Metastatic Breast CancerPhase 2NCT04389073
Safety and Efficacy of Toripalimab in HER2- Metastatic Breast Cancer Patients Treated With Metronomic Vinorelbine
A Phase 2 study testing Vinorelbine 40mg, Toripalimab 240mg and Bevacizumab 5 mg/kg in people with Metastatic Breast Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 2 sites in China.
Trial summary
The investigators hypothesize that the administration of Toripalimab (anti-PD-1 antibody, JS001) combined to metronomic Vinorelbine may be an interesting therapeutic option for female patients with HER2- metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Vinorelbine 40mg, Toripalimab 240mg and Bevacizumab 5 mg/kg
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 2 sitesChina
- Study dates
- 1 Apr 2020to 31 Dec 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients with life expectancy ≥ 3 months, age ≥ 18 years at the time
- informed consent is signed.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 as assessed within 21 days prior to first dosage.
- Subjects with HER2 negative metastasis breast cancer, source documented, defined as per American Society of Clinical Oncology - College of American Pathologists (ASCO/CAP) guidelines.
- Subjects previously treated with no more than one prior line of standard chemotherapy
- Subjects with measurable metastatic disease defined by Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) guidelines.
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- Subjects may previously exposed to anthracyclines (e.g. doxorubicin, epirubicin) and/or taxanes (e.g., paclitaxel, docetaxel) including:
- has been pretreated in the adjuvant or neoadjuvant setting with anthracyclines and/or taxanes before breast cancer relapsing;
- has experienced treatment failure while receiving or after completing anthracycline- and/or taxane- based chemotherapy;
- not suitable for the choice of anthracycline- and/or taxane- based chemotherapy as first-line treatment in the judgment of investigator.
- Prior radiotherapy must have completed before randomization, with full recovery from acute radiation side effects. An interval of less than 4 weeks after radiotherapy was not allowed.Concurrent limited field radiation therapy (RT) is allowed. At least one measurable lesion must be completely outside the radiation portal in accordance with RECIST 1.1 guidelines;
- At least 30 days from major surgery before randomization, with full recovery;
- Adequate bone marrow function as evidenced by the following:
- Absolute Neutrophil Count (ANC) ≥ 1500/mm2;
- Platelets ≥ 100,000/mm2;
- Hemoglobin (Hb) ≥ 10 g/dL.
- Adequate liver function as evidenced by the following:
- Total serum bilirubin ≤ 1.5 times upper limit of normal range (ULN);
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 2.5 times ULN (if hepatic metastases present ≤ 5.0 times ULN);
- Alkaline phosphatase < 5 x ULN.
- Adequate renal function as evidenced by the following:
- Creatinine clearance > 40 mL/min (by Cockcroft-Gault).
- Women of child-bearing potential must have a negative pregnancy test (urine or serum) within 7 days of randomization and agree to take an adequate contraceptive measure.
- Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted.
- Able to adhere to the study visit schedule and other protocol requirements.
Who cannot join
- History of, or current active cancer other than breast cancer, with the exception of curatively resected non-melanomatous skin cancer, curatively treated cervical carcinoma in situ, or other primary solid tumors curatively treated with no known active disease present and no curative treatment administered for the last 3 years.
- Patients with medical conditions that the only manifestation is hydrothorax, ascites, bone lesions or other un-measurable diseases.
- Subjects with visceral crisis in the judgment of investigator. Visceral crisis is defined as severe organ dysfunction as assessed by signs and symptoms, laboratory studies, and rapid progression of disease. Visceral crisis is not the mere presence of disease of visceral metastases, but implies important visceral compromise leading to a clinical indication for a more rapidly efficacious therapy, particularly since chemotherapy option at progression will probably not be possible.
- Malabsorption syndrome or disease significantly affecting gastro-intestinal function or major resection of the stomach or proximal small bowel that could affect absorption of Oral NVB.
- Subjects with dysphagia, or inability to swallow the tablets.
