SarcomaPhase 2ALTER-S001NCT03880695
Anlotinib Hydrochloride Combined With Liposomal Doxorubicin in the Treatment of Locally Advanced or Metastatic Soft Tissue Sarcoma
A Phase 2 study testing Anlotinib+ Liposomal Doxorubicin in people with Sarcoma, run by Peking University People's Hospital at 8 sites in China.
Trial summary
The investigators explored the activity of anlotinib combined with Liposomal Doxorubicin in patients with Locally Advanced or Metastatic Soft Tissue Sarcoma Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Sarcoma
- What is being tested?
- Anlotinib+ Liposomal Doxorubicin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 8 sitesChina
- Study dates
- Mar 2019to May 2021
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Signed the informed consent form prior to patient entry;
- ≥ 14 years of age , regardless of gender；ECOG :0-1;Expected Survival Time: Over 3 months;
- Histologically confirmed diagnosis of un-resectable or recurrent metastatic soft tissue sarcoma, such as: leiomyosarcoma, synovial sarcoma, undifferentiated pleomorphic sarcoma, liposarcoma , angiosarcoma, alveolar soft tissue sarcoma, and other sarcomas. The following histologies are excluded: embryonic rhabdomyosarcoma, chondrosarcoma, osteosarcoma, gastrointestinal stromal tumor and Ewing sarcoma/primary neuroectodermal tumor.
- Previously without anthracyclines or other anti-tumor drugs
- Evaluable disease by imaging or physical exam or measurable disease defined as at least one lesion that can be accurately measured according to RECIST version 1.1.
- Normal main organs function as defined below: Hemoglobin (Hb) ≥ 80g / L, Neutrophils (ANC) ≥ 1.5 × 10^9 / L, Platelet count (PLT) ≥ 80 × 10^9 / L, Serum creatinine (Cr) ≤ 1.5 × normal upper limit (ULN) or creatinine clearance (CCr) ≥ 60ml / min, Blood urea nitrogen (BUN) ≤ 2.5 × normal upper limit (ULN); Total bilirubin (TB) ≤ 1.5 × ULN; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN; If accompanied by liver metastases, ALT and AST ≤ 5 × ULN Albumin (ALB) ≥ 25 g/L. Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ normal low limit (50%)
- Women of childbearing potential should agree to use and utilize an adequate method of contraception (such as intrauterine device，contraceptive and condom) throughout treatment and for at least 6 months after study is stopped；the result of serum or urine pregnancy test should be negative within 7 days prior to study enrollment，and the patients required to be non-lactating；Man participants should agree to use and utilize an adequate method of contraception throughout treatment and for at least 6 months after study is stopped.
Who cannot join
- Prior treatment with anlotinib or any other VEGFR tyrosine kinase inhibitor (such as sunitinib, sorafenib, bevacizumab, imatinib, famitinib, apatinib, regorafenib and other drugs).
- Systemic anti-tumor therapy, including cytotoxic therapy, signal transduction inhibitors, and immunotherapy, is planned for the first 4 weeks prior to enrollment or during the study. Radiation radiotherapy (EF-RT) was performed within 4 weeks prior to enrollment.
- A history of other malignancy ≤ 3 years previous
- Known central nervous system metastases.
- Imaging (CT or MRI) shows tumor lesions from large vessels ≤ 5 mm, the tumor is very likely to invade the important blood vessels and cause fatal hemorrhage, or the formation of tumor thrombosis with large veins (iliac vessels, inferior vena cava, pulmonary veins, superior vena cava);
- The investigator judged that the presence of distinct pulmonary cavitary or necrotic tumors;
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- Serosal effusion with clinical symptoms requiring surgical management (including hydrothorax and ascites pericardial effusion)
- With uncontrollable hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg, despite optimal drug treatment).
- Arrhythmias with grade II and above myocardial ischemia or myocardial infarction, poor control (including corrected QT interval(QTc) men ≥ 450 ms, women ≥ 470 ms).
