Actively Recruiting
Multi-arm Phase II Study of Intraperitoneal Serplulimab, Bevacizumab, and Recombinant Mutant Human Tumor Necrosis Factor for Malignant Ascites After Standard Therapy Failure
Led by Sun Yat-sen University · Updated on 2024-05-30
60
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Malignant ascites, often arising from digestive system tumors with peritoneal metastases, is associated with poor prognosis and limited treatment options. Researchers are studying a combination of drugs including serplulimab (a PD-1 inhibitor), bevacizumab, and recombinant mutant human tumor necrosis factor (rmhTNF-NC) to explore their effects on malignant ascites in patients who have not responded to standard therapies. This phase II clinical trial aims to evaluate the efficacy of these treatments administered locally into the abdominal cavity. Participants are assigned to one of three groups receiving different combinations: serplulimab with bevacizumab; serplulimab with rmhTNF-NC; or serplulimab combined with both bevacizumab and rmhTNF-NC. The drugs are given via intraperitoneal injection on specific days, with serplulimab and bevacizumab administered on day 1 and day 15, while rmhTNF-NC is given on days 1, 4, 7, and 10. This approach targets the local tumor environment and malignant fluid buildup to assess potential benefits and interactions. During the study, participants will be monitored for responses in their malignant ascites over two months, including the objective response rate and control of ascites fluid. Other evaluations include duration of ascites relief up to one year, side effects, and changes in abdominal effusion symptoms. Assessments will involve clinical examinations, imaging, laboratory tests, and scoring of abdominal function. The trial involves regular follow-up to observe treatment effects and ensure safety throughout the participation period.
CONDITIONS
Brief Title
The Efficacy of Bevacizumab and Serplulimab Combined With Recombinant Mutant HumanTumor Necrosis Factor(rmhTNF-NC) in the Treatment of Malignant Ascites
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- Malignant ascites confirmed by histology or cytology from digestive system tumors
- Moderate or greater abdominal fluid with symptoms related to fluid buildup
- Failed initial treatment or received conventional chemotherapy or biological agents
- ECOG physical status score between 0 and 2
- Expected survival time greater than 3 months
- Basic normal cardiopulmonary function
- Adequate organ function based on blood counts, kidney and liver tests, and coagulation
- Thyroid function within normal range or stable with assessment
- Use of medically approved contraception during treatment and for 6 months after if of reproductive age
- Voluntary consent and ability to comply with follow-up
You will not qualify if you...
- Allergy to tumor necrosis factor, bevacizumab analogues, or serplulimab
- Malignancies other than digestive tract cancers diagnosed within 5 years (except certain skin cancers)
- Use of other investigational or anti-tumor drugs within 7 days prior to study start
- Pregnancy, lactation, or unwillingness to use contraception when applicable
- Significant organ damage or bleeding tendency
- Uncontrolled heart disease or arrhythmia
- Abnormal ECG findings deemed clinically significant
- Uncontrolled hypertension despite treatment
- Severe uncontrolled infections or fever
- Encapsulated abdominal effusion or diagnosed abdominal infection
- Active hepatitis B or C infection above specified viral load thresholds
- HIV infection
- Recent significant bleeding or clotting disorders
- History of organ or stem cell transplantation
- Major surgery within 4 weeks prior to first dose or expected during study
- Incomplete recovery from surgery or toxicity
- Radiotherapy within 4 weeks prior to study without full recovery
- Uncontrolled neurological or mental disorders
- Other conditions judged inappropriate by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 months
Participants receive intraperitoneal injections of serplulimab combined with bevacizumab, rmhTNF-NC, or both, to treat malignant ascites.
Multiple visits for intraperitoneal injections on Days 1, 4, 7, 10, and 15
Trial Site Locations
Total: 3 locations
1
Cancer center of SunYat-sen University
Guangzhou, Guangdong, China, 510060
Actively Recruiting
2
Zhang Dongsheng
Guangzhou, China
Actively Recruiting
3
Zhang Dongsheng
Guangzhou, China
Actively Recruiting
Research Team
D
dongsheng zhang, PHD
Y
yunxin LU, PHD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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