- Subjects with symptoms suggesting central nervous system (CNS) involvement or leptomeningeal metastases, any suspicious sins or symptoms of CNS involvement or leptomeningeal metastases should be excluded by CT or MRI scans.
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- Other serious illness or medical conditions by the investigator during screening:
- Clinically significant cardiac disease;
- Unstable diabetes;
- Uncontrolled hypercalcemia;
- Clinically significant active infections (current or in the last two weeks).
- Previous organ allograft.
- Current peripheral neuropathy ≥grade 2 according to NCI version 4.0 criteria.
- Concomitant hormonal therapy for MBC.
- Ongoing anti-coagulation therapy.
- Subjects of reproductive potential who are pregnant, breast feeding or not willing to use effective contraceptive precautions during the study and for at least one month after the last dose of investigational product in the judgment of the investigator.
- Patients with psychiatric disorder or other disease leading to incompliance to the therapy.
- An interval of less than 3 weeks between the last dose of previous chemotherapy and randomization.
- Previous treated by oral NVB.
- Treatment with any investigational drug within 30 days before the beginning of treatment with study drug. Less than 30 days since receipt of any other investigational product or device.
- Known hypersensitivity to any ingredient of the study drug.
Trial locations and contacts
2 sites in 1 country.
Hongnan Mo contact
China2 sites, 2 recruiting
- Recruiting
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Fei Ma, MD, 86-10-87788060, drmafei@126.com
- Recruiting
Beijing Huanxing Cancer Hospital
Beijing, Beijing Municipality
Hongnan Mo, MD, 86-10-87788120
About this study
Official title: Safety and Efficacy of Metronomic Vinorelbine in Combination With Toripalimab for Patients With HER2- Metastatic Breast Cancer
The investigators hypothesize that the administration of Toripalimab (anti-PD-1 antibody, JS001) combined to metronomic Vinorelbine may be an interesting therapeutic option for female patients with HER2- metastatic breast cancer. The approach suggested here is to deplete and active the immune response of these patients. The combination of Toripalimab and Vinorelbine would provide a higher gain in anti-tumor response in these patients than in those with chemotherapy alone.
The investigators proposal is to conduct a multicentric, single arm, Phase II trial in HER2- patients with metastatic breast cancer, aiming to evaluate the clinical activity of the combination therapy Toripalimab + metronomic Vinorelbine. Patients will receive Vinorelbine (40 mg/day, tiw, per os) and Toripalimab (240 mg every 3 weeks, intravenously [IV]). The adverse events of the two drugs are well known.
Read the detailed description
Both study drugs will continue to be administered as long as patient experience clinical benefit in the opinion of the investigator or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data and clinical status or withdrawal of consent.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Vinorelbine 40mg, Toripalimab 240mg, Bevacizumab 5 mg/kg, Cyclophosphamide 50 mg, Capecitabine 500Mg Oral Tablet
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vinorelbine 40mgDrug
Two tablets per day, three times a week. Vinorelbine will continue to be administered as long as patient experiences clinical benefit in the opinion of the investigator or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data and clinical status or withdrawal of consent.
Toripalimab 240mgBiological
Also called JS001
Toripalimab 240 MG IV infusion every 3 weeks. Toripalimab will continue to be administered as long as patient experiences clinical benefit in the opinion of the investigator or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data and clinical status or withdrawal of consent.
Bevacizumab 5 mg/kgBiological
Bevacizumab 5 mg/kg IV infusion every 3 weeks. Bevacizumab will continue to be administered as long as patient experiences clinical benefit in the opinion of the investigator or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data and clinical status or withdrawal of consent.
Cyclophosphamide 50 mgDrug
50 mg per day. Cyclophosphamide will continue to be administered as long as patient experiences clinical benefit in the opinion of the investigator or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data and clinical status or withdrawal of consent.