- According to NYHA criteria, grade III to IV cardiac insufficiency, or cardiac color Doppler ultrasound examination showed left ventricular ejection fraction (LVEF) <50%, myocardial infarction occurred within 6 months before enrollment, ≥ 2 congestive heart failure (New York Heart Association ( NYHA) rating ), uncontrolled angina, clinical pericardial disease, or electrocardiogram suggesting acute ischemia or active conduction system abnormalities.
- Uncontrolled comorbid diseases, including but not limited to: poorly controlled diabetes, persistent active infections, or mental illness or social condition that may affect a subject's adherence to the study.
- Patients with active hepatitis B or hepatitis C (hepatitis B: HBsAg-positive and hepatitis B virus(HBV) DNA ≥ 500 IU/mL; hepatitis C: hepatitis C virus(HCV) RNA-positive and abnormal liver function), or active infection requiring antimicrobial treatment (eg Treated with antibacterial drugs, antiviral drugs, antifungal drugs)
- Renal insufficiency: urine routine indicates urinary protein ≥ ++, or confirmed 24-hour urine protein ≥ 1.0 g;
- Patients with seizures and need treatment
- Abnormal coagulation (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds or activated partial thromboplastin time(APTT) > 1.5 ULN), with bleeding tendency or undergoing thrombolytic or anticoagulant therapy.
- Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin.
- Significant coughing blood in the 2 months before enrollment, or daily hemoptysis of 2.5ml or more.
- History of psychotropic substance abuse who are unable to quit or have a mental disorder.
- Tendencies of hereditary or acquired hemorrhagic and thrombotic (such as hemophilia patients, coagulopathy, thrombocytopenia, hypersplenism, etc.)
- Any major unhealed wound, ulcer, or fracture occurred in a patient who had undergone major surgery or trauma within 4 weeks prior to enrollment.
- Active period digestive ulcers.
- Cavity sinus or perforation occurred within 6 months.
- Participated in other anti-tumor clinical trials within 4 weeks.
- Received a potent CYP3A4 inhibitor (such as ketoconazole, itraconazole, erythromycin, and clarithromycin) within 7 days, or received a potent CYP3A4 inducer within 12 days prior to the study (eg. catarrh Treatment with imipramine, rifampicin and phenobarbital).
- Allergic reactions, hypersensitivity reactions or intolerance to anlotinib hydrochloride or its excipients.
- Pregnancy or lactation.
- The investigator believes that there are any conditions that may damage the subject or result in the subject not being able to meet or perform the research request.
Trial locations and contacts
8 sites in 1 country.
Xin Sun contact
8 sites in 1 country
China8 sites, 8 recruiting
- Not yet recruiting
Peking University Shougang Hospital
Beijing, Beijing Municipality, 100034
Jin Gu, zlgujin@126.com
Jie Xu, M.D., xujie_pkuph@sina.com
- Not yet recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality
Zhengfu Fan, zhengfufan@126.com
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality
Wei Guo, +86-10-66583761, bonetumor@163.com
Xin Sun, +86-10-66583761
- Not yet recruiting
First Hospital of Jilin University
Changchun, Jilin
Di Wu, Wudi888991@163.com
- Not yet recruiting
Hunan Cancer Hospital
Changsha, Hunan
Xian'an Li, lixianan2001@163.com
- Not yet recruiting
Ruijin Hospital
Shanghai, Shanghai Municipality
Weibin Zhang, zhangweibin10368@sina.com
- Not yet recruiting
Liaoning Tumor Hospital & Institute
Shenyang, Liaoning
Xiaojing Zhang, zhangxiaojingwu@163.com
- Not yet recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality
Guowen Wang, wgwhrb@163.com
About this study
Official title: Anlotinib Hydrochloride Combined With Liposomal Doxorubicin in the Treatment of Locally Advanced or Metastatic Soft Tissue Sarcoma : a One-arm, Multi-center, Prospective Clinical Trial (ALTER-S001)
The investigators explored the activity of anlotinib combined with Liposomal Doxorubicin in patients with Locally Advanced or Metastatic Soft Tissue Sarcoma
- Conditions
- Sarcoma
- Being tested
- Anlotinib+ Liposomal Doxorubicin
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anlotinib+ Liposomal DoxorubicinDrug
Also called Anlotinib+ LPD
Anlotinib : 12 mg, qd, po day 8-21 every 3 weeks Liposomal Doxorubicin: 50 mg/m2, day 1 every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Anlotinib+ Liposomal Doxorubicin | Experimental | Anlotinib Hydrochloride Combined With Liposomal Doxorubicin Liposomal Doxorubicin 50mg/m2 Day 1 every-3-weeks (Q3W) and Anlotinib 12mg QD po at Day 8-21 Q3W and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent. Dose reductions/modifications will be applied as indicated by toxicities and/or patient tolerance. Receives: Drug: Anlotinib+ Liposomal Doxorubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progress free survival (PFS)
Calculated from the date of treatment start until last follow-up or death, whichever comes first.
