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New treatment option for Malignant Ascites
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
ClinicalTrials.gov ID: NCT07397819
What this study is testing
What is liposomal irinotecan monotherapy?
liposomal irinotecan monotherapy is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for malignant ascites.
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
- 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.
- 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
- Aged ≥18 years old, gender unrestricted.
- Histologically or cytologically confirmed malignant peritoneal effusion derived from digestive system tumors (malignancy confirmed by ascites...
- Moderate to large volume of peritoneal effusion, with failure of initial treatment or previous intraperitoneal therapy with conventional...
- ECOG performance status score 0-2.
- Expected survival time \>3 months.
You likely can't join if
- History of hypersensitivity to tumor necrosis factor (TNF), its derivative drugs, bevacizumab or its analogs, irinotecan, or liposomal irinotecan.
- Diagnosis of malignant diseases other than gastrointestinal tumors within 5 years prior to the first dose (excluding radically treated basal cell...
- Receipt of any other investigational drug treatment or participation in an treatment clinical trial within 7 days prior to the first dose; or receipt...
- Pregnant or lactating women; women of childbearing potential who are unwilling to take contraceptive measures during the study period; or men who are...
- Significant impairment of major organ function.
- Patients with obvious bleeding tendency.
See the full eligibility criteria
Who can join
- Aged ≥18 years old, gender unrestricted.
- Histologically or cytologically confirmed malignant peritoneal effusion derived from digestive system tumors (malignancy confirmed by ascites cytology, or peritoneal metastases diagnosed clinically based on imaging...
- Moderate to large volume of peritoneal effusion, with failure of initial treatment or previous intraperitoneal therapy with conventional chemotherapeutic agents and/or biological response modifiers. Moderate volume of...
- ECOG performance status score 0-2.
- Expected survival time \>3 months.
- Essentially normal cardiopulmonary function.
- Adequate organ function, with people required to meet the following laboratory parameters:
- Peripheral blood count: WBC ≥4.0×10⁹/L, PLT ≥80×10⁹/L, Hb ≥90 g/L.
- Renal function: Serum creatinine ≤2×ULN and creatinine clearance rate (calculated by the Cockcroft-Gault formula) ≥40 ml/min.
- Hepatic function: Total bilirubin ≤1.5×ULN; or total bilirubin \>ULN with direct bilirubin ≤ULN. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN (for patients with liver metastases, ALT or...
- Adequate coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN.
- Thyroid stimulating hormone (TSH) ≤ULN. If TSH is abnormal, serum triiodothyronine (T3) and thyroxine (T4) levels, together with clinical manifestations, shall be evaluated comprehensively; people in non-acute active...
- For non-surgically sterilized people of childbearing potential or female people of childbearing potential: A medically approved contraceptive method (e.g., intrauterine device, oral contraceptives, or condoms) must be...
- Voluntarily participate in the study with good compliance, sign a written informed consent form, and be able to cooperate with follow-up assessments.
What rules you out
- History of hypersensitivity to tumor necrosis factor (TNF), its derivative drugs, bevacizumab or its analogs, irinotecan, or liposomal irinotecan.
- Diagnosis of malignant diseases other than gastrointestinal tumors within 5 years prior to the first dose (excluding radically treated basal cell carcinoma of the skin, cutaneous squamous cell carcinoma, and/or...
- Receipt of any other investigational drug treatment or participation in an treatment clinical trial within 7 days prior to the first dose; or receipt of anti-tumor therapy (including Chinese herbal medicines with...
- Pregnant or lactating women; women of childbearing potential who are unwilling to take contraceptive measures during the study period; or men who are unwilling to use effective contraceptive measures during treatment...
- Significant impairment of major organ function.
- Patients with obvious bleeding tendency.
- Clinically significant or uncontrolled cardiac diseases, including unstable angina pectoris, acute myocardial infarction within 6 months prior to the first dose, New York Heart Association (NYHA) Class III/IV congestive...
- Clinically significant ECG abnormalities or relevant medical history as judged by the investigator; screening QTcF interval \> 480 ms. For people with intraventricular conduction block (QRS interval \> 120 ms), JTc...
- Uncontrolled hypertension, defined as systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mmHg despite optimal medical treatment; a history of hypertensive crisis or hypertensive encephalopathy.
- Severe acute infection that is uncontrolled; current fever (\> 38℃), purulent or chronic infection, or unhealed wounds.
- Patients with radiologically confirmed loculated peritoneal effusion; definitely diagnosed peritoneal infection.
- Active acute or chronic hepatitis B or C infection, with hepatitis B virus (HBV) DNA \> 2000 IU/mL or 10⁴ copies/mL; hepatitis C virus (HCV) RNA \> 10³ copies/mL; concurrent positivity for hepatitis B surface antigen...
- Evidence or history of obvious bleeding tendency within 3 months prior to enrollment (bleeding \> 30 mL within 3 months, hematemesis, melena, hematochezia); hemoptysis (\> 5 mL of fresh blood within 4 weeks); a history...
- A history of arterial or venous thrombotic disease within 6 weeks prior to enrollment.
- A known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Receipt of major surgery (craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to the first dose of study treatment, or anticipated need for major surgery during the study treatment period.
- Failure to achieve adequate recovery from toxicity and/or complications of major surgery prior to the start of treatment.
- Pregnant or lactating women; or people who plan to conceive or give birth during the study period from screening visit to completion of safety follow-up visit (90 days after the last dose for male people).
- Receipt of radiotherapy within 4 weeks prior to the first dose of study drug.
- Radiotherapy-related toxicities in people must have fully resolved, without the need for corticosteroid therapy, and radiation pneumonitis must be definitely excluded. For palliative radiotherapy for non-central nervous...
- Uncontrolled neurological or psychiatric diseases/disorders with poor compliance, resulting in inability to cooperate or report treatment responses. Uncontrolled primary brain tumors or central nervous system metastases...
- Other conditions that, in the investigator's judgment, make the subject unsuitable for participation in this trial.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, 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. 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.