Actively Recruiting
The Efficacy of Bevacizumab and Serplulimab Combined With Recombinant Mutant HumanTumor Necrosis Factor(rmhTNF-NC) in the Treatment of Malignant Ascites
Led by Sun Yat-sen University · Updated on 2024-05-30
60
Participants Needed
3
Research Sites
159 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
1. More than half of peritoneal metastases are from digestive tract. Peritoneal metastasis has poor prognosis, poor treatment response and limited means. 2. rmhTNF-NC or bevacizumab are effective in the treatment of malignant pleuroabdominal effusion. 3, There is increasing evidence that PD-1/PD-L1 inhibitors in combination with vascular endothelial growth factor receptor (VEGFR) inhibitors have a complementary mechanism of action: VEGF pathway inhibitors normalize blood vessels in tumors and promote immune cell maturation and infiltration, thus playing a synergistic role with ICIs. The strategy of systemic immunotherapy combined with antivascular therapy has been confirmed by several large phase III clinical trials such as IMbrave-150. Basic studies have confirmed that uncontrolled tumor vessels in peritoneal metastasis and malignant ascites microenvironment also play an important role in promoting disease progression. Therefore, this project intends to explore the treatment of malignant abdominal effusion by local intraperitoneal injection of bevacizumab and PD-1 on the basis of rmhTNF-NC
CONDITIONS
Official 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 pathology or cytology linked to digestive system tumors
- Moderate or greater abdominal fluid causing symptoms and resistant to initial treatments
- ECOG performance status between 0 and 2
- Expected survival time longer than 3 months
- Basic normal heart and lung function
- Adequate organ function shown by blood counts, kidney, liver, and coagulation tests
- Thyroid function within normal limits or stable
- Use of approved contraception methods during and 6 months after study for women of childbearing age; men must use contraception if partners are of childbearing age
- Voluntary consent with good compliance and ability to follow study requirements
You will not qualify if you...
- Allergy to tumor necrosis factor, bevacizumab, or serplulimab
- Other malignant diseases within 5 years except certain skin cancers
- Use of other investigational or anti-tumor drugs within 7 days before study
- Pregnant or breastfeeding women, or lack of contraception use
- Significant organ damage or bleeding disorders
- Uncontrolled heart diseases or abnormal ECG findings
- Uncontrolled high blood pressure
- Severe uncontrolled infections or abdominal infections
- Active hepatitis B or C infections or HIV
- Major recent bleeding or clotting disorders
- History of organ or stem cell transplant
- Major surgery within 4 weeks before treatment
- Unrecovered surgery or toxicity complications
- Radiotherapy within 4 weeks before treatment unless fully recovered
- Uncontrolled neurological or mental disorders
- Other conditions deemed unsuitable by researchers
AI-Screening
AI-Powered Screening
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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
CONTACT
Y
yunxin LU, PHD
CONTACT
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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