Measured: each 42 days to evaluate up to intolerance the toxicity or PD (in first 24 weeks), each 84 days to evaluate up to intolerance the toxicity or PD (up to 24 months)
Secondary outcomes (4)
Overall Survival (OS)
Calculated from the date of treatment start until last follow-up or death, whichever comes first.
Measured: From randomization until death (up to 24 months)
Objective Response Rate (ORR)
Overall objective response measured using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Measured: each 42 days to evaluate up to intolerance the toxicity or PD (in first 24 weeks), each 84 days to evaluate up to intolerance the toxicity or PD (up to 24 months)
Disease Control Rate (DCR)
Disease Control Rate measured using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Measured: each 42 days to evaluate up to intolerance the toxicity or PD (in first 24 weeks), each 84 days to evaluate up to intolerance the toxicity or PD (up to 24 months)
Quality of Life (QoL)
QoL is measured by the World Health Organization Quality of Life (WHOQOL-BREF)
Measured: each 42 days to evaluate up to intolerance the toxicity or PD (in first 24 weeks), each 84 days to evaluate up to intolerance the toxicity or PD (up to 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study startMar 2019 (estimated)
- Primary completionApr 2021 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Shougang Hospital, Peking University Cancer Hospital & Institute, Tianjin Medical University Cancer Institute and Hospital, The First Hospital of Jilin University, Hunan Cancer Hospital, Ruijin Hospital, Liaoning Cancer Hospital & Institute
- Responsible party
- Principal investigator, GUO WEI, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03880695
- Sponsor's protocol ID
- 2018PHD008-01
- Acronym
- ALTER-S001
- Status last verified
- Mar 2019
- First submitted
- 14 Mar 2019
- Last updated
- 21 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anlotinib Hydrochloride Combined With Liposomal Doxorubicin in the Treatment of Locally Advanced or Metastatic Soft Tissue Sarcoma : a One-arm, Multi-center, Prospective Clinical Trial (ALTER-S001)
- ClinicalTrials.gov ID
- NCT03880695
- Acronym / sponsor ID
- ALTER-S001 / 2018PHD008-01
- Conditions
- Sarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Peking University Shougang Hospital, Peking University Cancer Hospital & Institute, Tianjin Medical University Cancer Institute and Hospital, The First Hospital of Jilin University, Hunan Cancer Hospital, Ruijin Hospital, Liaoning Cancer Hospital & Institute
- Study start
- Mar 2019 (estimated)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 19 Mar 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 explored the activity of anlotinib combined with Liposomal Doxorubicin in patients with Locally Advanced or Metastatic Soft Tissue Sarcoma
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anlotinib+ Liposomal Doxorubicin | Experimental | Drug: Anlotinib+ Liposomal DoxorubicinAnlotinib Hydrochloride Combined With Liposomal Doxorubicin Liposomal Doxorubicin 50mg/m2 Day 1 every-3-weeks (Q3W) and Anlotinib 12mg QD po at Day 8-21 Q3W and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent. Dose reductions/modifications will be applied as indicated by toxicities and/or patient tolerance. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Signed the informed consent form prior to patient entry;
- ≥ 14 years of age , regardless of gender；ECOG :0-1;Expected Survival Time: Over 3 months;
- Histologically confirmed diagnosis of un-resectable or recurrent metastatic soft tissue sarcoma, such as: leiomyosarcoma, synovial sarcoma, undifferentiated pleomorphic sarcoma, liposarcoma , angiosarcoma, alveolar soft tissue sarcoma, and other sarcomas. The following histologies are excluded: embryonic rhabdomyosarcoma, chondrosarcoma, osteosarcoma, gastrointestinal stromal tumor and Ewing sarcoma/primary neuroectodermal tumor.
