Ovarian CancerPhase 2NCT04590625
Apatinib Combined With Abraxane and Carboplatin or Cisplatinum as First-line Treatment for Epithelial Ovarian Cancer
A Phase 2 study testing Apatinib Mesylate, Abraxane and Cis Platinum in people with Ovarian Cancer, run by Zhongshan Hospital Xiamen University at 1 site in China.
Trial summary
This monocentric, prospective, observational study will evaluate the safety and efficacy of apatinib in combination with albumin binds paclitaxel and carboplatin or cisplatinum as first-line treatment for stage II-IV epithelial ovarian cancer followed by apatinib maintenance therapy in routine clinical practice. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Apatinib Mesylate, Abraxane and Cis Platinum
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteChina
- Study dates
- Oct 2020to Dec 2023
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -
- 1.Age 18 - 75 years; 2.Histologically confirmed, stage II or IV epithelial ovarian carcinoma; 3.For Group1,patients with stage III-IV ovarian cancer who are considered unlikely to achieve satisfactory tumor reduction after preoperative evaluation by gynecological oncologists or not suitable for direct surgery are required; 4.Patients with at least one evaluable or measurable lesions as per RECIST version 1.1(CT scan length and diameter of tumor lesion≥10mm CT scan of lymph node lesion was short diameter≥15mm,scan slice thickness 5mm); 5.ECOG performance status (PS) 0 - 2; 6.Life expectancy of at least 12 weeks; 7.Patients with adequate organ function at the time of enrollment as defined below:
- Blood routine examination standard:(without blood transfusion within 14 days before enrollment)
- Hb ≥ 100g/L，
- WBC ≥ 3.0×109/L
- ANC ≥ 1.5×109/L，
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- PLT ≥ 100×109/L；
- Biochemical examination shall meet the following standards:
- BIL ≤ 1.5 times the upper limit of normal(ULN);
- ALT and AST ≤ 3 ×upper limit of normal(ULN);
- Serum creatinine Cr ≤ 1ULN;
- Serum creatinine ALB ≥ 30g/L. 8.Women of childbearing age in the serum or urine pregnancy test is negative within 7 days prior to study enrollment and must be Non-lactating patients,and agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during the study period and within 8 months after the end of the study; males should agree to patients who must use contraception during the study period and within 8 months after the end of the study period.
- 9.Subjects voluntarily joined the study, signed informed consent, good compliance, and followed up;
Who cannot join
- Women who are pregnant or breastfeedind;
- Except for other malignant tumors, basal cell carcinoma of the skin and cervical cancer in situ in the past 5 years;
- Patients with symptomatic brain metastasis;Significant neurological or psychiatric disorders;
- Patients who have participated in other clinical trials in recent three months;
- Prior treatment with apatinib or other anti-vascular drugs and other small molecule tyrosine kinase inhibitors;
- Patients who have undergone systemic chemotherapy, radiotherapy, surgery, hormone therapy, or immunotherapy before enrollment;
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- Within 3 months before treatment, there were esophageal (gastric fundus) varicose bleeding, intestinal obstruction and gastrointestinal perforation;
- Patients had clinically demonstrated cancerous ascites or pleural effusion;
- Patients has active infection or unexplained fever ≥38.5℃ within 7 days before enrollment;
- Severe liver, kidney, heart, lung, brain and other major organ failure;
- Patients with hypertension that is difficult to control (systolic blood pressure ≥140 mmHg and diastolic blood pressure ≥90 mmHg) despite treatment with several hypotensive agents;
- Previous or current had idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radioactive pneumonia, histopathological pneumonia (e.g., bronchitis, obliterans), drug-induced pneumonia, or screening stage CT with active pneumonia;
- Patients with abnormal coagulation function (INR > 1.5 or prothrombin time (PT) > ULN+4 seconds), bleeding tendency or receiving thrombolytic or anticoagulant therapy are allowed to receive low-dose LMWH or oral aspirin to prevent anticoagulant therapy during the trial;
- Urine protein ≥ ++ or confirmed 24 hour urine protein quantitation;
- Patients with cardiac clinical symptoms or diseases that are not well controlled,such as:(1) NYHA2 or above heart failure;(2) Unstable angina;(3) Myocardial infarction occurred within 1 year;(4) Clinically significant supraventricular or ventricular arrhythmias require treatment or intervention;(5) QTc > 470ms;
- Inability to swallow pills, malabsorption syndrome, or any condition that affects gastrointestinal absorption;
- In the 6 months prior to enrollment, patients had been arteriovenous thrombosis (AVT), such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis (DVT) and pulmonary embolism;
- Patients with a history of hereditary or acquired bleeding or coagulation disorders.There were clinically significant bleeding symptoms or definite bleeding tendency within 3 months before enrollment, such as gastrointestinal bleeding and hemorrhagic gastric ulcer;
- According to the judgment of the researcher, the patients have other factors that may lead to the forced termination of this study, such as other serious diseases (including mental diseases) requiring combined treatment, severe laboratory test abnormalities, accompanied by family or social factors, which will affect the safety of the subjects, or the collection of data.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital Affiliated to Xiamen University
Xiamen, Fujian, 361000
Shuntian Cai, +86 18030190632, nktianxingjian@163.com
About this study
Official title: Apatinib Mesylate Combined With Albumin Binds Paclitaxel and Carboplatin or Cisplatinum as First-line Treatment for Stage II-IV Epithelial Ovarian Cancer Followed by Apatinib Maintenance Therapy:a Single-arm,Exploratory Clinical Study
This monocentric, prospective, observational study will evaluate the safety and efficacy of apatinib in combination with albumin binds paclitaxel and carboplatin or cisplatinum as first-line treatment for stage II-IV epithelial ovarian cancer followed by apatinib maintenance therapy in routine clinical practice. Eligible patients will be followed for approximately 20 months.
