[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metastatic-malignant-neoplasm-in-the-peritoneum\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metastatic-malignant-neoplasm-in-the-peritoneum":34},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,62,89,113,134,177,201],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":35,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":50,"lastUpdatePostDateStruct":51,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":58,"locationsCount":61},"100424807","phase-1-pressurized-intraperitoneal-aerosol-chemotherapy-pipac-associated-with-systemic-chemotherapy-in-women-with-advanced-ovarian-cancer-100424807",false,"NCT04811703","Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Associated With Systemic Chemotherapy in Women With Advanced Ovarian Cancer","Phase I Dose Escalation Study Evaluating the Safety of Adding Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) With Cisplatin-doxorubicin to the Systemic Chemotherapy, and the Recommended Phase II Dose, in Women With Insufficient Response to Carboplatin-paclitaxel for Advanced Epithelial Cancer of the Ovary, Fallopian Tubes or Peritoneum","PIPACOVA","Inclusion Criteria:\n\n* Age ≥ 18 years and ≤ 75 years;\n* ECOG Performance Status 0-2;\n* Histologically confirmed epithelial carcinoma of the ovary, fallopian tubes, or peritoneum, FIGO stage IIb to IVa, with a tumor response after three cycles of carboplatin-paclitaxel that does not correspond to disease progression but is insufficient to allow complete cytoreductive surgery, as assessed by the investigators after multidisciplinary tumor board discussion and validation;\n* Adequate hematological function:\n\n  * Absolute neutrophil count \\> 1,500\u002Fmm³ (or 1.5 × 10⁹\u002FL);\n  * Hemoglobin ≥ 9.0 g\u002FdL;\n  * Platelet count \\> 100 × 10⁹\u002FL;\n* Adequate renal and hepatic function:\n\n  * Serum creatinine ≤ 1.5 × upper limit of normal (ULN) or estimated glomerular filtration rate ≥ 60 mL\u002Fmin\u002F1.73 m² (CKD-EPI equation);\n  * Total bilirubin ≤ 1.5 × ULN;\n  * AST and ALT ≤ 1.5 × ULN (≤ 5 × ULN in patients with liver metastases);\n* No unstable medical conditions, including myocardial infarction within 6 months prior to study entry, congestive heart failure, unstable angina, active cardiomyopathy, unstable arrhythmia, uncontrolled hypertension, uncontrolled psychiatric disorders, severe infection, peptic ulcer disease, or any condition that could be worsened by the study treatment or impair compliance, as judged by the investigator;\n* Written informed consent obtained prior to any study-specific procedures;\n* Patient affiliated with a national health insurance system.\n\nExclusion Criteria:\n\n* Extra-peritoneal metastases whose location or extent precludes a potentially curative surgical procedure;\n* Signs of bowel obstruction, bowel lesions with a high risk of intestinal perforation based on their location, or evidence of inflammatory bowel disease;\n* Contraindication to intravenous carboplatin-paclitaxel chemotherapy, including known severe hypersensitivity to paclitaxel;\n* Contraindication to PIPAC procedures, including:\n\n  * Known hypersensitivity to cisplatin or other platinum compounds;\n  * Known hypersensitivity to doxorubicin or other anthracyclines or anthracenediones;\n  * Cardiac disease with myocardial insufficiency;\n  * Uncontrolled coronary artery disease;\n* Known hypersensitivity to sodium thiosulfate, sulfites, or any of its excipients;\n* Administration of a live attenuated vaccine within 3 months prior to study treatment initiation or planned during the study;\n* Pregnant or breastfeeding women;\n* Individuals deprived of liberty, under guardianship, or subject to legal protection measures;\n* Participation in another interventional research study with an ongoing exclusion period at inclusion, or in a study that could interfere with the results of the present study, as judged by the investigator;\n* Inability to comply with study follow-up for geographical, social, or psychological reasons, as judged by the investigator.","FEMALE","18 Years","75 Years",{"count":21,"type":22},15,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","Women with a history of tumor response insufficient to allow complete cytoreductive surgery after three cycles of prior neoadjuvant systemic carboplatin-paclitaxel chemotherapy will be prospectively enrolled in this phase I study. After providing written informed consent and confirmation of unresectable disease by multidisciplinary assessment, patients will undergo three cycles of combined chemotherapy consisting of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) with doxorubicin and cisplatin at escalating dose levels, combined with systemic intravenous chemotherapy using carboplatin and paclitaxel at standard doses. Treatment cycles will last 28 days, with PIPAC administered on Day 1 and systemic chemotherapy on Day 8, for a maximum of three cycles in the absence of unacceptable toxicity.\n\nDose escalation of PIPAC chemotherapy will follow a Continual Reassessment Method (CRM) algorithm. The first patient will be treated at the lowest dose level, and subsequent patients will receive the recommended dose according to the CRM, conditional on the occurrence of dose-limiting toxicity (DLT) observed during Cycle 1. From dose level 7 onward, corresponding to cisplatin and doxorubicin doses associated with an increased risk of renal toxicity, sodium thiosulfate will be systematically administered prior to each PIPAC procedure for its nephroprotective effect, in accordance with the cisplatin dose level and current clinical practice.\n\nThe primary objective of the study is to determine the maximum tolerated dose (MTD) of doxorubicin-cisplatin administered by PIPAC and to define the recommended dose for a subsequent phase II trial. DLTs will be actively collected and reviewed as soon as they are identified during the first treatment cycle.\n\nSecondary objectives include evaluation of pathological response, radiological tumor response, and changes in the extent of peritoneal disease following combined chemotherapy, as well as characterization of the pharmacokinetics of PIPAC-administered drugs. Additional exploratory objectives include assessment of the KELIM parameter as a predictive marker of sensitivity to combined chemotherapy and evaluation of the overall safety profile of the treatment strategy.