[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"peritoneal-carcinomatosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:peritoneal-carcinomatosis":30},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,30,0,25,[9,49,88,120,142,166,208,235,264,288,316,346,376,409,429,455,493,521,567,587,624,648,680,708,730],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100054242","phase-2-docetaxel-oxaliplatin-and-5-fu-for-gastric-cancer-with-inoperable-malignant-bowel-obstruction-100054242",false,"NCT04840264","Docetaxel, Oxaliplatin and 5-FU for Gastric Cancer With Inoperable Malignant Bowel Obstruction","A Multi-center, Non-randomized, Three-cohort, Phase II Trial of a Modified Triplet Combination of Docetaxel, Oxaliplatin and Fluorouracil for Gastric Cancer With Peritoneal Carcinomatosis and Inoperable Malignant Bowel Obstruction","Inclusion Criteria:\n\n* 18-75 years of age;\n* ECOG PS ≤3;\n* pathologically diagnosed gastric or gastroesophageal junctional adenocarcinoma;\n* peritoneal carcinomatosis established by imaging data or pathological evidence;\n* MBO below the Treitz ligament based on clinical grounds or radiological findings;\n* considered as inoperable MBO by two independent surgical consultants;\n* Hb≥60g\u002FL, WBC ≥4×10E9\u002FL, ANC≥2×10E9\u002FL，PLT≥100×10E9\u002FL;\n* Cr≤ Upper Normal Limit(UNL);\n* Tbil≤1.5 UNL,AST≤1.5 UNL, ALT≤1.5 UNL, ALP≤1.5 UNL;\n* Written informed consent form paticipants.\n\nExclusion Criteria:\n\n* treated by a combination regimen containing all the study drugs;\n* allergy to any of the study drugs;\n* HER-2 amplification or overexpression, mismatch repair protein expression deletion (dMMR), or genetic testing suggestive of high microsatellite instability (MSI-H);\n* strangulated intestinal obstruction;\n* active gastrointestinal bleeding;\n* uncontrolled active infection;\n* unstable heart diseases with severe ECG abnormalities or affect clinical treatment (such as cardiac insufficiency, myocardial infarction, angina);\n* severe lung diseases (such as interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc);\n* mental disorders that affect clinical treatment or central nervous system diseases;\n* concomitant cerebral parenchymal or meningeal metastasis;\n* HIV infection or untreated active hepatitis;\n* bowel surgery or stenting required due to obstruction;\n* pregnant or lactating women;\n* other conditions that are not suitable for participation in the study.","ALL","18 Years","75 Years",{"count":21,"type":22},79,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This is a multi-center, non-randomized, 3-cohort, phase II trial, evaluating a triplet combination of docetaxel, oxaliplatin and fluorouracil for gastric cancer with peritoneal carcinomatosis and inoperable malignant bowel obstruction.",[28,29,30],"Metastatic Gastric Adenocarcinoma","Metastatic Gastroesophageal Junction Adenocarcinoma","Peritoneal Carcinomatosis",[32,33,34,35],"Malignant Bowel Obstruction","Docetaxel","Oxaliplatin","Fluorouracil","RECRUITING","2026-07-09",{"date":39,"type":40},"2026-07-13","ACTUAL",{"date":42,"type":40},"2022-01-07",{"date":44,"type":22},"2028-06-30",{"name":46,"class":47},"Sixth Affiliated Hospital, Sun Yat-sen University","OTHER",1,{"id":50,"slug":51,"hasResults":12,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":59,"briefSummary":61,"conditions":62,"keywords":69,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":48},"100427519","phase-1-individual-response-to-hyperthermic-intraperitoneal-chemotherapy-hipec-treatment-of-peritoneal-carcinomatosis-from-peritoneal-mesothelioma-or-atypical-mesothelial-proliferation-or-from-ovarian-colorectal-or-appendiceal-histologies-100427519","NCT04847063","Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Histologies","Individualized Response Assessment to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for the Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Primaries","* INCLUSION CRITERIA:\n* Confirmation of peritoneal carcinomatosis from peritoneal mesothelioma or atypical mesothelial proliferation, or from appendiceal, colorectal, or ovarian, histologies by the Laboratory of Pathology, NCI.\n* Measurable or evaluable disease as defined by RECIST v1.1. criteria and\u002For by peritoneal carcinomatosis index (PCI) score.\n* Participants must be assessed to be able to undergo optimal cytoreduction (i.e., completeness of cytoreduction score of 1 or 0) with laparoscopically assessed PCI score threshold as indicated below:\n\n  * Primary Histology: Appendiceal\u002FColorectal\u002FOvarian \u002F PCI Cutoff for Eligibility: Total Score \\\u003C 20 (out of 39 possible points)\n  * Primary Histology: Mesothelioma or atypical mesothelial proliferation \u002F PCI Cutoff for Eligibility: Total Score \\\u003C= 30 (out of 39 possible points)\n* Age \\>= 18 years.\n* ECOG performance status \\\u003C= 1 (Karnofsky \\>= 80%).\n* Participants must have adequate organ and marrow function as defined below:\n\n  * Absolute neutrophil count \\>= 1,000\u002FmcL\n  * Platelets \\>= 75,000\u002FmcL\n  * Total bilirubin within \\\u003C=1.5x institutional upper limit of normal (ULN)\n  * AST (SGOT)\u002F ALT (SGPT) \\\u003C= 3x institutional upper limit of normal (ULN), or \\\u003C= 5.0x ULN in participants with liver metastases (only)\n  * Creatinine within normal institutional limits\n\nOR\n\n--Creatinine clearance \\>= 60 mL\u002Fmin\u002F1.73 m\\^2 for participants with creatinine levels above institutional normal calculated using eGFR.\n\n* Because therapeutic agents used in this trial are known to be teratogenic, individuals of child-bearing potential (IOCBP) and individuals who are able to father a child must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for 180 days after last study treatment.\n* Ability of participant to understand and the willingness to sign a written informed consent document.\n* Ability and willingness of the participant to co-enroll on the tissue collection protocol 13C0176, Tumor, Normal Tissue and Specimens from Patients Undergoing Evaluation or Surgical Resection of Solid Tumors .\n\nEXCLUSION CRITERIA:\n\n* Participants with known extra-abdominal metastatic disease from the participant s appendiceal, colorectal, ovarian, or peritoneal mesothelioma primary.\n* Participants who have received intraperitoneal chemotherapy or other anti-cancer therapy within the last 4 weeks prior to the start of study treatment.\n* Participants who have undergone major surgery within the last 12 weeks prior to the start of study treatment.\n* History of allergic reactions attributed to platinum-containing compounds.\n* History of dihydropyrimidine dehydrogenase deficiency (only participants with appendiceal or colorectal cancer).\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Pregnant individuals are excluded from this study because the protocol involves major abdominal surgery and chemotherapeutic agents with the potential for teratogenic or abortifacient effects. Note: Due to an unknown but potential risk for adverse events in nursing infants secondary to treatment of the participant, nursing (including breastfeeding) should be discontinued if the participant is undergoing treatment (i.e., nursing participants must agree to discontinue nursing activities).\n* HIV-positive participants with detectable viral load despite antiretroviral therapy are ineligible because of participants increased risk of lethal infections when treated with marrow-suppressive therapy. HIV-positive participants who have undetectable viral load on antiretroviral therapy may be considered for this study only after consultation with a NIAID physician.","120 Years",{"count":58,"type":22},60,[60],"PHASE1","Background:\n\nCytoreductive surgery (CRS) removes tumors in the abdomen. HIPEC is hyperthermic (heated) chemotherapy that washes the inside of the abdomen. CRS with HIPEC may help people with peritoneal carcinomatosis. These are tumors that have spread to the lining of the abdomen from other cancers. Researchers think they can improve the results of CRS with HIPEC treatment on these tumors by choosing the chemotherapy drugs used in HIPEC.\n\nObjective:\n\nTo see if HIPEC after CRS can be improved, using either a model called the SMART (Sustained Microenvironment for Analysis of Resected Tissue) System or using 3-D cell culture (organoid) models, in order to test different chemotherapy drugs on tumors that were surgically removed prior to HIPEC treatment (these models are not attached to the body) versus tumors that were treated with HIPEC while still inside the body before being immediately surgically removed.\n\nEligibility:\n\nAdults ages 18 and older who have peritoneal carcinomatosis that cannot be fully removed safely with surgery.\n\nDesign:\n\nParticipants will be screened with:\n\nMedical history\n\nPhysical exam\n\nBlood and urine tests\n\nElectrocardiogram (EKG)\n\nComputed tomography (CT) scan\n\nOther imaging scans, as needed\n\nTumor biopsy, if needed\n\nLaparoscopy (small cuts are made in the abdomen, and a tube with a light and a camera is used to see the organs in the abdomen), if needed\n\nParticipants will enroll in NIH protocol #13C0176. This allows their tumor samples to be used in future research.\n\nSome screening tests may be repeated in the study.\n\nParticipants will have CRS. As many of their visible tumors will be removed as possible during surgery except for a few specific tumors left to receive the HIPEC treatment. Then they will receive HIPEC and the remaining tumors will be immediately removed. Participants will be in the hospital for 7-21 days after this surgery (CRS with HIPEC).\n\nParticipants will give tumor, fluid samples (from the abdomen during surgery), blood, saliva, cheek swab, and stool for research. They will complete surveys about their health and quality of life.\n\nParticipants with peritoneal mesothelioma (mesothelioma primary only) will have genetic (DNA) testing to determine clinical (CLIA level) germline BAP1 status for research use.\n\nParticipants will have follow-up visits for up to 5 years from CRS with HIPEC.\n\nIf there is disease progression, participants may have CRS with HIPEC again. Participants will then have follow-up visits for up to 5 years from the date of last CRS with HIPEC.\n\n...",[63,30,64,65,66,67,68],"Peritoneal Mesothelioma","Ovarian Cancer","Gastrointestinal Cancer","Appendiceal Cancer","Atypical Mesothelial Proliferation","Colorectal Cancer",[70,71,72,73,74,75,76,77],"cytoreduction","organoid model","cell culture model","SMART System","Peritoneal Metastasis","necrosis","Ki-67","cytoreductive surgery (CRS)","2026-07-01",{"date":80,"type":40},"2026-07-02",{"date":82,"type":40},"2021-10-19",{"date":84,"type":22},"2034-12-30",{"name":86,"class":87},"National Cancer Institute (NCI)","NIH",{"id":89,"slug":90,"hasResults":12,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":23,"phases":98,"briefSummary":100,"conditions":101,"keywords":104,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":119},"100593077","phase-2-testing-the-addition-of-paclitaxel-administered-into-the-abdominal-cavity-combined-with-chemotherapy-for-patients-with-gastric-cancer-spread-to-the-abdominal-cavity-100593077","NCT07001748","Testing the Addition of Paclitaxel Administered Into the Abdominal Cavity Combined With Chemotherapy for Patients With Gastric Cancer Spread to the Abdominal Cavity","Protocol EA2234: A Randomized Phase II\u002FIII Trial of Intraperitoneal Paclitaxel Plus Systemic Treatment vs Systemic Treatment Alone in Gastric Carcinomatosis - STOPGAP II","STOPGAP II","STEP 0 REGISTRATION:\n\n* Patient must be at least 18 years of age\n* Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n* Patient must have histologically or cytologically confirmed microsatellite stable (MSS) or mismatch repair (MMR) protein expression proficient primary gastric or gastroesophageal adenocarcinoma (Siewert 3) with synchronous cytology positive disease (cyt+) OR peritoneal carcinomatosis detected by imaging, laparoscopy or laparotomy. Patients with microsatellite instability-high (MSI-H\u002FdMMR) mismatch repair deficient disease are not eligible\n* Patient must have received a minimum of 3 months and a maximum of 6 months of first line systemic treatment\n* Patient must be registered to Step 0 within 4 weeks of the last dose of first line systemic therapy. Patient must not have any ongoing significant adverse events that would prohibit them from undergoing a diagnostic laparoscopy procedure followed by further systemic and intraperitoneal therapy\n* Patient must have no evidence of small or large bowel obstruction other than gastric outlet obstruction due to primary malignancy\n* Patient must have no evidence of solid organ metastases except for ovarian metastases. Baseline imaging must be done within 30 days prior to Step 0 registration\n* Patient must have no evidence of clinically significant radiologic peritoneal disease progression during first line systemic therapy\n* Patient must