Apatinib Combined With Chemotherapy in the Treatment of Soft Tissue Sarcoma

NCT04126811 | Unknown Phase 2

• 1 other identifier: E2019145
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Soft Tissue Sarcoma

Keywords

Soft tissue sarcoma; apatinib; Jilong Yang

Outcome Measures

Primary Outcomes (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.

  Within 2 years

Secondary Outcomes (3)

• Disease control rate(DCR）

  Within 2 years

• Objective tumor response rate(ORR)

  Within 2 years

• Overall survival(OS)

  Within 3 years

Study Arms (3)

Apatinib and Chemotherapy Test Group

EXPERIMENTAL

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.

Drug: Apatinib Mesylate, Pirarubicin, Ifosfamide

Apatinib Group

ACTIVE COMPARATOR

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

Drug: Apatinib Mesylate

Chemotherapy Group

ACTIVE COMPARATOR

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.

Drug: Pirarubicin, Ifosfamide

Interventions

Apatinib Mesylate, Pirarubicin, Ifosfamide DRUG

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 and Chemotherapy Test Group

Apatinib Mesylate DRUG

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

Apatinib Group

Pirarubicin, Ifosfamide DRUG

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

Chemotherapy Group

Eligibility Criteria

• Age: 14 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• \~75 years old, PS score: 0\~1 (Amputation patient can be relaxed to 2 points); the expected survival time is more than 3 months;

You may not qualify if:

• 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.
• 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);
• 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;

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Hospital & Institute

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

MeSH Terms

Conditions

Sarcoma

Interventions

apatinib; pirarubicin; Ifosfamide

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Jilong Yang, M.D., Ph.D

CONTACT

+8618622221626; yangjilong@tjmuch.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2019
• First Posted: October 15, 2019
• Study Start: June 1, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2020
• Last Updated: October 15, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CN (1)