Malignant AscitesPhase 2NCT03020979
A Clinical Trial With Apatinib for Subjects With Refractory Malignant Ascites
A Phase 2 study testing Apatinib in people with Malignant Ascites and Apatinib, run by The First Affiliated Hospital of Bengbu Medical University at 1 site in China.
Trial summary
Malignant ascites is a severe complication of many types of human cancer. Animal and clinical analyses have shown that angiogenesis plays a critical role in the formation of malignant ascites. Therefore, drugs such as apatinib that target angiogenesis may control the development of malignant ascites. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Malignant Ascites, Apatinib
- What is being tested?
- Apatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Jan 2017to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Persistent or symptomatic ascites with positive cytology secondary to any histologically confirmed tumor type not amenable to cytoreductive surgery or additional chemotherapy
- Patients may enroll in this study irrespective of previous therapy including diuretics, surgery, chemotherapy, immunotherapy and radiation therapy
- Must have received a minimum of two paracentesis procedures and a trial of diuretic therapy within 60 days of study entry
- Age Restrictions: 18-75 years
- Life Expectancy: 12 weeks or more
- ECOG Performance Status: 0-2
- Able and willing to provide informed consent and comply with study and/or follow-up procedures
- Normal organ and marrow function as defined by: Leukocytes >/= 3,000/mcL; Absolute neutrophil count >/= 1,500/mcL; Platelets >/= 100,000/mcL; Total bilirubin within normal institutional limits; AST (SGOT)/ALT(SGPT) </= 2.5 X institutional upper limit of normal (ULN); Creatinine within normal institutional limits OR Creatinine clearance >/+ 60 mL/min for patients with creatinine levels above the institutional normal; Serum Potassium within normal institutional limits; Serum Sodium within normal institutional limits
Who cannot join
- Patients having received anti-angiogenic agents as part of the treatment of their malignancy within 60 days prior to study entry
- Current, recent (within 30 days of the first infusion of this study) or planned administration of chemotherapy (including all routes of administration), immunotherapy, biologic therapy, radiation therapy or any other anti-angiogenic therapy (e.g., bevacizumab, other tyrosine kinase inhibitors)
- Current, recent (within 30 days of the first infusion of this study), or planned participation in any other experimental drug study
- Pregnant women; A serum pregnancy test will be given to females of childbearing potential prior to study enrollment and the participant must agree to use adequate contraception (barrier or hormonal methods) prior to study entry and for the duration of study participation.
- Un-controlled hypertension (defined as systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg
- History of hypertensive crisis or hypertensive encephalopathy
Show all 20Show fewer
- New York Heart Association (NYHA) Grade III or greater congestive heart failure
- History of myocardial infarction, unstable angina, stroke or transient ischemic attack within 6 months prior to study entry
- Known CNS disease, except for treated brain metastasis.
- Significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to study entry
- History of gastrointestinal hemorrhage within 6 month prior to study entry
- Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study entry or anticipation of need for major surgical procedure during the course of the study
- Core biopsy or other minor surgical procedure, excluding placement of a vascular access device or paracentesis/thoracentesis, within 7 days prior to study entry
- History of abdominal fistula or gastrointestinal perforation within 6 months prior to study entry
- Any bowel obstruction that has not fully recovered despite medical or surgical intervention prior to study entry
- Evidence of bowel wall thickening outside the site of the known primary malignancy on baseline radiographs
- Serious, non-healing wound, active ulcer, or untreated bone fracture
- Proteinuria as demonstrated by a Urine Protein/Creatinine ration >/= 1.0 at screening
- Known hypersensitivity to any component of apatinib.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Qiong Wu
Bengbu, Anhui
Rui Wang, MD, +86-0552-3074480, byzlnk@163.com
About this study
Official title: A Phase II, Single-Arm, Open-Label, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Apatinib in Patients With Refractory Malignant Ascites
Malignant ascites is a severe complication of many types of human cancer. Animal and clinical analyses have shown that angiogenesis plays a critical role in the formation of malignant ascites. Therefore, drugs such as apatinib that target angiogenesis may control the development of malignant ascites. The study is to evaluate the efficacy and safety of apatinib in patients with refractory malignant ascites.
Read the detailed description
The study is to investigate the efficacy and safety of apatinib in patients with refractory malignant ascites. A total of 120 patients with performance status 0-2 were enrolled in this study and 500mg apatinib tablets were administered orally, once daily until disease progression or intolerable toxicity or patients withdrawal of consent.
