Soft Tissue SarcomaPhase 2NCT04012827
Apatinib Mesylate Combined With Doxorubicin and Ifosfamide in Advanced Soft-tissue Sarcoma
A Phase 2 study testing Apatinib Mesylate, doxorubicin, ifosfamide in people with Soft Tissue Sarcoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
Apatinib mesylate is a multitarget receptor tyrosine kinase inhibitor. This trial is to evaluate the efficacy and safety of apatinib mesylate combined with doxorubicin and ifosfamide in the treatment of advanced soft tissue sarcoma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Soft Tissue Sarcoma
- What is being tested?
- Apatinib Mesylate, doxorubicin, ifosfamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteChina
- Study dates
- 20 Aug 2019to 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients voluntarily participated in this study and signed the informed consent;
- The pathology diagnosed with at least one measurable lesion according to RECIST 1.1 standard. The pathology includes synovial sarcoma, leiomyosarcoma, angiosarcoma, undifferentiated pleomorphic sarcoma/malignant fibrous histiocytoma, liposarcoma, fibrosarcoma, clear cell sarcoma, epithelioid sarcoma, malignant peripheral nerve sheath tumor, undifferentiated sarcoma, rhabdomyosarcoma, dermatofibrosarcoma protuberans, ewing's sarcoma /primary neural ectoderm tumors, desmoplastic small round cell tumor, inflammatory myofibroblastic sarcoma, malignant solitary fibroma. Except for chondrosarcoma, osteosarcoma, malignant mesothelioma, alveolar soft tissue sarcoma, gastrointestinal stromal tumor;
- Patients with recurrence after surgery or with lymph nodes or distant metastasis after imaging evaluation;
- 18 ~ 70 years old; ECOG PS score: 0~1; Expected survival beyond 3 months;
- Major organs functions should meet the following standards within 7 days before treatment:
- Blood routine examination standard (without blood transfusion within 14 days) : Hemoglobin (HB) ≥90g/L; The absolute value of neutrophils (ANC) ≥1.5×109/L; Platelet (PLT) ≥80 ×109/L.
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- Biochemical examination shall meet the following standards: Total bilirubin (TBIL) ≤ 1.5 times ULN (Upper Limit Of Normal); alanine aminotransferase （ALT）and aspartate aminotransferase AST≤2.5 times ULN. If accompanied by liver metastasis, ALT and AST≤5 times ULN；Serum creatinine（Cr）≤1.5 times ULN or creatinine clearance rate (CCr)≥ 60ml/min；
- Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) ≥ normal low limit (50%).
- 6. Women of reproductive age should agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during and within 6 months after the study; Negative serum or urine pregnancy test within 7 days prior to study enrollment and must be non-lactating; Men should agree to use contraceptives during and within 6 months after the study period.
Who cannot join
- Patients who have previously used apatinib mesylate;
- Received any form of chemotherapy after recurrence or metastasis;
- Patients previously treated with targeted drugs of vascular endothelial growth inhibitors, such as sunitinib, sorafenib, bevacizumab, imatinib, famitinib, pazopanib, regorafenib, and anlotinib.
- Other malignancies that have occurred or are present at the same time within 5 years, except for cured cancers including carcinoma in situ of the cervix, non-melanoma skin cancer and superficial bladder tumor [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)];
- Systemic anti-tumor therapy, including cytotoxic therapy, signal transduction inhibitors, and immunotherapy (or mitomycin C administration within 6 weeks before the treatment with the experimental drug), is planned within 4 weeks before enrollment or during the medication period of this study. In the first 4 weeks of enrollment, the patients were treated with field expanding radiotherapy (ef-rt) or the limited field radiotherapy designed to evaluate tumor lesions in the first 2 weeks of enrollment.
