Apatinib Mesylate Combined With Doxorubicin and Ifosfamide in Advanced Soft-tissue Sarcoma

NCT04012827 | Unknown Phase 2

• 1 other identifier: SunYat-senU-apatinib
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Soft Tissue Sarcoma

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 24 months

Secondary Outcomes (3)

• Progress free survival

  From treatment until progression (up to 24 months)

• Overall Survival

  From treatment until death (up to 24 months)

• Disease Control Rate

  each 42 days up to intolerance the toxicity or PD (up to 24 months)

Study Arms (1)

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.

Drug: Apatinib Mesylate, doxorubicin, ifosfamide

Interventions

Apatinib Mesylate, doxorubicin, ifosfamide DRUG

Doxorubicin 50mg/m2 d1 , Ifosfamide 2.5g/m2 d1-3 , Apatinib mesylate 375mg qd

Also known as: Apatinib

Apatinib Mesylate Combined With Doxorubicin and Ifosfamide

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• \~ 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:
• (1) 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.
• (2) 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；
• (3) Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) ≥ normal low limit (50%).
• \. 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.

You may not qualify if:

• 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 \[grade 2 dyspnea refers to shortness of breath when there is a small amount of activity; it affects instrumental daily life activities\]);
• 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:
• )Patients with unsatisfactory blood pressure control (systolic blood pressure 150 mmHg, diastolic blood pressure 100 mmHg);
• )Patients with grade I or above myocardial ischemia or myocardial infarction, arrhythmia (including QTC 480ms) and grade II congestive heart failure (NYHA classification);
• )Active or uncontrolled severe infection (CTCAE grade 2 infection);
• )Cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis require antiviral treatment;
• \) Renal failure requires hemodialysis or peritoneal dialysis;

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, China

RECRUITING

MeSH Terms

Conditions

Sarcoma

Interventions

apatinib; Doxorubicin; Ifosfamide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Xing Zhang

CONTACT

02087343383; zhangxing@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice director of department of medical sarcoma and melanoma,Principal Investigator,Clinical Professor

Study Record Dates

• First Submitted: July 7, 2019
• First Posted: July 9, 2019
• Study Start: August 20, 2019
• Primary Completion: June 15, 2023
• Study Completion: December 31, 2023
• Last Updated: September 7, 2022

Record last verified: 2022-09

Locations

CN (1)