have no evidence of extensive retroperitoneal lymph node metastases not amenable to resection during gastrectomy\n* Patient must have no history of prior surgery that would preclude safe diagnostic laparoscopy and port placement\n* Patient must have no evidence of massive ascites on imaging or history of two therapeutic paracentesis with drainage of more than 1.0 liter of ascites each time in 30 days prior to Step 0 registration\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better\n* Patient must not have any uncontrolled intercurrent illness or any other significant condition(s) that would make this protocol unreasonably hazardous\n* Patient must not have any known contraindications or drug allergies to the protocol treatment agents: paclitaxel, 5-fluorouracil, or leucovorin\n* Leukocytes ≥ 2,000\u002FuL (≤ 30 days prior to Step 0 registration)\n* Absolute neutrophil count (ANC) ≥ 1,500\u002FuL (≤ 30 days prior to Step 0 registration)\n* Platelets ≥ 75,000\u002FuL (≤ 30 days prior to Step 0 registration)\n* Total bilirubin ≤ 1.5 institutional upper limit of normal (ULN). If patient has Gilbert's syndrome, total bilirubin must be \\\u003C 2.0 mg\u002FdL (≤ 30 days prior to Step 0 registration)\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3.0 x institutional ULN (≤ 30 days prior to Step 0 registration)\n* Creatinine clearance ≥ 30 mL\u002Fmin (estimated using Cockcroft and Gault formula or measured) (≤ 30 days prior to Step 0 registration)\n* Hemoglobin ≥ 8 g\u002FdL (≤ 30 days prior to Step 0 registration)\n* Serum albumin ≥ 2.5 g\u002FdL (≤ 30 days prior to Step 0 registration)\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of Step 0 registration are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a 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* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used\n\n  * All patients of childbearing potential must have a blood test or urine study within 14 days prior to Step 0 registration to rule out pregnancy\n  * A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)\n* Patient must not expect to conceive or father children by using accepted and effective method(s) of contraception (or by abstaining from sexual intercourse) for the duration of their participation in the study. Arm A patients must adhere to the contraceptive requirements outlined in the product specific package inserts while on protocol treatment. Arm B patients must continue contraceptive measures for at least 3 months after the last dose of protocol treatment. In addition, both Arm A and Arm B patients who continue with targeted agents must adhere to the contraceptive requirements outlined in the product specific package inserts while on protocol treatment\n* Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and\u002For family member available will also be considered eligible\n\nSTEP 1 RANDOMIZATION:\n\n* Patient must have undergone a diagnostic laparoscopy with peritoneal lavage performed and aspiration for cytology obtained\n* The extent of peritoneal disease burden must have been assessed during the diagnostic laparoscopy with the Peritoneal Cancer Index (PCI) available\n* Patient must not have extensive intraabdominal adhesions that preclude safe placement of the intraperitoneal port",{"count":97,"type":22},148,[25,99],"PHASE3","This study is being done to answer the following questions:\n\nCan we lower the chance of your gastric cancer from growing or spreading by administering paclitaxel chemotherapy directly into your abdominal cavity in addition to chemotherapy given through a vein in your arm? Will administering paclitaxel chemotherapy directly into your abdominal cavity, in addition to chemotherapy given through a vein in your arm help you live longer? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your gastric cancer. The usual approach is defined as care most people get for gastric cancer.\n\nIf you decide to take part in this study, you will first receive a surgical procedure called a diagnostic laparoscopy. This will help the study doctors learn more about your gastric cancer. Laparoscopy is a minimally invasive surgery for which you will be placed under general anesthesia. Then the surgeon will make small incisions (5mm) on your belly through which a camera and thin instruments are introduced to evaluate the abdomen. This procedure takes about 1 hour to complete. Your study group will be assigned during the surgery. The study groups are described further in the 'What are the study groups?' section below.\n\nIf you are placed into the study group 1, you will not have an intraperitoneal port (a small device which is placed under the skin and fat of your upper abdomen and a tube that is placed into the abdomen).\n\nIf you are placed into the study group 2, you will have an intraperitoneal port placed. The reason is that in addition to standard chemotherapy, which is given through a vein in your arm, this port will be used to deliver the medication paclitaxel directly inside your abdomen when you are ready to start study treatment.\n\nIt is important to know that you will not know your study group until after the surgery is over. This is because information that is learned during the surgery will help determine which study group you are put in.\n\nOnce you have fully healed from this surgery, you will start study treatment. Depending on which study group you are assigned, you will either receive a standard chemotherapy regimen (the regimen will be chosen by you and your doctor) if you are in study group 1, or paclitaxel through a tube in your belly plus chemotherapy given through a vein in your arm if you are in study group 2. All participants will get treatment for three (3) months after which you will undergo reevaluation. If the disease is under control or responding to treatment, you may continue the assigned treatment until your disease gets worse, the side effects become too severe, or you may be offered a surgical procedure to remove the cancer if the amount of disease is low and can be completely removed as determined by a surgeon.\n\nThere is a very small chance that during the laparoscopy surgical procedure, the doctor might find something called \"intra-abdominal adhesions\". These are areas where the stomach has healed previously and created scar tissue. If this scar tissue prevents the surgeon from being able to place a port in the correct area, you would be ineligible to receive the study treatment. If this happens, you may still receive standard of care therapy after your surgery, but you will not be able to continue on the study. If you have more questions about this, you can ask your surgeon or the study team to help.\n\nAfter you finish your study treatment, your doctor or study team will watch you for side effects. They will continue to follow your condition every three (3) months during the first two (2) years, then every six (6) months until year 5. You may be reevaluated with Chest\u002FAbdomen\u002FPelvis scans every three-six (3-6) months for up to five (5) years if decided by your doctor.",[102,103,30],"Gastric Adenocarcinoma","Gastroesophageal Junction Adenocarcinoma",[105,106,94,107,108],"EA2234","Intraperitoneal Paclitaxel","STOPGAP I","Gastric Carcinomatosis","2026-06-16",{"date":111,"type":40},"2026-06-17",{"date":113,"type":40},"2025-08-19",{"date":115,"type":22},"2030-05-30",{"name":117,"class":118},"ECOG-ACRIN Cancer Research Group","NETWORK",55,{"id":121,"slug":122,"hasResults":12,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":4,"eligibilityCriteria":126,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":127,"targetDuration":4,"studyType":23,"phases":129,"briefSummary":130,"conditions":131,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":48},"100370724","phase-2-phase-ii-study-of-the-effects-of-laparoscopic-hyperthermic-intraperitoneal-chemotherapy-hipec-in-patients-with-advanced-gastric-cancer-100370724","NCT04107077","Phase II Study of the Effects of Laparoscopic Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Patients With Advanced Gastric Cancer","A Phase IIa Study of Laparoscopic Hyperthermic Intraperitoneal Chemotherapy (HIPEC) and PD-L1 Expression in Gastric Cancer With Peritoneal Metastases","Inclusion Criteria:\n\n* Patients with histologically confirmed GC\u002FPM only and\u002For positive peritoneal cytology, who have completed prior systemic chemotherapy for a minimum of 2 to 4 months duration.\n* Age ≥18 years. Because no dosing or adverse event data are currently available on the use of HIPEC for GC\u002FPM in patients under 18 years of age, children are excluded from this study, but will be eligible for future pediatric trials.\n* ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A).\n* Patients must have adequate organ and marrow function as defined below:\n\n  * leukocytes ≥3,000\u002FmcL\n  * absolute neutrophil count ≥1,500\u002FmcL\n  * platelets ≥100,000\u002FmcL\n  * total bilirubin ≤ institutional upper limit of normal (ULN)\n  * AST(SGOT)\u002FALT(SGPT) ≤3 × institutional ULN\n  * creatinine ≤ institutional ULN OR\n  * glomerular filtration rate (GFR) ≥50 mL\u002Fmin\u002F1.73 m2 unless data exists supporting safe use at lower kidney function values, no lower than 30 mL\u002Fmin\u002F1.73 m2 (see Appendix B).\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Patients with a 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* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.\n* Expected survival greater than 3 months.\n* Because cisplatin and Mitomycin C are pregnancy category D and potentially teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of the study.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Patients with coexistence of another untreated malignant neoplasm other than basal cell carcinoma of the skin within the last five years.\n* Sites of metastases other than loco-regional lymph nodes and peritoneum (ex. Visceral metastases such as liver, lungs, bone, brain).\n* 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.\n* Patients who are receiving any other investigational agents.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to cisplatin and Mitomycin C.\n* Patients with uncontrolled intercurrent illness.\n* Patients with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Pregnant women are excluded from this study because cisplatin and Mitomycin C are class D agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with cisplatin and Mitomycin C, breastfeeding should be discontinued if the mother is treated with cisplatin and Mitomycin C.",{"count":128,"type":22},21,[25],"To assess if PD-L1 expression can be upregulated in peritoneal metastases from gastric cancer after the administration of HIPEC with greater frequency compared to systemic chemotherapy alone",[132,30],"Gastric Cancer","2026-06-08",{"date":135,"type":40},"2026-06-11",{"date":137,"type":40},"2025-09-09",{"date":139,"type":22},"2030-06-01",{"name":141,"class":47},"University of Chicago",{"id":143,"slug":144,"hasResults":12,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":4,"eligibilityCriteria":148,"healthyVolunteers":12,"sex":149,"minAge":18,"maxAge":4,"enrollmentInfo":150,"targetDuration":4,"studyType":23,"phases":152,"briefSummary":153,"conditions":154,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":165},"100554827","phase-2-a-study-of-radspherin-in-patients-with-primary-advanced-epithelial-cancer-with-peritoneal-metastasis-that-are-homologous-recombination-proficient-scheduled-to-undergo-neoadjuvant-chemotherapy-and-interval-debulking-surgery-100554827","NCT06504147","A Study of Radspherin® in Patients With Primary Advanced Epithelial Cancer, With Peritoneal Metastasis That Are Homologous Recombination Proficient Scheduled to Undergo Neoadjuvant Chemotherapy and Interval Debulking Surgery","A Phase 2, Randomised, Open Label, Multicentre Study of an Intraperitoneal α-emitting Radionuclide Therapy (Radspherin®) in Patients With Primary Advanced High-grade Serous or High-grade Endometrioid Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer, With Peritoneal Metastasis That Are Homologous Recombination Proficient and Scheduled to Undergo Neoadjuvant Chemotherapy and Interval Debulking Surgery","Inclusion Criteria:\n\n1. Able and willing to provide written informed consent and to comply with the clinical study protocol (CSP).\n2. Female of age ≥ 18 years.\n3. Patients with primary advanced high-grade serous or high-grade endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer (FIGO Stage IIIB\u002FC or IV).\n4. Peritoneal and other metastases eligible for IDS to no residual tumour.\n5. Adverse events recovered to at least Grade 1 from the effects (excluding alopecia) of any prior medical therapy for malignancy.\n6. Confirmed HR proficient tumour.\n7. Received NACT (numbers of cycles as per investigator's discretion) with regress or stable disease on diagnostic imaging and assessed to be operable to R0 pre-surgery.\n8. Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0 to 2 and patient fit enough to undergo IDS and further treatment according to standard of care.\n9. Adequate renal function:\n\n   • Calculated creatinine clearance using the Cockcroft-Gault formula ≥ 40 ml\u002Fmin or measured creatinine clearance ≥ 40 ml\u002Fmin.\n10. Adequate hepatic function:\n\n    * Serum bilirubin \\\u003C 1.5 x upper limit of normal (ULN), and\n    * Aspartate transaminase and alanine transaminase ≤ 3 x ULN.\n11. Adequate bone marrow function:\n\n    * Absolute neutrophil count ≥ 1.0 x 10\\^9\u002Fl, and\n    * Platelets ≥ 100 x 10\\^9\u002Fl, and\n    * Haemoglobin ≥ 9 g\u002FdL.\n12. For females of childbearing potential, a negative pregnancy test must be documented prior to enrolment.\n13. For females of childbearing potential agreement to use at least one of the following highly effective (failure rate \\\u003C 1%) methods of contraception during the treatment period and for at least 9 months if they receive Radspherin®, unless hysterectomy or oophorectomy is performed during IDS.\n\n    * Total abstinence (when this is in line with the preferred and usual lifestyle of the patient), periodic abstinence (e.g. calendar, ovulation, symptothermal, post ovulation methods) and withdrawal are not acceptable methods of contraception.\n    * Female sterilisation (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least 6 weeks before enrolment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.\n    * Use of oral (oestrogen and progesterone), injected or implanted hormonal methods of contraception or placement of an intrauterine device or intrauterine system, or other forms of hormonal contraception that have comparable efficacy (failure rate \\\u003C 1%), for example hormone vaginal ring or transdermal hormone contraception. In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment.\n\nNote: In addition to the use of one highly effective method of contraception as listed above, a condom is required for all male partners during the treatment period and for at least 9 months after the dose of IMP, unless vasectomised at least 6 months prior to enrolment.\n\nExclusion Criteria:\n\n1. Known somatic or germline BRCA1 or BRCA2 mutations or confirmed HR deficient.\n2. Suspicion of peritoneal leak, shunt, or otherwise suspected atypical target compartment pharmacokinetics, based on investigator's judgement, patient history and diagnostic images.\n3. Epithelial borderline tumours, ovarian clear cell carcinoma, mucinous ovarian carcinoma, malignant Brenner tumours, non-epithelial ovarian malignancies, carcinosarcoma and neuroendocrine tumours or recurrent ovarian cancer.\n4. Symptomatic central nervous system metastasis.\n5. Another primary malignancy within the past 3 years (except for non melanoma skin cancer, cutaneous melanoma stage 1, cervical cancer in situ or FIGO 2023 Stage IA1 or IA3 prior or synchronous endometrial cancer).\n6. Prior abdominal\u002Fpelvic radiotherapy.\n7. Disease progression during NACT.\n8. Pregnant or lactating (nursing) women.\n9. Active infections requiring antibiotics, and\u002For physician monitoring, or recurrent fever \\> 38.0⁰C associated with a clinical diagnosis of active infection.\n10. Active liver disease with positive serology for active hepatitis B, hepatitis C or known human immunodeficiency virus (HIV).\n11. Concurrent congestive heart failure or prior history of New York Heart Association (NYHA) class III\u002FIV cardiac disease.\n12. Any condition or illness that, in the opinion of the investigator or the medical monitor, would compromise the safety of the patients or interfere with the evaluation of the safety of the investigational medicinal product.\n13. In the investigator's opinion not able to comply with study procedures. Any medical or psychological condition that would preclude participation in the study or compromise the ability to give informed consent.\n14. Administration of an investigational medicinal product within 4 weeks, or at least 5 times the half life, prior to enrolment.\n15. Concurrent administration of any cancer therapy other than planned study treatment within 4 weeks prior to, and up to 4 weeks after the surgery.\n16. Treatment with bevacizumab within 5 weeks prior to IDS.\n17. Known hypersensitivity to any of the excipients of the study drug.","FEMALE",{"count":151,"type":22},114,[25],"This is a Phase 2, controlled, randomised, parallel assignment, open label, multicentre study to evaluate efficacy and safety of a single intraperitoneal injection of Radspherin® in patients with primary advanced high-grade serous or high-grade endometrioid epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer, with peritoneal metastasis that are HR proficient and scheduled to undergo NACT and IDS. The study will be conducted in 2 parts; first, a Safety Lead-in Cohort will be recruited followed by the randomised part of the study. For both parts of the study, patients must be scheduled to undergo NACT and IDS and complete resection to no residual tumour (R0) should be deemed to be achievable during diagnostic work-up. Patients in both parts of the study will undergo the same procedures and assessments.",[30,64],"2026-05-18",{"date":157,"type":40},"2026-05-20",{"date":159,"type":40},"2024-06-15",{"date":161,"type":22},"2031-02-28",{"name":163,"class":164},"Oncoinvent Solutions AS","INDUSTRY",10,{"id":167,"slug":168,"hasResults":12,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":172,"eligibilityCriteria":173,"healthyVolunteers":12,"sex":149,"minAge":18,"maxAge":19,"enrollmentInfo":174,"targetDuration":4,"studyType":23,"phases":176,"briefSummary":177,"conditions":178,"keywords":185,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":207},"100424807","phase-1-pressurized-intraperitoneal-aerosol-chemotherapy-pipac-associated-with-systemic-chemotherapy-in-women-with-advanced-ovarian-cancer-100424807","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.",{"count":175,"type":22},15,[60],"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.",[179,30,180,181,182,183,184],"Metastatic Ovarian Carcinoma","Stage III Ovarian Cancer","Stage IV Ovarian Cancer","Stage III Fallopian Tube Cancer","Stage IV Fallopian Tube Cancer","Metastatic Malignant Neoplasm in the Peritoneum",[186,187,188,189,190,191,192,193,194,195,196,197,198],"Dose escalation","Phase I study","Intravenous Chemotherapy","Intraperitoneal chemotherapy","PIPAC","RP2D","cytoreductive surgery","Ovarian epithelial cancer","peritoneal cancer","doxorubicin","cisplatin","CA-125 antigen","pharmacokinetic",{"date":200,"type":40},"2026-05-22",{"date":202,"type":40},"2021-07-30",{"date":204,"type":22},"2029-01",{"name":206,"class":47},"Hospices Civils de Lyon",6,{"id":209,"slug":210,"hasResults":12,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":4,"eligibilityCriteria":214,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":215,"targetDuration":4,"studyType":23,"phases":217,"briefSummary":218,"conditions":219,"keywords":220,"overallStatus":225,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":48},"100630399","phase-1-safety-and-efficacy-of-pipac-using-single-agent-mitomycin-in-solid-tumors-100630399","NCT07487168","Safety and Efficacy of PIPAC Using Single Agent Mitomycin in Solid Tumors","Phase 1 Single Center Study to Evaluate Safety and Efficacy of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Using Single Agent Mitomycin C (MMC) in Peritoneal Carcinomatosis (PC) From Solid Gastrointestinal Malignancies (sGI-PC) in Palliative Setting","Inclusion Criteria:\n\n* Participants must have histologically confirmed peritoneal disease from colorectal, small bowel, or high grade appendiceal adenocarcinoma. High grade appendiceal cancers include moderate or poorly differentiated mucinous or non-mucinous adenocarcinoma, signet ring cell adenocarcinoma, or goblet cell adenocarcinoma. This can be established by image guided biopsy, diagnostic laparoscopy, or previous surgery.\n* Patients must be ineligible for CRS\u002FHIPEC through one of the following criteria: a) PCI score ≥16. b) Inability to achieve complete cytoreduction due to extent of disease. c) Significant small bowel involvement precluding a complete CRS. d) Unresectable disease in porta hepatis, pelvic side wall or other critical structure. e) Patients who decline invasive cytoreduction.\n* Participants must be 18 years of age or older.\n* Participants must have completed at least 4 months of first-line systemic therapy (5-FU based approach with or without biologic therapy).\n* Participants must have Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1.\n* Participants must have adequate organ and marrow function as defined below: a) absolute neutrophil count ≥1500\u002FmcL. b) platelets ≥100,000\u002FmcL. c) total bilirubin ≤ institutional upper limit of normal (ULN). d) AST(SGOT)\u002FALT(SGPT) ≤3 × institutional ULN. e) creatinine ≤ 1.5 institutional ULN. or f) glomerular filtration rate (GFR) ≥60 mL\u002Fmin\u002F1.73 m2.\n* Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n* For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should undergo a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification (see Appendix C).\n\nTo be eligible for this trial, participants should be class 2B or better.\n\n* MMC is a known teratogen, for this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of study drug administration. For women of child-bearing potential a negative urine pregnancy test is required on the morning of surgery.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Participants who have received targeted therapy, immunotherapy, or radiotherapy within 4 weeks (6 weeks for VEGF inhibitors, nitrosoureas or mitomycin C) prior to entering the study.\n* Participants who have not recovered from adverse events (AEs) due to prior anti-cancer therapy (i.e., have residual toxicities \\> Grade 1), except for alopecia and chemotherapy induced peripheral neuropathy \\\u003C 2.\n* Patients with extensive metastatic liver disease (\\>50% liver volume) are excluded from the trial as are patients with brain metastases. Patients with non-peritoneal metastatic disease are otherwise eligible provided they meet the survival expectations of \\>6 months.\n* Patients with brain metastases are excluded\n* Patients with bowel obstruction or need for nutritional support (i.e., TPN or tube feeds).\n* Participants who are receiving any other investigational agents or enrolled on other research protocols that may interfere with compliance with requirements of the study.\n* History of allergic reactions or poor tolerance attributed to compounds of similar chemical or biologic composition to MMC, fluoropyrimidines, or anesthesia medications.\n* Participants with uncontrolled intercurrent illnesses.\n* Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Pregnant women are excluded from this study because MMC is an antibiotic alkylating antineoplastic agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with MMC, breastfeeding should be discontinued if the mother is treated with MMC.\n* Inability to safely perform laparoscopy due to previously noted adhesions or extensive prior surgery which the treating surgeon feels would exclude safe abdominal access.\n* Life expectancy less than 6 months.\n* Patients with history of thromboembolic complications that cannot discontinue for the perioperative duration.",{"count":216,"type":22},24,[60],"This single-center, Phase 1 dose-escalation study will evaluate the safety, tolerability, and recommended Phase 2 dose (RP2D) of pressurized intraperitoneal aerosol chemotherapy with mitomycin C (PIPAC-MMC) for patients with unresectable peritoneal carcinomatosis from gastrointestinal primaries (colorectal, high-grade appendiceal, or small bowel). Up to three PIPAC procedures are planned at 8-week intervals while patients continue 5-fluorouracil\u002Fleucovorin (5-FU\u002FLV) between procedures. The trial uses a Bayesian optimal interval (BOIN) design to determine dose-limiting toxicities (DLTs) and maximum tolerated dose (MTD). Pharmacokinetics (PK), pharmacodynamics (PD), and quality of life (QoL) will be assessed.",[30],[221,222,223,224],"Appendiceal cancer","Peritoneal disease","Colorectal cancer","Pressurized Intraperitoneal Aerosolized Chemotherapy","NOT_YET_RECRUITING","2026-05-14",{"date":228,"type":40},"2026-05-15",{"date":230,"type":22},"2026-08",{"date":232,"type":22},"2028-03",{"name":234,"class":47},"H. Lee Moffitt Cancer Center and Research Institute",{"id":236,"slug":237,"hasResults":12,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":241,"eligibilityCriteria":242,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":243,"targetDuration":4,"studyType":23,"phases":245,"briefSummary":246,"conditions":247,"keywords":250,"overallStatus":225,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":262,"locationsCount":48},"100639502","phase-2-mri-guided-adaptive-radiotherapy-for-limited-peritoneal-metastases-maracas-trial-100639502","NCT07593261","MRI-Guided Adaptive Radiotherapy for Limited Peritoneal Metastases (MARACAS Trial).","MARACAS: A Phase II Trial of MRI-guided Adaptive Stereotactic RAdiotherapy in oligometastatiC Patients With Peritoneal Spread.","MARACAS","Inclusion Criteria:\n\n* Age ≥18 years\n* ECOG performance status 0-2\n* Life expectancy ≥6 months\n* Up to 5 MRI-visible peritoneal nodules\n* PCI ≤20\n* No prior radiotherapy in the same abdominal region within 6 months\n* Signed informed consent\n* History of prior CRS and\u002For HIPEC\n\nExclusion Criteria:\n\n* Diffuse peritoneal carcinomatosis\n* Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule (those conditions should be discussed with the patient before registration in the trial)\n* Significant comorbidities (such as: severe cardiac or coagulative disease, moderate or severe\n* restrictive\u002Fobsiructive lung deficit, severe cognitive impairment, moderate and severe renal and hepatic impairment.