[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"peritoneal-metastatic-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:peritoneal-metastatic-cancer":241},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,42,76,107,135,160,195,226],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100599051","phase-2-comparing-18f-fapi-pet-guided-abdominal-radiotherapy-combined-with-second-line-standard-therapy-and-cadonilimab-versus-second-line-standard-therapy-in-colorectal-cancer-with-peritoneal-metastasis-100599051",false,"NCT07079462","Comparing 18F-FAPI PET-Guided Abdominal Radiotherapy Combined With Second-Line Standard Therapy and Cadonilimab Versus Second-Line Standard Therapy in Colorectal Cancer With Peritoneal Metastasis","A Prospective Randomized Controlled Study Comparing 18F-FAPI PET-Guided Abdominal Radiotherapy Combined With Second-Line Standard Therapy and Cadonilimab Versus Second-Line Standard Therapy in Colorectal Cancer With Peritoneal Metastasis","Inclusion Criteria:\n\n* 1\\. Age of 18 years or older. 2. Peritoneal metastasis of colorectal cancer confirmed by histological or cytological examination (International Union Against Cancer 8th edition of colorectal cancer staging).\n\n  3\\. Progression after receiving standard first-line treatment before enrollment; but excluding any type of immunotherapy.\n\n  4\\. Eastern Cooperative Oncology Group (ECOG) score of 0-1, with an expected survival time of more than 6 months.\n\n  5\\. ECOG score of 0-1. 6. Expected survival time of ≥ 24 weeks. 7. Laboratory tests for bone marrow, liver and kidney organ functions and coagulation function within 7 days before the first administration were in compliance with the study requirements (no blood transfusion, blood products, use of granulocyte colony-stimulating factor or other hematopoietic stimulating factors for correction within 7 days before the laboratory tests).\n\n  8\\. Women with reproductive capacity must have a negative blood pregnancy test result within 7 days before the first administration. Male or female patients with reproductive capacity voluntarily use effective contraceptive methods during the study period and within 6 months after the last study medication, such as double barrier contraceptive methods, condoms, oral or injectable contraceptive drugs, intrauterine devices, abstinence, etc. All female patients will be considered to have reproductive capacity, unless the female patient has naturally menopause, artificial menopause or sterilization (uterus removal, bilateral ovary removal).\n\n  9\\. Voluntary enrollment and signing of informed consent form, following the trial treatment plan and visit schedule.\n\nExclusion Criteria:\n\n* 1\\. Absolute neutrophil count (ANC) \\\u003C 1.5 × 109\u002FL, or platelet count \\\u003C 100 × 109\u002FL (for patients with liver metastasis, platelet count \\\u003C 80 × 109\u002FL), or hemoglobin \\\u003C 9 g\u002FdL; blood transfusion within 2 weeks prior to enrollment is not allowed to meet the inclusion criteria.\n\n  2\\. Serum total bilirubin \\> 1.5 times the upper limit of normal (ULN); for patients with liver metastasis, \\> 2.5 times ULN.\n\n  3\\. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\> 2.5 times ULN, or for patients with liver metastasis, ALT and\u002For AST \\> 5 times ULN.\n\n  4\\. Serum creatinine \\> 1.5 times ULN, or creatinine clearance rate \\\u003C 50 ml\u002Fmin (calculated according to the Cockcroft-Gault formula).\n\n  5\\. Partial thromboplastin time (APTT) or prothrombin time (PT) \\> 1.5 times ULN (based on the normal values of the clinical trial center).\n\n  6\\. The researcher determines clinically significant severe electrolyte abnormalities.\n\n  7\\. Urine protein test of 2+ or above, or 24-hour urine protein quantification ≥ 1.0 g\u002F24h.\n\n  8\\. Hypertension that is not well controlled by medication, defined as: systolic blood pressure \\> 140 mmHg or diastolic blood pressure \\> 90 mmHg.\n\n  9\\. The patient currently has active peptic ulcer, ulcerative colitis, or other digestive tract diseases or active bleeding from an unresected tumor, or the researcher determines that it may cause gastrointestinal bleeding or perforation; or if there was a previous gastrointestinal perforation or gastrointestinal fistula, and the patient has not recovered after surgical treatment.\n\n  10\\. Within 6 months before enrollment, there is a history of arterial thrombosis or deep vein thrombosis, or within 2 months before enrollment, there is evidence or history of bleeding tendency or history of bleeding, regardless of severity.\n\n  11\\. Within 12 months before enrollment, a stroke event or transient ischemic attack occurred.\n\n  12\\. Within 6 months before enrollment, heart disease including congestive heart failure, acute myocardial infarction, severe\u002Funstable angina pectoris or coronary artery bypass surgery; or NYHA class 2 or above heart dysfunction patients; left ventricular ejection fraction (LVEF) \\\u003C 50%.