\n\nOn Day 1 of the first treatment cycle, blood samples will be collected for pharmacokinetic analysis of doxorubicin and cisplatin. Serum CA-125 levels will be measured before each intraperitoneal or intravenous chemotherapy administration throughout the study. At the end of combined chemotherapy, radiological tumor assessment by CT scan or MRI and a final CA-125 measurement will be performed. Patients achieving complete response, partial response, or stable disease according to RECIST v1.1 criteria will undergo re-evaluation for surgical resectability. If complete cytoreductive surgery is deemed feasible, surgery will be scheduled with a post-operative follow-up visit planned one month later. Patients with progressive or persistently unresectable disease will discontinue study participation.",[28,29,30,31,32,33,34],"Metastatic Ovarian Carcinoma","Peritoneal Carcinomatosis","Stage III Ovarian Cancer","Stage IV Ovarian Cancer","Stage III Fallopian Tube Cancer","Stage IV Fallopian Tube Cancer","Metastatic Malignant Neoplasm in the Peritoneum",[36,37,38,39,40,41,42,43,44,45,46,47,48],"Dose escalation","Phase I study","Intravenous Chemotherapy","Intraperitoneal chemotherapy","PIPAC","RP2D","cytoreductive surgery","Ovarian epithelial cancer","peritoneal cancer","doxorubicin","cisplatin","CA-125 antigen","pharmacokinetic","RECRUITING","2026-05-18",{"date":52,"type":53},"2026-05-22","ACTUAL",{"date":55,"type":53},"2021-07-30",{"date":57,"type":22},"2029-01",{"name":59,"class":60},"Hospices Civils de Lyon","OTHER",6,{"id":63,"slug":64,"hasResults":11,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":4,"eligibilityCriteria":68,"healthyVolunteers":11,"sex":69,"minAge":18,"maxAge":70,"enrollmentInfo":71,"targetDuration":4,"studyType":23,"phases":73,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":88},"100497135","phase-2-robotic-cytoreduction-and-hyperthermic-intraperitoneal-chemotherapy-for-treatment-of-gastric-cancer-with-limited-peritoneal-metastasis-robo-chip-study-100497135","NCT05753306","Robotic Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy for Treatment of Gastric Cancer With Limited Peritoneal Metastasis, ROBO-CHIP Study","A Phase II Study of Robotic Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Patients With Gastric Cancer and Limited Peritoneal Metastasis: ROBO-CHIP Trial","Inclusion Criteria:\n\n* Restricted to 18 to 80 years of age\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 2\n* Histologic confirmation of gastric adenocarcinoma including all subtypes and Siewert type II\u002FIII gastroesophageal (GE) junction adenocarcinomas\n* Absolute neutrophil count \\>= 1,500 \u002F uL\n* Platelets \\>= 50,000 \u002F Ul\n* Serum creatinine \\\u003C= 1.5 mg \u002F dL\n* Adequate nutritional status (Albumin \\>= 3.5)\n* Metastasis confined to the peritoneum:\n\n  * Positive peritoneal cytology\n  * Peritoneal metastasis on diagnostic laparoscopy\n  * Peritoneal metastasis on imaging\n* Response to systemic chemotherapy defined as at least one of the following:\n\n  * Reduction (\\>= 30%) in standardized uptake value (SUV) max \\[Response Evaluation Criteria in Solid Tumors (RECIST) criteria\\]\n  * Reduction in size of primary tumor, regional lymph node or peritoneal metastasis on imaging (\\>= 20% decrease in the longest diameter of target lesion) RECIST criteria\n  * Reduction ( \\>= 30%) in Peritoneal Carcinomatosis Index (PCI) or conversion of peritoneal cytology\n  * Reduction ( \\>= 30%) in serum tumor markers CEA or CA 19-9\n* Peritoneal Carcinomatosis Index (PCI) =\\\u003C 7 and surgeon deems high likelihood for a complete cytoreduction\n* Body Mass Index (BMI) =\\\u003C 35 kg\u002Fm\\^2\n\nExclusion Criteria:\n\n* Distant metastatic disease not limited to peritoneum, such as solid organ metastases (liver, lung, bone, distant lymph node, etc)\n* Malignant ascites at time of study enrollment\n* Comorbidities that would preclude protocol therapy\n* Subjects deemed unable to comply with study and\u002For follow-up procedures\n* Subjects with a known hypersensitivity to protocol systemic chemotherapy that was life-threatening, required hospitalization or prolongation of existing hospitalization, or resulted in persistent or significant disability or incapacity","ALL","80 Years",{"count":72,"type":22},40,[74],"PHASE2","This phase II clinical trial tests how well robotic cytoreduction and hyperthermic intraperitoneal chemotherapy (HIPEC) in treating patients with gastric cancer that has spread to the tissue that lines the wall of the abdominal cavity (peritoneum). Gastric cancer is the third leading cause of cancer related deaths worldwide and peritoneal metastasis are found in 30% of patients at time of diagnosis. Patients with peritoneal metastasis have poor survival rates. Traditional surgery is done with a large incision and has a high complication rate and longer hospital stays. Robot assisted (robotic) cytoreduction is a surgical option that uses small incisions and there is less risk of complications. HIPEC involves infusing heated chemotherapy into the abdominal cavity during surgery. Robotic cytoreduction together with HIPEC may improve recovery and decrease complications after surgery.",[77,78,34],"Gastric Adenocarcinoma","Gastroesophageal Junction Adenocarcinoma","2026-04-02",{"date":81,"type":53},"2026-04-08",{"date":83,"type":53},"2023-04-20",{"date":85,"type":22},"2030-03-25",{"name":87,"class":60},"Mayo Clinic",1,{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":69,"minAge":18,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":23,"phases":98,"briefSummary":99,"conditions":100,"keywords":4,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":112},"100536834","phase-1-intraperitoneal-oxaliplatin-and-fluorouracil-for-the-treatment-of-patients-with-peritoneal-metastases-from-colorectal-cancer-100536834","NCT06269978","Intraperitoneal Oxaliplatin and Fluorouracil for the Treatment of Patients With Peritoneal Metastases From Colorectal Cancer","A Phase I Study of Intraperitoneal 5FU+Oxaliplatin in Patients With Colorectal Cancer With Isolated Peritoneal Metastasis","Inclusion Criteria:\n\n* Age \\>= 18 years\n* Biopsy proven colorectal cancer with peritoneal metastasis. Patients with extraperitoneal metastases will not be eligible. Patients with involvement of intra-abdominal lymph nodes may be eligible at the discretion of the treating physician\n* Primary colorectal cancer may either be left in place or have been resected prior to study enrollment\n* Patients are allowed to have received prior colorectal cancer-directed systemic therapy.