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Tests treatment safety and results for Malignant Ascites
Official title The Efficacy of Bevacizumab and Serplulimab Combined With Recombinant Mutant HumanTumor Necrosis Factor(rmhTNF-NC) in the Treatment of Malignant Ascites
ClinicalTrials.gov ID: NCT06433869
What this study is testing
What is serplulimab?
serplulimab is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for malignant ascites.
Also referred to as PD-1 inhibitor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 1. More than half of peritoneal metastases are from digestive tract.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥18 years old, gender unlimited;
- Malignant ascites confirmed by histology or cytology as originating from digestive system tumors (malignant confirmed by ascites cytology or...
- Patients with more than a moderate amount of abdominal fluid, who have failed initial treatment or have been treated with conventional chemotherapy...
- B ultrasound examination of ascites ≥3cm in lying position;
- Accompanied by clinical symptoms (chest tightness, shortness of breath, abdominal distension and discomfort, which were judged by researchers to be...
You likely can't join if
- History of allergy to tumor necrosis factor and its derivatives, bevacizumab analogues, and Serplulimab;
- Malignant diseases other than digestive tract neoplasms were diagnosed within 5 years prior to initial administration (excluding radical basal cell...
- Received any other investigational drug therapy or participated in an treatment clinical investigator within 7 days prior to initial dosing; Or...
- Pregnant or lactating women, women of childbearing age who did not want to use contraception during the study period; Or the man is unwilling to use...
- Significant damage to the function of important organs;
- Patients with obvious bleeding tendency;
See the full eligibility criteria
Who can join
- Age ≥18 years old, gender unlimited;
- Malignant ascites confirmed by histology or cytology as originating from digestive system tumors (malignant confirmed by ascites cytology or clinically diagnosed as peritoneal metastases by imaging and symptoms);
- Patients with more than a moderate amount of abdominal fluid, who have failed initial treatment or have been treated with conventional chemotherapy drugs and/or biological response modulators intravenously. Moderate...
- B ultrasound examination of ascites ≥3cm in lying position;
- Accompanied by clinical symptoms (chest tightness, shortness of breath, abdominal distension and discomfort, which were judged by researchers to be related to abdominal fluid accumulation);
- ECOG physical status is 0-2;
- Expected survival time \>3 months;
- Cardiopulmonary function is basically normal;
- For adequate organ function, people must meet the following laboratory criteria:
- Peripheral blood imaging: WBC≥4.0×109/L, PLT≥80×109/L, Hb≥90g/L;
- Renal function: serum creatinine ≤2×ULN and creatinine clearance (calculated by Cockcroft-Gault formula) ≥40 ml/min;
- Liver function: total bilirubin ≤1.5× upper limit of normal value (ULN); Or total bilirubin \>ULN but direct bilirubin ≤ ULN; Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤2.5×ULN (ALT or AST ≤5×ULN...
- Good coagulation function, defined as International standardized ratio (INR) or prothrombin time (PT) ≤1.5 times ULN;
- Thyroid stimulating hormone (TSH) ≤ULN; If abnormal, T3 and T4 levels and clinical manifestations should be investigated, and comprehensive assessment of non-acute activity can be included;
- Non-surgical sterilization or female patients of reproductive age who are required to use a medically approved contraceptive method (such as an IUD, contraceptive pill or condom) during the study treatment period and...
- Voluntarily enrolled in this study, with good compliance, signed written informed consent, and able to cooperate with follow-up observation.
What rules you out
- History of allergy to tumor necrosis factor and its derivatives, bevacizumab analogues, and Serplulimab;
- Malignant diseases other than digestive tract neoplasms were diagnosed within 5 years prior to initial administration (excluding radical basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin...
- Received any other investigational drug therapy or participated in an treatment clinical investigator within 7 days prior to initial dosing; Or received anti-tumor drug treatment (including Chinese herbal medicine with...
- Pregnant or lactating women, women of childbearing age who did not want to use contraception during the study period; Or the man is unwilling to use effective contraception during treatment and during the following 1...
- Significant damage to the function of important organs;
- Patients with obvious bleeding tendency;
- Clinically significant or uncontrolled heart disease, including unstable angina pectoris, acute myocardial infarction within 6 months prior to first dosing, New York Heart Association Class III/IV congestive heart...
- Presence of ECG changes or medical history that investigators consider clinically significant; Screening QTcF interval \>480 ms, people with indoor block (QRS interval \>120 ms) can use JTc interval instead of QTc...
- Uncontrolled hypertension, systolic blood pressure \>160 mmHg or diastolic blood pressure \>100 mmHg after optimal medical treatment, history of hypertensive crisis or hypertensive encephalopathy;
- Severe acute infection that is not under control; The patient is having fever (\> 38℃), or has suppurative and chronic infection, and the wound is prolonged and does not heal;
- Patients with encapsulated abdominal effusion confirmed by imaging; A definite diagnosis of abdominal infection;
- Persons infected with acute or chronic active hepatitis B or hepatitis C, hepatitis B virus (HBV) DNA\>2000IU/ml or 104 copies /ml; Hepatitis C virus (HCV) RNA\> 103 copies /ml; Hepatitis B surface antigen (HbsAg) and...
- Patients with obvious evidence of bleeding tendency or history within 3 months prior to enrollment (hemorrhage \>30 mL within 3 months, hematemesis, stool, and blood in the stool), hemoptysis (\>5 mL fresh blood within...
- Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;
- Had a major surgical procedure (craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to the first dose of study therapy or expected to require major surgery during study therapy;
- Complications of toxicity and/or major surgery have not fully recovered before starting treatment;
- Women who are pregnant or nursing, or who are expected to become pregnant or give birth during the study period from screening visits to completion of safety follow-up visits (male people to 90 days after the last...
- Radiotherapy was received within 4 weeks prior to the first administration of the study drug. people must have fully recovered from radiation-related toxicities without the need for corticosteroid therapy, confirming...
- Patients with uncontrollable neurological, mental illness or mental disorder, poor compliance, unable to cooperate with and describe the response to treatment; Patients with uncontrolled primary brain tumor or central...
- There are other conditions that researchers consider inappropriate to participate in this experiment.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
- Guangzhou, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China; Guangzhou, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.