Actively Recruiting
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
Led by Dong sheng Zhang · Updated on 2026-02-09
48
Participants Needed
1
Research Sites
187 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
This study is a prospective, multi-cohort Phase Ib/II clinical trial, consisting of two stages as follows: 1. Phase Ib Dose-Escalation Stage To explore the dose-limiting toxicities (DLT) of intraperitoneally administered liposomal irinotecan in patients with malignant peritoneal effusion who have failed prior standard therapy, and to estimate the maximum tolerated dose (MTD) of the investigational agent. 2. Phase II Expansion Stage To evaluate the efficacy and safety of liposomal irinotecan as monotherapy or in combination with recombinant modified human tumor necrosis factor or bevacizumab, in the treatment of malignant peritoneal effusion in patients who have failed prior standard therapy.
CONDITIONS
Official 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
- Malignant peritoneal effusion confirmed by biopsy or cytology from digestive system tumors
- Moderate to large peritoneal effusion with symptoms and failed prior standard or intraperitoneal therapy
- ECOG performance status score 0-2
- Expected survival time longer than 3 months
- Normal heart and lung function
- Adequate blood counts, kidney, liver, and coagulation function as defined by lab tests
- Thyroid stimulating hormone within normal limits or stable non-acute thyroid condition
- Use of medically approved contraception during treatment and for 6 months after if of childbearing potential
- Negative pregnancy test within 7 days prior to enrollment for females of childbearing potential
- Willingness and ability to comply with study procedures and provide informed consent
You will not qualify if you...
- Allergy or hypersensitivity to tumor necrosis factor, bevacizumab, irinotecan, or liposomal irinotecan
- Other malignant diseases diagnosed within 5 years except certain skin cancers
- Participation in another clinical trial or receiving other anti-tumor therapy within 7 days prior to first dose
- Pregnant or breastfeeding women or unwillingness to use contraception during and after study
- Significant major organ dysfunction
- Active bleeding or bleeding disorders
- Uncontrolled or significant heart diseases
- Abnormal ECG findings or prolonged QTc interval
- Uncontrolled high blood pressure
- Severe infections or unhealed wounds
- Loculated peritoneal effusion or peritoneal infection
- Active hepatitis B or C infection above defined viral load thresholds or HIV infection
- Recent major surgery within 4 weeks or incomplete recovery from surgery
- Recent radiotherapy within 4 weeks or unresolved radiotherapy toxicities
- Uncontrolled neurological or psychiatric disorders affecting compliance
- Other conditions judged unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510555
Actively Recruiting
Research Team
Z
Zhang Dongsheng
CONTACT
W
Wang Yingnan
CONTACT
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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