Apatinib Treating Patients With Advanced Cervical Cancer After Radiotherapy and First-line Chemotherapy.
Primary Purpose
Cervical Cancer
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Apatinib
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Cancer
Eligibility Criteria
Inclusion Criteria:
- Cervical cancer confirmed by pathology;
- At least one measuring lesion (RECIST 1.1) or ascites (B ultrasound);
- Recurrence after the treatment of pelvic radiotherapy and first-line chemotherapy;
Baseline blood routine and biochemical indicators meet the following criteria:
① ANC ≥ 1.5 × 109 / L;
HB ≥ 90g / L;
PLT ≥ 100 × 109 / L; ④ ALB≥30g / L;
- TBIL≤1.5 times the upper limit of normal (ULN); ⑥ ALT and AST<2 × ULN; ⑦ Plasma Cr<1.5 × ULN
- no blood transfusion , blood products, g-csf and other hematopoietic stimulation factors were used in 14 days ;
- The expected survival time is longer than 3 months;
- The pregnancy test (serum or urine)should be carried out for women in childbearing age before 7 days into the group and the results were negative, and willing to use appropriate methods of contraception during the test and after 8 weeks out of group
- The subjects volunteered to participate in this study, signed informed consent, followed up with good compliance and follow-up.
Exclusion Criteria:
- Allergies to apatinib and/or its excipients
- People with high blood pressure and antihypertensive drug treatment can not drop to normal range (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg), with level-1 above coronary heart disease, arrhythmia over class I (including QTc lengthened men > 450 ms, women > 470 ms).
- According to NYHA standard, Ⅲ ~ Ⅳ cardiac insufficiency, or LVEF < 50%;
- Various factors that affect oral drugs (such as inability to swallow, nausea, vomiting, chronic diarrhea, intestinal obstruction, etc.);
- Patients with a clear tendency of gastrointestinal bleeding, including the following situations: local active ulcer lesions, and fecal occult blood (++); Patients with black stool and hematemesis in 2 months;
- Abnormal coagulation function (INR>1.5, APTT>1.5 ULN), with bleeding tendency;Hereditary or acquired bleeding and thrombosis tendencies (such as hemophilia, coagulation dysfunction, thrombocytopenia, hypersplenism, etc.);
- Long-term unhealed wounds or fractures; Major surgery or severe traumatic injury, fracture or ulcer in 4 weeks;
- With abdominal fistula, gastrointestinal perforation or abdominal abscess;Active patients with HBVor HCV;
- Active brain metastases, meningitis, cancer patients with spinal cord compression, CT or MRI examination revealed brain or soft meningeal disease (21 days before the drug treatment; the symptoms of patients with brain metastases from stable can into the group, but need to be confirmed by the cerebral MRI, CT or vein imaging evaluation for no symptoms in cerebral hemorrhage).
- CT or MRI showed that the tumor lesion was less than 5 mm away from the large vessel, or the lesion invaded local large vessels;
- Pregnant or lactating women;
- Patients with a history of psychotropic substance abuse or have mental disorders;
- According to the researchers' judgment, patients who have serious harm to the patient's safety or affect the patients for completing the research;
- Subjects considered inappropriate by the researchers.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
treatment group
Arm Description
apatinib 500mg/d po.28d as one cycle
Outcomes
Primary Outcome Measures
Apatinib treating patients with advanced cervical cancer after radiotherapy and first-line chemotherapy.
The time from the beginning of treatment to observing the progression of the disease or the death of any cause.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03546855
Brief Title
Apatinib Treating Patients With Advanced Cervical Cancer After Radiotherapy and First-line Chemotherapy.
Official Title
Clinical Study of Apatinib Mesylate in the Treatment of Advanced Cervical Cancer After Radiotherapy and First-line Chemotherapy.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2018 (Anticipated)
Primary Completion Date
December 1, 2019 (Anticipated)
Study Completion Date
June 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Anhui Provincial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To Observe and Evaluate the Efficacy and Safety of Apatinib in Patients With Advanced Cervical Cancer After Radiotherapy and First-line Chemotherapy.
