Mesylate Apatinib for Stage Ⅳ STS After Failure of Chemotherapy

• Status: Unknown status
• Trial end date: 2019-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Prospective, Open-label, Single-Arm, Multi-center phase II clinical trial evaluating the efficacy and safety of Apatinib for Chemotherapy Failure Ⅳ Stage Soft Tissue Sarcoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital
• Collaborators: Fudan University; Gansu Cancer Hospital; Liaoning Tumor Hospital & Institute; Zhejiang Cancer Hospital
• Treatments: Apatinib

Criteria

Inclusion Criteria:

• Patients voluntarily join the study, signed informed consent, good compliance;

• The pathology was diagnosed as stage Ⅳ soft tissue sarcoma patients, clinical staging using the American Cancer Research Joint Committee (AJCC) TNM staging criteria. According to CT or MRI at least one measurable lesion;

• At least one chemotherapy regimen (containing anthracycline) was treated and evaluated as "disease progression" in terms of the efficacy evaluation criteria of solid tumors (RECIST 1.1).

• 18 to 70 years old, PS score: 0 ~ 2; expected survival period of more than 3 months;

• The laboratory check meets the following criteria:

• Blood routine examination: HB ≥ 100g / L (14 days without blood transfusion); ANC ≥ 1.5 × 109 / L; PLT ≥ 80 × 109 / L

• Biochemical tests: serum creatinine Cr ≤ normal upper limit (ULN), bilirubin BIL ≤ normal upper limit (ULN), ALT, AST ≤ 1.5 × normal upper limit (ULN), for liver metastases ≤ 5 × normal upper limit (ULN); fasting triglyceride ≤ 3.0mmol / L, fasting cholesterol ≤ 7.75mmol / L;

• Doppler ultrasonography: left ventricular ejection fraction (LVEF) ≥ normal low (50%).

• Women should agree that contraceptive measures (such as IUDs, contraceptives or condoms) must be used within six months of the study period and after the end of the study; serum or urine pregnancy studies were negative for 7 days prior to study , and must be non-lactating patients; men should agree that contraceptive measures must be used within six months of the study period and after the end of the study period.

Exclusion Criteria:

• Patients who have received antiangiogenic therapy or other targeted treatment for no more than 3 months, such as Endostar, Erlotinib, Sunitinib, Sorafenib, Avastin, Imatinib, Famitinib, Pazopanib and other drugs.

• Past or concurrent with other malignancies, except for cured skin basal cell carcinoma and cervical in situ cancer;

• Participated in other drug clinical researchers within four weeks;

• Previously received anticancer treatment patients with NCI CTC AE grade> 1 grade toxicity;

• Have a variety of factors that affect oral medication (such as can not swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.)

• Known brain metastases, spinal cord compression, cancerous meningitis, or screening when the CT or MRI examination found that the brain or pia mater disease;

• Patients with any severe and / or uncontrolled disease, for example:

• Unstable angina, symptomatic congestive heart failure, myocardial infarction within 6 months prior to randomization, severe uncontrollable arrhythmia; poor blood pressure control (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg )patient;

• Active or uncontrollable serious infection;

• Liver diseases such as cirrhosis, decompensated liver disease, chronic active hepatitis;

• Poor control of diabetes (fasting blood glucose (FBG)> 10mmol / L);

• Urinary routine urinary protein ≥ ++, and confirmed 24 hours urine protein> 1.0 g;

• Long untreated wound or fracture;

• Patients with bleeding tendency (such as active gastrointestinal ulcers) or treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or analogues;

• Interventional venous thrombosis events such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis, and pulmonary embolism before the first medication.

• Have a history of psychiatric abuse and can not quit or have mental disorders;

• Have a history of immunodeficiency, including HIV testing positive or other acquired, congenital immune deficiency disease, or a history of organ transplantation;

• According to the researcher's judgment, there are serious illnesses that compromise the patient's safety or affect the patient's completion of the study.