- Conditions
- Malignant Ascites, Apatinib
- Being tested
- Apatinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApatinibDrug
Patients will take 500mg apatinib daily orally.
| Study group | Role | What they receive |
|---|---|---|
| 500mg apatinib | Experimental | Patients will receive 500mg of apatinib tablet orally, once daily. Receives: Drug: Apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
The repeat paracentesis response rate (proportion of subjects who have a doubling of baseline time to repeat paracentesis)
Measured: 12 weeks after initiation of study treatment
Secondary outcomes (3)
The time to the need for the first repeat abdominal paracentesis after the start of apatinib therapy as compared with historical control data.
Measured: 12 weeks after initiation of study treatment
The mean number of paracentesis procedures required in each patient over the course of three months.
Measured: 12 weeks after the initiation of study treatment
The effect of apatinib therapy on quality of life in patients with malignant ascites by using EORTC QLQ-C30 V3.0.
Measured: 12 weeks after the initiation of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionSep 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant AscitesStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Bengbu Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yan Yang, MD, Ph.D, The First Affiliated Hospital of Bengbu Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03020979
- Sponsor's protocol ID
- BYEC20161201
- Status last verified
- Sep 2026
- First submitted
- 10 Jan 2017
- Last updated
- 3 Sep 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Single-Arm, Open-Label, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Apatinib in Patients With Refractory Malignant Ascites
- ClinicalTrials.gov ID
- NCT03020979
- Acronym / sponsor ID
- BYEC20161201
- Conditions
- Malignant Ascites, Apatinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Bengbu Medical UniversityUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 13 Jan 2017 (estimated)
- 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.
Malignant ascites is a severe complication of many types of human cancer. Animal and clinical analyses have shown that angiogenesis plays a critical role in the formation of malignant ascites. Therefore, drugs such as apatinib that target angiogenesis may control the development of malignant ascites. The study is to evaluate the efficacy and safety of apatinib in patients with refractory malignant ascites.
Detailed description
The study is to investigate the efficacy and safety of apatinib in patients with refractory malignant ascites. A total of 120 patients with performance status 0-2 were enrolled in this study and 500mg apatinib tablets were administered orally, once daily until disease progression or intolerable toxicity or patients withdrawal of consent.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 500mg apatinib | Experimental | Drug: ApatinibPatients will receive 500mg of apatinib tablet orally, once daily. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Persistent or symptomatic ascites with positive cytology secondary to any histologically confirmed tumor type not amenable to cytoreductive surgery or additional chemotherapy
- Patients may enroll in this study irrespective of previous therapy including diuretics, surgery, chemotherapy, immunotherapy and radiation therapy
- Must have received a minimum of two paracentesis procedures and a trial of diuretic therapy within 60 days of study entry
- Age Restrictions: 18-75 years
- Life Expectancy: 12 weeks or more
Key exclusion criteria (20 listed)
- Patients having received anti-angiogenic agents as part of the treatment of their malignancy within 60 days prior to study entry
- Current, recent (within 30 days of the first infusion of this study) or planned administration of chemotherapy (including all routes of administration), immunotherapy, biologic therapy, radiation therapy or any other anti-angiogenic therapy (e.g., bevacizumab, other tyrosine kinase inhibitors)
- Current, recent (within 30 days of the first infusion of this study), or planned participation in any other experimental drug study
- Pregnant women; A serum pregnancy test will be given to females of childbearing potential prior to study enrollment and the participant must agree to use adequate contraception (barrier or hormonal methods) prior to study entry and for the duration of study participation.
- Un-controlled hypertension (defined as systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg
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 |
|---|---|---|
| ApatinibPatients will take 500mg apatinib daily orally. | Drug | 500mg apatinib |
Primary outcome
The repeat paracentesis response rate (proportion of subjects who have a doubling of baseline time to repeat paracentesis)
Time frame: 12 weeks after initiation of study treatment
3 secondary outcomes
The time to the need for the first repeat abdominal paracentesis after the start of apatinib therapy as compared with historical control data.
Time frame: 12 weeks after initiation of study treatment
The mean number of paracentesis procedures required in each patient over the course of three months.
Time frame: 12 weeks after the initiation of study treatment
The effect of apatinib therapy on quality of life in patients with malignant ascites by using EORTC QLQ-C30 V3.0.
Time frame: 12 weeks after the initiation of study treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
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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.
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 in people with Malignant Ascites and Apatinib, run by The First Affiliated Hospital of Bengbu Medical 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 8 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 3 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qiong Wu, M.D. Ph.D. (+86-552-3074480, byzlnk@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The repeat paracentesis response rate (proportion of subjects who have a doubling of baseline time to repeat paracentesis) (time frame: 12 weeks after initiation of study treatment). 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 3 Sep 2026.