Soft Tissue SarcomasPhase 2NCT03946943
Study of Anlotinib Hydrochloride and Toripalimab in Subjects With Unresectable or Metastatic Undifferentiated Pleomorphic Sarcoma
A Phase 2 study testing Anlotinib, Toripalimab and Blood Draw in people with Soft Tissue Sarcomas and Undifferentiated Pleomorphic Sarcoma, run by Di Wu at 1 site in China.
Trial summary
The investigators hypothesize that combination anlotinib with toripalimab will improve progression-free survival relative to historical controls in patients with Unresectable or Metastatic Undifferentiated Pleomorphic Sarcoma. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Soft Tissue Sarcomas, Undifferentiated Pleomorphic Sarcoma
- What is being tested?
- Anlotinib, Toripalimab and Blood Draw
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 19 Jul 2019to 19 Jul 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must have histologically confirmed Undifferentiated Pleomorphic Sarcoma with pathology review required for any outside samples.
- Only patients with untreated and rejected first-line standard chemotherapy with high-grade Undifferentiated Pleomorphic Sarcoma can be enrolled
- Any other histology or standard of care therapy not specifically addressed will be reviewed by the principal investigator and pathologist for final determination of eligibility.
- Measurable disease as defined by RECIST v1.1
- Radiographic progression as defined by RECIST v1.1, based on comparison between two radiographic studies no greater than 3 months apart. or Inability to undergo complete resection of the disease by surgery.
- Adequate organ function as defined:
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- Hematological
- Absolute neutrophil count (ANC) ≥1,000 / microliter (mcL)
- Platelets ≥75,000 / mcL
- Hemoglobin ≥8 g/dL without transfusion or erythropoietin (EPO) dependency (within 7 days of assessment)
- Renal
- Serum creatinine ≤1.5 X upper limit of normal (ULN) OR Measured or calculated creatinine clearance ≥ 60 mL/min for subject with creatinine levels > 1.5 X institutional ULN. (GFR can also be used in place of creatinine or CrCl). Creatinine clearance should be calculated per institutional standard.
- Hepatic
- Serum total bilirubin ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 ULN.
- Aspartate Aminotransferase (AST/SGOT) and Alanine Transaminase (ALT/SGPT) ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases.
- Albumin >2.5 mg/dL
- Coagulation
- International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants.
- Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants.
- Age ≥ 16 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Expected Survival Time: Over 3 months;
- Patients must consent and be willing to undergo three core needle biopsies at baseline, prior to starting Cycle 3, and at off-study. At least one tumor site must be amenable to biopsy in the judgment of the interventional radiologist.
- Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- Females of child bearing potential that are sexually active must agree to either practice 2 medically accepted highly effective methods of contraception at the same time or abstain from heterosexual intercourse from the time of signing the informed consent through 120 days after the last dose of study drug. See Appendix G for protocol-approved highly effective methods of contraceptive combinations. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year.
- Negative test for pregnancy is required of females of child-bearing potential; A female of child bearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1. has not undergone a hysterectomy or bilateral oophorectomy; or 2. has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months or 730 days).
- Conception while on treatment must be avoided
- Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy. Prior history of vasectomy does NOT replace requirement for contraceptive use.
- Suitable venous access to allow for all study related blood sampling
- Ability to understand and willingness to sign a written informed consent document.
- For minors that are 16 to 18 years of age, assent and parental (or legally acceptable representative) written informed consent must be obtained.
Who cannot join
- Prior therapy with anlotinib. Patients who have received prior tyrosine kinase inhibitor (TKI) therapy including imatinib, sunitinib, pazopanib, or similar. Patients who have received immunotherapy including Programmed death 1 (PD-1)/Programmed death-ligand 1 (PD-L1) and CTLA-4.
- Hypersensitivity to anlotinib, pembrolizumab or any of its excipients.
- Patients may not be receiving any other investigational agents (within 4 weeks prior to Cycle 1, day 1).
- If subject received palliative surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
- Additional known malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, or squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in situ cervical cancer.
- Patients with end-organ dysfunction as defined in inclusion criterion (i.e. #6 above).
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- Patients with bone-only lesions.
- Patients with underlying immune deficiency, chronic infections including HIV, hepatitis, or tuberculosis (TB) or autoimmune disease.
- Any major unhealed wound, ulcer, or fracture occurred in a patient who had undergone major surgery or trauma within 4 weeks and/or had any bleeding or bleeding episodes which the degree is bigger than CTCAE 3 grade within 4 weeks prior to enrollment.
- Arteriovenous thrombosis events occurred within 6 months. Such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis and pulmonary embolism
- History of steroid-related (non-infectious) pneumonia or current pneumonia.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis or leptomeningeal disease. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
- Concomitant (or receipt of) treatment with medications that may affect the metabolism of pembrolizumab and/or axitinib within 7 days prior to Cycle 1, day 1 of anlotinib.