- Accompanied by pleural effusion or ascites, causing respiratory syndrome (CTCAE grade 2 dyspnea [grade 2 dyspnea refers to shortness of breath when there is a small amount of activity; it affects instrumental daily life activities]);
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- Unrelieved toxic reactions caused by any previous treatment higher than CTCAE (4.1) level 1 or above, excluding hair loss;
- Patients with multiple factors (such as inability to swallow, chronic diarrhea and intestinal obstruction) affecting oral drugs;
- Patients with brain metastases with symptoms or with symptoms for less than 2 months;
- Patients with any severe and/or uncontrolled disease, including:
- 1)Patients with unsatisfactory blood pressure control (systolic blood pressure 150 mmHg, diastolic blood pressure 100 mmHg);
- 2)Patients with grade I or above myocardial ischemia or myocardial infarction, arrhythmia (including QTC 480ms) and grade II congestive heart failure (NYHA classification);
- 3)Active or uncontrolled severe infection (CTCAE grade 2 infection);
- 4)Cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis require antiviral treatment;
- 5) Renal failure requires hemodialysis or peritoneal dialysis;
- 6) Have a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation;
- 7)Poor control of diabetes mellitus (FBG) > 10mmol/L);
- 8)Urine routine test indicated urine protein ++, and confirmed the 24-hour urine protein quantitative > 1.0g;
- 9)Patients with seizures requiring treatment;
- 11. Received major surgical treatment, open biopsy or obvious traumatic injury within 28 days before enrollment;
- 12. Patients with any signs of bleeding constitution or medical history, regardless of the severity; Patients with any bleeding or bleeding event CTCAE level 3 within 4 weeks before enrollment have unhealed wounds, ulcers or fractures;
- 13. Hyperactive/venous thrombosis events within 6 months, such as cerebrovascular accidents (including temporary ischemic attack), deep venous thrombosis and pulmonary embolism;
- 14. Patients with active ulcer, intestinal perforation and intestinal obstruction;
- 15. Have a history of mental drug abuse and cannot quit or have mental disorder;
- 16. Participated in clinical trials of other anti-tumor drugs within 28 days before enrollment;
- 17.According to the judgment of the researcher, there are those who seriously endanger the safety of patients or affect the patients' completion of the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou
Xing Zhang
About this study
Official title: A Single-arm, Open, Multicenter Study of Apatinib Mesylate Combined With Doxorubicin and Ifosfamide in Advanced Soft-tissue Sarcoma
Apatinib mesylate is a multitarget receptor tyrosine kinase inhibitor. This trial is to evaluate the efficacy and safety of apatinib mesylate combined with doxorubicin and ifosfamide in the treatment of advanced soft tissue sarcoma.
Read the detailed description
Apatinib mesylate has demonstrated good efficacy and acceptable safety in patients with metastatic or recurrent soft tissue sarcoma (STS). A retrospective study has evaluated the efficacy of apatinib in the treatment of advanced soft tissue sarcoma. A total of 31 patients with soft tissue sarcoma were enrolled in this study, including 4 patients receiving apatinib first-line treatment, 8 patients receiving second-line treatment, and 19 patients receiving third-line or post-third-line treatment. The results showed that ORR 33.3%, DCR 75%, and mTTP 4.6 months (1.8-11.6 months). In another multicentric retrospective study of apatinib for osteosarcoma and soft tissue sarcoma, a total of 56 patients were enrolled and 44 were treated with apatinib monotherapy. The overall results showed that ORR was 62.5%, mPFS was 6.6 months, and mOS was 9.9 months. In a phase II multi-center single-arm study results published by Yang Jilong Yang et al at the 2018 AACR conference, ORR and DCR at 3 months also reached 13.95% and 81.39%, respectively. The end point assessment ORR was further increased to 15.25% at the end of the study, because some patients achieved partial remission after a long period of treatment, and the final DCR reached 57.63%. Apatinib had a significant effect in the treatment of stage IV osteosarcoma with failed chemotherapy. Jing Chen et al published a study researching the effectiveness and security in advanced sarcoma patients after apatinib treatment , the results show that 24.3% of subjects to achieve objective response, including 1 case of adenoid vesicular soft tissue sarcoma patients achieved CR, seven adenoid vesicular soft tissue sarcoma patients achieved the objective response, indicates that apatinib is effective and well tolerated in some specific sarcoma subtype.