\n* Pregnancy or breastfeeding\n* MRI contraindications (e.g., pacemaker, severe claustrophobia)",{"count":244,"type":22},34,[25],"This prospective phase II study evaluates the efficacy and safety of MRI-guided stereotactic body radiotherapy (MRIgSBRT) in patients with oligometastatic peritoneal carcinomatosis from gastrointestinal or gynecological tumors. Eligible patients with up to 5 MRI-visible peritoneal lesions and PCI ≤20 will be treated with MRIgSBRT using a hybrid MRI-linear accelerator with online adaptive planning and real-time tumor tracking.\n\nThe primary endpoint is radiologic response rate according to RECIST 1.1 criteria. Secondary endpoints include overall survival, progression-free survival, local control, chemotherapy-free survival, and treatment-related toxicity. The study aims to assess MRIgSBRT as a safe and non-invasive treatment option for selected patients with limited peritoneal metastatic disease.",[30,248,249],"Oligometastatic Disease","Peritoneal Metastases",[251,252,253,254,255],"MRI-guided radiotherapy","Stereotactic body radiotherapy","Peritoneal carcinomatosis","Peritoneal metastases","Online adaptive radiotherapy","2026-05-12",{"date":155,"type":40},{"date":259,"type":22},"2026-07",{"date":261,"type":22},"2032-07",{"name":263,"class":47},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":265,"slug":266,"hasResults":12,"nctId":267,"briefTitle":268,"officialTitle":268,"acronym":4,"eligibilityCriteria":269,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":270,"targetDuration":4,"studyType":23,"phases":271,"briefSummary":272,"conditions":273,"keywords":276,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":281,"startDateStruct":282,"completionDateStruct":284,"leadSponsor":286,"locationsCount":48},"100509457","phase-2-technical-feasibility-of-modified-early-post-operative-intraperitoneal-chemotherapy-mepic-100509457","NCT05913674","Technical Feasibility of Modified Early Post-Operative Intraperitoneal Chemotherapy (mEPIC)","Inclusion Criteria:\n\n* Patient's age 18 years or older, both genders.\n* In good general health as evidenced by an ECOG score of 0 or 1.\n* Histological diagnosis of appendicular or colorectal tumors with peritoneal carcinomatosis, either synchronous (\\\u003C 12 months after primary diagnosis) or metachronous (\\>12 months after the primary diagnosis)\n* Complete staging defined as: (1)Computed tomography (CT) scan of the chest, abdomen and pelvis. (2) Positron emission tomography (PET) scan when clinically appropriate. (3) Diagnostic laparoscopy reporting Peritoneal carcinomatosis index (PCI) +\u002F- biopsy\n* Meets criteria for recommendation by combined multidisciplinary team and tumor board for cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS+HIPEC) followed by mEPIC\n* Surgery must be performed within 4-6 weeks following the end of neoadjuvant therapy or 4-6 weeks following the patient's enrollment if no neoadjuvant therapy needed.\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with all study procedures and availability for the study duration\n* Hematology: Absolute neutrophil count (ANC) ≥ 1,500\u002F μL; Platelets \\> 75,000\u002F μL.\n* Adequate Renal function Creatinine \\\u003C1.5 x the upper limit of normal (ULN) or calculated creatinine clearance of ≥ 50ml\u002Fmin.\n* Adequate Hepatic function: Bilirubin less than 1.5mg\u002FdL; (except in patients with Gilbert's Syndrome, who must have a total bilirubin less than 3.0mg\u002FdL).\n\nExclusion Criteria:\n\nPre-cytoreductive surgery:\n\n* Other malignancies other than appendicular and colorectal neoplasms with peritoneal involvement\n* Inability to complete cytoreductive surgery (ECOG 2 or above) or any patient deemed unfit for surgery\n* Known allergic reaction or major toxicity to Fluorouracil\n* Contraindications to Fluorouracil, including history of coronary spasm and\u002For known dihydropyrimidine dehydrogenase deficiency\n* Pregnancy\n* Evidence of extensive intraperitoneal adhesions at the time of surgery which prohibits intraperitoneal therapy, as determined by the operating surgeon.\n* Any condition that would preclude the ability to deliver appropriate intraperitoneal (IP) therapy.\n\nPost-cytoreductive surgery:\n\n* Patient deemed not medically suitable to receive mEPIC protocol according to surgical team\n* Uncorrected coagulopathy and\u002For thrombocytopenia and\u002For neutropenia\n* Active infection\n* Hemodynamic and \u002F or respiratory compromise\n* Evidence of extensive intraperitoneal adhesions at the time of surgery which prohibits intraperitoneal therapy, as determined by the operating surgeon.\n* Any condition that would preclude the ability to deliver appropriate IP therapy.",{"count":7,"type":22},[25],"The goal of this prospective phase II unicentric Canadian clinical trial is to clarify the feasibility of modified early post-operative intraperitoneal chemotherapy (mEPIC) following cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) in the clinical context of peritoneal carcinomatosis from colorectal and appendicular neoplasms.\n\nThe primary objective of this study is to confirm the feasibility of mEPIC by evaluating its completion rate compared to the one of historical standard early post-operative intraperitoneal chemotherapy (EPIC) cohorts. The secondary objectives of the study are to evaluate the safety of the mEPIC protocol by monitoring adverse events arising during the protocol and to assess logistical implementation barriers for the nursing and Oncology pharmacy teams, respectively.\n\nParticipants will undergo a modified schedule of EPIC (mEPIC) designed to maximize therapeutic benefit by exploiting the known pharmacokinetics and pharmacodynamics properties of fluorouracil (5-FU) while limiting the logistical issues of the standard protocol. mEPIC consists in shortening the original protocol from five to two days of postoperative intraperitoneal chemotherapy. Additionally, instead of solely administering a singular 5-FU bolus per 24 hours-period, mEPIC is based on the De Gramont intravenous regimen and consists of administering one intraperitoneal bolus of 5-FU (400 mg\u002Fm2) followed by a 24 hours-intraperitoneal infusion of 5-FU (1200 mg\u002Fm2) on postoperative days 1 and 2.",[30,274,275],"Appendiceal Neoplasms","Colorectal Cancer Metastatic",[189,277,35,278,279,280],"Early post-operative intraperitoneal chemotherapy","Hyperthermic intraperitoneal chemotherapy","Cytoreductive surgery","mEPIC",{"date":226,"type":40},{"date":283,"type":40},"2026-05-01",{"date":285,"type":22},"2028-09",{"name":287,"class":47},"Ciusss de L'Est de l'Île de Montréal",{"id":289,"slug":290,"hasResults":12,"nctId":291,"briefTitle":292,"officialTitle":293,"acronym":294,"eligibilityCriteria":295,"healthyVolunteers":12,"sex":149,"minAge":18,"maxAge":19,"enrollmentInfo":296,"targetDuration":4,"studyType":23,"phases":298,"briefSummary":299,"conditions":300,"keywords":302,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":306,"lastUpdatePostDateStruct":307,"startDateStruct":309,"completionDateStruct":311,"leadSponsor":313,"locationsCount":48},"100632500","phase-2-intensification-treatment-of-ovarian-cancer-by-pipac-100632500","NCT07514494","Intensification Treatment of Ovarian Cancer by PIPAC","Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) as a Component of Combined Treatment in Patients With Advanced Epithelial Ovarian Cancer and Peritoneal Carcinomatosis: A Randomized Phase II Trial (PrimPIPAC)","PrimPIPAC","Inclusion Criteria:\n\n* Female, age 18-75 years.\n* Histologically verified ovarian cancer with peritoneal carcinomatosis.\n* FIGO stage IIIB or IIIC.\n* visually detectable peritoneal carcinomatosis.\n* Peritoneal metastatic involvement documented preoperatively by ultrasound, CT, MRI, PET-CT, or equivalent imaging.\n* Ability to comply with protocol procedures and provide written informed consent.\n\nExclusion Criteria:\n\n* Age \\> 75 years; ECOG 3-4; cachexia with BMI \\\u003C= 16.\n* Severe concomitant disease in exacerbation or decompensation.\n* Extra-abdominal metastases, including metastatic pleuritis.\n* Mucinous ovarian carcinoma or another active malignant neoplasm, except malignancies in clinical remission for more than 2 years.\n* Pronounced adhesive disease of the abdominal cavity.\n* Pregnancy or breastfeeding.\n* Positive BRCA1 or BRCA2 status.\n* Any condition precluding safe PIPAC or protocol execution, including hollow-organ perforation, gastrointestinal resection with anastomosis, or repair of a hollow-viscus defect.\n* Refusal of treatment at any study stage.",{"count":297,"type":22},160,[25],"The goal of this clinical trial is to learn whether repeated cisplatin-based PIPAC added to standard TC chemotherapy can improve outcomes in women aged 18-75 years with newly diagnosed FIGO IIIB-IIIC epithelial ovarian cancer and visually detectable peritoneal carcinomatosis. The main questions are whether repeated PIPAC increases the rate of complete surgical cytoreduction (CRS R0) and whether it improves disease control, survival outcomes, and safety compared with standard combined treatment including a single PIPAC procedure. Participants will undergo screening, intraoperative randomization, systemic chemotherapy, PIPAC procedures according to study arm, interval cytoreductive surgery, protocol-specified postoperative treatment if needed, and regular follow-up assessments.",[301,30],"Advanced Epithelial Ovarian Cancer",[190,303,304,253,189,305],"Pressurized intraperitoneal aerosol chemotherapy","Advanced epithelial ovarian cancer","First-line treatment","2026-03-31",{"date":308,"type":40},"2026-04-07",{"date":310,"type":40},"2025-04-02",{"date":312,"type":22},"2030-04-02",{"name":314,"class":315},"Moscow Regional Oncological Dispensary","OTHER_GOV",{"id":317,"slug":318,"hasResults":12,"nctId":319,"briefTitle":320,"officialTitle":321,"acronym":322,"eligibilityCriteria":323,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":324,"targetDuration":4,"studyType":23,"phases":326,"briefSummary":328,"conditions":329,"keywords":330,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":336,"lastUpdatePostDateStruct":337,"startDateStruct":339,"completionDateStruct":341,"leadSponsor":343,"locationsCount":345},"100630915","enhanced-recovery-after-surgery-eras-in-patients-with-peritoneal-carcinomatosis-undergoing-cytoreductive-surgery-with-or-without-hyperthermic-intraperitoneal-chemotherapy-hipec-100630915","NCT07493876","Enhanced Recovery After Surgery (ERAS) in Patients With Peritoneal Carcinomatosis Undergoing Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy (HIPEC)","Prospective Multicenter Interventional Pre-Post Study of an Enhanced Recovery After Surgery (ERAS) Protocol in the Perioperative Management of Patients With Peritoneal Carcinomatosis Undergoing Cytoreductive Surgery With or Without HIPEC (EPICH)","EPICH","Inclusion Criteria:\n\n* Written informed consent signed before the procedure\n* Histological or cytological diagnosis of advanced solid tumor with documented peritoneal carcinomatosis originating from one of the following: peritoneal mesothelioma or other primary malignant peritoneal tumor, gynecologic tumor, gastric tumor, or intestinal tumor\n* Age \\>18 years\n* ECOG performance status ≤1\n* ASA score ≤3\n\nExclusion Criteria:\n\n* Missing written informed consent\n* ASA score ≥4\n* Palliative surgery or other unplanned surgery\n* Severe renal insufficiency, severe hepatic insufficiency, severe heart failure, recent myocardial infarction, or severe arrhythmia\n* Immunocompromised patients, patients receiving immunosuppressive therapy, or patients with immune system diseases",{"count":325,"type":22},300,[327],"NA","This prospective multicenter interventional pre-post study aims to evaluate the effect of implementing an Enhanced Recovery After Surgery (ERAS) protocol in patients with peritoneal carcinomatosis undergoing cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy (HIPEC). Approximately 300 patients will be enrolled across 20 Italian centers. During an initial pre-intervention