Recurrent, or Metastatic Cervical Cancer With PD-L1 Positive (CPS≥1)Phase 3NCT05715840
Efficacy and Safety Study of First-line Treatment With SG001 Plus Chemotherapy ± Bevacizumab Versus Placebo Plus Chemotherapy ±Bevacizumab for Recurrent, or Metastatic Cervical Cancer With PD-L1 Positive (CPS≥1)
A Phase 3 study testing SG001 injection, Paclitaxel and Cisplatin in people with Recurrent, or Metastatic Cervical Cancer With PD-L1 Positive (CPS≥1), run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd..
Trial summary
This study is a randomised, double-blind, placebo-controlled, multicentre phase 3 clinical study to evaluate the efficacy and safety of SG001 plus chemotherapy±bevacizumab versus placebo plus chemotherapy±bevacizumab, as first-line treatment, in patients with PD-L1 positive (CPS≥1), Recurrent or Metastatic Cervical… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Recurrent, or Metastatic Cervical Cancer With PD-L1 Positive (CPS≥1)
- What is being tested?
- SG001 injection, Paclitaxel and Cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 368 participants
- Where
- No sites listed yet
- Study dates
- 31 Jan 2023to 31 May 2026
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 and ≤ 70 on the day of signing informed consent and volunteered to participated in this study.
- Has histologically documented recurrent, or metastatic squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix which has not been treated with systemic chemotherapy and is not amenable to curative treatment (such as with surgery and/or radiation).
- (Safety Lead-in)Has a measurable lesion per RECIST 1.1 via CT or MRI. (Phase 3) Has a assessable lesion per RECIST 1.1 via CT or MRI.
- Has provided enough archival tumor tissue sample or willing to provide newly obtained core or excisional biopsy of a tumor lesion not previously irradiated for prospective determination of Programmed Cell Death-Ligand 1 (PD-L1) status prior to first dose.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 14 days prior to first dose.
- Has a predicted survival period ≥ 3 months assessed by investigators.
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- Adverse reactions from the previous anti-tumor treatment have not yet recovered to ≤ level 1 based on CTCAE 5.0.
- Adequate organ function as defined below:
- Blood routine tests (No blood transfusions and hematopoietic stimulators have been used, and no drugs have been used to correct blood cell counts ): Absolute neutrophil count (ANC) ≥1.5×10^9/L; Platelets ≥100 ×10^9/L; Hemoglobin (HGB)≥9 g/dL;
- Serum biochemical indexs: Serum creatinine ≤1.5 × ULN or >1.5 × ULN with creatinine clearance (CCr) ≥ 60 mL/min; Serum total bilirubin (TBIL) ≤ 1.5 × ULN (Patients with Gilbert's syndrome can be up to 3 × ULN); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN or ≤5 X ULN for patients with liver metastases;
- Coagulation function: Activated partial thromboplastin time (APPT) and International Normalized Ratio (INR)≤1.5 × ULN (No anticoagulants or other drugs affecting clotting function have been used within 14 days prior to the first dose, except for patients requiring long-term anticoagulant therapy).
Who cannot join
- Active malignancy within 2 years prior to first dose of the investigational drug, except for cervical cancer studied in this trial and any locally curable tumor that has received radical therapy (e.g., resected basal or squamous cell skin cancer, superficial bladder cancer, cervical cancer in situ, breast cancer in situ, etc).
- History of primary immunodeficiency.
- History of active tuberculosis.
- Patients with any active autoimmune disease, except for patients with well-controlled type I diabetes, well-controlled hypothyroidism with hormone replacement therapy, skin diseases (such as vitiligo, psoriasis, or hair loss) without systemic treatment, or those who are not expected to relapse without external triggers.
- Serious cardiovascular disease within 6 months prior to the first dose, including but not limited to: stable angina with functional class III-IV; unstable angina or myocardial infarction; NYHA grade III-IV congestive heart failure; severe arrhythmias requiring drug therapy (congestive heart failure allowed if ventricular rate can be controlled; severe arrhythmias requiring drug therapy (congestive heart failure is allowed if the ventricular rate can be controlled).
- History of interstitial lung disease, or non-infectious pneumonitis requiring glucocorticoid therapy.