\n* Not previously undergone cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (HIPEC) for colorectal cancer\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 at the time of enrollment\n* Absolute neutrophil count (ANC) ≥ 1,500 \u002FmcL\n* Platelets ≥ 100,000 \u002F mcL\n* Serum creatinine ≤ 1.5 x upper limit of normal (ULN) OR measured or calculated creatinine clearance ≥ 60 mL\u002Fmin for patient with creatinine levels \\> 1.5 x institutional ULN (glomerular filtration rate \\[GFR\\] can also be used in place of creatinine or creatinine clearance \\[CrCl\\])\n\n  * Creatinine clearance should be calculated per institutional standard\n* Serum total bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ ULN for patient with total bilirubin levels \\> 1.5 ULN\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN\n\n  * Both values must be in the specified range\n* Albumin \\>= 2.5 g\u002FdL\n* International normalized ratio (INR) or prothrombin time (PT) =\\\u003C 1.5 x ULN unless patient is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants\n* Activated partial thromboplastin time (aPTT) =\\\u003C 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants\n* Patients on anticoagulation or antiplatelet agents may be enrolled at the discretion of the treating physician, provided these can be safely held as needed for surgical procedures\n* Anticipated life expectancy of ≥ 6 months\n* Willing to comply with study procedures\n* Female subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study and at least 9 months after the last dose of study medication\n* For female patients of childbearing potential, a negative pregnancy test is required at or within 7 days prior to enrollment\n* Be willing and able to understand and sign the written informed consent document\n* Be willing to undergo two diagnostic laparoscopies with tumor biopsy tissue. Patients must consent to on-treatment biopsies prior to initiation of clinical trial\n* Be willing to provide peripheral blood and peritoneal samples for correlative studies\n\nExclusion Criteria:\n\n* Patients who are receiving any other investigational drugs\n* Evidence of metastatic disease other than peritoneum based on standard of care (SOC) imaging\n* Patients with primary mucinous appendiceal tumors will not be eligible. These tumors often produce mucin, which may affect the penetration of IP chemotherapy. Patients with non-mucinous appendiceal adenocarcinomas will be eligible.\n* Patients with \\>= grade 2 peripheral neuropathy\n* Uncontrolled concurrent illness including, but not limited to, ongoing or active infection, cardiac arrhythmia, active bleeding diatheses, and psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Major surgical procedure or significant traumatic injury less than 3 weeks or those who receive minor surgical procedures within 1 week from first dose of study drug administration\n* Known active chronic infections - uncontrolled human immunodeficiency virus (HIV)\u002Facquired immunodeficiency syndrome (AIDS), known active (i.e., with detectable polymerase chain reaction \\[PCR\\]) hepatitis B or C\n* Cirrhosis (Child-Pugh B or worse) or cirrhosis with history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis\n* Pregnancy or breastfeeding\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating physician",{"count":97,"type":22},24,[25],"This phase I trial tests the safety, side effects, and best dose of intraperitoneal oxaliplatin and fluorouracil in treating patients with colorectal cancer that has spread to the peritoneal cavity (peritoneal metastasis). Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It damages the cell's DNA and may kill cancer cells. Fluorouracil stops cells from making DNA and it may kill cancer cells. Both oxaliplatin and fluorouracil are approved by the Food and Drug Administration to treat patients with colorectal cancer, however administration of these drugs directly into the area between the muscles and organs in the abdomen (intraperitoneal) for the treatment of peritoneal metastases is experimental. Giving oxaliplatin and fluorouracil directly into the peritoneal space may be a safe and effective way of treating patients with peritoneal metastases from colorectal cancer.",[101,34,102],"Metastatic Colorectal Carcinoma","Stage IV Colorectal Cancer AJCC v8","2026-03-06",{"date":105,"type":53},"2026-03-10",{"date":107,"type":53},"2024-12-31",{"date":109,"type":22},"2026-09-30",{"name":111,"class":60},"Arjun Mittra",2,{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":69,"minAge":18,"maxAge":70,"enrollmentInfo":120,"targetDuration":4,"studyType":23,"phases":121,"briefSummary":122,"conditions":123,"keywords":4,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":88},"100428359","phase-2-hyperthermic-intraperitoneal-chemotherapy-for-the-treatment-of-pancreatic-cancer-and-peritoneal-metastasis-100428359","NCT04858009","Hyperthermic Intraperitoneal Chemotherapy for the Treatment of Pancreatic Cancer and Peritoneal Metastasis","A Phase II Study of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Patients With Pancreatic Cancer and Peritoneal Metastasis","Inclusion Criteria:\n\n* Age \\>= 18 but =\\\u003C 80\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 2\n* Cytologic or histologic proof of adenocarcinoma of the pancreas\n* Leukocytes \\>= 3,000\u002FuL\n* Absolute neutrophil count \\>= 1,500\u002FuL\n* Platelets \\>= 60,000\u002FUl\n* Serum creatinine =\\\u003C 1.5 mg\u002FdL\n* Distant metastatic disease of peritoneum may be visualized on imaging:\n\n  * Positive peritoneal cytology\n  * Limited carcinomatosis on diagnostic laparoscopy or laparotomy\n  * KRASD assay positive peritoneal washings\u002Fcytology\n* Completion of preoperative systemic chemotherapy with biochemical, metabolic, and\u002For radiographic response defined as a reduction in the baseline CA 19-9 by \\> 50% or radiographic response as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or metabolic response on positron emission tomography (PET)-magnetic resonance imaging (MRI) defined by PET Response Criteria in Solid Tumors (PERCIST) criteria\n* Peritoneal Carcinomatosis Index (PCI) =\\\u003C 7 and surgeons deems high likelihood for a complete cytoreduction\n\nExclusion Criteria:\n\n* Distant metastatic disease not limited to peritoneum:\n\n  * Solid organ metastases (liver, central nervous system, lung)\n* Infections such as pneumonia or wound infections that would preclude protocol therapy\n* Women with a positive urine or serum pregnancy test are excluded from this study; women of childbearing potential (defined as those who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) must agree to refrain from breast feeding and practice adequate contraception as specified in the informed consent. Adequate contraception consists of oral contraceptive, implantable contraceptives, injectable contraceptives, a double barrier method, or abstinence\n* Subjects deemed unable to comply with study and\u002For follow-up procedures\n* Subjects with a known hypersensitivity to protocol systemic chemotherapy that was life-threatening, required hospitalization or prolongation of existing hospitalization, or resulted in persistent or significant disability or incapacity",{"count":72,"type":22},[74],"This phase II trial studies the effects of hyperthermic