Capecitabine 500Mg Oral TabletDrug
500mg three times a day. Capecitabine will continue to be administered as long as patient experiences clinical benefit in the opinion of the investigator or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data and clinical status or withdrawal of consent.
CisplatinDrug
Cisplatin 50mg/m2 IV infusion every 3 weeks. Cisplatin will continue to be administered as long as patient experiences clinical benefit in the opinion of the investigator or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data and clinical status or withdrawal of consent.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (PD-1+NVB) | Experimental | The treatments received are:
* Vinorelbine (40 mg/day, tiw, per os)
* Toripalimab (240 mg every 3 weeks, intravenously [IV]). Receives: Drug: Vinorelbine 40mg; Biological: Toripalimab 240mg |
| Arm 2 (PD-1+NVB+Bev) | Experimental | The treatments received are:
* Vinorelbine (40 mg/day, tiw, per os)
* Toripalimab (240 mg every 3 weeks, intravenously [IV])
* Bevacizumab (5 mg/kg every 3 weeks, intravenously [IV]). Receives: Drug: Vinorelbine 40mg; Biological: Toripalimab 240mg; Biological: Bevacizumab 5 mg/kg |
| Arm 3 (PD-1+NVB+DDP) | Experimental | * Vinorelbine (40 mg/day, tiw, per os)
* Toripalimab (240 mg every 3 weeks, intravenously [IV])
* Cisplatin (50mg/m2 every 3 weeks, intravenously [IV]). Receives: Drug: Vinorelbine 40mg; Biological: Toripalimab 240mg; Drug: Cisplatin |
| Arm 4 (PD-1+VEX) | Experimental | * Vinorelbine (40 mg/day, tiw, per os)
* Toripalimab (240 mg every 3 weeks, intravenously [IV])
* Cyclophosphamide (50 mg/day, qd, per os)
* Capecitabine (500 mg, tid, per os) Receives: Drug: Vinorelbine 40mg; Biological: Toripalimab 240mg; Drug: Cyclophosphamide 50 mg; Drug: Capecitabine 500Mg Oral Tablet |
| Arm 5 (NVB) | Active comparator | • Vinorelbine (40 mg/day, tiw, per os) Receives: Drug: Vinorelbine 40mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Benefit Rate (CBR)
CBR, defined as the percentage of Complete Response (CR), (Partial Response) PR or Stable Disease (SD) . Response will be evaluated by Response Evaluation Criteria In Solid Tumors (RECIST) V1.1.
Measured: 6 weeks of treatment
Secondary outcomes (4)
Overall response Rate (ORR)
The objective response rate (ORR) will be defined as the proportion of patients (described on the efficacy-evaluable population) who achieve complete response (CR) or partial response (PR) as best overall response at 6 weeks of treatment. ORR is based on tumor assessments.
Measured: 6 weeks of treatment
Progression-Free Survival (PFS)
Measured from the date of study drugs start to the date of the first objective disease progression or death.
Measured: 15 months
Overall Survival (OS)
Defined as the duration of time from start of treatment to time of death.
Measured: 15 months
Adverse events reporting
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2020
- Study start1 Apr 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Huanxing Cancer Hospital
- Responsible party
- Principal investigator, Ma Fei，MD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04389073
- Sponsor's protocol ID
- NCC2167
- Status last verified
- Feb 2022
- First submitted
- 8 May 2020
- Last updated
- 25 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mo H, Yu Y, Sun X, Ge H, Yu L, Guan X, Zhai J, Zhu A, Wei Y, Wang J, Yan X, Qian H, Xu B, Ma F. Metronomic chemotherapy plus anti-PD-1 in metastatic breast cancer: a Bayesian adaptive randomized phase 2 trial. Nat Med. 2024 Sep;30(9):2528-2539. doi: 10.1038/s41591-024-03088-2. Epub 2024 Jul 5.
