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Ascites clinical trials

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NCT ID: NCT06433869 Recruiting - Malignant Ascites Clinical Trials

The Efficacy of Bevacizumab and Serplulimab Combined With Recombinant Mutant HumanTumor Necrosis Factor(rmhTNF-NC) in the Treatment of Malignant Ascites

Start date: December 14, 2023
Phase: Phase 2
Study type: Interventional

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

NCT ID: NCT06432296 Recruiting - Malignant Ascites Clinical Trials

Treatment of Malignant Ascites Caused by Advanced Epithelial Solid Tumors With M701 Bispecific Antibody

Start date: March 20, 2024
Phase: Phase 3
Study type: Interventional

A Randomized, Controlled, Multi-Center Phase III Clinical Study to Compare the Efficacy and Safety of Recombinant Anti-EpCAM and Anti-CD3 Human-Mouse Chimeric Bispecific Antibody (M701) for Intraperitoneal Injection to Paracentesis alone in Patients with Malignant Ascites Caused by Advanced Epithelial Solid Tumors.

NCT ID: NCT06413212 Recruiting - Breast Cancer Clinical Trials

Exploratory Study of Precise Therapy for Advanced Tumor Patients With Malignant Hydrothorax or Ascites by Using PTC Drug Sensitivity Testing

Start date: August 4, 2023
Phase:
Study type: Observational

To explore the consistency between result of PTC drug screening tests and actual clinical outcome for patients with advanced malignancy.

NCT ID: NCT06402071 Recruiting - Clinical trials for Cirrhotic Ascitic Patients

Clinical Value of the Developed Scoring Systems for Predicting Spontaneous Bacterial Peritonitis in Cirrhotic Ascites

Start date: May 1, 2024
Phase:
Study type: Observational

Liver cirrhosis is the clinical end stage of different entities of chronic liver disease when patients suffer from considerable mortality and morbidity, both of which are correlated positively with disease severity. Ascites are the most common complication, and around 60% of patients with compensated cirrhosis develop ascites within 10 years of disease onset (D'Amico et al., 2015). Spontaneous bacterial peritonitis (SBP) which is defined by acute infection of ascitic fluid, an abnormal accumulation of fluid in the abdomen without a distinct or identifiable source of infection, with ascitic fluid absolute neutrophil count >250 cells/mm³, whether or not there is culture growth. is a major cause of morbidity and mortality in cirrhotic patients with ascites. SBP is estimated to affect 10-30% of cirrhotic patients hospitalized with ascites, and mortality in this group approaches 30%. Many of these patients are asymptomatic, and it is therefore recommended that all patients with ascites undergo paracentesis at the time of admission to confirm the SBP status. Although SBP is less prevalent in an outpatient setting, it is reasonable to also evaluate the ascitic fluid of outpatients because of the high mortality associated with SBP Platelets are considered an important source of pro-thrombotic agents associated with inflammatory markers and play a role in the initiation and propagation of inflammatory diseases. Platelets with large sizes have many granules that can exert their hemostatic and proinflammatory actions with greater efficiency. For these reasons, the mean platelet volume (MPV) and platelet distribution width (PDW) may be considered indicators of platelet function and activation (Abdelmoez et al., 2016). MPV and PDW are routine tests that are a part of a complete blood count. An increase in MPV has been observed in chronic viral hepatitis because of an increase in the entry of newly produced platelets into circulation, which are larger in volume than the old platelets (Castellote et al., 2008; Suvak et al., 2013). Therefore, mean platelet volume and platelet distribution width measurement may be used in predicting spontaneous bacterial peritonitis (Gálvez-Martínez et al., 2015; Abdelmoez et al., 2017). The blood neutrophil-lymphocyte ratio (NLR) is a crucial parameter for the balance of the inflammatory and immune systems, reflecting responses to systemic inflammation In patients with decompensated liver cirrhosis, NLR is a non-invasive marker that can be used to predict the occurrence of hospital infection (Cai et al., 2017), NLR is a predictor of SBP that can be utilized in combination with other markers. According to (Mousa et al., 2016), blood NLR > 2.89 had an 80.3% sensitivity and 88.9% specificity for diagnosing SBP, while blood NLR and CRP combined (cut-off 11.3 mg/dL) had a 95.1% sensitivity and 96.3% specificity (Mousa et al., 2016). Although single tests have shown some value in predicting SBP, their studies have been small and inconsistent. In order to predict SBP in patients with cirrhotic ascites, prediction scores in conjunction with clinical and laboratory indicators are therefore being developed recently (Dahiya et al., 2023; Wehmeyer et al., 2014). In summary, Infections are common in liver cirrhosis patients, and SBP is one of the most prevalent, with varying frequency but a significant fatality rate. One of the most crucial factors in treating this significant consequence of decompensated liver cirrhosis is early detection. Finding non-invasive, affordable, and simple-to-implement parameters related to SBP that have a predictive role is essential. However, need to be kept in mind these methods cannot completely replace paracentesis, more studies are needed to determine whether non-invasive methods are sufficiently accurate to identify the development of SBP in cirrhosis.