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- Patients with active soft meningeal disease or poorly controlled brain metastasis.
- Prior therapy with any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways including anti-PD-1, anti-PD-L1, anti-PD-L2, anti CTLA-4, OX40 agonist, and anti-CD137, etc.
- Has received prior radiotherapy within 14 days prior to the first dose.
- Has received prior chemosensitizer within 14 days prior to the first dose.
- Presence of clinically significant hydronephros which cannot be relieved by ventriculostomy or ureteral stent placement assessed by investigator.
- Patients with un-controlled pleural effusion, pericardial effusion or seroperitoneum requiring repeated drainage.
- Has any active infection requiring systemic treatment by intravenous infusion within 14 days prior to the first dose.
- Has received systemic corticosteroids (at doses equivalent to or greater than 10 mg/day of prednisone) or other immunosuppressive drugs within 14 days prior to the first dose.
- Have received major surgery, open biopsy or traumatism within 28 days before the first dose, or planned to receive elective major surgery during the study period.
- planned to receive during the study period.
- Have received Chinese herbal medicine or Chinese patent medicine with anti-tumor activity within14 days prior to the first dose.
- History of organ transplant or allogenic haemopoietic stem cell transplantation.
- Patients should be excluded if they have a positive test for human immunodeficiency virus antibody (HIV-Ab) or treponema pallidum antibody (TP-Ab). Patients with positive Hepatitis B virus surface antigen (HBsAg) and/or hepatitis B virus core antibody (HBcAb) as well quantitative HBV-DNA above upper limit of normal value, and patients with positive hepatitis C virus antibody (HCV-Ab) as well quantitative HCV-RNA above upper limit of normal value, should also be excluded.
- Pregnant or lactating women; Or the blood pregnancy test of women at child-bearing age is positive during screening.
- History of severe allergic reactions and uncontrolled allergic asthma to all components of the monoclonal antibody formulation.
- Has a contraindication or hypersensitivity to any component of cisplatin, carboplatin, paclitaxel, or bevacizumab.
- Have participated other clinical trials and received related investigated drugs within 28 days prior to the first dose (counted from the date of the last treatment in the previous clinical trial, patients participated in the overall survival follow-up of the previous clinical trial can be accepted).
- Women of child-bearing potential (WOCBP) refuse to take reliable contraceptive methods from signing the informed consent form to 6 months after last dose of investigational drug.
- Not suitable for this study as determined by the investigator due to other reasons.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomised, Double-blind, Placebo-controlled, Multicentre Phase Ш Clinical Study to Evaluate the Efficacy and Safety of First-line Treatment With SG001 Plus Chemotherapy±Bevacizumab Versus Placebo Plus Chemotherapy±Bevacizumab for PD-L1 Positive (CPS≥1) Women With Recurrent, or Metastatic Cervical Cancer
This study is a randomised, double-blind, placebo-controlled, multicentre phase 3 clinical study to evaluate the efficacy and safety of SG001 plus chemotherapy±bevacizumab versus placebo plus chemotherapy±bevacizumab, as first-line treatment, in patients with PD-L1 positive (CPS≥1), Recurrent or Metastatic Cervical Cancer. The study contains a Safety Lead-in Phase in which the safety and tolerability of SG001＋Chemotherapy±Bevacizumab will be assessed prior to the Phase 3 portion of the study.
Read the detailed description
The purpose of this study is to assess the efficacy and safety of SG001 plus one of four platinum-based chemotherapy regimens compared to the placebo plus one of four platinum-based chemotherapy regimens in the treatment of adult PD-L1 positive (CPS≥1) women with recurrent, or metastatic cervical cancer. Possible chemotherapy regimens include paclitaxel plus cisplatin with or without bevacizumab and paclitaxel plus carboplatin with or without bevacizumab. The study include two stages: the safety run-in phase and phase Ⅲ trail. Upon completion of the first stage study, the Safety Monitoring Committee (SMC) will decide whether to proceed directly to Phase Ⅲ study.
The primary study hypotheses are that the combination of SG001 plus chemotherapy is superior to placebo plus chemotherapy with respect to: 1) Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1), 2) Overall Survival (OS).