PubMed 38969879
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Metronomic Vinorelbine in Combination With Toripalimab for Patients With HER2- Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT04389073
- Acronym / sponsor ID
- NCC2167
- Conditions
- Metastatic Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Beijing Huanxing Cancer Hospital
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 15 May 2020 (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.
The investigators hypothesize that the administration of Toripalimab (anti-PD-1 antibody, JS001) combined to metronomic Vinorelbine may be an interesting therapeutic option for female patients with HER2- metastatic breast cancer. The approach suggested here is to deplete and active the immune response of these patients. The combination of Toripalimab and Vinorelbine would provide a higher gain in anti-tumor response in these patients than in those with chemotherapy alone.
The investigators proposal is to conduct a multicentric, single arm, Phase II trial in HER2- patients with metastatic breast cancer, aiming to evaluate the clinical activity of the combination therapy Toripalimab + metronomic Vinorelbine. Patients will receive Vinorelbine (40 mg/day, tiw, per os) and Toripalimab (240 mg every 3 weeks, intravenously [IV]). The adverse events of the two drugs are well known.
Detailed description
Both study drugs will continue to be administered as long as patient experience clinical benefit in the opinion of the investigator or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data and clinical status or withdrawal of consent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (PD-1+NVB) | Experimental | Drug: Vinorelbine 40mg, Biological: Toripalimab 240mgThe treatments received are: * Vinorelbine (40 mg/day, tiw, per os) * Toripalimab (240 mg every 3 weeks, intravenously [IV]). |
| Arm 2 (PD-1+NVB+Bev) | Experimental | Drug: Vinorelbine 40mg, Biological: Toripalimab 240mg, Biological: Bevacizumab 5 mg/kgThe treatments received are: * Vinorelbine (40 mg/day, tiw, per os) * Toripalimab (240 mg every 3 weeks, intravenously [IV]) * Bevacizumab (5 mg/kg every 3 weeks, intravenously [IV]). |
| Arm 3 (PD-1+NVB+DDP) | Experimental | Drug: Vinorelbine 40mg, Biological: Toripalimab 240mg, Drug: Cisplatin* Vinorelbine (40 mg/day, tiw, per os) * Toripalimab (240 mg every 3 weeks, intravenously [IV]) * Cisplatin (50mg/m2 every 3 weeks, intravenously [IV]). |
| Arm 4 (PD-1+VEX) | Experimental | Drug: Vinorelbine 40mg, Biological: Toripalimab 240mg, Drug: Cyclophosphamide 50 mg, Drug: Capecitabine 500Mg Oral Tablet* Vinorelbine (40 mg/day, tiw, per os) * Toripalimab (240 mg every 3 weeks, intravenously [IV]) * Cyclophosphamide (50 mg/day, qd, per os) * Capecitabine (500 mg, tid, per os) |
| Arm 5 (NVB) | Active comparator | Drug: Vinorelbine 40mg• Vinorelbine (40 mg/day, tiw, per os) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Female patients with life expectancy ≥ 3 months, age ≥ 18 years at the time
- informed consent is signed.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 as assessed within 21 days prior to first dosage.
- Subjects with HER2 negative metastasis breast cancer, source documented, defined as per American Society of Clinical Oncology - College of American Pathologists (ASCO/CAP) guidelines.
- Subjects previously treated with no more than one prior line of standard chemotherapy
Key exclusion criteria (21 listed)
- History of, or current active cancer other than breast cancer, with the exception of curatively resected non-melanomatous skin cancer, curatively treated cervical carcinoma in situ, or other primary solid tumors curatively treated with no known active disease present and no curative treatment administered for the last 3 years.
- Patients with medical conditions that the only manifestation is hydrothorax, ascites, bone lesions or other un-measurable diseases.
- Subjects with visceral crisis in the judgment of investigator. Visceral crisis is defined as severe organ dysfunction as assessed by signs and symptoms, laboratory studies, and rapid progression of disease. Visceral crisis is not the mere presence of disease of visceral metastases, but implies important visceral compromise leading to a clinical indication for a more rapidly efficacious therapy, particularly since chemotherapy option at progression will probably not be possible.
