Clinical trial · Interventional
Mesylate Apatinib for Stage Ⅳ STS After Failure of Chemotherapy
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
NCT03121846CI-TRIAL-00027724unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Soft Tissue Sarcoma, Adult, Stage II | Adult Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Apatinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- apatinib group
- description
- apatinib 500mg po qd, 28 days for a cycle.
- interventionNames
- Drug: Apatinib
Primary outcomes (1)
- measure
- Progression-free survival (PFS)
- timeFrame
- 2 year
- description
- 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.
Secondary outcomes (4)
- measure
- Disease control rate(DCR)
- timeFrame
- 2 year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.