intraperitoneal chemotherapy (HIPEC) in treating patients with pancreatic cancer that has spread to the internal abdominal area (peritoneal metastasis). Chemotherapy drugs, such as nab-paclitaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. HIPEC involves \"heated\" chemotherapy that is placed directly in the abdomen through laparoscopic instruments, instead of through an intravenous injection. This study may help doctors determine how safe and effective HIPEC work in treating patient with pancreatic cancer.",[124,125,34],"Metastatic Pancreatic Carcinoma","Stage IV Pancreatic Cancer AJCC v8","2025-12-10",{"date":128,"type":53},"2025-12-16",{"date":130,"type":53},"2024-02-15",{"date":132,"type":22},"2029-07",{"name":87,"class":60},{"id":135,"slug":136,"hasResults":11,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":4,"eligibilityCriteria":140,"healthyVolunteers":11,"sex":69,"minAge":18,"maxAge":4,"enrollmentInfo":141,"targetDuration":4,"studyType":23,"phases":143,"briefSummary":144,"conditions":145,"keywords":4,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":176},"100387804","phase-1-pipac-for-the-treatment-of-peritoneal-carcinomatosis-in-patients-with-ovarian-uterine-appendiceal-colorectal-or-gastric-cancer-100387804","NCT04329494","PIPAC for the Treatment of Peritoneal Carcinomatosis in Patients With Ovarian, Uterine, Appendiceal, Colorectal, or Gastric Cancer","Safety and Efficacy of Pressurized Intraperitoneal Aerosolized Chemotherapy (PIPAC) in Ovarian, Uterine, Appendiceal, Colorectal, and Gastric Cancer Patients With Peritoneal Carcinomatosis (PC)","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n* Patients must have histologically confirmed ovarian, uterine, gastric, appendiceal or colorectal cancer with PC\n* Prior IP chemotherapy is permitted\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) =\\\u003C 2\n* Absolute neutrophil count (ANC) \\>= 1500\u002Fmm\\^3\n* Platelets \\>= 100,000\u002Fmm\\^3\n* Hemoglobin \\>= 9 g\u002Fdl\n* Serum total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN)\n* Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) and aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\]) =\\\u003C 2.5 x ULN, unless liver metastases (Arm 1) are present or unless patients is know to have chronic liver disease (hepatitis) in which case AST and ALT must be =\\\u003C 5 x ULN\n* Alkaline phosphatase =\\\u003C 2 x ULN\n* Serum creatinine (sCr) =\\\u003C 1.5 x ULN, or creatinine clearance (Ccr) \\>= 40 ml\u002Fmin as calculated by the Cockcroft-Gault formula\n* No contraindications for a laparoscopy\n* The peritoneal disease does not have to be measurable by RECIST 1.1 but needs to be visible on cross sectional imaging or diagnostic laparoscopy\n* Patients must have progressed on at least one evidence-based chemotherapeutic regimen (Arm 1 and 2). For Arm 3, patients should have stable or responsive disease on at least 4 months first-line systemic chemotherapy\n* For patients with a known history of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a known history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Women of childbearing potential (WOCBP) and male patients with WOCBP partner must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 12 weeks after the last dose of investigational product in such a manner that the risk of pregnancy is minimized. WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal. Post menopause is define as:\n\n  * Amenorrhea \\>= 12 consecutive months without another cause or\n  * For women with irregular menstrual periods and on hormone replacement therapy (HRT), a documented serum follicle stimulating hormone (FSH) level \\> 35 mIU\u002FmL\n  * Women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (e.g., vasectomy) should be considered to be of childbearing potential\n* INCLUSION TO PROCEED WITH PIPAC: Laparoscopy findings must meet all of the below criteria in order to proceed to PIPAC:\n\n  * PIPAC access is feasible\n  * There is room for aerosol therapy\n  * There is no evidence of impending bowel obstruction\n  * =\\\u003C 5 L of ascites\n  * Not a candidate for cytoreduction and HIPEC\n\nExclusion Criteria:\n\n* Gastric and colorectal\u002Fappendiceal:\n\n  * Extra-peritoneal metastatic disease\n* Arm 1 (ovarian, uterine, gastric): Previous treatment with maximum cumulative doses of doxorubicin, daunorubicin, epirubicin, idarubicin, and\u002For other anthracyclines and anthracenediones\n* Arm 2 (colorectal\u002Fappendiceal): Known dihydropyrimidine dehydrogenase deficiency (DPD) deficiency\n* Arm 2 (colorectal\u002Fappendiceal): Bowel obstruction requiring nasogastric tube, percutaneous endoscopic gastrostomy or exclusive total parenteral nutrition\n* Arm 2 (colorectal\u002Fappendiceal): Prior unanticipated severe reaction or hypersensitivity to platinum based compounds\n* Arm 2 (colorectal\u002Fappendiceal): Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1), with the exception of alopecia, hearing loss, or non-clinically significant laboratory abnormalities. Grade 2 peripheral neuropathy is permitted\n* Arm 2 (colorectal\u002Fappendiceal): Life expectancy of less than 6 months\n* Arm 2 (colorectal\u002Fappendiceal): Chemotherapy or surgery within the last 4 weeks prior to enrollment (6 weeks for prior bevacizumab therapy). Five half-lives for other anti-cancer agents\n* Arm 2 (colorectal\u002Fappendiceal): Previous anaphylactic reaction to the chemotherapy drug used\n* Arm 2 (colorectal\u002Fappendiceal): Patients may not be receiving any other investigational or concurrent anti-cancer agents\n* Arm 2 (colorectal\u002Fappendiceal): Ascites due to decompensated liver cirrhosis; portal vein thrombosis\n* Arm 2 (colorectal\u002Fappendiceal): Simultaneous tumor debulking with gastrointestinal resection\n* Arm 2 (colorectal\u002Fappendiceal): Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, severe myocardial insufficiency, recent myocardial infarction, severe arrhythmias, severe renal impairment, myelosuppression, or severe hepatic impairment\n* Arm 2 (colorectal\u002Fappendiceal): Immunocompromised patients such as those with an immunosuppressive medication or a known disease of the immune system\n* Arm 2 (colorectal\u002Fappendiceal): Involvement in the planning and conduct of the study\n* Arm 2 (colorectal\u002Fappendiceal): Pregnancy\n* Arm 2 (colorectal\u002Fappendiceal): Patients with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Arm 2 (colorectal\u002Fappendiceal): New York Heart Association (NYHA) class 3 or 4; myocardial infarction, acute coronary syndrome, diabetes mellitus with ketoacidosis or chronic obstructive pulmonary disease (COPD) requiring hospitalization in the preceding 6 months\n* Arm 2 (colorectal\u002Fappendiceal): Major systemic infection requiring