- Being tested
- SG001 injection, Paclitaxel, Cisplatin, Carboplatin, Bevacizumab injection
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SG001 injectionDrug
360 mg，Q3W，IV infusion
PaclitaxelDrug
175 mg/m^2，Q3W，IV infusion
CisplatinDrug
50 mg/m^2，Q3W，IV infusion
CarboplatinDrug
AUC=5，Q3W，IV infusion
Bevacizumab injectionDrug
15 mg/kg，Q3W，IV infusion
SG001 placeboDrug
Q3W，IV infusion
| Study group | Role | What they receive |
|---|---|---|
| safety run-in Stage(single arm) and Phase 3: SG001+Platinum-based chemotherapy±Bevacizumab | Experimental | SG001 360 mg, Intravenous infusion, D1, Q3W, up to approximately 2 years ; paclitaxel 175 mg/m^2, Intravenous infusion, D1, Q3W, up to 6 cycles; cisplatin 50 mg/m^2 or carboplatin(AUC=5) , Intravenous infusion, D1, Q3W, up to 6 cycles; with or without bevacizumab 15 mg/kg, Intravenous infusion, D1, Q3W, up to approximately 2 years All treatments will be administered until disease progression or toxicity Receives: Drug: SG001 injection; Drug: Paclitaxel; Drug: Cisplatin; Drug: Carboplatin; Drug: Bevacizumab injection |
| Phase 3: Placebo+Platinum-based chemotherapy±Bevacizumab | Placebo comparator | Placebo, Intravenous infusion, D1, Q3W, up to approximately 2 years ; paclitaxel 175 mg/m^2, Intravenous infusion, D1, Q3W, up to 6 cycles; cisplatin 50 mg/m^2 or carboplatin(AUC=5) , Intravenous infusion, D1, Q3W, up to 6 cycles; with or without bevacizumab 15 mg/kg, Intravenous infusion, D1, Q3W, up to approximately 2 years All treatments will be administered until disease progression or toxicity Receives: Drug: Paclitaxel; Drug: Cisplatin; Drug: Carboplatin; Drug: Bevacizumab injection; Drug: SG001 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Lead-in
Incidence and grade of the TRAE、SAE and irAE
Measured: Up to 42 days after the last patient of the lead-in phase
PFS per RECIST 1.1
Phase 3
Measured: Up to approximately 3 years
Overall survival (OS)
Phase 3
Measured: Up to approximately 3 years
Secondary outcomes (11)
Safety Lead-in and phase 3
ORR per RECIST 1.1
Measured: Up to approximately 3 years
Peak Plasma Concentration（Cmax）
Safety Lead-in and phase 3
Measured: Up to approximately 2 years
DOR per RECIST 1.1
Safety Lead-in and phase 3
Measured: Up to approximately 3 years
DCR per RECIST 1.1
Safety Lead-in and phase 3
Measured: Up to approximately 3 years
TTR per RECIST 1.1
Safety Lead-in and phase 3
Measured: Up to approximately 3 years
Area under the plasma concentration versus time curve (AUC)
Safety Lead-in and phase 3
Measured: Up to approximately 2 years
half-time（t1/2）
Safety Lead-in and phase 3
Measured: Up to approximately 2 years
Plasma clearance（CL）
Safety Lead-in and phase 3
Measured: Up to approximately 2 years
Volume of Distribution at Steady State（Vss）
Safety Lead-in and phase 3
Measured: Up to approximately 2 years
PFS per iRECIST 1.1
phase 3
Measured: Up to approximately 3 years
Incidence and grade of the TRAE、SAE and irAE
phase 3
Measured: Up to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start31 Jan 2023 (estimated)
- Primary completion31 Jul 2024 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent, or Metastatic Cervical Cancer With PD-L1 Positive (CPS≥1)Studies of the same condition, open and under way.
