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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
Anhui Provincial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Cervical cancer confirmed by pathology;
  2. At least one measuring lesion (RECIST 1.1) or ascites (B ultrasound);
  3. Recurrence after the treatment of pelvic radiotherapy and first-line chemotherapy;
  4. 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
  5. no blood transfusion , blood products, g-csf and other hematopoietic stimulation factors were used in 14 days ;
  6. The expected survival time is longer than 3 months;
  7. 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
  8. The subjects volunteered to participate in this study, signed informed consent, followed up with good compliance and follow-up.

Exclusion Criteria:

  1. Allergies to apatinib and/or its excipients
  2. 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).
  3. According to NYHA standard, Ⅲ ~ Ⅳ cardiac insufficiency, or LVEF < 50%;
  4. Various factors that affect oral drugs (such as inability to swallow, nausea, vomiting, chronic diarrhea, intestinal obstruction, etc.);
  5. 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;
  6. 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.);
  7. Long-term unhealed wounds or fractures; Major surgery or severe traumatic injury, fracture or ulcer in 4 weeks;
  8. With abdominal fistula, gastrointestinal perforation or abdominal abscess;Active patients with HBVor HCV;
  9. 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).
  10. 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;
  11. Pregnant or lactating women;
  12. Patients with a history of psychotropic substance abuse or have mental disorders;
  13. According to the researchers' judgment, patients who have serious harm to the patient's safety or affect the patients for completing the research;
  14. 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

    First Posted
    May 23, 2018
    Last Updated
    May 23, 2018
    Sponsor
    Anhui Provincial Hospital
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    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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