antibiotics 72 hours or less prior to the first dose of study drug\n* Arm 2 (colorectal\u002Fappendiceal): Exclusive total parenteral nutrition\n* Arm 2 (colorectal\u002Fappendiceal): Prior intra-abdominal aerosol chemotherapy\n* Arm 3 (colorectal\u002Fappendiceal): Progression on first- AND second-line systemic therapy\n* Arm 3 (colorectal\u002Fappendiceal): Hematologic toxicities requiring significant dose reductions while on systemic chemotherapy\n* Arm 3 (colorectal\u002Fappendiceal): Intolerance to prior 5-FU at 2400mg\u002Fm\\^2 IV every 2 weeks or to irinotecan at 180mg\u002Fm\\^2. Intolerance is defined as the need of significant dose reduction or treatment interruption of \\> 1 week due to toxicity\n* Arm 3 (colorectal\u002Fappendiceal): Known DPD deficiency\n* Arm 3 (colorectal\u002Fappendiceal): Bowel obstruction requiring nasogastric tube, percutaneous endoscopic gastrostomy or exclusive total parenteral nutrition\n* Arm 3 (colorectal\u002Fappendiceal): Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1), with the exception of alopecia, hearing loss, or non-clinically significant laboratory abnormalities. Grade 2 peripheral neuropathy is permitted\n* Arm 3 (colorectal\u002Fappendiceal): Life expectancy of less than 6 months\n* Arm 3 (colorectal\u002Fappendiceal): Chemotherapy or surgery within the last 2 weeks prior to enrollment (6 weeks for prior bevacizumab therapy). Five half-lives for other anti-cancer agents\n* Arm 3 (colorectal\u002Fappendiceal): Previous anaphylactic reaction to the chemotherapy drug used\n* Arm 3 (colorectal\u002Fappendiceal): Patients may not be receiving any other investigational anti-cancer agents\n* Arm 3 (colorectal\u002Fappendiceal): Ascites due to decompensated liver cirrhosis; portal vein thrombosis\n* Arm 3 (colorectal\u002Fappendiceal): Simultaneous tumor debulking with gastrointestinal resection\n* Arm 3 (colorectal\u002Fappendiceal): Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, severe myocardial insufficiency, recent myocardial infarction, severe arrhythmias, severe renal impairment, myelosuppression, or severe hepatic impairment\n* Arm 3 (colorectal\u002Fappendiceal): Immunocompromised patients such as those with an immunosuppressive medication or a known disease of the immune system\n* Arm 3 (colorectal\u002Fappendiceal): Involvement in the planning and conduct of the study\n* Arm 3 (colorectal\u002Fappendiceal): Pregnancy\n* Arm 3 (colorectal\u002Fappendiceal): Patients with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Arm 3 (colorectal\u002Fappendiceal): New York Heart Association (NYHA) class 3 or 4; myocardial infarction, acute coronary syndrome, diabetes mellitus with ketoacidosis or chronic obstructive pulmonary disease (COPD) requiring hospitalization in the preceding 6 months\n* Arm 3 (colorectal\u002Fappendiceal): Major systemic infection requiring antibiotics 72 hours or less prior to the first dose of study drug\n* Arm 3 (colorectal\u002Fappendiceal): Exclusive total parenteral nutrition\n* Arm 3 (colorectal\u002Fappendiceal): Prior intra-abdominal aerosol chemotherapy",{"count":142,"type":22},49,[25],"This phase I trial studies the side effects of pressurized intraperitoneal aerosol chemotherapy (PIPAC) in treating patients with ovarian, uterine, appendiceal, stomach (gastric), or colorectal cancer that has spread to the lining of the abdominal cavity (peritoneal carcinomatosis). Chemotherapy drugs, such as cisplatin, doxorubicin, oxaliplatin, leucovorin, fluorouracil, mitomycin, and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. PIPAC is a minimally invasive procedure that involves the administration of intraperitoneal chemotherapy. The study device consists of a nebulizer (a device that turns liquids into a fine mist), which is connected to a high-pressure injector, and inserted into the abdomen (part of the body that contains the digestive organs) during a laparoscopic procedure (a surgery using small incisions to introduce air and to insert a camera and other instruments in the abdominal cavity for diagnosis and\u002For to perform routine surgical procedures). Pressurization of the liquid chemotherapy through the study device results in aerosolization (a fine mist or spray) of the chemotherapy intra-abdominally (into the abdomen). Giving chemotherapy through PIPAC may reduce the amount of chemotherapy needed to achieve acceptable drug concentration, and therefore potentially reduces side effects and toxicities.",[146,147,148,149,150,101,151,34,152,28,153,29,154,155,102,156,157,158,159,160,161,162,163,164,165,166,167],"Clinical Stage IV Gastric Cancer AJCC v8","Clinical Stage IVA Gastric Cancer AJCC v8","Clinical Stage IVB Gastric Cancer AJCC v8","Malignant Uterine Neoplasm","Metastatic Appendix Carcinoma","Metastatic Gastric Carcinoma","Metastatic Malignant Solid Neoplasm","Pathologic Stage IV Gastric Cancer AJCC v8","Postneoadjuvant Therapy Stage IV Gastric Cancer AJCC v8","Stage IV Appendix Carcinoma AJCC v8","Stage IV Ovarian Cancer AJCC v8","Stage IV Uterine Corpus Cancer AJCC v8","Stage IVA Appendix Carcinoma AJCC v8","Stage IVA Colorectal Cancer AJCC v8","Stage IVA Ovarian Cancer AJCC v8","Stage IVA Uterine Corpus Cancer AJCC v8","Stage IVB Appendix Carcinoma AJCC v8","Stage IVB Colorectal Cancer AJCC v8","Stage IVB Ovarian Cancer AJCC v8","Stage IVB Uterine Corpus Cancer AJCC v8","Stage IVC Appendix Carcinoma AJCC v8","Stage IVC Colorectal Cancer AJCC v8","2025-12-03",{"date":126,"type":53},{"date":171,"type":53},"2020-08-21",{"date":173,"type":22},"2028-01-05",{"name":175,"class":60},"City of Hope Medical Center",3,{"id":178,"slug":179,"hasResults":11,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":4,"eligibilityCriteria":183,"healthyVolunteers":11,"sex":69,"minAge":18,"maxAge":4,"enrollmentInfo":184,"targetDuration":4,"studyType":23,"phases":186,"briefSummary":188,"conditions":189,"keywords":4,"overallStatus":191,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":200},"100613804","phase-3-pressurized-intraperitoneal-aerosolized-chemotherapy-with-mitomycin-for-the-treatment-of-unresectable-appendix-or-colorectal-cancer-with-peritoneal-metastases-the-impact-trial-100613804","NCT07271355","Pressurized Intraperitoneal Aerosolized Chemotherapy With Mitomycin for the Treatment of Unresectable Appendix or Colorectal Cancer With Peritoneal Metastases, The IMPACT Trial","Investigation of Mitomycin C PIPAC - FOLFIRI Combination for Unresectable Appendiceal or Colorectal Peritoneal Metastases Treatment (IMPACT): A Multicenter, Randomized, Open-Label, Phase 3 Trial","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* Agreement to allow the use of archival tissue from diagnostic tumor biopsies\n\n  * If unavailable, exceptions may be granted with study principal investigator (PI) approval\n* Age: ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Histologically or cytologically confirmed appendiceal or colorectal cancer peritoneal metastases\n* No extraperitoneal metastases except lung ≤ 5 lesions with largest ≤ 1cm as identified on CT imaging or MRI. CT scan or MRI to assess measurable disease must have been completed within 28 days prior to registration\n* Visible peritoneal metastatic disease on cross-sectional imaging or diagnostic laparoscopy (does not have to be measurable by RECIST (v1.1)\n* Completed at least 4 months (8 cycles) of first-line standard-of-care oxaliplatin-based systemic therapy without progression of disease. Or completed less than 4 months of oxaliplatin based therapy due to intolerance and without progressive disease. Or progressed on first-line standard-of-care oxaliplatin-based systemic therapy. Permissible first-line systemic therapies include leucovorin calcium, fluorouracil, and oxaliplatin (FOLFOX) or capecitabine and oxaliplatin (XELOX) or fluorouracil, leucovorin, oxaliplatin and irinotecan (FOLFOXIRI). Receipt of anti-EGFR, anti-VEGF, or anti-BRAF therapy in the first-line is acceptable. Mismatch repair-deficient patients are permissible if they have progressed on first-line immunotherapy\n* Not a candidate for cytoreductive surgery as determined by site investigator\n* Fully recovered from the acute toxic effects of prior anti-cancer therapy to Common Terminology Criteria for Adverse Events (CTCAE) grade 1 or lower except alopecia, hearing loss, neuropathy, or non-clinically significant laboratory abnormalities\n* Complete medical history and physical exam (To be performed within 28 days prior to Day 1 of protocol therapy)\n* Absolute neutrophil count (ANC) ≥ 1,500\u002FmcL (To be performed within 28 days prior to Day 1 of protocol therapy)\n* Platelets ≥ 100,000\u002FmcL (To be performed within 28 days prior to Day 1 of protocol therapy)\n* Hemoglobin ≥ 8 g\u002FdL (To be performed within 28 days prior to Day 1 of protocol therapy)\n* Serum albumin ≥ 2.8 g\u002FdL (To be performed within 28 days prior to Day 1 of protocol therapy)\n* Total bilirubin ≤ 1.5 X upper limit of normal (ULN) (unless has Gilbert's disease, then direct bilirubin \\\u003C 1.5 mg\u002FdL) (To be performed within 28 days prior to Day 1 of protocol therapy)\n* Aspartate aminotransferase (AST) ≤ 5 x ULN (To be performed within 28 days prior to Day 1 of protocol therapy)\n* Alanine aminotransferase (ALT) ≤ 5 x ULN (To be performed within 28 days prior to Day 1 of protocol therapy)\n* Calculated creatinine clearance of ≥ 45 mL\u002Fmin per 24-hour urine test or the Cockcroft-Gault formula (To be performed within 28 days prior to Day 1 of protocol therapy)\n* Women of childbearing potential (WOCBP): Negative urine or serum pregnancy test (To be performed within 28 days prior to Day 1 of protocol therapy)\n\n  * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Agreement by females and males of childbearing potential to use an effective method of birth control (e.g. licensed hormonal\u002Fbarrier methods or surgery intended to prevent pregnancy \\[or with a side effect of pregnancy prevention\\]) or abstain from heterosexual activity for the course of the study through at least 14 months after the last dose of protocol therapy\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only)\n* CROSS-OVER ARM INCLUSION: Documented informed consent of the participant and\u002For legally authorized representative\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* CROSS-OVER ARM INCLUSION: Agreement to allow the use of archival tissue from diagnostic tumor biopsies\n\n  * If unavailable, exceptions may be granted with Study PI approval\n* CROSS-OVER ARM INCLUSION: Age: ≥ 18 years\n* CROSS-OVER ARM INCLUSION: ECOG performance status of 0 or 1\n* CROSS-OVER ARM INCLUSION: No extraperitoneal metastases except lung ≤ 5 lesions with largest ≤ 1cm as identified on CT imaging or MRI. CT scan or MRI to assess measurable disease must have been completed within 28 days prior to registration\n* CROSS-OVER ARM INCLUSION: Progression on Control Arm of the Study as determined by RECIST v1.1. Non-radiographic progression will need to be assessed on a case-by-case basis by central review\n* CROSS-OVER ARM INCLUSION: Fully recovered from the acute toxic effects of prior anti-cancer therapy to CTCAE grade 1 or lower except alopecia, hearing loss, neuropathy, or non-clinically significant laboratory abnormalities\n* CROSS-OVER ARM INCLUSION: Complete medical history and physical exam (To be performed within 28 days prior to Day 1 of protocol therapy)\n* CROSS-OVER ARM INCLUSION: ANC ≥ 1,500\u002FmcL (To be performed within 28 days prior to Day 1 of protocol therapy)\n* CROSS-OVER ARM INCLUSION: Platelets ≥ 100,000\u002FmcL (To be performed within 28 days prior to Day 1 of protocol therapy)\n* CROSS-OVER ARM INCLUSION: Hemoglobin ≥ 8 g\u002FdL (To be performed within 28 days prior to Day 1 of protocol therapy)\n* CROSS-OVER ARM INCLUSION: Serum albumin ≥ 2.8 g\u002FdL (To be performed within 28 days prior to Day 1 of protocol therapy)\n* CROSS-OVER ARM INCLUSION: Total bilirubin ≤ 1.5 X ULN (unless has Gilbert's disease, then direct bilirubin \\\u003C1.5 mg\u002FdL) (To be performed within 28 days prior to Day 1 of protocol therapy)\n* CROSS-OVER ARM INCLUSION: AST ≤ 5 x ULN (To be performed within 28 days prior to Day 1 of protocol therapy)\n* CROSS-OVER ARM INCLUSION: ALT ≤ 5 x ULN (To be performed within 28 days prior to Day 1 of protocol therapy)\n* CROSS-OVER ARM INCLUSION: Calculated creatinine clearance of ≥ 45 mL\u002Fmin per 24-hour urine test or the Cockcroft-Gault formula (To be performed within 28 days prior to Day 1 of protocol therapy)\n* CROSS-OVER ARM INCLUSION: Women of childbearing potential (WOCBP): negative urine or serum pregnancy test (To be performed within 28 days prior to Day 1 of protocol therapy)\n\n  * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* CROSS-OVER ARM INCLUSION: Agreement by females and males of childbearing potential to use an effective method of birth control (e.g. licensed hormonal\u002Fbarrier methods or surgery intended to prevent pregnancy \\[or with a side effect of pregnancy prevention\\]) or abstain from heterosexual activity for the course of the study through at least 14 months after the last dose of protocol therapy\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only)\n\nExclusion Criteria:\n\n* More than 8 cycles of first line irinotecan therapy\n* Progression on irinotecan\n* Receipt of any second-line systemic chemotherapy (Note: Sequential administration of FOLFOX followed by FOLFIRI is considered second line therapy. However, FOLFOXIRI followed by FOLFIRI is considered first line as long as no more than 8 cycles of