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
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Anticipated)
Enrollment
Phase
Phase
- Phase 2
Contacts and Locations
Study Contact
Study Contact
- Name: Jilong Yang, M.D., Ph.D.
- Phone Number: +8618622221626
- Email: yangjilong@tjmuch.com
Study Locations
-
-
Tianjin
-
Tianjin, Tianjin, China, 300060
- Recruiting
- Tianjin Medical University Cancer Hospital & Institute
-
Contact:
- Jilong Yang, M.D., Ph.D.
- Phone Number: +8618622221626
- Email: yangjilong@tjmuch.com
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: apatinib group
apatinib 500mg po qd, 28 days for a cycle.
|
Apatinib 500 mg is administered orally daily, until disease progression or untolerable toxicity.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Progression-free survival (PFS)
Time Frame: 2 year
|
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 Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Disease control rate(DCR)
Time Frame: 2 year
|
Investigators will assess treatment response according to Response Evaluation Criteria in Solid Tumors 1.1(RECIST1.1)
|
2 year
|
|
Objective tumor response rate(ORR)
Time Frame: 2 year
|
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
|
|
Overall survival(OS)
Time Frame: 3 year
|
OS is defined as the length of time from random assignment to death or to last contact.
|
3 year
|
|
Adverse Events(AEs)
Time Frame: 2 year
|
AEs are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v4.0.
|
2 year
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Study Chair: Jilong Yang, M.D., Ph.D., Tianjin Medical University Cancer Institute and Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Anticipated)
Primary Completion
Study Completion (Anticipated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- S201602
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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Clinical Trials on Soft Tissue Sarcoma, Adult, Stage II
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NCT03613259WithdrawnStage III Adult Soft Tissue Sarcoma | Stage IV Adult Soft Tissue Sarcoma | Stage II Adult Soft Tissue Sarcoma | Stage IIA Adult Soft Tissue Sarcoma | Stage IIB Adult Soft Tissue Sarcoma | Stage IIC Adult Soft Tissue Sarcoma
-
NCT01169350TerminatedRecurrent Adult Soft Tissue Sarcoma | Stage III Adult Soft Tissue Sarcoma | Stage IV Adult Soft Tissue Sarcoma | Stage I Adult Soft Tissue Sarcoma | Stage II Adult Soft Tissue Sarcoma
-
NCT00089544TerminatedRecurrent Adult Soft Tissue Sarcoma | Stage I Adult Soft Tissue Sarcoma AJCC v7 | Stage II Adult Soft Tissue Sarcoma AJCC v7 | Stage III Adult Soft Tissue Sarcoma AJCC v7
-
NCT00087074CompletedGastrointestinal Stromal Tumor | Recurrent Adult Soft Tissue Sarcoma | Stage III Adult Soft Tissue Sarcoma | Stage IV Adult Soft Tissue Sarcoma | Stage I Adult Soft Tissue Sarcoma | Stage II Adult Soft Tissue Sarcoma
-
NCT00019968CompletedRecurrent Adult Soft Tissue Sarcoma | Stage III Adult Soft Tissue Sarcoma | Stage IVA Adult Soft Tissue Sarcoma | Stage IIB Adult Soft Tissue Sarcoma | Stage IIC Adult Soft Tissue Sarcoma | Stage IVB Adult Soft Tissue Sarcoma
-
NCT01446809CompletedStage III Adult Soft Tissue Sarcoma | Stage IV Adult Soft Tissue Sarcoma | Stage IIA Adult Soft Tissue Sarcoma
-
NCT00017160WithdrawnRecurrent Adult Soft Tissue Sarcoma | Stage III Adult Soft Tissue Sarcoma | Stage IVA Adult Soft Tissue Sarcoma | Stage IIB Adult Soft Tissue Sarcoma | Stage IIC Adult Soft Tissue Sarcoma
-
NCT00003958CompletedStage III Adult Soft Tissue Sarcoma | Stage I Adult Soft Tissue Sarcoma | Stage II Adult Soft Tissue Sarcoma | Adult Rhabdomyosarcoma | Adult Malignant Mesenchymoma | Alveolar Childhood Rhabdomyosarcoma | Embryonal Childhood Rhabdomyosarcoma | Embryonal-botryoid Childhood Rhabdomyosarcoma | Previously Untreated Childhood Rhabdomyosarcoma | Childhood Malignant Mesenchymoma
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NCT00022542TerminatedRecurrent Adult Soft Tissue Sarcoma | Stage III Adult Soft Tissue Sarcoma | Stage IV Adult Soft Tissue Sarcoma
-
NCT01782313CompletedRecurrent Adult Soft Tissue Sarcoma | Stage III Adult Soft Tissue Sarcoma | Stage IV Adult Soft Tissue Sarcoma
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