- Has received a live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.
- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
- Any uncontrolled, intercurrent illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia
- rolonged corrected QT (QTc) interval on Screening EKG >475 ms. Ejection Fraction <40% by 2D echocardiogram (ECHO) at Screening.
- Any serious medical or psychiatric illness/condition including substance use disorders likely in the judgment of the Investigator(s) to interfere or limit compliance with study requirements/treatment.
- Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
Trial locations and contacts
1 site in 1 country.
China1 site
First Hospital of Jilin University
Changchun, Jilin
Di Wu, 13944888991 ext. 13944888991, Wudi991202@163.com
About this study
Official title: A Single-arm, Single-center Prospective Study of Anlotinib Hydrochloride and Toripalimab in Subjects With Unresectable or Metastatic Undifferentiated Pleomorphic Sarcoma Patients
The investigators hypothesize that combination anlotinib with toripalimab will improve progression-free survival relative to historical controls in patients with Unresectable or Metastatic Undifferentiated Pleomorphic Sarcoma.
Read the detailed description
This is a single-institution, open-label, single-arm Phase II study to determine the efficacy and safety of anlotinib in combination with Toripalimab compared with historical controls as first-line treatment in patients with Unresectable or Metastatic Undifferentiated Pleomorphic Sarcoma.
Since the primary endpoint is survival outcome, progression-free survival (PFS) sample size calculation is based on a single-arm survival design. The investigators will employ early stopping rules for lack of efficacy, based on previously reported historical controls progression-free rate at 3 months was 57% in MFH and This study predicts that as the First-Line treatment of Undifferentiated Pleomorphic Sarcoma, progression-free rate at 3 months is expected to reach more than 80%.
Patients will be treated with once a day dosing of anlotinib alone for the first 7 days, followed by concurrent anlotinib administered once a day at 12mg orally (PO), plus intravenous administration of toripalimab every 21 days. Patients will be assessed every six weeks for toxicity. After the first five patients are enrolled, the investigators will assess safety of the combination. If 2 or fewer patients exhibit dose-limiting toxicity (DLT), the investigators will then proceed with intrapatient titration of anlotinib dosing at each cycle based on the presence or absence of predefined toxicities.
Correlative studies characterizing T-cells in tumor tissue and in peripheral blood will be performed at three timepoints: 1. pre-treatment, 2. on-treatment on cycle 3 day 1, and 3. off-study. Additional exploratory imaging investigations, and assessment of circulating tumor cells are included for all patients.
Trial therapy will last until withdrawal of consent, disease progression and/or unacceptable toxicity, whichever occurs first.
- Being tested
- Anlotinib, Toripalimab, Blood Draw, Tumor Specimen Collection
- Keywords
- TKI, PD-1 inhibitor, Anlotinib
- Medical subject headings
- Sarcoma, Histiocytoma, Malignant Fibrous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnlotinibDrug
Once a day dosing of anlotinib alone for the first 7 days, Anlotinib ( 12mg, QD, PO, d1-14, 21 days per cycle), take once when limosis in the morning. If patients cannot suffer from AEs, they can get declined dosage.
ToripalimabDrug
Toripalimab 240mg shall be administered via intravenous (IV) infusion, once every 21 days, on day 8 and day 29 of the first cycle, and days 1 and 22 of the following cycles.
Blood DrawProcedure or surgery
Also called Phlebotomy
Peripheral blood draws for correlative studies characterizing T-cells in peripheral blood will be performed at three timepoints: 1) pre-treatment, 2) on-treatment on cycle 3 day 1, and 3) off-study.
Tumor Specimen CollectionProcedure or surgery
Also called Core-Needle Biopsy
Tumor specimen collection via core needle biopsy for correlative studies characterizing T-cells in tumor tissue will occur at three timepoints: 1) pre-treatment, 2) on-treatment on cycle 3 day 1, and 3) off-study.
| Study group | Role | What they receive |
|---|---|---|
| anlotinib + Toripalimab | Experimental | Concurrent anlotinib and Toripalimab therapy, with Blood Draw and Tumor Specimen Collection for correlative studies Receives: Drug: Anlotinib; Drug: Toripalimab; Procedure: Blood Draw; Procedure: Tumor Specimen Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Participants Achieving 3-Month Progression-Free Survival (PFS)
Rate of participants who are progression-free at 3 months after the start of protocol therapy, using Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 criteria. Progression-free survival (PFS) is defined as the time from treatment initiation until documented disease progression or death (by any cause, in the absence of progression).
