the 6-month visit (V4). After the interim analysis, if the safety of continuous administration is as expected, subjects receiving APL-1202 will continue to do the same, otherwise it will be adjusted to the administration of APL-1202 at every 3-month interval which is proven to be safe and tolerable.
- Second stage: After the interim analysis of the first stage, the subjects of the second stage will be enrolled, and the subjects were randomly assigned to receive APL-1202 single-agent oral treatment or intravesical instillation of Epirubicin hydrochloride at a ratio of 1:1. For treatment, according to the results of the interim analysis, if the safety of continuous administration reaches the expected level, subjects receiving APL-1202 will continue to do the same, otherwise it will be adjusted to the administration of APL-1202 at every 3-month interval which is proven to be safe and tolerable.
In this trial, the APL-1202 dosing regimen will continue until subjects exit the trial early for any reason, complete 24 months' treatment or the trial is terminated early.
Cystoscopy will be performed every 3 months in the enrolled subjects. If there is no recurrence in the enrolled subject during the treatment period (2 years after enrollment), cystoscopy will be performed every 6 months during the follow-up period until recurrence or the end of the clinical trial.
Safety assessment will be performed every 3 months during the treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epirubicin hydrochloride group | Active comparator | Drug: Epirubicin Hydrochlorideintravesical instillation of Epirubicin hydrochloride |
| APL-1202 group | Experimental | Drug: APL-1202receive APL-1202 single-agent oral treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Must be informed of the investigational nature of this study and must provide written informed consent
- Age ≥18 years, male or female
- Non-muscle invasive transitional cell carcinoma of the bladder is histologically confirmed by Independent Pathology Review Committee (IPRC). Diagnosis and classification of intermediate-risk NMIBC is according to 2014 CUA Guideline of Diagnosis and Treatment of Urological Diseases in China:
- Low-risk: Primary, solitary, TaGl (PUNLMP, low-grade urothelial carcinoma), <3cm, no CIS. (Note: the above conditions must be met at the same time as a low-risk NMIBC) Intermediate-risk: All tumours not defined in the two adjacent categories (between the category of low and high risk) High-risk: Any of the following: ① T1 tumour; ②G3(high-grade urothelial carcinoma) tumour;③carcinoma in situ (CIS); ④ Multiple, recurrent and large (> 3 cm) TaG1G2(low-grade urothelial carcinoma) tumours (all features must be present)
- No visible tumor after transurethral resection of bladder tumor (TURBT) on tumor lesion. Some requirements about Re-TURBT are as follows: It is recommended to conduct the secondary TURBT under following situations: incomplete first TURBT; no muscle tissue found in the first TURBT specimen, except Ta G1 (low grade) tumor and CIS only.
Key exclusion criteria (24 listed)
- Low-risk: Primary, solitary, TaGl (PUNLMP, low-grade urothelial carcinoma), <3cm, no CIS. (PS: the above conditions must be met at the same time as a low-risk NMIBC)
- High-risk: Any of the following: ① T1 tumour; ②G3(high-grade urothelial carcinoma) tumour;③carcinoma in situ (CIS); ④ Multiple, recurrent and large (> 3 cm) TaG1G2(low-grade urothelial carcinoma) tumours (all features must be present)
- Tumors of T2 stage or more serious
- The histological types are mainly non-urothelial carcinomas such as squamous cell carcinoma and adenocarcinoma
- Urothelial carcinoma outside the bladder (renal pelvis, ureter or urethra)
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 |
|---|---|---|
| APL-1202APL-1202 single-agent oral treatment | Drug | APL-1202 group |
| Epirubicin HydrochlorideEpirubicin hydrochloride | Drug | Epirubicin hydrochloride group |
Primary outcome
Event-free survival (EFS)
Time frame: Up to 48 months
Event-free survival (EFS) based on the assessment of pathological report from the Independent Pathology Review Committee (IPRC)
7 secondary outcomes
Event-free survival (EFS) based on the assessment of pathological report from each site
Time frame: Up to 48 months
Overall survival (OS)
Time frame: Up to 48 months
Recurrence-free rate
Time frame: Up to 48 months
Progression-free rate
Time frame: Up to 48 months
Clinical benefit rates
Time frame: Up to 48 months
Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life Total Score
Time frame: Up to 48 months
Change from Baseline in EORTC-QLQ-Non-muscle Invasive Bladder Cancer Module 24 (NMIBC24) Total Score
Time frame: Up to 48 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2022.
- Individual participant dataSharing planned: No
Related trials for Non-muscle Invasive Bladder Cancer
Not yet recruitingObservational study
Outcomes for IR and High Risk (HR) Non-muscle Invasive Bladder Cancer (NMIBC) and ctDNA-based Biomarkers for Response and Recurrence in Muscle Invasive Bladder Cancer (MIBC)
NMIBC, MIBC
Active, not recruitingPhase 2
Testing the Addition of an Anti-cancer Drug, Pembrolizumab, to the Usual Intravesical Chemotherapy Treatment (Gemcitabine) for the Treatment of BCG-Unresponsive Non-muscle Invasive Bladder Cancer
Bladder Flat Urothelial Carcinoma In Situ, Non-Muscle Invasive Bladder Urothelial Carcinoma
RecruitingPhase 2
A Phase II Trial of Bicalutamide in Patients Receiving Intravesical BCG for Non-muscle Invasive Bladder Cancer
Non-Muscle Invasive Bladder Cancer
Active, not recruitingPhase 3
Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC) (MK-3475-676/KEYNOTE-676)
High-risk Non-muscle Invasive Bladder Cancer
Not yet recruitingPhase 2
Antibody-Drug Conjugate Plus Immunotherapy Versus Immunotherapy Plus Chemotherapy for Extensive Transurethrally Unresectable Very-High-Risk Non-Muscle-Invasive Bladder Cancer
Bladder (Urothelial, Transitional Cell) Cancer, Antibody-drug Conjugates
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 3 study testing APL-1202 and Epirubicin Hydrochloride in people with Non-muscle Invasive Bladder Cancer, run by Jiangsu Yahong Meditech Co., Ltd aka Asieris 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 16 inclusion and 24 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 22 Feb 2022. 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 Mingming Zhang, MD (8613816002336, mmzhang@asieris.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-free survival (EFS) (time frame: Up to 48 months). 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 22 Feb 2022.