period, usual perioperative management will be described; during a subsequent intervention period, participating centers will apply a predefined ERAS protocol. The primary objective is to assess the effect of ERAS implementation on mean postoperative hospital length of stay.",[30],[331,332,333,334,335],"Cytoreductive Surgery","HIPEC","Enhanced Recovery After Surgery","ERAS","Peritoneal Surface Malignancies","2026-03-30",{"date":338,"type":40},"2026-04-03",{"date":340,"type":40},"2025-01-23",{"date":342,"type":22},"2027-12-30",{"name":344,"class":47},"Fondazione del Piemonte per l'Oncologia",2,{"id":347,"slug":348,"hasResults":12,"nctId":349,"briefTitle":350,"officialTitle":351,"acronym":4,"eligibilityCriteria":352,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":353,"targetDuration":4,"studyType":23,"phases":355,"briefSummary":356,"conditions":357,"keywords":358,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":368,"startDateStruct":370,"completionDateStruct":372,"leadSponsor":374,"locationsCount":345},"100422340","phase-2-flat-dose-vs-weight-based-ip-chemotherapy-for-crshipec-100422340","NCT04779554","Flat Dose vs. Weight-based IP Chemotherapy for CRS\u002FHIPEC","A Randomized Phase 2 Trial of Flat Dose vs. Weight-based Dose of Intra-peritoneal (IP) Chemotherapy for Patients Undergoing Cytoreductive Surgery and Heated Intra-peritoneal Chemotherapy (CRS\u002FHIPEC) for Advanced Gastrointestinal Malignancy","Inclusion Criteria:\n\n* Patients diagnosed with one of the following: low-grade appendiceal mucinous neoplasm, pseudomyxoma peritonei, appendiceal cancer with peritoneal carcinomatosis, colorectal cancer with peritoneal carcinomatosis\n* ECOG performance status \\\u003C 3\n* Candidate for grossly complete cytoreductive surgery\n* Life expectancy greater than 3 months\n* Adequate organ and marrow function\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Any extra-abdominal metastases\n* Untreated lung metastases\n* Liver metastases not amenable to resection or ablation\n* Known brain metastases\n* Chemotherapy or radiotherapy within 4 weeks prior to entering the study\n* Presence of residual significant adverse events attributed to prior cancer treatment\n* Currently receiving any other investigational therapeutic agents\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to Mitomycin C.\n* Pregnant or breast-feeding women\n* Uncontrolled ongoing illness",{"count":354,"type":22},100,[25],"Peritoneal carcinomatosis from advanced gastro-intestinal malignancy has historically been associated with poor overall survival (≤ 12 months) with few treatment options. Cytoreductive surgery (CRS), which involves removal of all macroscopic tumor nodules, combined with direct administration of heated intra-peritoneal (IP) chemotherapy (HIPEC) to the affected peritoneal surfaces, has been shown to be an effective treatment option that extends overall survival among certain cases of peritoneal carcinomatosis. IP chemotherapy allows delivery of a high dose of cytostatic drug directly onto the peritoneal surfaces at risk for microscopic residual disease while systemic exposure remains limited. Additionally, hyperthermia is known to enhance the cytotoxicity of several agents (including Mitomycin C) and improves the depth of peritoneal penetration.\n\nThis trial will be a randomized phase 2 comparison of flat dose versus weight-based dose Mitomycin C. The hypothesis of this study is that HIPEC weight-based dosing may result in similarly effective peritoneal Mitomycin C concentrations with less systemic absorption and potential systemic toxicity, compared with the HIPEC flat dosing approach in patients undergoing CRS\u002FHIPEC.",[30],[192,359,360,361,362,363,364,332,365,366],"colorectal cancer","pseudomyxoma peritonei","appendiceal mucinous neoplasm","mitomycin C","pharmacokinetics","CRS\u002FHIPEC","Appendix cancer","LAMN","2026-03-26",{"date":369,"type":40},"2026-04-01",{"date":371,"type":40},"2021-06-04",{"date":373,"type":22},"2028-02",{"name":375,"class":47},"Prakash Pandalai",{"id":377,"slug":378,"hasResults":12,"nctId":379,"briefTitle":380,"officialTitle":381,"acronym":382,"eligibilityCriteria":383,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":384,"enrollmentInfo":385,"targetDuration":4,"studyType":23,"phases":387,"briefSummary":388,"conditions":389,"keywords":393,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":400,"lastUpdatePostDateStruct":401,"startDateStruct":403,"completionDateStruct":405,"leadSponsor":407,"locationsCount":48},"100614687","phase-2-heated-versus-aerosol-based-laparoscopic-chemotherapy-for-cancer-that-has-spread-to-the-peritoneum-abdominal-lining-100614687","NCT07282834","Heated Versus Aerosol-based Laparoscopic Chemotherapy for Cancer That Has Spread to the Peritoneum (Abdominal Lining)","Randomized Phase II Trial of Heated Vs. Pressurized\u002FAerosolized Chemotherapy (HIPEC vs. PIPAC) for Peritoneal Carcinomatosis","Charlie-2","Inclusion Criteria:\n\n1. Males or females age 18 to 80 years.\n2. Biopsy-proven or clinically suspected peritoneal carcinomatosis\n3. Receipt of at least three months of standard systemic chemotherapy prior with persistence of disease at the time of randomization\n4. Not a candidate for surgical cytoreduction at the time of laparoscopy\n5. Women at least 18 years of age of childbearing potential must have a negative urine\u002Fserum pregnancy test and must use an acceptable method of contraception, including abstinence, a barrier method (diaphragm or condom), Depo-Provera, or an oral contraceptive, for the duration of the study.\n6. Must be able to read and understand English and consent for themselves\n\nExclusion Criteria:\n\n1. Patients who are eligible for definitive cytoreductive surgery at the time of enrollment\n2. Laboratory abnormalities that indicate clinically significant hematologic, hepatobiliary, or renal disease:\n\n   AST\u002FSGOT \\> 2.5 times the upper limit of normal ALT\u002FSGPT \\> 2.5 times the upper limit of normal Total bilirubin \\> 2.5 times the upper limit of normal Hemoglobin \\\u003C 7 gm\u002FdL White blood cell count \\\u003C 3,000\u002F mm3 Platelet count \\\u003C 50,000\u002Fmm3\n3. Any investigational drug use within 30 days prior to enrollment.\n4. Systemic therapy within 14 days prior to randomization\n5. Allergy or medical contra-indication to chemotherapy utilized in this study\n6. Medical contraindication to laparoscopic surgery or complex cytoreductive surgery\n7. Pregnant or lactating females.\n8. Subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.","80 Years",{"count":386,"type":22},200,[25],"This research study aims to improve the treatment of Peritoneal Carcinomatosis (PC), a condition where cancer spreads within the abdomen. Patients with PC often experience significant pain and nutritional problems. Currently, there isn't a standard treatment approach, and doctors use different combinations of chemotherapy, surgery, and methods to deliver chemotherapy directly into the abdomen (intra-peritoneal or \"IP\" chemotherapy).\n\nThe study will compare two IP chemotherapy methods: HIPEC and PIPAC. HIPEC involves circulating heated chemotherapy through the abdomen during surgery, while PIPAC delivers chemotherapy as a pressurized aerosol during a laparoscopic procedure. Both methods aim to achieve the same goal, but they haven't been directly compared to see which is safer, more tolerable, more effective, and provides better value.",[390,30,391,392],"Peritoneal (Metastatic) Cancer","Abdominal Cancer","Abdominal Cancer Patients",[394,395,396,190,332,397,398,399,70],"intraperitoneal","peritoneal cavity","mitomycin-C","Heated Intra-Peritoneal Chemotherapy","Pressurized Intraperitoneal Aerosol Chemotherapy","intra-abdominal","2026-02-25",{"date":402,"type":40},"2026-02-27",{"date":404,"type":40},"2026-01-05",{"date":406,"type":22},"2040-11",{"name":408,"class":47},"Patrick Wagner, MD, FACS",{"id":410,"slug":411,"hasResults":12,"nctId":412,"briefTitle":413,"officialTitle":414,"acronym":4,"eligibilityCriteria":415,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":416,"targetDuration":4,"studyType":23,"phases":417,"briefSummary":419,"conditions":420,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":421,"lastUpdatePostDateStruct":422,"startDateStruct":423,"completionDateStruct":425,"leadSponsor":427,"locationsCount":48},"100555357","early-phase-1-phi-pilot-study-pafolacianine-inject-for-intraoperative-imaging-on-outcomes-of-gi-cancer-peritoneal-carcinomatosis-100555357","NCT06511037","PhI Pilot Study Pafolacianine Inject for Intraoperative Imaging on Outcomes of GI Cancer Peritoneal Carcinomatosis","The Impact of Pafolacianine Injection for Intraoperative Imaging on Outcomes of Gastrointestinal Cancer Peritoneal Carcinomatosis - A Pilot Study","Inclusion Criteria:\n\n* Adult patients 18 years of age and older\n* Have a primary diagnosis of primary gastrointestinal cancer (of adenocarcinoma), planned for cytoreductive surgery\n* Female patients must have a negative serum pregnancy test at screening, followed by a negative urine pregnancy test on the day of scheduled study drug infusion, or day of surgery\n* Female patients of childbearing potential, or less than two (2) years postmenopausal, agree to use an acceptable form of contraception from time of signing informed consent until 30 days after study completion\n* Ability to understand the requirements of the study, provide written informed consent for participation in the study and authorization of use and disclosure of protected health information, and agree to abide by study restrictions\n\nExclusion Criteria:\n\n* Previous exposure to CYTALUX™ (PAFOLACIANINE)\n* Patients with known gastrointestinal cancer with carcinomatosis determined pre-operatively to be inoperable\n* Any medical condition that in the opinion of the investigators could potential jeopardize the safety of the patient\n* History of anaphylactic reaction\n* History of allergy to any components of CYTALUX™ (PAFOLACIANINE), including folic acid\n* Pregnancy, or positive pregnancy test\n* Clinically significant abnormalities on ECG\n* Impaired renal function defined as eGFR \\\u003C50 mL\u002Fmin\u002F1.73m2\n* Impaired liver function defined as values \\>3x the upper limit of normal (ULN) for alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or total bilirubin\n* Received an investigational agent in another trial within 30 days prior to surgery\n* Known sensitivity to fluorescent light",{"count":165,"type":22},[418],"EARLY_PHASE1","This is a pilot, single-arm, open label study to evaluate the ability of CYTALUX™ (pafolacianine) to help identify cancerous lesions in subjects with gastrointestinal cancers and peritoneal carcinomatosis during cytoreductive surgery.",[65,30],"2026-02-23",{"date":402,"type":40},{"date":424,"type":40},"2024-11-13",{"date":426,"type":22},"2027-11-30",{"name":428,"class":47},"University of California, Irvine",{"id":430,"slug":431,"hasResults":12,"nctId":432,"briefTitle":433,"officialTitle":434,"acronym":435,"eligibilityCriteria":436,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":437,"targetDuration":4,"studyType":23,"phases":439,"briefSummary":440,"conditions":441,"keywords":443,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":447,"lastUpdatePostDateStruct":448,"startDateStruct":450,"completionDateStruct":452,"leadSponsor":454,"locationsCount":48},"100587486","blood-clearance-kinetics-of-the-nucleosome-and-ctcf-in-peritoneal-metastasis-colorectal-cancer-100587486","NCT06929013","Blood Clearance Kinetics of the Nucleosome and CTCF in Peritoneal Metastasis Colorectal Cancer.","Monitoring of Blood Clearance Kinetics of the Nucleosome and CTCF in Peri-operative Management of Peritoneal Metastasis Colorectal Cancer.","NUCLEAR","Inclusion Criteria:\n\n* Common criteria:\n\n  * Male\u002Ffemale over 18 years of age.\n  * Weight ≥ 55 kg at inclusion.\n  * Signature of a free and informed consent form.\n* Specific criteria:\n\nGroup 1:\n\n* Peritoneal metastases colorectal cancer histologically proven\n* Synchronous or metachronous peritoneal metastases.\n* Patients eligible for initial cytoreduction surgery.\n* Non mucinous tumor (mucinous cells contingent \\\u003C30%).\n\nGroup 2:\n\nColorectal cancer\n\nGroup 3:\n\nNon-oncological chronic inflammatory diseases\n\nGroup 4:\n\nNon-oncological chronic inflammatory diseases : parietal repairs, elective sigmoidectomy for diverticulosis\n\nGroup 5:\n\nAbdominal sepsis conditions: peritonitis due to digestive perforation in non-oncological pathology, non-perforated appendicitis, cholecystitis.\n\nNon inclusion Criteria:\n\n* Patient with an active cancer (excluding colorectal cancer).