irinotecan are given)\n* Any concurrent chemotherapy, investigational product, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable\n* Strong CYP3A4 inducers\u002Finhibitors within 14 days prior to Day 1 of protocol therapy\n* Prior peritoneal-directed chemotherapy (Prior cytoreductive surgery is permitted)\n* Participation in another clinical study with an investigational product administered in the last 2 months\n* Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study\n* Low-grade appendiceal mucinous neoplasm or low-grade appendiceal mucinous adenocarcinoma\n* Extraperitoneal metastases (except lung ≤ 5 lesions with largest being ≤ 1cm)\n* Any history of bowel obstruction requiring nasogastric tube, percutaneous endoscopic gastrostomy, or need for total parenteral nutrition. Even if the bowel obstruction resolved with conservative measures, the patient would be excluded. The exception is if the bowel obstruction was surgically addressed with ostomy, resection or bypass. This exception should be documented\n* Fused mesenteric disease-causing mesenteric shortening and bowel sequestration (\"cauliflowering\")\n* Bulky mesenteric disease where chemotherapy is unlikely to penetrate the tumor\n* Contraindication to laparoscopy\n* Rapid weight loss (\\> 10% in \\\u003C 3 months)\n* Ascites (\\> 2L drained per month)\n* Adhesions involving \\> 50% of abdominal cavity on diagnostic laparoscopy\n* Life expectancy \\\u003C 6 months\n* Treatment with therapeutic oral or IV antibiotics within 14 days prior to Day 1 Cycle 1 of treatment\n\n  * Patients receiving prophylactic antibiotics are eligible, provided the signs of active infection have resolved\n* Any prior malignancy except adequately treated basal or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for two years\n* History of allergic or hypersensitivity reactions attributed to compounds of similar chemical or biologic composition to study agents (platinum-based compounds, etc.)\n* History of allogeneic organ transplantation or other active primary immunodeficiency\n* Active and uncontrolled infection, including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice), or human immunodeficiency virus (positive HIV 1\u002F2 antibodies)\n* Clinically significant uncontrolled illness, including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, active interstitial lung disease (ILD), serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirement, substantially increase the risk of incurring AEs, or compromise the ability of the patient to give written informed consent\n* Females only: Pregnant or breastfeeding\n* Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)\n* CROSS-OVER ARM EXCLUSION: Any concurrent chemotherapy, investigational product, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable\n* CROSS-OVER ARM EXCLUSION: Strong CYP3A4 inducers\u002Finhibitors within 14 days prior to Day 1 of protocol therapy\n* CROSS-OVER ARM EXCLUSION: Participation in another clinical study with an investigational product administered in the last 2 months other than the current study\n* CROSS-OVER ARM EXCLUSION: Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study\n* CROSS-OVER ARM EXCLUSION: Extraperitoneal metastases (except lung ≤ 5 lesions with largest being ≤ 1cm)\n* CROSS-OVER ARM EXCLUSION: Any history of bowel obstruction requiring nasogastric tube, percutaneous endoscopic gastrostomy, or need for total parenteral nutrition. Even if the bowel obstruction resolved with conservative measures, the patient would be excluded. The exception is if the bowel obstruction was surgically addressed with ostomy, resection or bypass. This exception should be documented\n* CROSS-OVER ARM EXCLUSION: Fused or bulky mesenteric disease-causing mesenteric shortening and bowel sequestration\n* CROSS-OVER ARM EXCLUSION: Contraindication to laparoscopy\n* CROSS-OVER ARM EXCLUSION: Rapid weight loss (\\> 10% in \\\u003C 3 months)\n* CROSS-OVER ARM EXCLUSION: Ascites (\\> 2L drained per month)\n* CROSS-OVER ARM EXCLUSION: Adhesions involving \\> 50% of abdominal cavity on diagnostic laparoscopy\n* CROSS-OVER ARM EXCLUSION: Life expectancy \\\u003C 6 months\n* CROSS-OVER ARM EXCLUSION: Treatment with therapeutic oral or IV antibiotics within 14 days prior to Day 1 Cycle 1 of treatment\n\n  * Patients receiving prophylactic antibiotics are eligible, provided the signs of active infection have resolved",{"count":185,"type":22},129,[187],"PHASE3","This phase III trial studies how well pressurized intraperitoneal aerosolized chemotherapy (PIPAC) with mitomycin works versus (vs) standard chemotherapy (leucovorin calcium, fluorouracil, and irinotecan hydrochloride \\[FOLFIRI regimen\\] plus bevacizumab) in treating patients with appendix or colorectal cancer that cannot be removed by surgery (unresectable) and has spread from where it first started (primary site) to the abdominal cavity (peritoneal metastases). PIPAC is a new therapeutic approach that is minimally invasive, does not require surgery (laparotomy), and can be frequently repeated. Chemotherapy is delivered as a pressurized mist directly inside the abdominal cavity (peritoneum) during a minimally invasive surgery called a laparoscopy. The pressure helps the chemotherapy absorb into the cancer tissue and spread more evenly. Mitomycin is an antibiotic used as a chemotherapy drug. It stops or slows the growth of cancer cells and other rapidly growing cells by damaging their deoxyribonucleic acid (DNA). Standard chemotherapy drugs, such as those in the FOLFIRI regimen, are given via infusion into a vein (intravenously), and work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Another standard intravenous drug, bevacizumab, is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Giving mitomycin via PIPAC in combination with the standard FOLFIRI regimen, with or without bevacizumab, may work better than standard FOLFIRI plus bevacizumab alone in treating patients with unresectable appendix or colorectal cancer with peritoneal metastases.",[150,101,34,155,167,190],"Unresectable Colorectal Carcinoma","NOT_YET_RECRUITING","2025-11-28",{"date":194,"type":53},"2025-12-09",{"date":196,"type":22},"2026-07-01",{"date":198,"type":22},"2031-02-28",{"name":175,"class":60},5,{"id":202,"slug":203,"hasResults":11,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":4,"eligibilityCriteria":207,"healthyVolunteers":11,"sex":69,"minAge":18,"maxAge":4,"enrollmentInfo":208,"targetDuration":4,"studyType":23,"phases":210,"briefSummary":211,"conditions":212,"keywords":4,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":215,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":88},"100567971","phase-1-nab-paclitaxel-pipac-in-combination-with-paclitaxel-and-ramucirumab-for-the-treatment-of-stomach-cancer-with-peritoneal-metastases-100567971","NCT06675136","Nab-Paclitaxel