NCT ID: NCT06256432 Recruiting - Acute Kidney Injury Clinical Trials

Endothelin Receptor Antagonism With Ambrisentan to Treat Hepatorenal Syndrome

Start date: April 17, 2024
Phase: Phase 2
Study type: Interventional

Patients with advanced cirrhosis of the liver develop kidney problems occasionally. This condition is called Hepatorenal Syndrome, requires hospitalization and frequently results in death. The goal of this clinical trial is to test whether the administration of low doses of ambrisentan can help patients with Hepatorenal Syndrome and to determine if it is safe. Ambrisentan is a drug that is approved for the treatment of high blood pressure in the lungs at higher doses. This clinical trial will compare the safety and effects of ambrisentan to another drug called terlipressin, which is commonly used to treat patients with hepatorenal syndrome. The main questions the clinical trial aims to answer are: - Does ambrisentan help the kidney function of the patient? - Does ambrisentan help prevent death in patients with Hepatorenal Syndrome? - Does ambrisentan prevent Hepatorenal Syndrome from reappearing? While in the hospital, trial participants will receive either one of two doses of ambrisentan or terlipressin. If in the first 4 days, ambrisentan is not helpful, the patient may be eligible to receive terlipressin. Patients assigned to receive ambrisentan will continue taking this medication at home after leaving the hospitals and until they complete 60 days of treatment.

NCT ID: NCT06224023 Recruiting - Cirrhosis, Liver Clinical Trials

Predictive Values of Presepsin Levels in ASciteS in Patients With Chronic Liver Failure

PASS
Start date: May 6, 2024
Phase:
Study type: Observational

The investigators aim to study the predictive value of presepsin in ascites in newly admitted patients with chronic liver failure.

NCT ID: NCT06200376 Recruiting - Malignant Ascites Clinical Trials

A Clinical Study of Intraperitoneal T3011 Given as a Single Agent in Patients With Malignant Ascites Induced by Advanced Colorectal Cancer

Start date: September 28, 2023
Phase: Phase 1
Study type: Interventional

This is a prospective, open, single-arm, investigator-initiated clinical study to evaluate the safety and efficacy of intraperitoneal administration of T3011 at different doses in the treatment of malignant ascites induced by advanced colorectal cancer.

NCT ID: NCT06121479 Recruiting - Clinical trials for Decompensated Cirrhosis and Ascites

Oral Branched-chain Amino Acid Supplementation for Decompensated Cirrhotic Patients

Start date: November 13, 2023
Phase: Phase 3
Study type: Interventional

The goal of this clinical trial is to compare the nutritional parameters after 12-week supplementation of branched-chain amino acids in cirrhotic patients with ascites and serum albumin less than 3 g/dL. The main questions it aims to answer are: 1. Would thigh muscle thickness change after 12-week supplementation of branched-chain amino acids in cirrhotic patients with ascites and serum albumin less than 3 g/dL? 2. Would triceps skin fold thickness, mid-arm circumferences, mid-arm muscle circumferences, skeletal muscle mass, appendicular skeletal muscle mass, skeletal muscle index and fat mass change after 12-week supplementation of branched-chain amino acids in cirrhotic patients with ascites and serum albumin less than 3 g/dL? 3. Would handgrip strength change after 12-week supplementation of branched-chain amino acids in cirrhotic patients with ascites and serum albumin less than 3 g/dL? 4. Would serum albumin change after 12-week supplementation of branched-chain amino acids in cirrhotic patients with ascites and serum albumin less than 3 g/dL? 5. Would score for cirrhotic severity such as Model for End-Stage Liver Disease-Sodium Score (MELD-Na score) and Child Turcotte Pugh Score change after 12-week supplementation of branched-chain amino acids in cirrhotic patients with ascites and serum albumin less than 3 g/dL? Participants will be asked to do following tasks: 1. Participants will be asked for basic information such as age, place of residence, and contact telephone number. 2. Participants will undergo measurements of weight, height, body mass index, skinfold thickness on the arms, circumference of the arms and legs, muscle mass, and body fat content using a body composition analyzer, both at the beginning and end of the research study. 3. Participants will perform grip strength measurements, at both the beginning and end of the research study. 4. Participants will undergo laboratory tests, including a complete blood count, liver and kidney function tests, blood clotting factors, and blood mineral levels, with a total blood volume of approximately 15 milliliters (1 tablespoon), collected twice during the study (at the beginning and end). 5. Participants will be administered supplements containing branched-chain amino acids (BCAA) twice a day for a total of 12 weeks. 6. Participants will be appointed for follow-up during the study, totaling 2 appointments at weeks 4 and 12. Side effects related to medication will be asked. 7. Participants will undergo ultrasound measurements of the right thigh to assess thigh muscle thickness, both at the beginning and end of the research study. 8. Participants will will complete questionnaires to assess your overall quality of life twice, both at the beginning and end of the research study.

NCT ID: NCT06046963 Recruiting - Gastric Cancer Clinical Trials

Sintilimab in Combination With S-1/Oxaliplatin With Nab-paclitaxel Intraperitoneal Infusion for Untreated Advanced Gastric Cancer With Malignant Ascites

Start date: March 1, 2023
Phase: Phase 2
Study type: Interventional

To evaluate the efficacy and safety of Sintilimab in Combination With S-1/oxaliplatin With nab-paclitaxel intraperitoneal infusion as First-line Treatment for advanced gastric/gastroesophageal junction (GC/GEJ) adenocarcinoma with malignant ascites

NCT ID: NCT06016179 Recruiting - Clinical trials for Malignant Pleural Effusion

Tocilizumab Delivered Via Pleural and Peritoneal Catheters in Patients With Advanced Metastatic Cancer

RIOT2
Start date: January 30, 2024
Phase: Phase 1
Study type: Interventional

The purpose of this study to find out if tocilizumab can be safely infused into chest or abdominal cavities of patients with malignancy ascites (MA) or malignant pleural effusions (MPE). Patients will have a total of 4 doses, one dose administered each week. Each dose will be greater than the previous one.