Can a blood vessel blocker stop Cancer-Related belly fluid?
NCT ID NCT03020979
First seen Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time
Summary
This trial tests whether the oral drug apatinib can control malignant ascites, a painful buildup of fluid in the belly that can happen with advanced cancer. The study enrolls adults with persistent or symptomatic ascites that has not responded to standard treatments, including diuretics and repeated drainage. Participants take apatinib daily, and researchers measure how long they can go without needing another drainage procedure, along with quality of life and safety.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- apatinib, an oral drug that blocks blood vessel growth to tumors
- What this could lead to
- If it works, apatinib could offer a new way to control malignant ascites, reducing the need for repeated drainage procedures and improving quality of life for people with advanced cancer.
- What could go wrong
- This is a phase II trial, so the drug may not prove effective or safe in a larger population. Apatinib can cause side effects like high blood pressure, fatigue, and bleeding, and it is not a cure for the underlying cancer.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2017
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Qiong Wu
RECRUITINGBengbu, Anhui, China
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