\n* Person with a progressive autoimmune disease.",{"count":438,"type":22},58,[327],"Colorectal cancer is highly prevalent in France, ranking second among women and third among men. Its primary metastatic sites include the liver, lungs, and peritoneum. For peritoneal metastases, when the disease is moderately extensive, cytoreductive surgery is recommended in an expert centre. Following this procedure, the surgeon uses the CC-Score (Completeness of Cytoreduction after Surgery Score) to assess the completeness of surgical resection by evaluating the largest remaining tumor residue. This subjective score is currently the main prognostic factor for oncological outcomes post-surgery. However, there is no objective score based on biological criteria to evaluate the radicality of resection, despite the hypothesis that the micrometastatic component of the disease could be biologically assessed using appropriate circulating markers.\n\nNew biomarkers are emerging and appear relevant for determining the presence of tumor residual disease. Notable among these are circulating tumor DNA, which can detect mutated DNA released by tumor cells into the patient's blood through high-throughput sequencing, and new markers related to epigenetic modifications in cancer cells. These markers target specific nucleosomes or the transcription factor CTCF and show promise in detecting residual disease.\n\nTo effectively use these markers for constructing a biological score to detect residual disease in peritoneal carcinomatosis, it is essential to understand their perioperative kinetics. This is crucial because cellular debris release is expected post-surgery, necessitating the determination of the most relevant time point for measurement. Additionally, these markers appear to be correlated with blood inflammation levels, requiring a description of this correlation to account for this potential confounding factor. Finally, the sensitivity and specificity of these markers must be determined by studying their perioperative kinetics in patient groups undergoing surgeries other than cytoreductions for peritoneal carcinomatosis.",[30,442],"Peritoneal Metastases From Colorectal Cancer",[444,253,445,446],"Biomarkers","CTCF","Nucleosome","2026-02-12",{"date":449,"type":40},"2026-02-13",{"date":451,"type":40},"2025-05-06",{"date":453,"type":22},"2026-06-20",{"name":206,"class":47},{"id":456,"slug":457,"hasResults":12,"nctId":458,"briefTitle":459,"officialTitle":460,"acronym":4,"eligibilityCriteria":461,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":462,"targetDuration":4,"studyType":23,"phases":464,"briefSummary":465,"conditions":466,"keywords":474,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":483,"lastUpdatePostDateStruct":484,"startDateStruct":486,"completionDateStruct":488,"leadSponsor":490,"locationsCount":492},"100563994","phase-1-a-study-of-mesothelin-targeted-car-t-cell-therapy-in-people-with-esophagogastric-cancer-100563994","NCT06623396","A Study of Mesothelin-Targeted CAR T-Cell Therapy in People With Esophagogastric Cancer","A Phase I Trial of Intraperitoneal Mesothelin-Targeted CAR T-Cell Therapy in Patients With Mesothelin-Positive Esophagogastric Adenocarcinoma With Peritoneal Carcinomatosis","Inclusion Criteria:\n\n* Aged ≥18 years\n* Diagnosis of pathologically confirmed EG adenocarcinoma\n* Diagnosis of metastatic or recurrent disease\n* ECOG performance status of 0-1\n* Life expectancy of ≥4 months\n\nInclusion Criteria for Leukapheresis:\n\n* Written informed consent for the study (from participant)\n* Life expectancy of ≥4 months\n* ECOG performance status of 0-1\n* Histologic diagnosis that \\& \\>25% of the tumor expresses MSLN by IHC analysis. Archival tissue obtained up to 2 years before study enrollment is acceptable. IHC testing of a cell block from cytology (e.g., ascitic fluid) is acceptable if approved by the study pathologist. If adequate archival tissue is not available at screening, a fresh tumor biopsy should be obtained\n* Stage IV disease with gross peritoneal carcinomatosis on imaging and\u002For microscopic peritoneal involvement by cytology or noted during diagnostic laparoscopy\n* Disease progression or treatment intolerance after receiving at least 1 treatment regimen in the metastatic setting; patients with disease recurrence within 6 months of completing curative systemic therapy (chemotherapy, chemoradiation or adjuvant immunotherapy) are also eligible\n* Patients with Her2 positive disease must have received ≥1 line of anti-Her2 based therapy\n* At least 1 measurable or evaluable lesion per RECIST 1.1. Screening imaging must be obtained within 6 weeks of signing the informed consent form\n* Completion of systemic therapy at least 7 days before leukapheresis\n\n  o Immune checkpoint inhibitor therapy must be completed at least 14 days before leukapheresis\n* Lab requirements (hematology):\n\n  * Absolute neutrophil count ≥1.0 K\u002FmcL\n  * Hemoglobin ≥9 gm\u002FdL\n  * Platelet count ≥75 K\u002FmcL\n  * Blood product transfusion or growth factor support cannot occur within 7 days of testing\n* Lab requirements (serum chemistry):\n\n  * Bilirubin ≤1.5× upper limit of normal (ULN)\n  * Serum alanine aminotransferase and serum aspartate aminotransferase (ALT\u002FAST) level ≤3× ULN\n  * Calculated clearance of ≥50 mL\u002Fmin by Cockcroft-Gault equation\n* Negative screen for infectious disease markers, including hepatitis B core antibody, hepatitis B surface antigen, hepatitis C antibody, HIV 1-2 antibody, HTLV antibody and syphilis antibody\n\n  o Note: Patients with a history of hepatitis B virus infection are eligible if the hepatitis B viral load is undetectable. Patients with a history of hepatitis C virus infection who were treated for hepatitis C and cured are eligible if the hepatitis C viral load is undetectable\n* Serum pregnancy test with negative result at screening and preconditioning and must be willing to use effective and reliable contraception for at least 12 months after T cell infusion (for female participants of childbearing age)\n* Resolution of all acute toxic effects of any previous therapeutic or palliative chemotherapy, radiotherapy, or surgical procedures to grade ≤1 (CTCAE v5.0), except for neuropathy and alopecia\n\nInclusion Criteria for lymphodepleting chemotherapy\u002FCAR T cell infusion\n\n* Life expectancy of ≥4 months\n* ECOG performance status of 0-1\n* At least 1 measurable or evaluable lesion per RECIST 1.1. Screening imaging must be obtained within 4 weeks before the date of lymphodepletion\n* Completion of systemic therapy at least 14 days before lymphodepleting chemotherapy\n\n  o Immune checkpoint inhibitor therapy must be completed at least 28 days before lymphodepleting chemotherapy\n* Lab requirements (hematology):\n\n  * Absolute neutrophil count ≥1.5 K\u002FmcL\n  * Hemoglobin ≥8 gm\u002FdL\n  * Platelet count ≥75 K\u002FmcL\n* Lab requirements (serum chemistry):\n\n  * Bilirubin ≤1.5× upper limit of normal (ULN)\n  * Serum alanine aminotransferase and serum aspartate aminotransferase (ALT\u002FAST) level ≤3× ULN\n  * Calculated clearance of ≥50 mL\u002Fmin by Cockcroft-Gault equation\n* Serum pregnancy test with negative result within 7 days of planned lymphodepletion date and must be willing to use effective and reliable contraception for at least 12 months after T cell infusion (for female participants of childbearing age)\n* Resolution of all acute toxic effects of any previous therapeutic or palliative chemotherapy, radiotherapy, or surgical procedures to grade ≤1 (CTCAE v5.0), except for neuropathy and alopecia\n\nParticipant Exclusion Criteria\n\nExclusion Criteria for Leukapheresis or Lymphodepleting chemotherapy\u002FCAR T cell infusion: Participants are excluded from enrollment if any of the following criteria apply:\n\n* Pregnant or lactating\n* HIV, active hepatitis C virus, or active hepatitis B virus infection, as determined by quantitative PCR (patients who have undergone negative testing prior to leukapheresis do not require repeat testing)\n* Receiving therapy for concurrent active malignancy\n\n  * Note: Patients receiving treatment for in situ skin malignancies are not excluded.\n  * Patients with any malignancy diagnosed \\>3 years before that is thought to be curatively treated and\u002For has a low risk of recurrence are eligible. Patients may continue to receive adjuvant therapy at the time of study enrollment (e.g., adjuvant hormonal therapy for curatively treated breast cancer).\n* Known hematologic malignancy requiring treatment in the preceding 5 years or a known history of lymphoid malignancy\n* Previous receipt of CAR T cell therapy or any other cellular therapy\n* Previous mesothelin-directed therapy Any major abdominal surgery (laparotomy with resection of gastrointestinal tract or organ resection) that is completed \\<28 days before study enrollment. Patients who have undergone diagnostic laparoscopy can be included in the study without regard to timing\n* Untreated or active central nervous system (CNS) metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control). Patients with a history of treated CNS metastases are eligible if all of the following criteria are met:\n\n  * Radiographic demonstration of improvement upon completion of CNS-directed therapy and no evidence of interim progression between completion of CNS-directed therapy and the screening radiographic study\n  * Completion of radiotherapy ≥4 weeks before the screening radiographic study\n* Active autoimmune disease that has required systemic treatment within 1 year before leukapheresis (with the use of disease-modifying agents, corticosteroids, or immunosuppressive drugs)\n\n  o Note: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.\n* Receiving daily systemic corticosteroids ≥10 mg of prednisone daily or equivalent or receiving immunosuppressive or immunomodulatory treatment\n* Any of the following cardiac conditions:\n\n  * New York Heart Association stage III or IV congestive heart failure\n  * Myocardial infarction ≤6 months before enrollment\n  * History of myocarditis\n  * Serious uncontrolled cardiac arrhythmia, unstable angina, or uncontrolled infection\n  * Left ventricular ejection fraction ≤40%\n* Active interstitial lung disease\u002Fpneumonitis or a history of interstitial lung disease\u002Fpneumonitis requiring treatment with systemic steroids\n* Baseline pulse oximetry \\<90% on room air at the screening time point\n* Known active infection requiring antibiotic treatment 7 days before leukapheresis\n\n  o Note: Treatment can be delayed at the discretion of the treating physician to allow the patient to recover from the infection.\n* Any other medical condition, e.g. fever \\>38.0 degrees C, that, in the opinion of the PI, may interfere with the subject's participation in or compliance with the study\n* Receipt of live, attenuated vaccine within 8 weeks before the planned lymphodepleting chemotherapy date\n* Deemed to be noncompliant by the study team for administration of a high-risk treatment agent and for close follow-up after treatment as required by the protocol",{"count":463,"type":22},18,[60],"Participants will have a sample of their white blood cells, called T cells, collected using a procedure called leukapheresis. The collected T cells will be sent to a laboratory at Memorial Sloan Kettering to be changed (modified) to become MSLN-targeted CAR T cells, the CAR T-cell therapy that participants will receive during the study. Participant study therapy will take about 3-4 weeks.",[467,468,469,470,471,30,472,473],"Mesothelin Positive","Mesothelin-Expressing Tumors","Esophageal Adenocarcinoma","Esophageal Adenocarcinomas","Esophagogastric Adenocarcinoma","Breast Neoplasms","Diabetes Mellitus",[475,476,477,478,479,480,481,482],"mesothelin positive","mesothelin-expressing tumors","esophageal adenocarcinoma","esophageal adenocarcinomas","esophagastric adenocarcinoma","peritoneal carcinomatosis","CAR T-Cell Therapy","24-214","2026-02-09",{"date":485,"type":40},"2026-02-11",{"date":487,"type":40},"2024-09-30",{"date":489,"type":22},"2028-09-30",{"name":491,"class":47},"Memorial Sloan Kettering Cancer Center",7,{"id":494,"slug":495,"hasResults":12,"nctId":496,"briefTitle":497,"officialTitle":498,"acronym":499,"eligibilityCriteria":500,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":501,"targetDuration":4,"studyType":23,"phases":502,"briefSummary":503,"conditions":504,"keywords":507,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":512,"lastUpdatePostDateStruct":513,"startDateStruct":515,"completionDateStruct":517,"leadSponsor":519,"locationsCount":48},"100364414","impact-of-cardiac-coherence-on-anxiety-in-patients-operated-on-for-a-peritoneal-carcinosis-100364414","NCT04024917","Impact of Cardiac Coherence on Anxiety in Patients Operated on for a Peritoneal Carcinosis","Implementation of a Cardiac Coherence Program to Reduce Anxiety in Patients With Peritoneal Carcinosis Treated by Surgery: Randomized Pilot Study","COCOON","Inclusion Criteria:\n\n1. Age over 18 years\n2. Patients with peritoneal carcinosis awaiting cytoreductive surgery\n3. Patients who scored strictly above 3 on the visual analogue anxiety scale and\u002For the psychological distress scale\n4. Patients with sufficient command of the French language\n5. Patient affiliated