- Malabsorption syndrome or disease significantly affecting gastro-intestinal function or major resection of the stomach or proximal small bowel that could affect absorption of Oral NVB.
- Subjects with dysphagia, or inability to swallow the tablets.
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 |
|---|---|---|
| Vinorelbine 40mgTwo tablets per day, three times a week. Vinorelbine will continue to be administered as long as patient experiences clinical benefit in the opinion of the investigator or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data and clinical status or withdrawal of consent. | Drug | Arm 1 (PD-1+NVB), Arm 2 (PD-1+NVB+Bev), Arm 3 (PD-1+NVB+DDP), Arm 4 (PD-1+VEX), Arm 5 (NVB) |
| Toripalimab 240mgAlso: JS001Toripalimab 240 MG IV infusion every 3 weeks. Toripalimab will continue to be administered as long as patient experiences clinical benefit in the opinion of the investigator or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data and clinical status or withdrawal of consent. | Biological | Arm 1 (PD-1+NVB), Arm 2 (PD-1+NVB+Bev), Arm 3 (PD-1+NVB+DDP), Arm 4 (PD-1+VEX) |
| Bevacizumab 5 mg/kgBevacizumab 5 mg/kg IV infusion every 3 weeks. Bevacizumab will continue to be administered as long as patient experiences clinical benefit in the opinion of the investigator or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data and clinical status or withdrawal of consent. | Biological | Arm 2 (PD-1+NVB+Bev) |
| Cyclophosphamide 50 mg50 mg per day. Cyclophosphamide will continue to be administered as long as patient experiences clinical benefit in the opinion of the investigator or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data and clinical status or withdrawal of consent. | Drug | Arm 4 (PD-1+VEX) |
| Capecitabine 500Mg Oral Tablet500mg three times a day. Capecitabine will continue to be administered as long as patient experiences clinical benefit in the opinion of the investigator or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data and clinical status or withdrawal of consent. | Drug | Arm 4 (PD-1+VEX) |
| CisplatinCisplatin 50mg/m2 IV infusion every 3 weeks. Cisplatin will continue to be administered as long as patient experiences clinical benefit in the opinion of the investigator or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data and clinical status or withdrawal of consent. | Drug | Arm 3 (PD-1+NVB+DDP) |
Primary outcome
Clinical Benefit Rate (CBR)
Time frame: 6 weeks of treatment
CBR, defined as the percentage of Complete Response (CR), (Partial Response) PR or Stable Disease (SD) . Response will be evaluated by Response Evaluation Criteria In Solid Tumors (RECIST) V1.1.
4 secondary outcomes
Overall response Rate (ORR)
Time frame: 6 weeks of treatment
Progression-Free Survival (PFS)
Time frame: 15 months
Overall Survival (OS)
Time frame: 15 months
Adverse events reporting
Time frame: 15 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2022.
- Derived from this study: PubMed 38969879Mo H, Yu Y, Sun X, Ge H, Yu L, Guan X, Zhai J, Zhu A, Wei Y, Wang J, Yan X, Qian H, Xu B, Ma F. Metronomic chemotherapy plus anti-PD-1 in metastatic breast cancer: a Bayesian adaptive randomized phase 2 trial. Nat Med. 2024 Sep;30(9):2528-2539. doi: 10.1038/s41591-024-03088-2. Epub 2024 Jul 5.
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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.
Hongnan Mo contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vinorelbine 40mg, Toripalimab 240mg and Bevacizumab 5 mg/kg in people with Metastatic Breast Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 2 sites 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 25 inclusion and 21 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 25 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 2 sites 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 Fei Ma (86-10-87788060, drmafei@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Benefit Rate (CBR) (time frame: 6 weeks of treatment). 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 NCT04389073, which also lists 1 linked publication.
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 25 Feb 2022.