- Conditions
- Ovarian Cancer
- Being tested
- Apatinib Mesylate, Abraxane, Cis Platinum, Carboplatin
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apatinib MesylateDrug
apatinib one course will last 21 days.Oral administration at a dose of 250 mg, qd
AbraxaneDrug
abraxane one course will last 21 days.Intravenously guttae at a dose of 260 mg/m2,d1
Cis PlatinumDrug
cis-platinum one course will last 21 days.cis-platinum introperitoneal injection at a dose of 75-100 mg/m2,d1
CarboplatinDrug
carboplatin one course will last 21 days.carboplatin intravenous injection at a dose of AUC=5-6,d1
| Study group | Role | What they receive |
|---|---|---|
| Group1 | Experimental | 1. Neoadjuvant therapy:
Apatinib:apatinib one course will last 21 days.Oral administration at a dose of 250 mg, qd; Abraxane:abraxane one course will last 21 days.Intravenously guttae at a dose of 260 mg/m2,d1; Cis-platinum or Carboplatin:cis-platinum or carboplatin one course will last 21 days.cis-platinum introperitoneal injection at a dose of 75-100 mg/m2,d1;carboplatin intravenous injection at a dose of AUC=5-6,d1.
Neoadjuvant therapy is 3-4 cycles.After Neoadjuvant therapy will received interval cytoreductive surgery.
2. Adjuvant therapy:
After interval cytoreductive surgery,patients will received adjuvant therapy same as neoadjuvant therapy.
Adjuvant therapy is 3 cycles
3. maintenance treatment: After above treatment finished,patients will received aptinib for 2 years. Receives: Drug: Apatinib Mesylate; Drug: Abraxane; Drug: Cis Platinum; Drug: Carboplatin |
| Group2 | Experimental | 1.Adjuvant therapy:
After primary cytoreductive surgery,patients will received adjuvant therapy:
Apatinib:apatinib one course will last 21 days.Oral administration at a dose of 250 mg, qd; Abraxane:abraxane one course will last 21 days.Intravenously guttae at a dose of 260 mg/m2,d1; Cis-platinum or Carboplatin:cis-platinum or carboplatin one course will last 21 days.cis-platinum introperitoneal injection at a dose of 75-100 mg/m2,d1;carboplatin intravenous injection at a dose of AUC=5-6,d1.
Adjuvant therapy is 3 cycles 3.maintenance treatment: After above treatment finished,patients will received aptinib for 2 years. Receives: Drug: Apatinib Mesylate; Drug: Abraxane; Drug: Cis Platinum; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
R0 resection rate
defined as the proportion of patients with no gross tumor tissue residual after interval cytoreductive surgery
Measured: approximately 2 years
Progression-free survival
defined as time from first administration of first-line therapy to documented disease progression
Measured: approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study startOct 2020 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongshan Hospital Xiamen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li Xiao, Doctor, Principal investigator, Zhongshan Hospital Xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04590625
- Sponsor's protocol ID
- Arise-FJ-O001
- Status last verified
- Oct 2020
- First submitted
- 10 Oct 2020
- Last updated
- 19 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apatinib Mesylate Combined With Albumin Binds Paclitaxel and Carboplatin or Cisplatinum as First-line Treatment for Stage II-IV Epithelial Ovarian Cancer Followed by Apatinib Maintenance Therapy:a Single-arm,Exploratory Clinical Study
- ClinicalTrials.gov ID
- NCT04590625
- Acronym / sponsor ID
- Arise-FJ-O001
- Conditions
- Ovarian Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Zhongshan Hospital Xiamen UniversityUniversity, hospital or other
- Study start
- Oct 2020 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 19 Oct 2020 (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.