to a French social security system\n6. Patient hospitalized at the Institute of cancer of Montpellier the day before his cytoreductive surgery (at T1 = D-1)\n7. Signing of informed consent before any specific trial procedure\n\nExclusion Criteria:\n\n1. Patients who already have daily practice of cardiac coherence\n2. Presence of proven psychiatric disorders (e.g., mental retardation, psychotic disorders, learning disabilities, attention deficit\u002Fhyperactivity, bipolar disorder, etc.) other than mood disorders that are reactive to the disease experience, or receiving psychotic treatment that may impair thinking, judgment or discernment\n3. Physical or sensory inability to respond to questionnaires\n4. Patients who have had a heart transplant or bypass surgery in the Year before surgery\n5. Patient with a history of uncontrolled neurological pathology within the last 6 months before inclusion in the trial\n6. Patients with a history of psychoactive substance dependence (excluding smoking) in the last 6 months before inclusion in the trial\n7. Patients with brain metastases\n8. Known natural bradycardia 50 beats per minute\n9. Beta-blocker intake in progress\n10. Ongoing cardiac arrhythmias\n11. Known severe heart failure with ventricular ejection fraction strictly Below 40 %\n12. Chronic uncontrolled pain and making it difficult to practice the technique\n13. Patient with chronic obstructive pulmonary disease\n14. Legal incapacity (patient under guardianship or curatorship)",{"count":58,"type":22},[327],"The investigator proposes to use the cardiac coherence technique to diminish anxiety before the surgery of a peritoneal carcinosis of colon or stomach or ovary and pseudomyxoma or peritoneal mesothelioma.",[30,505,506],"Pseudomyxoma Peritonei","Mesothelioma Peritoneum",[508,509,510,511],"Colon","Rectum","Stomach","Ovary","2026-01-15",{"date":514,"type":40},"2026-01-16",{"date":516,"type":40},"2021-09-21",{"date":518,"type":22},"2026-12",{"name":520,"class":47},"Institut du Cancer de Montpellier - Val d'Aurelle",{"id":522,"slug":523,"hasResults":12,"nctId":524,"briefTitle":525,"officialTitle":526,"acronym":4,"eligibilityCriteria":527,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":528,"targetDuration":4,"studyType":23,"phases":530,"briefSummary":531,"conditions":532,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":557,"lastUpdatePostDateStruct":558,"startDateStruct":560,"completionDateStruct":562,"leadSponsor":564,"locationsCount":566},"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":529,"type":22},49,[60],"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.",[533,534,535,536,537,538,539,184,540,179,541,30,542,543,544,545,546,547,548,549,550,551,552,553,554,555,556],"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 Colorectal 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 Colorectal Cancer 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":559,"type":40},"2025-12-10",{"date":561,"type":40},"2020-08-21",{"date":563,"type":22},"2028-01-05",{"name":565,"class":47},"City of Hope Medical Center",3,{"id":568,"slug":569,"hasResults":12,"nctId":570,"briefTitle":571,"officialTitle":571,"acronym":4,"eligibilityCriteria":572,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":573,"targetDuration":4,"studyType":23,"phases":575,"briefSummary":576,"conditions":577,"keywords":579,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":580,"lastUpdatePostDateStruct":581,"startDateStruct":583,"completionDateStruct":585,"leadSponsor":586,"locationsCount":48},"100504175","patient-derived-vascularized-microtumor-model-of-gastrointestinal-peritoneal-carcinomatosis-100504175","NCT05844865","Patient Derived Vascularized MicroTumor Model of Gastrointestinal Peritoneal Carcinomatosis","Inclusion Criteria:\n\n* Patients must have a GI tumor\n* Must have planned standard of care surgical procedure\n* Age ≥ 18 years.\n* Ability to understand and the willingness to sign a written informed consent\n\nExclusion Criteria:\n\n\\- Pattens who are unable to comply with the study protocol",{"count":574,"type":22},20,[327],"This is a pilot study gathering and using samples and data from patients with gastrointestinal peritoneal carcinomatosis. Participants will be asked for permission to provide blood and ascites\u002Fperitoneal wash fluid, tumor samples during their planned surgical procedure.",[30,578],"Gastrointestinal Peritoneal Carcinomatosis",[30,578],"2025-07-24",{"date":582,"type":40},"2025-07-29",{"date":584,"type":40},"2023-05-04",{"date":518,"type":22},{"name":428,"class":47},{"id":588,"slug":4,"hasResults":12,"nctId":589,"briefTitle":590,"officialTitle":591,"acronym":592,"eligibilityCriteria":593,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":594,"targetDuration":4,"studyType":23,"phases":596,"briefSummary":597,"conditions":598,"keywords":603,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":615,"lastUpdatePostDateStruct":616,"startDateStruct":618,"completionDateStruct":620,"leadSponsor":622,"locationsCount":48},"100460602","NCT05277766","Intraperitoneal Aerosolized Nanoliposomal Irinotecan (Nal-IRI) in Peritoneal Carcinomatosis From Gastrointestinal Cancer","Intraperitoneal Aerosolized Nanoliposomal Irinotecan (Nal-IRI) in Peritoneal Carcinomatosis From Gastrointestinal Cancer: a Phase I Study","PIPAC-NAL-IRI","Inclusion Criteria:\n\n* Biopsy proven cancer of the pancreas, gallbladder or biliary tract, stomach, small bowel, colon, rectum, or appendix with extensive or irresectable peritoneal carcinomatosis\n* Estimated life expectancy \\> 6 months; \\> 3 months if primary cancer is pancreatic\n* Age ≥ 18 years\n* Adequate performance status (Karnofsky index \\> 60% and WHO performance status \\\u003C 2)\n* Written informed consent obtained prior any act of the research\n\nExclusion Criteria:\n\n* Concomitant systemic (IV) treatment with irinotecan (either as monotherapy or as part of a combination regimen such as FOLFIRI, CAPIRI, or FOLFOXIRI)\n* Pregnancy or breastfeeding during the clinical study\n* Patients of childbearing age unable or unwilling to provide effective contraception during the study and until the end of relevant exposure (extended by 30 days (female participants) or 120 days (male participants) since the IMP is genotoxic).\n* Known allergy or intolerance to irinotecan\n* Significant amount of ascites detectable (exceeding 3l in volume)\n* Intestinal or urinary tract obstruction\n* Extensive hepatic and\u002For extra-abdominal metastatic disease\n* Impaired renal function (serum creatinine \\> 1.5 mg\u002Fdl or calculated GFR (CKD-EPI) \\\u003C 60 mL\u002Fmin\u002F1.73 m²\n* Impaired liver function (serum total bilirubin \\> 1.5 mg\u002Fdl, except for known Gilbert's disease)\n* Platelet count \\\u003C 100.000\u002Fµl\n* Hemoglobin \\\u003C 9g\u002Fdl\n* Neutrophil granulocytes \\\u003C 1.500\u002Fml\n* Patients known to use:\n\n  * CYP3A4 inducers (rifampin, phenytoin, carbamazepine, rifabutin, rifapentine, phenobarbital, St John's wort)\n  * inhibitors of CYP3A4 (clarithromycin, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telaprevir, voriconazole) or UGT1A1 (atazanavir, gemfibrozil, indinavir, regorafenib)",{"count":595,"type":22},45,[60],"The PIPAC NAL-IRI study is designed to examine the maximal tolerated dose of nanoliposomal irinotecan (Nal-IRI, Onivyde) administered with repeated pressurized intraperitoneal aerosol chemotherapy (PIPAC), in a monocentric, phase I trial.",[30,249,68,599,600,132,601,602],"Small Bowel Cancer","Appendix Cancer","Pancreatic Cancer","Bile Duct Cancer",[190,604,253,605,363,606,607,608,609,223,610,365,611,612,613,614,254],"Nal-IRI","dose-finding study","pharmacodynamics","safety and efficacy","Onivyde","Primary gastrointestinal cancer","Small bowel cancer","Stomach cancer","Pancreatic cancer","Cholangiocarcinoma","dose-escalation study","2025-06-26",{"date":617,"type":40},"2025-07-01",{"date":619,"type":40},"2022-11-21",{"date":621,"type":22},"2027-04",{"name":623,"class":47},"University Hospital, Ghent",{"id":625,"slug":626,"hasResults":12,"nctId":627,"briefTitle":628,"officialTitle":628,"acronym":629,"eligibilityCriteria":630,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":631,"targetDuration":4,"studyType":633,"phases":4,"briefSummary":634,"conditions":635,"keywords":637,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":639,"lastUpdatePostDateStruct":640,"startDateStruct":642,"completionDateStruct":644,"leadSponsor":646,"locationsCount":345},"100489379","response-prediction-of-hyperthermic-intraperitoneal-chemotherapy-in-gastro--intestinal-cancer-100489379","NCT05652348","Response Prediction of Hyperthermic Intraperitoneal Chemotherapy in Gastro- Intestinal Cancer","Hi-STEP1","Inclusion Criteria:\n\n* (Suspected) synchronous or metachronous peritoneal metastasis of adenocarcinoma of the stomach \u002F gastroesophageal junction (GEJ) or of the colon or rectum\n* intraoperative histological confirmation of synchronous or metachronous peritoneal carcinomatosis in gastric carcinoma (incl. GEJ) or colon carcinoma (incl. rectal carcinoma)\n* Intraoperative peritoneal cancer index (PCI) ≤ 15 for gastric carcinoma and ≤ 20 for colon carcinoma.\n* Possibility of surgical resection of peritoneal carcinomatosis (cytoreductive surgery) in curative intention with achievement of a Completeness of Cytoreduction Score (CCS) of 0-1\n* No contraindication to surgery\n* No contraindication against the performance of HIPEC\n* Expected survival of 6 months at least\n* ECOG ≤ 2\n* Female and male patients ≥ 18 years of age\n* Patient is able and willing to give written informed consent and comply with the study protocol\n\nExclusion Criteria:\n\n* Presence of non-resectable distant metastases\n* Patients with extensive metastasis (e.g., multiple bilobular liver metastases, hepatic and pulmonary metastases, multiple retroperitoneal lymph node metastases; oligometastasis is allowed)\n* Patients with recurrence of peritoneal carcinomatosis (e.g., previous peritonectomy in the course of primary tumor resection)\n* Patients after previous palliative chemotherapy or radiation of the tumor (exception: neoadjuvant and\u002For adjuvant therapies)\n* Hypersensitivity\u002Fallergy to components of the planned intraperitoneal chemotherapy\n* Patients not eligible for surgery\u002FHIPEC (e.g., heart failure NYHA ≥III, myocardial infarction within the last 3 months before surgery, high-risk cardiac arrhythmias)\n* Secondary malignant disease that occurred \\\u003C5 years ago (exception: early stage of a localized tumor with in-sano resection, for example in situ carcinoma of the cervix, Adequately treated basal cell carcinoma of the skin)\n* Patients who are housed in a closed facility\n* Pregnant or breastfeeding patients, or patients who plan to become pregnant within 7 Months after the end of treatment to become pregnant",{"count":632,"type":22},48,"OBSERVATIONAL","Patients with gastric or colon cancer with peritoneal carcinomatosis will receive a biopsy of the tumor during their primary curative surgery. The operation is performed according to standard and includes resection of the primary tumor and any metastases and followed by HIPEC (Intraperitoneal hyperthermic chemoperfusion) according to the respective hospital standard. Organoid cultures from the biopsies are established in the research laboratory.\n\nVarious chemotherapeutic agents are tested on these tumor organoids in the laboratory and the tumor organoids are analyzed in detail with regard to genetic alterations in order to find alterations that can be addressed, if necessary, by means of targeted drugs against peritoneal carcinomatosis.",[132,636,30],"Colon Cancer",[638],"Organoid","2025-05-27",{"date":641,"type":40},"2025-05-29",{"date":643,"type":40},"2022-12-08",{"date":645,"type":22},"2028-12-31",{"name":647,"class":47},"Technische Universität Dresden",{"id":649,"slug":650,"hasResults":12,"nctId":651,"briefTitle":652,"officialTitle":653,"acronym":654,"eligibilityCriteria":655,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":656,"targetDuration":4,"studyType":23,"phases":658,"briefSummary":659,"conditions":660,"keywords":662,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":671,"lastUpdatePostDateStruct":672,"startDateStruct":674,"completionDateStruct":676,"leadSponsor":678,"locationsCount":48},"100520846","ga68-fapi-46-petct-for-preoperative-assessment-of-peritoneal-carcinomatosis-100520846","NCT06061874","Ga68-FAPI-46 PET\u002FCT for Preoperative Assessment of Peritoneal Carcinomatosis","Ga68-labeled Fibroblast Activation Protein Inhibitor-46 (Ga68-FAPI-46) PET\u002FCT for Preoperative Assessment of Peritoneal Carcinomatosis","FAPeCa","Inclusion Criteria:\n\n* Histologically proven colorectal and ovarian cancer.\n* Known or suspected peritoneal metastases from the tumour of origin.\n* Scheduled for peritoneal complete cytoreductive surgery with curative intent with or without neoadjuvant chemotherapy.\n* ECOG (Eastern Cooperative Oncology Group) Performance status ≤2.