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RecruitingLast updated: 21 May 2025

REZOLV3R: This study is recruiting people with solid organ cancers with malignant ascites that haven't responded to prior treatment to test whether an infusion with targeted therapy is effective treatmentEfficacy of intraperitoneal bevacizumab for decreasing or delaying re-accumulation of recurrent malignant ascites in chemotherapy resistant solid tumours: a randomised trial

Trial purpose

Medical clipboardCancer treatment

Tumor type

Multi-Cancer Multi-Cancer

Age

People18+

Trial acronym

REZOLV3R

Clinical summary

Summary

The purpose of this study is to investigate whether a short injection of a drug called bevacizumab into the abdominal cavity (known as intraperitoneal infusion) after drainage of excess fluid in the abdomen may delay the return of the ascites compared to an injection of saline only. Bevacizumab is a type of targeted cancer drug treatment. Ascites is the medical name for a build up of fluid in the abdomen.

You may be eligible for this study if you are an adult with symptomatic, cytologically confirmed malignant ascites arising from a solid organ malignancy, excluding pancreatic cancer. In addition, you are either not receiving or not planned to receive additional systemic anti-cancer treatment for the duration of the study treatment.

Eligible participants will be randomly allocated to either receive bevacizumab with saline, or saline alone, into the abdominal cavity through an intraperitoneal infusion. This will be followed by a larger infusion of saline over a 30-60 minute period. This therapeutic drainage process may be repeated for re-accumulation of ascites during the study period, if required. Data from participant electronic medical records and quality of life questionnaires will be collected.

It is hoped that this research will help demonstrate the potential activity of bevacizumab to decrease or delay the re-accumulation of malignant ascites. 

Conditions

This trial is treating people with solid organ cancers (excluding pancreatic cancer) with malignant ascites

Eligibility

Inclusion

 

1. Patients with symptomatic, cytologically confirmed malignant ascites:
a. who have any solid organ malignancy excluding pancreatic cancer
b. who are either not receiving or not planned to receive additional systemic anticancer treatment for the duration of study treatment
c. that has recurred following at least one therapeutic ascitic drainage within 28 days prior to study registration
d. who require therapeutic paracentesis for symptomatic management
2. Age: 18 years and over
3. Eastern Cooperative Oncology Group (ECOG) performance status 0-3
4. Estimated survival of 12 weeks or more
5. Study treatment both planned and able to start within 14 days of registration
6. Willing and able to comply with all study requirements, including treatment timing and/or nature of required assessments
7. Signed, written informed consent.

Exclusion

 

1. At high risk of bowel perforation, including but not limited to any one or more of the following:
a. History of bowel obstruction within 6 months prior to study entry
b. CT scan that demonstrates involvement of bowel by tumour
c. Symptoms to suggest impending bowel obstruction
d. Prior whole abdominal radiotherapy
2. Active or non-healing intra-abdominal fistulae or history of fistulae within previous 60 days
3. Major surgery within the preceding 6 weeks
4. Pulmonary emboli or deep vein thrombosis unless on anticoagulation and no thrombotic episode in the preceding 6 weeks
5. Known bleeding diathesis, or history of active bleeding including known gastric ulceration within 60 days
6. Uncontrolled hypertension, or unstable cardiac disease
7. Concurrent illness, including severe infection that may jeopardize the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety
8. Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol
9. Pregnancy, lactation, or inadequate contraception. Women must be post-menopausal, infertile, or use a reliable means of contraception. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to registration.
10. Previous episode of ascites due to non-malignant causes, for example hepatic failure, portal venous obstruction
11. Known hypersensitivity to or serious reaction resulting from any components of bevacizumab, Chinese hamster ovary cell products or other recombinant human or humanised antibodies
12. Have received anti-VEGF therapy within the last 4 weeks.

Inclusion

  • You have had treatment, but your cancer has come back (relapsed or recurrent).
  • You are currently receiving treatment for your cancer.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ANZCTR *. View further details about this trial on the registry via the links below:

Trial sponsor

The University of Sydney

Scientific Title

Efficacy of intraperitoneal bevacizumab for decreasing or delaying re-accumulation of recurrent malignant ascites in chemotherapy resistant solid tumours: a randomised trial

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