This monocentric, prospective, observational study will evaluate the safety and efficacy of apatinib in combination with albumin binds paclitaxel and carboplatin or cisplatinum as first-line treatment for stage II-IV epithelial ovarian cancer followed by apatinib maintenance therapy in routine clinical practice. Eligible patients will be followed for approximately 20 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group1 | Experimental | Drug: Apatinib Mesylate, Drug: Abraxane, Drug: Cis Platinum, Drug: Carboplatin1. Neoadjuvant therapy: Apatinib:apatinib one course will last 21 days.Oral administration at a dose of 250 mg, qd; Abraxane:abraxane one course will last 21 days.Intravenously guttae at a dose of 260 mg/m2,d1; Cis-platinum or Carboplatin:cis-platinum or carboplatin one course will last 21 days.cis-platinum introperitoneal injection at a dose of 75-100 mg/m2,d1;carboplatin intravenous injection at a dose of AUC=5-6,d1. Neoadjuvant therapy is 3-4 cycles.After Neoadjuvant therapy will received interval cytoreductive surgery. 2. Adjuvant therapy: After interval cytoreductive surgery,patients will received adjuvant therapy same as neoadjuvant therapy. Adjuvant therapy is 3 cycles 3. maintenance treatment: After above treatment finished,patients will received aptinib for 2 years. |
| Group2 | Experimental | Drug: Apatinib Mesylate, Drug: Abraxane, Drug: Cis Platinum, Drug: Carboplatin1.Adjuvant therapy: After primary cytoreductive surgery,patients will received adjuvant therapy: Apatinib:apatinib one course will last 21 days.Oral administration at a dose of 250 mg, qd; Abraxane:abraxane one course will last 21 days.Intravenously guttae at a dose of 260 mg/m2,d1; Cis-platinum or Carboplatin:cis-platinum or carboplatin one course will last 21 days.cis-platinum introperitoneal injection at a dose of 75-100 mg/m2,d1;carboplatin intravenous injection at a dose of AUC=5-6,d1. Adjuvant therapy is 3 cycles 3.maintenance treatment: After above treatment finished,patients will received aptinib for 2 years. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- -
- 1.Age 18 - 75 years; 2.Histologically confirmed, stage II or IV epithelial ovarian carcinoma; 3.For Group1,patients with stage III-IV ovarian cancer who are considered unlikely to achieve satisfactory tumor reduction after preoperative evaluation by gynecological oncologists or not suitable for direct surgery are required; 4.Patients with at least one evaluable or measurable lesions as per RECIST version 1.1(CT scan length and diameter of tumor lesion≥10mm CT scan of lymph node lesion was short diameter≥15mm,scan slice thickness 5mm); 5.ECOG performance status (PS) 0 - 2; 6.Life expectancy of at least 12 weeks; 7.Patients with adequate organ function at the time of enrollment as defined below:
- Blood routine examination standard:(without blood transfusion within 14 days before enrollment)
- Biochemical examination shall meet the following standards:
- 9.Subjects voluntarily joined the study, signed informed consent, good compliance, and followed up;
Key exclusion criteria (19 listed)
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 |
|---|---|---|
| Apatinib Mesylateapatinib one course will last 21 days.Oral administration at a dose of 250 mg, qd | Drug | Group1, Group2 |
| Abraxaneabraxane one course will last 21 days.Intravenously guttae at a dose of 260 mg/m2,d1 | Drug | Group1, Group2 |
| Cis Platinumcis-platinum one course will last 21 days.cis-platinum introperitoneal injection at a dose of 75-100 mg/m2,d1 | Drug | Group1, Group2 |
| Carboplatincarboplatin one course will last 21 days.carboplatin intravenous injection at a dose of AUC=5-6,d1 | Drug | Group1, Group2 |
Primary outcome
R0 resection rate
Time frame: approximately 2 years
defined as the proportion of patients with no gross tumor tissue residual after interval cytoreductive surgery
Progression-free survival
Time frame: approximately 2 years
defined as time from first administration of first-line therapy to documented disease progression
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Individual participant dataSharing planned: No
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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.
Li Xiao, Doctor principal investigator
Zhongshan Hospital Xiamen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Apatinib Mesylate, Abraxane and Cis Platinum in people with Ovarian Cancer, run by Zhongshan Hospital Xiamen University at 1 site in China.
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 13 inclusion and 19 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 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Li Xiao, Doctor (2292201 ext. 0592, xiaolibohan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
R0 resection rate (time frame: approximately 2 years). The study lists 2 primary outcomes in all. 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 19 Oct 2020.