\n* Signed written informed consent obtained before any study-specific screening procedures.\n\nExclusion Criteria:\n\n* Non-resectable extra-abdominal metastasis and\u002For \\>3 hepatic metastases on standard work-up\n* Known chronic inflammatory conditions including the intestinal system (eg. inflammatory bowel disease, Crohn's disease)\n* Pregnant and lactating women\n* Previous or concurrent malignancy diagnosed within the last 3 years except adequately treated in situ carcinoma of the cervix uteri and basal or squamous cell skin cancer.\n* Subjects with another significant medical condition which, in the investigator's opinion, may interfere with the completion of the study.",{"count":657,"type":22},80,[327],"This is a prospective, phase II, non-randomized clinical imaging trial. Ga68-FAPI-46 is a novel radiotracer used in PET\u002FCT imaging, targeting a protein of the tumor microenvironment called FAP (Fibroblast activation protein).\n\nThe aim of the study is to assess the accuracy of Ga68-FAPI-46 PET\u002FCT for preoperative assessment of peritoneal carcinomatosis in colorectal and ovarian cancer.",[661,30],"Cancer",[359,663,480,664,665,666,667,668,669,670],"ovarian cancer","fibroblast activation protein inhibitor","positron emission tomography","FAPI-46","PET","FAPI","PET\u002FCT","fibroblast activation protein","2025-03-26",{"date":673,"type":40},"2025-03-31",{"date":675,"type":40},"2023-05-30",{"date":677,"type":22},"2025-12",{"name":679,"class":47},"Jules Bordet Institute",{"id":681,"slug":682,"hasResults":12,"nctId":683,"briefTitle":684,"officialTitle":685,"acronym":686,"eligibilityCriteria":687,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":688,"targetDuration":4,"studyType":23,"phases":690,"briefSummary":692,"conditions":693,"keywords":694,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":698,"lastUpdatePostDateStruct":699,"startDateStruct":701,"completionDateStruct":703,"leadSponsor":705,"locationsCount":707},"100458517","phase-4-clinical-trial-on-hipec-with-mitomycin-c-in-colon-cancer-peritoneal-metastases-gecop-mmc-100458517","NCT05250648","Clinical Trial on HIPEC With Mitomycin C in Colon Cancer Peritoneal Metastases (GECOP-MMC)","Phase IV Multicentric Clinical Trial to Evaluate the Efficacy of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) With Mytomicin-C After Complete Surgical Cytoreduction in Patients With Colon Cancer Peritoneal Metastases","GECOP-MMC","Inclusion Criteria:\n\n1. Histologically confirmed colon adenocarcinoma, except signet ring cell carcinomas (those with \\> 50% of the tumor composed of these cells, which comprise only 1% of all colon adenocarcinomas).\n2. Absence of previously treated or current extraperitoneal metastases, including distant lymphadenopathy (retroperitoneal, mediastinal, etc), liver metastases, or lung metastases (ruled out by PET-scan in case of doubt).\n3. Synchronous or metachronous peritoneal metastasis of mild to moderate volume, with a PCI ≤ 20 (Appendix 2) (intraoperative confirmation).\n4. Macroscopically complete surgical cytoreduction CCS-0 (intraoperative confirmation).\n5. Treatment with perioperative systemic chemotherapy (SCT), before and\u002For after surgical procedure.\n6. Age\\> 18 years.\n7. Acceptable anesthetic\u002Fsurgical risk: ASA 1-3 (Appendix 3), ECOG 0-1 (Appendix 4). No severe alterations in hematological, renal, cardiac, pulmonary or hepatic function (operable patients).\n8. Information to the patient and signing of a study-specific informed consent.\n\nExclusion Criteria:\n\n1. Peritoneal carcinomatosis of any other origin, particularly rectal cancer or appendicular adenocarcinoma, or signet ring cell colon cancer on histology.\n2. No intraoperative confirmation of peritoneal disease (PCI 0). Likewise, cases of perianastomotic (local) or lymph node (locoregional) recurrences will be excluded.\n3. High volume peritoneal disease with a PCI\\> 20 (intraoperative evaluation).\n4. Concurrent or previously treated extraperitoneal disease.\n5. Disease progression during preoperative chemotherapy, if received.\n6. Patients previously treated with HIPEC.\n7. History of other cancers (except cutaneous basal cell carcinoma or cervix carcinoma in situ) in the 5 years prior to entry into the study.\n8. Patients included in another first-line clinical trial for the studied disease.\n9. Pregnancy (or suspicion of it) or lactation period.\n10. Emergency surgical intervention for obstruction or perforation of a primary tumour with synchronous PM (although rescue and secondary CRS + HIPEC after emergency surgery of the primary tumour are acceptable if inclusion criteria are fulfilled).\n11. Persons deprived of liberty or under legal or administrative supervision.\n12. Inability to understand the nature of the intervention, the risks, benefits, expected evolution and the need to undergo periodic medical examinations, either for geographical, social or psychological reasons.",{"count":689,"type":22},216,[691],"PHASE4","The aim of this study is to assess whether there are differences in PERITONEAL RECURRENCE in patients with Colon Cancer Peritoneal Metastases treated with complete surgical resection and systemic chemotherapy, with (Group 1) or without (Group 2) HIPEC with Mitomycin-C.",[30,636],[332,695,696,697],"Mitomycin","Colon Neoplasms","Peritoneal metastasis","2024-10-06",{"date":700,"type":40},"2024-10-09",{"date":702,"type":40},"2022-03-02",{"date":704,"type":22},"2029-10",{"name":706,"class":47},"Hospital Universitario de Fuenlabrada",31,{"id":709,"slug":4,"hasResults":12,"nctId":710,"briefTitle":711,"officialTitle":712,"acronym":4,"eligibilityCriteria":713,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":714,"targetDuration":4,"studyType":23,"phases":715,"briefSummary":716,"conditions":717,"keywords":718,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":721,"lastUpdatePostDateStruct":722,"startDateStruct":724,"completionDateStruct":726,"leadSponsor":728,"locationsCount":345},"100493092","NCT05700656","Galunisertib Combined With Capecitabine in Advanced CRC With PM","Phase I\u002FII Study With Galunisertib Combined With Capecitabine in Patients With Advanced Chemotherapy Resistant Colorectal Cancer With Peritoneal Metastases","Inclusion Criteria:\n\n1. Histological or cytological proof of CRC with at least confirmed peritoneal metastases (presence of additional extraperitoneal metastases is allowed);\n2. Disease progression or relapse upon treatment for advanced CRC with fluoropyrimidine containing chemotherapy as single agent or in combination with other anti-cancer drugs, with no treatment options at time of inclusion (combinations with oxaliplatin, irinotecan, bevacizumab and cetuximab\u002Fpanitumumab are allowed);\n3. Age ≥ 18 years;\n4. Able and willing to give written informed consent and informed consent form must have been signed before start of the trial;\n5. WHO performance status of ≤1;\n6. Able and willing to undergo blood sampling for PK analysis;\n7. Able and willing to undergo tumor biopsy before start, during treatment and at the end of treatment;\n8. Life expectancy \\> 3 months allowing adequate follow up of toxicity and anti-tumor activity;\n9. Evaluable disease according to RECIST 1.1 criteria (measurable disease for the phase II part; evaluable disease is sufficient for the phase I part);\n10. Minimal acceptable safety laboratory values\n\n    1. ANC of ≥1.5 x 109\u002FL\n    2. Platelet count of ≥100 x 109\u002FL\n    3. Hepatic function as defined by serum bilirubin ≤ 1.5 x ULN, ALAT and ASAT ≤ 3.0 x ULN, or ALAT and ASAT \\\u003C 5 x ULN in patients with liver metastases\n    4. Renal function as defined by serum creatinine ≤ 1.5 x ULN\n    5. Creatinine clearance ≥ 50 ml\u002Fmin (by Cockcroft-Gault formula or MDRD);\n11. Negative pregnancy test (urine or serum) for female patients with childbearing potential.\n12. Able and willing to swallow tablets.\n\nExclusion Criteria:\n\n1. Any treatment with investigational drugs within 30 days prior to receiving the first dose of investigational treatment and\u002For radio- or chemotherapy within the last 2 weeks prior to receiving the first dose of investigational treatment. Palliative radiation (1x 8Gy) is allowed; except radiotherapy focused on the liver;\n2. Known or suspected complete or partial dihydropyrimidine dehydrogenase deficiency (Mutant for DPD\\*2A genotype, 1236G\\>A genotype, 1679T\\>G genotype and 2846A\\>T genotype);\n3. Symptomatic or untreated leptomeningeal disease;\n4. Symptomatic brain metastasis. Patients previously treated or untreated for these conditions that are asymptomatic in the absence of corticosteroid therapy are allowed to enrol. Brain metastasis must be stable with verification by imaging (e.g.\n\n   brain MRI or CT completed at screening demonstrating no current evidence of progressive brain metastases). Patients are not permitted to receive enzyme inducing anti-epileptic drugs or corticosteroids;\n5. History of cardiac disease, including myocardial infarction within 6 months before first dose of study medication, unstable angina pectoris, New York Heart Association Class III\u002FIV congestive heart failure, or uncontrolled hypertension, major cardiac abnormalities, a predisposition for developing aneurysms including family history of aneurysms, Marfan syndrome, bicuspid aortic valve, or evidence of damage to the large vessels of the heart;\n6. Treatment with CYP3A4 inducers or inhibitors and\u002For concomitant treatment with CYP2C9 substrates with narrow therapeutic window, including but not limited to vitamin K antagonizing anticoagulants (e.g. acenocoumarol, phenprocoumon and warfarin) and phenytoin is not allowed;\n7. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral galunisertib (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, major small bowel surgery);\n8. Woman who are pregnant or breast feeding;\n9. Patients who have undergone any major surgery within the last 2 weeks prior to starting study drug or who would not have fully recovered from previous surgery;\n10. Active infection requiring systemic antibiotics or uncontrolled infectious disease;\n11. Patients with a known history of hepatitis B or C or known Human Immunodeficiency Virus HIV-1 or HIV-2 type patients;\n12. Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or that may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for the study;\n13. Known hypersensitivity to one of the study drugs or excipients.\n14. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods with a failure rate of \\\u003C1% per year (when used consistently and correctly) during the treatment period and for at least 90 days after the last dose of galunisertib and\u002For capecitabine.\n15. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm.",{"count":707,"type":22},[60,25],"This is a two-center open-label non-randomized proof of principle study consisting of a dose-finding part (phase I) and phase II study with Simon two-stage design investigating the anti-tumor activity of the combination of capecitabine and galunisertib in patients with colorectal cancer with peritoneal metastases.",[275,30],[359,719,720],"metastatic colorectal cancer","peritonitis carcinomatosa","2024-07-19",{"date":723,"type":40},"2024-07-22",{"date":725,"type":40},"2023-07-28",{"date":727,"type":22},"2025-04",{"name":729,"class":47},"The Netherlands Cancer Institute",{"id":731,"slug":732,"hasResults":12,"nctId":733,"briefTitle":734,"officialTitle":735,"acronym":332,"eligibilityCriteria":736,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":737,"targetDuration":4,"studyType":633,"phases":4,"briefSummary":739,"conditions":740,"keywords":741,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":743,"lastUpdatePostDateStruct":744,"startDateStruct":746,"completionDateStruct":748,"leadSponsor":750,"locationsCount":48},"100179987","register-with-patients-in-which-hyperthermic-intra-peritoneal-chemotherapy-hipec-was-performed-100179987","NCT01617382","Register With Patients in Which Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) Was Performed","Register With Data From Patients With the Diagnosis of a Peritoneal Surface Malignancy, for Which Cytoreductive Surgery and Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) is Performed","Inclusion Criteria:\n\n* Patients with peritoneal carcinomatosis of colorectal origin, patients with pseudomyxoma peritonei (type DPAM or PMCA) and patients with peritoneal mesothelioma who are planned to undergo cytoreductive surgery and HIPEC because of a peritoneal surface malignancy",{"count":738,"type":22},125,"The purpose of this study is to register the follow-up data of patients who, because of a peritoneal surface malignancy, will undergo cytoreductive surgery and HIPEC.",[30,505,63],[332,742],"Hyperthermic (heated) chemotherapy after debulking","2024-06-25",{"date":745,"type":40},"2024-06-26",{"date":747,"type":4},"2012-05",{"date":749,"type":22},"2028-12",{"name":751,"class":47},"Universitaire Ziekenhuizen KU Leuven"]