- More trials run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.The 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 368 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lingying Wu, M.D, Principal investigator, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05715840
- Sponsor's protocol ID
- SYSA1802-007
- Status last verified
- Jan 2023
- First submitted
- 16 Jan 2023
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled, Multicentre Phase Ш Clinical Study to Evaluate the Efficacy and Safety of First-line Treatment With SG001 Plus Chemotherapy±Bevacizumab Versus Placebo Plus Chemotherapy±Bevacizumab for PD-L1 Positive (CPS≥1) Women With Recurrent, or Metastatic Cervical Cancer
- ClinicalTrials.gov ID
- NCT05715840
- Acronym / sponsor ID
- SYSA1802-007
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 368 participants (estimated)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Jan 2023 (estimated)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 8 Feb 2023 (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 study is a randomised, double-blind, placebo-controlled, multicentre phase 3 clinical study to evaluate the efficacy and safety of SG001 plus chemotherapy±bevacizumab versus placebo plus chemotherapy±bevacizumab, as first-line treatment, in patients with PD-L1 positive (CPS≥1), Recurrent or Metastatic Cervical Cancer. The study contains a Safety Lead-in Phase in which the safety and tolerability of SG001＋Chemotherapy±Bevacizumab will be assessed prior to the Phase 3 portion of the study.
Detailed description
The purpose of this study is to assess the efficacy and safety of SG001 plus one of four platinum-based chemotherapy regimens compared to the placebo plus one of four platinum-based chemotherapy regimens in the treatment of adult PD-L1 positive (CPS≥1) women with recurrent, or metastatic cervical cancer. Possible chemotherapy regimens include paclitaxel plus cisplatin with or without bevacizumab and paclitaxel plus carboplatin with or without bevacizumab. The study include two stages: the safety run-in phase and phase Ⅲ trail. Upon completion of the first stage study, the Safety Monitoring Committee (SMC) will decide whether to proceed directly to Phase Ⅲ study.
The primary study hypotheses are that the combination of SG001 plus chemotherapy is superior to placebo plus chemotherapy with respect to: 1) Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1), 2) Overall Survival (OS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| safety run-in Stage(single arm) and Phase 3: SG001+Platinum-based chemotherapy±Bevacizumab | Experimental | Drug: SG001 injection, Drug: Paclitaxel, Drug: Cisplatin, Drug: Carboplatin, Drug: Bevacizumab injectionSG001 360 mg, Intravenous infusion, D1, Q3W, up to approximately 2 years ; paclitaxel 175 mg/m^2, Intravenous infusion, D1, Q3W, up to 6 cycles; cisplatin 50 mg/m^2 or carboplatin(AUC=5) , Intravenous infusion, D1, Q3W, up to 6 cycles; with or without bevacizumab 15 mg/kg, Intravenous infusion, D1, Q3W, up to approximately 2 years All treatments will be administered until disease progression or toxicity |
| Phase 3: Placebo+Platinum-based chemotherapy±Bevacizumab | Placebo comparator | Drug: Paclitaxel, Drug: Cisplatin, Drug: Carboplatin, Drug: Bevacizumab injection, Drug: SG001 placeboPlacebo, Intravenous infusion, D1, Q3W, up to approximately 2 years ; paclitaxel 175 mg/m^2, Intravenous infusion, D1, Q3W, up to 6 cycles; cisplatin 50 mg/m^2 or carboplatin(AUC=5) , Intravenous infusion, D1, Q3W, up to 6 cycles; with or without bevacizumab 15 mg/kg, Intravenous infusion, D1, Q3W, up to approximately 2 years All treatments will be administered until disease progression or toxicity |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥ 18 and ≤ 70 on the day of signing informed consent and volunteered to participated in this study.
- Has histologically documented recurrent, or metastatic squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix which has not been treated with systemic chemotherapy and is not amenable to curative treatment (such as with surgery and/or radiation).
- (Safety Lead-in)Has a measurable lesion per RECIST 1.1 via CT or MRI. (Phase 3) Has a assessable lesion per RECIST 1.1 via CT or MRI.
- Has provided enough archival tumor tissue sample or willing to provide newly obtained core or excisional biopsy of a tumor lesion not previously irradiated for prospective determination of Programmed Cell Death-Ligand 1 (PD-L1) status prior to first dose.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 14 days prior to first dose.
Key exclusion criteria (25 listed)
- Active malignancy within 2 years prior to first dose of the investigational drug, except for cervical cancer studied in this trial and any locally curable tumor that has received radical therapy (e.g., resected basal or squamous cell skin cancer, superficial bladder cancer, cervical cancer in situ, breast cancer in situ, etc).