In this study ,Apatinib mesylate combined with doxorubicin and ifosfamide regimens were evaluated in the treatment of advanced or inoperable STS to determine the potential to achieve better outcomes.
- Conditions
- Soft Tissue Sarcoma
- Being tested
- Apatinib Mesylate, doxorubicin, ifosfamide
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apatinib Mesylate, doxorubicin, ifosfamideDrug
Also called Apatinib
Doxorubicin 50mg/m2 d1 , Ifosfamide 2.5g/m2 d1-3 , Apatinib mesylate 375mg qd
| Study group | Role | What they receive |
|---|---|---|
| Apatinib Mesylate Combined With Doxorubicin and Ifosfamide | Experimental | A course of treatment every 21 days. For patients with disease control (CR+ PR+SD) and tolerable adverse reactions after 6 courses of treatment, continuous drug use was considered by the researchers as inappropriate for patients to continue drug use or when the efficacy was assessed as disease progression (PD).No other antitumor treatment can be given during the treatment. Receives: Drug: Apatinib Mesylate, doxorubicin, ifosfamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Objective response rate is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1.prior to progression or any further therapy.
Measured: up to 24 months
Secondary outcomes (3)
Progress free survival
Progress free survival defined as the time from first dose of study treatment until the first date of either objective disease progression or death due to any cause.
Measured: From treatment until progression (up to 24 months)
Overall Survival
Overall survival is defined as the time until death due to any cause.
Measured: From treatment until death (up to 24 months)
Disease Control Rate
Defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1.
Measured: each 42 days 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 posted9 Jul 2019
- Study start20 Aug 2019
- Primary completion15 Jun 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue SarcomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Responsible party
- Principal investigator, Xing Zhang, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04012827
- Sponsor's protocol ID
- SunYat-senU-apatinib
- Status last verified
- Sep 2022
- First submitted
- 7 Jul 2019
- Last updated
- 7 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Open, Multicenter Study of Apatinib Mesylate Combined With Doxorubicin and Ifosfamide in Advanced Soft-tissue Sarcoma
- ClinicalTrials.gov ID
- NCT04012827
- Acronym / sponsor ID
- SunYat-senU-apatinib
- Conditions
- Soft Tissue Sarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Study start
- 20 Aug 2019 (actual)
- Primary completion
- 15 Jun 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 9 Jul 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.
Apatinib mesylate is a multitarget receptor tyrosine kinase inhibitor. This trial is to evaluate the efficacy and safety of apatinib mesylate combined with doxorubicin and ifosfamide in the treatment of advanced soft tissue sarcoma.
Detailed description
Apatinib mesylate has demonstrated good efficacy and acceptable safety in patients with metastatic or recurrent soft tissue sarcoma (STS). A retrospective study has evaluated the efficacy of apatinib in the treatment of advanced soft tissue sarcoma. A total of 31 patients with soft tissue sarcoma were enrolled in this study, including 4 patients receiving apatinib first-line treatment, 8 patients receiving second-line treatment, and 19 patients receiving third-line or post-third-line treatment. The results showed that ORR 33.3%, DCR 75%, and mTTP 4.6 months (1.8-11.6 months). In another multicentric retrospective study of apatinib for osteosarcoma and soft tissue sarcoma, a total of 56 patients were enrolled and 44 were treated with apatinib monotherapy. The overall results showed that ORR was 62.5%, mPFS was 6.6 months, and mOS was 9.9 months. In a phase II multi-center single-arm study results published by Yang Jilong Yang et al at the 2018 AACR conference, ORR and DCR at 3 months also reached 13.95% and 81.39%, respectively. The end point assessment ORR was further increased to 15.25% at the end of the study, because some patients achieved partial remission after a long period of treatment, and the final DCR reached 57.63%. Apatinib had a significant effect in the treatment of stage IV osteosarcoma with failed chemotherapy. Jing Chen et al published a study researching the effectiveness and security in advanced sarcoma patients after apatinib treatment , the results show that 24.3% of subjects to achieve objective response, including 1 case of adenoid vesicular soft tissue sarcoma patients achieved CR, seven adenoid vesicular soft tissue sarcoma patients achieved the objective response, indicates that apatinib is effective and well tolerated in some specific sarcoma subtype.
