Apatinib Treating Patients With Advanced Cervical Cancer After Radiotherapy and First-line Chemotherapy.

Clinical Study of Apatinib Mesylate in the Treatment of Advanced Cervical Cancer After Radiotherapy and First-line Chemotherapy.

To Observe and Evaluate the Efficacy and Safety of Apatinib in Patients With Advanced Cervical Cancer After Radiotherapy and First-line Chemotherapy.

Study Overview

• Status: Unknown
• Conditions: Cervical Cancer
• Intervention / Treatment: Drug: Apatinib

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.

• Study Type: Interventional
• Enrollment (Anticipated): 69
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

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

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: treatment group; apatinib 500mg/d po.28d as one cycle	Drug: Apatinib; Apatinib 500mg/d po,28 days as one cycle; Other Names: treatment group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 week

Collaborators and Investigators

• Sponsor: Anhui Provincial Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2018
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): June 1, 2020

Study Registration Dates

• First Submitted: May 23, 2018
• First Submitted That Met QC Criteria: May 23, 2018
• First Posted (Actual): June 6, 2018

Study Record Updates

• Last Update Posted (Actual): June 6, 2018
• Last Update Submitted That Met QC Criteria: May 23, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Uterine Cervical Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Apatinib
• Other Study ID Numbers: AHTH-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No