Actively Recruiting
Intraperitoneal Injection of Liposomal Irinotecan Alone or With Recombinant Mutant Human Tumor Necrosis Factor or Bevacizumab for Malignant Ascites After Standard Therapy Failure: A Phase Ib/II Clinical Study
Led by Dong sheng Zhang · Updated on 2026-02-09
48
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
D
Dong sheng Zhang
Lead Sponsor
C
CSPC Pharmaceutical Group Limited
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting a Phase Ib/II clinical trial to evaluate treatments for malignant peritoneal effusion, a condition where fluid builds up in the abdomen due to cancer that has not responded to standard therapies. The study aims to explore the safety and dosing of liposomal irinotecan administered into the abdominal cavity and to assess its effectiveness alone or combined with other drugs in patients who have failed prior treatments. The study has two stages. The first is a dose-escalation phase where patients receive increasing doses of liposomal irinotecan via intraperitoneal injection on Days 1, 8, 15, and 21 to determine the maximum tolerated dose. The second stage expands to test liposomal irinotecan alone or combined with recombinant mutant human tumor necrosis factor or bevacizumab given on specific schedules. Each participant receives treatment cycles, and doses are monitored carefully for safety. Participants will undergo various tests and evaluations during treatment, including safety monitoring, response assessments, and quality of life measurements over about one year. Researchers will track the maximum tolerated dose, response rates, duration of response, disease control, and side effects. Follow-up continues to evaluate treatment impact and participant well-being throughout the study period up to the end date in June 2029.
CONDITIONS
Brief Title
Intraperitoneal Injection of Liposomal Irinotecan as Monotherapy or in Combination With Recombinant Mutant Human Tumor Necrosis Factor or Bevacizumab for the Treatment of Malignant Ascites Following Failure of Prior Standard Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older, any gender
- Confirmed malignant peritoneal effusion from digestive system tumors by biopsy or cytology
- Moderate to large volume of peritoneal effusion with symptoms and failure of prior standard or intraperitoneal treatments
- ECOG performance status score between 0 and 2
- Expected survival time longer than 3 months
- Normal heart and lung function
- Adequate organ function based on specific blood, kidney, liver, and coagulation tests
- Thyroid function within normal limits or stable non-acute condition
- Use of medically approved contraception during and for 6 months after treatment for those of childbearing potential
- Willingness to participate voluntarily and comply with study procedures
You will not qualify if you...
- Allergy to tumor necrosis factor, bevacizumab, irinotecan, liposomal irinotecan, or related drugs
- Other cancers diagnosed within 5 years except certain skin cancers
- Participation in other clinical trials or anti-tumor treatments within 7 days before study
- Pregnant or breastfeeding women, or those not willing to use contraception
- Significant major organ dysfunction or bleeding disorders
- Uncontrolled or serious heart conditions
- Abnormal heart rhythm or ECG findings exceeding limits
- Uncontrolled high blood pressure despite treatment
- Active infections or unhealed wounds
- Loculated peritoneal effusion or peritoneal infection
- Active hepatitis B or C infections above specific viral loads or HIV infection
- Recent significant bleeding or clotting disorders
- History of organ or stem cell transplantation
- Recent major surgery with incomplete recovery
- Pregnant or planning pregnancy during study and follow-up
- Recent radiotherapy or unresolved radiation side effects
- Uncontrolled neurological or psychiatric conditions
- Other conditions judged by investigators as unsuitable for participation
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants receive intraperitoneal injections of liposomal irinotecan alone or in combination with recombinant mutant human tumor necrosis factor or bevacizumab. The treatment cycle includes doses on Day 1, Day 8, Day 15, and Day 21 with additional injections of combination drugs depending on the assigned regimen.
4 visits (in-person) during treatment
Duration - Up to 1 year
Participants are monitored for safety, treatment response, and quality of life after completion of the treatment cycle.
Visits scheduled periodically for up to 1 year
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510555
Actively Recruiting
Research Team
Z
Zhang Dongsheng
W
Wang Yingnan
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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