In this study ,Apatinib mesylate combined with doxorubicin and ifosfamide regimens were evaluated in the treatment of advanced or inoperable STS to determine the potential to achieve better outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Apatinib Mesylate Combined With Doxorubicin and Ifosfamide | Experimental | Drug: Apatinib Mesylate, doxorubicin, ifosfamideA course of treatment every 21 days. For patients with disease control (CR+ PR+SD) and tolerable adverse reactions after 6 courses of treatment, continuous drug use was considered by the researchers as inappropriate for patients to continue drug use or when the efficacy was assessed as disease progression (PD).No other antitumor treatment can be given during the treatment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients voluntarily participated in this study and signed the informed consent;
- The pathology diagnosed with at least one measurable lesion according to RECIST 1.1 standard. The pathology includes synovial sarcoma, leiomyosarcoma, angiosarcoma, undifferentiated pleomorphic sarcoma/malignant fibrous histiocytoma, liposarcoma, fibrosarcoma, clear cell sarcoma, epithelioid sarcoma, malignant peripheral nerve sheath tumor, undifferentiated sarcoma, rhabdomyosarcoma, dermatofibrosarcoma protuberans, ewing's sarcoma /primary neural ectoderm tumors, desmoplastic small round cell tumor, inflammatory myofibroblastic sarcoma, malignant solitary fibroma. Except for chondrosarcoma, osteosarcoma, malignant mesothelioma, alveolar soft tissue sarcoma, gastrointestinal stromal tumor;
- Patients with recurrence after surgery or with lymph nodes or distant metastasis after imaging evaluation;
- 18 ~ 70 years old; ECOG PS score: 0~1; Expected survival beyond 3 months;
- Major organs functions should meet the following standards within 7 days before treatment:
Key exclusion criteria (26 listed)
- Patients who have previously used apatinib mesylate;
- Received any form of chemotherapy after recurrence or metastasis;
- Patients previously treated with targeted drugs of vascular endothelial growth inhibitors, such as sunitinib, sorafenib, bevacizumab, imatinib, famitinib, pazopanib, regorafenib, and anlotinib.
- Other malignancies that have occurred or are present at the same time within 5 years, except for cured cancers including carcinoma in situ of the cervix, non-melanoma skin cancer and superficial bladder tumor [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)];
- Systemic anti-tumor therapy, including cytotoxic therapy, signal transduction inhibitors, and immunotherapy (or mitomycin C administration within 6 weeks before the treatment with the experimental drug), is planned within 4 weeks before enrollment or during the medication period of this study. In the first 4 weeks of enrollment, the patients were treated with field expanding radiotherapy (ef-rt) or the limited field radiotherapy designed to evaluate tumor lesions in the first 2 weeks of enrollment.
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 |
|---|---|---|
| Apatinib Mesylate, doxorubicin, ifosfamideAlso: ApatinibDoxorubicin 50mg/m2 d1 , Ifosfamide 2.5g/m2 d1-3 , Apatinib mesylate 375mg qd | Drug | Apatinib Mesylate Combined With Doxorubicin and Ifosfamide |
Primary outcome
Objective Response Rate
Time frame: up to 24 months
Objective response rate is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1.prior to progression or any further therapy.
3 secondary outcomes
Progress free survival
Time frame: From treatment until progression (up to 24 months)
Overall Survival
Time frame: From treatment until death (up to 24 months)
Disease Control Rate
Time frame: each 42 days 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 7 Sep 2022.
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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 Apatinib Mesylate, doxorubicin, ifosfamide in people with Soft Tissue Sarcoma, run by Sun Yat-sen University 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 9 inclusion and 26 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 7 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 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 Xing Zhang (02087343383, zhangxing@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: 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 7 Sep 2022.