- Previously without anthracyclines or other anti-tumor drugs
- Evaluable disease by imaging or physical exam or measurable disease defined as at least one lesion that can be accurately measured according to RECIST version 1.1.
Key exclusion criteria (27 listed)
- Prior treatment with anlotinib or any other VEGFR tyrosine kinase inhibitor (such as sunitinib, sorafenib, bevacizumab, imatinib, famitinib, apatinib, regorafenib and other drugs).
- Systemic anti-tumor therapy, including cytotoxic therapy, signal transduction inhibitors, and immunotherapy, is planned for the first 4 weeks prior to enrollment or during the study. Radiation radiotherapy (EF-RT) was performed within 4 weeks prior to enrollment.
- A history of other malignancy ≤ 3 years previous
- Known central nervous system metastases.
- Imaging (CT or MRI) shows tumor lesions from large vessels ≤ 5 mm, the tumor is very likely to invade the important blood vessels and cause fatal hemorrhage, or the formation of tumor thrombosis with large veins (iliac vessels, inferior vena cava, pulmonary veins, superior vena cava);
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 |
|---|---|---|
| Anlotinib+ Liposomal DoxorubicinAlso: Anlotinib+ LPDAnlotinib : 12 mg, qd, po day 8-21 every 3 weeks Liposomal Doxorubicin: 50 mg/m2, day 1 every 3 weeks | Drug | Anlotinib+ Liposomal Doxorubicin |
Primary outcome
Progress free survival (PFS)
Time frame: each 42 days to evaluate up to intolerance the toxicity or PD (in first 24 weeks), each 84 days to evaluate up to intolerance the toxicity or PD (up to 24 months)
Calculated from the date of treatment start until last follow-up or death, whichever comes first.
4 secondary outcomes
Overall Survival (OS)
Time frame: From randomization until death (up to 24 months)
Objective Response Rate (ORR)
Time frame: each 42 days to evaluate up to intolerance the toxicity or PD (in first 24 weeks), each 84 days to evaluate up to intolerance the toxicity or PD (up to 24 months)
Disease Control Rate (DCR)
Time frame: each 42 days to evaluate up to intolerance the toxicity or PD (in first 24 weeks), each 84 days to evaluate up to intolerance the toxicity or PD (up to 24 months)
Quality of Life (QoL)
Time frame: each 42 days to evaluate up to intolerance the toxicity or PD (in first 24 weeks), each 84 days to evaluate up to intolerance the toxicity or PD (up to 24 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2019.
- Individual participant dataSharing planned: No
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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.
Xin Sun contact
8 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 Anlotinib+ Liposomal Doxorubicin in people with Sarcoma, run by Peking University People's Hospital at 8 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 7 inclusion and 27 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 21 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 Wei Guo, MD (+86-13701195504, bonetumor@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progress free survival (PFS) (time frame: each 42 days to evaluate up to intolerance the toxicity or PD (in first 24 weeks), each 84 days to evaluate up to intolerance the toxicity or PD (up to 24 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 21 Mar 2019.