- History of primary immunodeficiency.
- History of active tuberculosis.
- Patients with any active autoimmune disease, except for patients with well-controlled type I diabetes, well-controlled hypothyroidism with hormone replacement therapy, skin diseases (such as vitiligo, psoriasis, or hair loss) without systemic treatment, or those who are not expected to relapse without external triggers.
- Serious cardiovascular disease within 6 months prior to the first dose, including but not limited to: stable angina with functional class III-IV; unstable angina or myocardial infarction; NYHA grade III-IV congestive heart failure; severe arrhythmias requiring drug therapy (congestive heart failure allowed if ventricular rate can be controlled; severe arrhythmias requiring drug therapy (congestive heart failure is allowed if the ventricular rate can be controlled).
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 |
|---|---|---|
| SG001 injection360 mg，Q3W，IV infusion | Drug | safety run-in Stage(single arm) and Phase 3: SG001+Platinum-based chemotherapy±Bevacizumab |
| Paclitaxel175 mg/m^2，Q3W，IV infusion | Drug | Phase 3: Placebo+Platinum-based chemotherapy±Bevacizumab, safety run-in Stage(single arm) and Phase 3: SG001+Platinum-based chemotherapy±Bevacizumab |
| Cisplatin50 mg/m^2，Q3W，IV infusion | Drug | Phase 3: Placebo+Platinum-based chemotherapy±Bevacizumab, safety run-in Stage(single arm) and Phase 3: SG001+Platinum-based chemotherapy±Bevacizumab |
| CarboplatinAUC=5，Q3W，IV infusion | Drug | Phase 3: Placebo+Platinum-based chemotherapy±Bevacizumab, safety run-in Stage(single arm) and Phase 3: SG001+Platinum-based chemotherapy±Bevacizumab |
| Bevacizumab injection15 mg/kg，Q3W，IV infusion | Drug | Phase 3: Placebo+Platinum-based chemotherapy±Bevacizumab, safety run-in Stage(single arm) and Phase 3: SG001+Platinum-based chemotherapy±Bevacizumab |
| SG001 placeboQ3W，IV infusion | Drug | Phase 3: Placebo+Platinum-based chemotherapy±Bevacizumab |
Primary outcome
Safety Lead-in
Time frame: Up to 42 days after the last patient of the lead-in phase
Incidence and grade of the TRAE、SAE and irAE
PFS per RECIST 1.1
Time frame: Up to approximately 3 years
Phase 3
Overall survival (OS)
Time frame: Up to approximately 3 years
Phase 3
11 secondary outcomes
Safety Lead-in and phase 3
Time frame: Up to approximately 3 years
Peak Plasma Concentration（Cmax）
Time frame: Up to approximately 2 years
DOR per RECIST 1.1
Time frame: Up to approximately 3 years
DCR per RECIST 1.1
Time frame: Up to approximately 3 years
TTR per RECIST 1.1
Time frame: Up to approximately 3 years
Area under the plasma concentration versus time curve (AUC)
Time frame: Up to approximately 2 years
half-time（t1/2）
Time frame: Up to approximately 2 years
Plasma clearance（CL）
Time frame: Up to approximately 2 years
Volume of Distribution at Steady State（Vss）
Time frame: Up to approximately 2 years
PFS per iRECIST 1.1
Time frame: Up to approximately 3 years
Incidence and grade of the TRAE、SAE and irAE
Time frame: Up to approximately 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
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BAT1308 Combined with Platinum-Based Chemotherapy± Bevacizumab for PDL1-Positive (CPS ≥1) Cervical Cancer
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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.
Lingying Wu, M.D principal investigator
Chinese Academy of Medical Sciences
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SG001 injection, Paclitaxel and Cisplatin in people with Recurrent, or Metastatic Cervical Cancer With PD-L1 Positive (CPS≥1), run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd..
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 11 inclusion and 25 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 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Fenglin She, MSc (010-63942533, shefenglin@mail.ecspc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Lead-in (time frame: Up to 42 days after the last patient of the lead-in phase). 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 8 Feb 2023.