Measured: 3 Months after start of protocol therapy
Secondary outcomes (7)
Rate of Participants Achieving 6-Month and 12-Month Progression-Free Survival (PFS)
Rate of participants who are progression-free at 6 months and 12-Month after the start of protocol therapy, using Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 criteria.
Measured: 6 Months and 12 Months after start of protocol therapy
Rate of Participants Achieving Objective Response (ORR)
Rate of participants achieving complete response (CR) or partial response (PR) at 3, 6 and 12 months after the start of protocol therapy, according to RECIST version 1.1 criteria.
Measured: 3, 6, and 12 Months after start of protocol therapy
Rate of Participants Achieving Clinical Benefit (CBR)
Rate of participants achieving complete response (CR), partial response (PR) or stable disease (SD) at 3, 6 and 12 months after the start of protocol therapy, according to RECIST version 1.1 criteria.
Measured: 3, 6, and 12 Months after the start of protocol therapy
Duration of Response（DOR）
Defined as the time between the first assessment of a tumor as PR or CR and the first assessment as PD or any cause of death，according to RECIST version 1.1 criteria.
Measured: up to two year
Time to initial Response（TTR）
Defined as the time between participant enrollment to the first assessment of a tumor as PR or CR，according to RECIST version 1.1 criteria.
Measured: up to two year
Overall Survival (OS)
Defined as the time between participant enrollment to death or date of censoring.
Measured: Through Study Completion, an Average of 12 months
Safety and Toxicity Profile: Rate of Toxicity in Study Participants
Rate of dose-limiting toxicities (DLTs) and/or grade 3 or 4 serious adverse events (SAEs) in study participants up to 30 days after the end of protocol therapy. Toxicity will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Measured: Up to 30 days after the end of protocol therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2019
- Study start19 Jul 2019 (estimated)
- Primary completion19 Jul 2022 (estimated)
- Study completion19 Jul 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 Soft Tissue SarcomasStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Di Wu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Di Wu, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03946943
- Sponsor's protocol ID
- FHJLU-003
- Status last verified
- Jul 2019
- First submitted
- 9 May 2019
- Last updated
- 10 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Van Glabbeke M, Verweij J, Judson I, Nielsen OS; EORTC Soft Tissue and Bone Sarcoma Group. Progression-free rate as the principal end-point for phase II trials in soft-tissue sarcomas. Eur J Cancer. 2002 Mar;38(4):543-9. doi: 10.1016/s0959-8049(01)00398-7.
PubMed 11872347
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Single-center Prospective Study of Anlotinib Hydrochloride and Toripalimab in Subjects With Unresectable or Metastatic Undifferentiated Pleomorphic Sarcoma Patients
- ClinicalTrials.gov ID
- NCT03946943
- Acronym / sponsor ID
- FHJLU-003
- Keywords
- TKI, PD-1 inhibitor, Anlotinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Di WuUniversity, hospital or other
- Study start
- 19 Jul 2019 (estimated)
- Primary completion
- 19 Jul 2022 (estimated)
- Study completion
- 19 Jul 2023 (estimated)
- First posted
- 13 May 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.
The investigators hypothesize that combination anlotinib with toripalimab will improve progression-free survival relative to historical controls in patients with Unresectable or Metastatic Undifferentiated Pleomorphic Sarcoma.
Detailed description
This is a single-institution, open-label, single-arm Phase II study to determine the efficacy and safety of anlotinib in combination with Toripalimab compared with historical controls as first-line treatment in patients with Unresectable or Metastatic Undifferentiated Pleomorphic Sarcoma.
Since the primary endpoint is survival outcome, progression-free survival (PFS) sample size calculation is based on a single-arm survival design. The investigators will employ early stopping rules for lack of efficacy, based on previously reported historical controls progression-free rate at 3 months was 57% in MFH and This study predicts that as the First-Line treatment of Undifferentiated Pleomorphic Sarcoma, progression-free rate at 3 months is expected to reach more than 80%.
Patients will be treated with once a day dosing of anlotinib alone for the first 7 days, followed by concurrent anlotinib administered once a day at 12mg orally (PO), plus intravenous administration of toripalimab every 21 days. Patients will be assessed every six weeks for toxicity. After the first five patients are enrolled, the investigators will assess safety of the combination. If 2 or fewer patients exhibit dose-limiting toxicity (DLT), the investigators will then proceed with intrapatient titration of anlotinib dosing at each cycle based on the presence or absence of predefined toxicities.
Correlative studies characterizing T-cells in tumor tissue and in peripheral blood will be performed at three timepoints: 1. pre-treatment, 2. on-treatment on cycle 3 day 1, and 3. off-study. Additional exploratory imaging investigations, and assessment of circulating tumor cells are included for all patients.
