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Soft Tissue SarcomaPhase 2NCT04126811

Apatinib Combined With Chemotherapy in the Treatment of Soft Tissue Sarcoma

A Phase 2 study testing Apatinib Mesylate, Pirarubicin, Ifosfamide, Apatinib Mesylate and Pirarubicin, Ifosfamide in people with Soft Tissue Sarcoma, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To observe the efficacy of apatinib combined with AI regimen chemotherapy compared with AI regimen chemotherapy and single-agent apatinib in patients with unresectable soft tissue sarcoma. Read more about this study

Who is it for?
Ages 14 to 75 years
Conditions the study is for
Soft Tissue Sarcoma
What is being tested?
Apatinib Mesylate, Pirarubicin, Ifosfamide, Apatinib Mesylate and Pirarubicin, Ifosfamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteChina
Study dates
1 Jun 2019to 31 Dec 2020
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Patients voluntarily join the study, sign informed consent, and have good compliance;
  • A distantly metastatic or locally advanced and soft tissue sarcoma subject determined by the investigator not suitable for surgical treatment (Confirmed by pathology or cytology, except for gastrointestinal stromal tumors, cartilage-bone tumors, embryonic/acinar rhabdomyosarcoma, Ewing's sarcoma, and distant metastatic soft tissue tumors such as dermatofibrosarcoma And inflammatory myofibroblastic sarcoma, clear cell sarcoma and alveolar soft tissue sarcoma, etc).
  • The clinical staging is based on the TNM staging criteria of the American Joint Committee on Cancer Research (AJCC). At least one double-path measurable lesion according to CT or MR I;
  • Patients who have not previously received chemotherapy for soft-tissue sarcoma; or who have benefited from chemotherapy and who have relapsed or metastasized more than 6 months after discontinuation of the drug. The accumulated amount of anthracycline used in the past <450mg/m2.
  • 14~75 years old, PS score: 0~1 (Amputation patient can be relaxed to 2 points); the expected survival time is more than 3 months;
  • All acute toxic reactions caused by previous anti-tumor treatment or surgery are relieved to 0-1 before screening (according to NCI CTCAE version 4.03) or to the level specified by the enrollment/exclusion criteria (alopecia, etc. Except for toxicity that does not pose a safety risk to the subject);
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  • There are sufficient organ and bone marrow functions, defined as follows: Blood routine (no blood transfusion within 14 days before treatment, no use of G-CSF, no use of drugs to correct), Neutrophil count (ANC) ≥ 1,500/mm3 (1.5 × 109/L), Platelet count (PLT) ≥ 100,000/mm3 (100 × 109/L), Hemoglobin (Hb) ≥ 9 g/dL (90 g/L); Blood chemistry, Serum creatinine (Cr) ≤ 1.5 × upper limit of normal (ULN) or creatinine clearance (Cockroft-Gault formula) ≥ 60 ml / min, Total bilirubin (TBIL) ≤ 1.5 × ULN; Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels ≤ 2.5 × ULN, liver metastases should be ≤ 5 × ULN; Coagulation, International normalized ratio (INR) ≤ 1.5, prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; Urine routine, Urine protein <2+; if urine protein ≥ 2+, 24-hour urine protein quantitation shows that the protein must be ≤ 1g; Thyroid function, Thyroid stimulating hormone (TSH) ≤ ULN; if abnormalities should be considered T3 and T4 levels, T3 and T4 levels can be selected;
  • Female subjects of childbearing age must undergo a serum pregnancy test within 7 days prior to treatment and the results are negative, and are willing to use a medically recognized effective contraceptive measure during the study period and within 3 months after the last administration of the study drug (eg: Intrauterine devices, contraceptives or condoms; for male subjects whose partners are women of childbearing age, surgical sterilization is required, or an effective method of contraception is recommended during the study period and within 3 months after the last study administration;
  • With my consent and signed informed consent, I am willing and able to follow planned visits, research treatments, laboratory tests and other testing procedures.

Who cannot join

  • The following treatments were received within 4 weeks of treatment: Radiotherapy, surgery, chemotherapy, immunization or molecular targeted therapy for tumors; Other clinical research drugs; Vaccination live attenuated vaccine;
  • Patients with previous chemotherapy failure or who have received anti-angiogenic targeted drugs within the past 3 months, such as Anlotinib, Pazopanib, Sorafenib, Sunitinib, Bevacizumab, Imatinib, Crizotinib, Apatinib, Regorafenib and Drugs such as endostatin;
  • Surgery and/or radiation therapy for soft tissue sarcomas is planned during the study (regardless of <5% of the bone marrow area);
  • Imaging diagnosis of central nervous system tumors;
  • Immune-suppressing drugs have been used within 14 days prior to initiation of treatment, excluding nasal and inhaled corticosteroids or physiological doses of systemic steroid hormones (That is, no more than 10 mg / day of prednisolone or equivalent physiological dose of other corticosteroids);
  • There is any active autoimmune disease or a history of autoimmune disease (Including but not limited to: Autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism; Subjects with vitiligo or asthma that have been completely relieved in childhood and currently do not require medical intervention may be included, or a history of allogeneic organ transplantation or a history of allogeneic hematopoietic stem cell transplantation);
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  • Severe infections (such as intravenous infusion of antibiotics, antifungal or antiviral drugs) within 4 weeks prior to treatment, or unexplained fever >38.5 °C during screening/first administration;
  • High blood pressure, and excellent control without antihypertensive medication (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg);
  • There are significant clinically significant bleeding symptoms or clear bleeding tendency within 3 months before treatment, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood ++ and above, vasculitis, etc. Or venous/venous thrombosis events occurring within 6 months prior to treatment, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism; or require long-term anticoagulant therapy with warfarin or heparin, or long-term antiplatelet therapy (aspirin ≥ 300 mg / day or clopidogrel ≥ 75 mg / day);
  • There were active heart disease in the 6 months before treatment, including myocardial infarction, severe/unstable angina. Echocardiography left ventricular ejection fraction <50%, poorly controlled arrhythmia (including QTcF interval men > 450 ms, women > 470 ms);
  • Any other malignant tumor was diagnosed within 3 years prior to treatment, except for adequately treated basal cells or squamous cell skin cancer or cervical carcinoma in situ;
  • It is known to be allergic to the study drug or any of its excipients;
  • Human immunodeficiency virus (HIV) infection, active hepatitis B (HBV-positive and HBV DNA ≥ 500 IU/ml), Hepatitis C (positive hepatitis C antibody and higher detection limit of HCV-RNA than analytical methods);
  • At the discretion of the investigator, there are concomitant diseases (such as poorly controlled hypertension, severe diabetes, neurological or psychiatric disorders, etc.) that seriously compromise the safety of the subject, may confuse the findings, or affect the subject's completion of the study. Any other situation.

