A halting of malignant ascites with apatinib in patients with cancer-related ascites
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
Run by The First Affiliated Hospital of Bengbu Medical University · NCT03020979 · Data updated 2026-11-12
This trial tests whether daily oral apatinib can help people with cancer-related malignant ascites who have not responded to other treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | The First Affiliated Hospital of Bengbu Medical University Academic / other |
| Drugs / interventions | bevacizumab, apatinib, chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Bengbu, Anhui) |
| Status | Recruiting |
| Started | January 2017 |
| Main results expected | September 2027 |
| Study ends | December 2027 |
| Registry record updated | September 3, 2026 |
| Trial ID | NCT03020979 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18-75 with cancer-related malignant ascites refractory to other treatments and adequate organ function, ECOG 0-2, and at least two prior paracenteses or diuretic trials.
✕Probably not a fit
Patients with rapid disease progression, intolerable toxicity, or extensive organ impairment may not experience benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 2 interventional study investigates the safety and effectiveness of apatinib, taken orally at 500 mg once daily, in patients with refractory malignant ascites. About 120 participants with decent organ function and performance status are enrolled until progression or intolerable toxicity occurs. Eligible patients have persistent ascites due to various cancers, have tried multiple prior therapies, and require paracentesis or diuretic treatment. The study monitors symptoms, fluid accumulation, and safety signals over time to determine whether apatinib can reduce ascites and improve quality of life. Enrollment is at a single site in Bengbu, Anhui, under the leadership of The First Affiliated Hospital of Bengbu Medical University.
Why it matters
Potential benefit: If successful, participants may experience a reduction in ascites-related symptoms and improved comfort and function.
How similar studies have gone: Prior studies in this area have explored anti-angiogenic approaches for malignant ascites, suggesting potential benefit but with variable outcomes; this study adds specific apatinib data.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Qiong Wu
Bengbu, Anhui, China Recruiting
Study contacts
- Study coordinator: Qiong Wu, M.D. Ph.D.
- Email: byzlnk@163.com
- Phone: +86-552-3074480
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.