Soft Tissue Sarcoma, Adult, Stage II Clinical Trial
Official title:
Mesylate Apatinib for Stage Ⅳ Soft Tissue Sarcoma Patients After Failure of Traditional Chemotherapy: Prospective, Open-label, Single-Arm, Multi-center Phase II Clinical Trial
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.
| Status | Recruiting |
| Enrollment | 80 |
| Est. completion date | May 1, 2019 |
| Est. primary completion date | November 1, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility |
Inclusion Criteria: - Patients voluntarily join the study, signed informed consent, good compliance; - The pathology was diagnosed as stage ? 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. |
| Country | Name | City | State |
|---|---|---|---|
| China | Tianjin Medical University Cancer Hospital & Institute | Tianjin | Tianjin |
| Lead Sponsor | Collaborator |
|---|---|
| Tianjin Medical University Cancer Institute and Hospital | Fudan University, Gansu Cancer Hospital, Liaoning Tumor Hospital & Institute, Zhejiang Cancer Hospital |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | 2 year | |
| Secondary | Disease control rate(DCR) | Investigators will assess treatment response according to Response Evaluation Criteria in Solid Tumors 1.1(RECIST1.1) | 2 year | |
| Secondary | 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. | 2 year | |
| Secondary | Overall survival(OS) | OS is defined as the length of time from random assignment to death or to last contact. | 3 year | |
| Secondary | Adverse Events(AEs) | AEs are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v4.0. | 2 year |