Detailed Description
Eligible patients will receive apatinib treatment until disease progression or intolerable toxicity or patients withdrawal of consent after the failure of chemotherapy or radiotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
69 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
treatment group
Arm Type
Experimental
Arm Description
apatinib 500mg/d po.28d as one cycle
Intervention Type
Drug
Intervention Name(s)
Apatinib
Other Intervention Name(s)
treatment group
Intervention Description
Apatinib 500mg/d po,28 days as one cycle
Primary Outcome Measure Information:
Title
Apatinib treating patients with advanced cervical cancer after radiotherapy and first-line chemotherapy.
Description
The time from the beginning of treatment to observing the progression of the disease or the death of any cause.
Time Frame
12 week
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Cervical cancer confirmed by pathology;
At least one measuring lesion (RECIST 1.1) or ascites (B ultrasound);
Recurrence after the treatment of pelvic radiotherapy and first-line chemotherapy;
Baseline blood routine and biochemical indicators meet the following criteria:
① ANC ≥ 1.5 × 109 / L;
HB ≥ 90g / L;
PLT ≥ 100 × 109 / L; ④ ALB≥30g / L;
TBIL≤1.5 times the upper limit of normal (ULN); ⑥ ALT and AST<2 × ULN; ⑦ Plasma Cr<1.5 × ULN
no blood transfusion , blood products, g-csf and other hematopoietic stimulation factors were used in 14 days ;
The expected survival time is longer than 3 months;
The pregnancy test (serum or urine)should be carried out for women in childbearing age before 7 days into the group and the results were negative, and willing to use appropriate methods of contraception during the test and after 8 weeks out of group
The subjects volunteered to participate in this study, signed informed consent, followed up with good compliance and follow-up.
Exclusion Criteria:
Allergies to apatinib and/or its excipients
People with high blood pressure and antihypertensive drug treatment can not drop to normal range (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg), with level-1 above coronary heart disease, arrhythmia over class I (including QTc lengthened men > 450 ms, women > 470 ms).
According to NYHA standard, Ⅲ ~ Ⅳ cardiac insufficiency, or LVEF < 50%;
Various factors that affect oral drugs (such as inability to swallow, nausea, vomiting, chronic diarrhea, intestinal obstruction, etc.);
Patients with a clear tendency of gastrointestinal bleeding, including the following situations: local active ulcer lesions, and fecal occult blood (++); Patients with black stool and hematemesis in 2 months;
Abnormal coagulation function (INR>1.5, APTT>1.5 ULN), with bleeding tendency;Hereditary or acquired bleeding and thrombosis tendencies (such as hemophilia, coagulation dysfunction, thrombocytopenia, hypersplenism, etc.);
Long-term unhealed wounds or fractures; Major surgery or severe traumatic injury, fracture or ulcer in 4 weeks;
With abdominal fistula, gastrointestinal perforation or abdominal abscess;Active patients with HBVor HCV;
Active brain metastases, meningitis, cancer patients with spinal cord compression, CT or MRI examination revealed brain or soft meningeal disease (21 days before the drug treatment; the symptoms of patients with brain metastases from stable can into the group, but need to be confirmed by the cerebral MRI, CT or vein imaging evaluation for no symptoms in cerebral hemorrhage).
CT or MRI showed that the tumor lesion was less than 5 mm away from the large vessel, or the lesion invaded local large vessels;
Pregnant or lactating women;
Patients with a history of psychotropic substance abuse or have mental disorders;
According to the researchers' judgment, patients who have serious harm to the patient's safety or affect the patients for completing the research;
Subjects considered inappropriate by the researchers.
12. IPD Sharing Statement
Learn more about this trial
Apatinib Treating Patients With Advanced Cervical Cancer After Radiotherapy and First-line Chemotherapy.
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