Trial locations and contacts

1 site in 1 country.

Jilong Yang, M.D., Ph.D contact

+8618622221626

yangjilong@tjmuch.com

China1 site, 1 recruiting

  • Tianjin Medical University Cancer Hospital & Institute

    Tianjin, Tianjin Municipality, 300060

    Jilong Yang, M.D., Ph.D., +8618622221626, yangjilong@tjmuch.com

    Recruiting

Other trials in China

About this study

Official title: Single-center, Open, Non-randomized, Phase II Prospective Study of Apatinib Combined With Chemotherapy in the Treatment of Unresectable Soft Tissue Sarcoma

To observe the efficacy of apatinib combined with AI regimen chemotherapy compared with AI regimen chemotherapy and single-agent apatinib in patients with unresectable soft tissue sarcoma. The main observations were progression-free survival (PFS) and progression-free control rate (PFR), followed by objective response rates (ORR, CR+PR), disease control rate (DCR, CR+PR+SD), and overall survival ( OS).

To observe the safety of apatinib combined with AI chemotherapy.

Being tested
Apatinib Mesylate, Pirarubicin, Ifosfamide, Apatinib Mesylate, Pirarubicin, Ifosfamide
Keywords
Soft tissue sarcoma, apatinib, Jilong Yang
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, Pirarubicin, IfosfamideDrug

    Apatinib 500mg, orally, once a day. One cycle every 4 weeks. Pirarubicin 75mg/m2 D1, intravenous infusion for 1-2 hours; every 4 weeks. Ifosfamide 2g/m2/d D1-D5, intravenously for 4-6 hours, 1 cycle every 4 weeks.

  • Apatinib MesylateDrug

    Apatinib 500mg, orally, once a day. One cycle every 4 weeks.

  • Pirarubicin, IfosfamideDrug

    Pirarubicin 75mg/m2 D1, intravenous infusion for 1-2 hours; every 4 weeks. Ifosfamide 2g/m2/d D1-D5, intravenously for 4-6 hours, 1 cycle every 4 weeks

Study groups in NCT04126811
Study groupRoleWhat they receive
Apatinib and Chemotherapy Test GroupExperimentalApatinib 500mg, orally, once a day. One cycle every 4 weeks. Pirarubicin 75mg/m2 D1, intravenous infusion for 1-2 hours; every 4 weeks. Ifosfamide 2g/m2/d D1-D5, intravenously for 4-6 hours, 1 cycle every 4 weeks.
Receives: Drug: Apatinib Mesylate, Pirarubicin, Ifosfamide
Apatinib GroupActive comparatorApatinib 500mg, orally, once a day. One cycle every 4 weeks.
Receives: Drug: Apatinib Mesylate
Chemotherapy GroupActive comparatorPirarubicin 75mg/m2 D1, intravenous infusion for 1-2 hours; every 4 weeks. Ifosfamide 2g/m2/d D1-D5, intravenously for 4-6 hours, 1 cycle every 4 weeks.
Receives: Drug: Pirarubicin, Ifosfamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival (PFS)

    PFS is defined as the length of time from random assignment to disease progression or to death resulting from any cause other than the progress.

    Measured: Within 2 years

Secondary outcomes (3)

  1. Disease control rate(DCR）

    Investigators will assess treatment response according to Response Evaluation Criteria in Solid Tumors 1.1（RECIST1.1）

    Measured: Within 2 years

  2. Objective tumor response rate(ORR)

    ORR is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as best overall response according to radiological assessments.

    Measured: Within 2 years

  3. Overall survival(OS)

    OS is defined as the length of time from random assignment to death or to last contact.

    Measured: Within 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2019
  2. Study start1 Jun 2019
  3. Primary completion31 Dec 2019 (estimated)
  4. Study completion31 Dec 2020 (estimated)

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04126811
Sponsor's protocol ID
E2019145
Status last verified
Sep 2019
First submitted
30 Sep 2019
Last updated
15 Oct 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Apatinib Mesylate, Pirarubicin, Ifosfamide, Apatinib Mesylate and Pirarubicin, Ifosfamide in people with Soft Tissue Sarcoma, run by Tianjin Medical University Cancer Institute and Hospital 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 14 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 15 Oct 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 Jilong Yang, M.D., Ph.D (+8618622221626, yangjilong@tjmuch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: Within 2 years). 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 NCT04126811.

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 15 Oct 2019.

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