Cervical CancerPhase 2NCT03546855
Apatinib Treating Patients With Advanced Cervical Cancer After Radiotherapy and First-line Chemotherapy.
A Phase 2 study testing Apatinib in people with Cervical Cancer, run by Anhui Provincial Hospital.
Trial summary
To Observe and Evaluate the Efficacy and Safety of Apatinib in Patients With Advanced Cervical Cancer After Radiotherapy and First-line Chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Apatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2018to 1 Jun 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.);
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- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cervical Cancer
- Being tested
- Apatinib
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApatinibDrug
Also called treatment group
Apatinib 500mg/d po,28 days as one cycle
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | apatinib 500mg/d po.28d as one cycle Receives: Drug: Apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study start1 Jun 2018 (estimated)
- Primary completion1 Dec 2019 (estimated)
- Study completion1 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Anhui Provincial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03546855
- Sponsor's protocol ID
- AHTH-101
- Status last verified
- May 2018
- First submitted
- 23 May 2018
- Last updated
- 6 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Apatinib Mesylate in the Treatment of Advanced Cervical Cancer After Radiotherapy and First-line Chemotherapy.
- ClinicalTrials.gov ID
- NCT03546855
- Acronym / sponsor ID
- AHTH-101
- Conditions
- Cervical Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Study start
- 1 Jun 2018 (estimated)
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- 1 Jun 2020 (estimated)
- First posted
- 6 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Drug: Apatinibapatinib 500mg/d po.28d as one cycle |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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;
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ApatinibAlso: treatment groupApatinib 500mg/d po,28 days as one cycle | Drug | treatment group |
Primary outcome
Apatinib treating patients with advanced cervical cancer after radiotherapy and first-line chemotherapy.
Time frame: 12 week
The time from the beginning of treatment to observing the progression of the disease or the death of any cause.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Apatinib in people with Cervical Cancer, run by Anhui Provincial Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apatinib treating patients with advanced cervical cancer after radiotherapy and first-line chemotherapy. (time frame: 12 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2018.