PIPAC in Combination With Paclitaxel and Ramucirumab for the Treatment of Stomach Cancer With Peritoneal Metastases","Phase 1 Trial of Nab-Paclitaxel PIPAC (Pressurized Intraperitoneal Aerosolized Chemotherapy) Given in Combination With Second-Line Therapy for Gastric Cancer With Peritoneal Metastases","Inclusion Criteria:\n\n* Patients must have failed first-line systemic therapy (fluorouracil, leucovorin calcium, oxaliplatin \\[FOLFOX\\] with or without immunotherapy, or other fluoropyrimidine and platinum-based therapy)\n\n  * Prior immunotherapy allowed\n  * Up to 4 cycles of second-line therapy allowed if no progression is documented\n* Documented informed consent of the participant and\u002For legally authorized representative\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* Agreement to allow the use of archival tissue from diagnostic tumor biopsies\n\n  * If unavailable, exceptions may be granted with study principal investigator (PI) approval\n* Age: ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Histologically or cytologically confirmed gastric adenocarcinoma\n* Visible peritoneal metastatic disease on cross-sectional imaging or diagnostic laparoscopy (does not have to be measurable by RECIST 1.1)\n* Fully recovered from acute toxic effects (except alopecia, hearing loss, or non-clinically significant laboratory abnormalities) ≤ grade 1 of prior anti-cancer therapy\n* The patient's urinary protein is ≤ 1+ on dipstick or routine urinalysis. If urine dipstick or routine analysis indicates proteinuria ≥ 2+, then a 24-hour urine must be collected and must demonstrate \\\u003C 1000mg protein in 24 hours\n* Complete medical history and physical exam (within 28 days prior to day 1 of protocol therapy)\n* Absolute neutrophil count (ANC) ≥ 1,500\u002FmcL (within 28 days prior to day 1 of protocol therapy)\n* Platelets ≥ 100,000\u002FmcL (within 28 days prior to day 1 of protocol therapy)\n* Hemoglobin ≥ 8 g\u002FdL (within 28 days prior to day 1 of protocol therapy)\n* Serum albumin ≥ 2.8 g\u002FdL (within 28 days prior to day 1 of protocol therapy)\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (unless has Gilbert's disease, then direct bilirubin \\\u003C 1.5 mg\u002FdL) (within 28 days prior to day 1 of protocol therapy)\n* Aspartate aminotransferase (AST) ≤ 5 x ULN (within 28 days prior to day 1 of protocol therapy)\n* Alanine aminotransferase (ALT) ≤ 5 x ULN (within 28 days prior to day 1 of protocol therapy)\n* International normalized ratio (INR) ≤ 1.5 x ULN (within 28 days prior to day 1 of protocol therapy)\n* Prothrombin time (PT) ≤ 1.5 x ULN (within 28 days prior to day 1 of protocol therapy)\n* Partial thromboplastin time (PTT) ≤ 1.5 x ULN (within 28 days prior to day 1 of protocol therapy)\n* Calculated creatinine clearance of ≥ 45 mL\u002Fmin per 24 hour urine test or the Cockcroft-Gault formula (within 28 days prior to day 1 of protocol therapy)\n* Seronegative for HIV antigen (Ag)\u002Fantibody (Ab) combo (within 28 days prior to day 1 of protocol therapy)\n\n  * If seropositive, patient may be eligible if they are stable on antiretroviral therapy, have a CD4 T cell count ≥ 200\u002FµL, and have an undetectable viral load\n* Documented virology status of hepatitis, confirmed by hepatitis B virus (HBV) and hepatitis C virus (HCV) tests (within 28 days prior to day 1 of protocol therapy)\n\n  * For patients with active HBV, HBV deoxyribonucleic acid (DNA) \\\u003C 500 IU\u002FmL during screening, initiation of anti-HBV treatment at least 14 days prior to day 1 of cycle 1, and willingness to continue anti-HBV treatment during the study (per standard of care)\n  * If seropositive for HCV, nucleic acid quantification must be performed. Viral load must be undetectable\n* WOMEN OF CHILDBEARING POTENTIAL (WOCBP): Negative urine or serum pregnancy test (within 28 days prior to day 1 of protocol therapy)\n\n  * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Agreement by females and males of childbearing potential to use an effective method of birth control (e.g., licensed hormonal\u002Fbarrier methods or surgery intended to prevent pregnancy \\[or with a side effect of pregnancy prevention\\]) or abstain from heterosexual activity for the course of the study through at least 14 months after the last dose of protocol therapy.\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only)\n\nExclusion Criteria:\n\n* Intolerance to taxanes\n* Bowel obstruction requiring exclusive total parenteral nutrition\n* Any history of, or current, brain or subdural metastases\n* Life expectancy \\\u003C 3 months\n* Treatment with therapeutic oral or IV antibiotics within 14 days prior to day 1 cycle 1 of treatment\n\n  * Patients receiving prophylactic antibiotics are eligible, provided the signs of active infection have resolved\n* Any prior malignancy except adequately treated basal or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for two years\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agents (taxanes, etc.)\n* Clinically significant uncontrolled illness such as uncontrolled hypertension (HTN)\n* History of arterial thromboembolic events such as myocardial infarction (MI), cerebrovascular accident (CVA)\n* History of gastrointestinal (GI) perforation\n* FEMALES ONLY: Pregnant or breastfeeding\n* Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)",{"count":209,"type":22},30,[25],"This phase I trial tests the safety, side effects and best dose of nab-paclitaxel pressurized intraperitoneal aerosolized chemotherapy (PIPAC) in combination with second-line chemotherapy, paclitaxel and ramucirumab, and tests how well they work in treating stomach cancer that has spread from where it first started to the tissue that lines the abdominal wall and organs (peritoneal metastases). Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Nab-paclitaxel is an albumin-stabilized nanoparticle formulation of paclitaxel which may have fewer side effects and work better than other forms of paclitaxel. PIPAC delivers chemotherapy, such as nab-paclitaxel, that has been turned into a fine mist (aerosolized) at a high pressure directly into the abdominal cavity. Aerosolized chemotherapy delivered directly into the peritoneal space has been shown to deliver higher drug concentrations to the tumor. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Giving nab-paclitaxel PIPAC in combination with paclitaxel and ramucirumab may be safe, tolerable, and\u002For effective in treating gastric cancer patients with peritoneal metastases.",[148,213,34],"Metastatic Gastric Adenocarcinoma","2025-11-06",{"date":216,"type":53},"2025-11-10",{"date":218,"type":53},"2025-10-29",{"date":220,"type":22},"2029-01-14",{"name":175,"class":60}]