Trial therapy will last until withdrawal of consent, disease progression and/or unacceptable toxicity, whichever occurs first.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| anlotinib + Toripalimab | Experimental | Drug: Anlotinib, Drug: Toripalimab, Procedure: Blood Draw, Procedure: Tumor Specimen CollectionConcurrent anlotinib and Toripalimab therapy, with Blood Draw and Tumor Specimen Collection for correlative studies |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (31 listed)
- Patients must have histologically confirmed Undifferentiated Pleomorphic Sarcoma with pathology review required for any outside samples.
- Only patients with untreated and rejected first-line standard chemotherapy with high-grade Undifferentiated Pleomorphic Sarcoma can be enrolled
- Any other histology or standard of care therapy not specifically addressed will be reviewed by the principal investigator and pathologist for final determination of eligibility.
- Measurable disease as defined by RECIST v1.1
- Radiographic progression as defined by RECIST v1.1, based on comparison between two radiographic studies no greater than 3 months apart. or Inability to undergo complete resection of the disease by surgery.
Key exclusion criteria (19 listed)
- Prior therapy with anlotinib. Patients who have received prior tyrosine kinase inhibitor (TKI) therapy including imatinib, sunitinib, pazopanib, or similar. Patients who have received immunotherapy including Programmed death 1 (PD-1)/Programmed death-ligand 1 (PD-L1) and CTLA-4.
- Hypersensitivity to anlotinib, pembrolizumab or any of its excipients.
- Patients may not be receiving any other investigational agents (within 4 weeks prior to Cycle 1, day 1).
- If subject received palliative surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
- Additional known malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, or squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in situ cervical cancer.
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 |
|---|---|---|
| AnlotinibOnce a day dosing of anlotinib alone for the first 7 days, Anlotinib ( 12mg, QD, PO, d1-14, 21 days per cycle), take once when limosis in the morning. If patients cannot suffer from AEs, they can get declined dosage. | Drug | anlotinib + Toripalimab |
| ToripalimabToripalimab 240mg shall be administered via intravenous (IV) infusion, once every 21 days, on day 8 and day 29 of the first cycle, and days 1 and 22 of the following cycles. | Drug | anlotinib + Toripalimab |
| Blood DrawAlso: PhlebotomyPeripheral blood draws for correlative studies characterizing T-cells in peripheral blood will be performed at three timepoints: 1) pre-treatment, 2) on-treatment on cycle 3 day 1, and 3) off-study. | Procedure or surgery | anlotinib + Toripalimab |
| Tumor Specimen CollectionAlso: Core-Needle BiopsyTumor specimen collection via core needle biopsy for correlative studies characterizing T-cells in tumor tissue will occur at three timepoints: 1) pre-treatment, 2) on-treatment on cycle 3 day 1, and 3) off-study. | Procedure or surgery | anlotinib + Toripalimab |
Primary outcome
Rate of Participants Achieving 3-Month Progression-Free Survival (PFS)
Time frame: 3 Months after start of protocol therapy
Rate of participants who are progression-free at 3 months after the start of protocol therapy, using Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 criteria. Progression-free survival (PFS) is defined as the time from treatment initiation until documented disease progression or death (by any cause, in the absence of progression).
7 secondary outcomes
Rate of Participants Achieving 6-Month and 12-Month Progression-Free Survival (PFS)
Time frame: 6 Months and 12 Months after start of protocol therapy
Rate of Participants Achieving Objective Response (ORR)
Time frame: 3, 6, and 12 Months after start of protocol therapy
Rate of Participants Achieving Clinical Benefit (CBR)
Time frame: 3, 6, and 12 Months after the start of protocol therapy
Duration of Response（DOR）
Time frame: up to two year
Time to initial Response（TTR）
Time frame: up to two year
Overall Survival (OS)
Time frame: Through Study Completion, an Average of 12 months
Safety and Toxicity Profile: Rate of Toxicity in Study Participants
Time frame: Up to 30 days after the end of protocol therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2019.
- Background: PubMed 11872347Van Glabbeke M, Verweij J, Judson I, Nielsen OS; EORTC Soft Tissue and Bone Sarcoma Group. Progression-free rate as the principal end-point for phase II trials in soft-tissue sarcomas. Eur J Cancer. 2002 Mar;38(4):543-9. doi: 10.1016/s0959-8049(01)00398-7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anlotinib, Toripalimab and Blood Draw in people with Soft Tissue Sarcomas and Undifferentiated Pleomorphic Sarcoma, run by Di Wu 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 31 inclusion and 19 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 10 Jul 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 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 Di Wu (139 4488 8991, Wudi991202@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Participants Achieving 3-Month Progression-Free Survival (PFS) (time frame: 3 Months after start of protocol therapy). 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 NCT03946943, 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 10 Jul 2019.