\n\n  13\\. Uncontrolled malignant pleural effusion, ascites or pericardial effusion (defined as not being effectively controlled by diuretics or puncture as determined by the researcher).\n\n  14\\. Any patient who has received any anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody or anti-cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) antibody (or any other antibody acting on the T cell co-stimulation or checkpoint pathways) before enrollment.\n\n  15\\. Within 4 weeks before enrollment, received any form of radiotherapy. 16. At the screening stage, there is a clinically detectable second primary malignant tumor, or other malignant tumors occurred in the past 5 years, excluding fully treated non-melanoma skin cancer, cervical carcinoma in situ and superficial bladder tumor \\[non-invasive tumors, carcinoma in situ and T1 (tumor invasion of the lamina propria)\\], if present.\n\n  17\\. Known clinical significance of liver disease history, including but not limited to known hepatitis B virus (HBV) infection and positive HBV DNA (≥ 1 × 104\u002Fml); known hepatitis C virus (HCV) infection and positive HCV RNA (≥ 1 × 103\u002Fml), or liver cirrhosis, etc.\n\n  18\\. Pregnant or lactating women or women with a possibility of pregnancy who have a positive pregnancy test before the first medication; or female participants who are unwilling to implement strict contraception during the study.\n\nThe researcher considers that the subject has any clinical or laboratory abnormalities or non-compliance issues that make them unsuitable to participate in this clinical study.","ALL","18 Years",{"count":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","Main objective:\n\n1\\. To compare the objective response rate (ORR) of 18F-FAPI PET-guided abdominal region radiotherapy combined with second-line standard treatment versus cabozantinib and second-line standard treatment in the treatment of peritoneal metastasis of colorectal cancer.\n\nSecondary objectives:\n\n1. To compare the disease control rate (DCR), duration of continuous remission (DoR), progression-free survival (PFS) and overall survival (OS) of 18F-FAPI PET-guided abdominal region radiotherapy combined with second-line standard treatment versus cabozantinib and second-line standard treatment in the treatment of peritoneal metastasis of colorectal cancer.\n2. To evaluate the safety and tolerability of 18F-FAPI PET-guided abdominal region radiotherapy combined with second-line standard treatment versus cabozantinib.",[26,27,28],"Colorectal Cancer","Peritoneal (Metastatic) Cancer","FAPI PET","RECRUITING","2026-06-30",{"date":32,"type":33},"2026-07-02","ACTUAL",{"date":35,"type":33},"2024-08-07",{"date":37,"type":20},"2028-01-31",{"name":39,"class":40},"Fudan University","OTHER",2,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":54,"conditions":55,"keywords":59,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":75},"100641183","phase-1-tlr9-immunotherapy-for-peritoneal-carcinomatosis-100641183","NCT07658196","TLR9 Immunotherapy for Peritoneal Carcinomatosis","TLR9 Immunotherapy for Peritoneal Carcinomatosis (TIPC) - Phase 1 Study of the Safety and Efficacy of ACM-CpG Intraperitoneal Injections for Treatment in Patients With Colorectal or Appendiceal Adenocarcinoma Peritoneal Metastases or Malignant Ascites","TIPC","Inclusion Criteria:\n\n* Patients eligible for inclusion in this study must meet all of the following criteria:\n\n  1. Male or female patients age ≥ 18 years of age at the time of informed consent\n  2. Must be able to provide written informed consent, stating an understanding of the procedures and investigational nature of the study treatment, and willingness to comply with study requirements\n  3. Must have documented CRC or appendiceal adenocarcinoma peritoneal carcinomatosis or malignant ascites. Primary tumor may be intact and limited liver and\u002For lung disease is permitted\n  4. Must have evaluable disease by physical examination, serum tumor markers, radiologic assessment, or laparoscopic visual assessment\n  5. Must have a life expectancy of ≥ 12 weeks as estimated by the investigator\n  6. Must have an ECOG status of ≤ 2\n  7. Patients with acceptable laboratory values defined as:\n\n     * Estimated creatinine clearance (calculated using Cockcroft-Gault formula, or measured) ≥ 60 mL\u002Fmin, not dialysis dependent\n     * Total bilirubin ≤ 1.5 mg\u002Fdl, unless elevated bilirubin is clearly related to Gilbert syndrome (and total bilirubin \\\u003C 6.0 mg\u002Fdl)\n     * Alanine aminotransferase (ALT) ≤ 3.5 x upper limit of normal (ULN)\n     * Aspartate aminotransferase (AST) ≤ 3.5 x ULN\n     * Absolute neutrophil count \\> 1.0 x 109\u002FL (must be independent of blood product administration)\n     * Platelet count \\> 100 x 109\u002FL (must be independent of blood product administration)\n     * Hemoglobin ≥ 8 g\u002FdL (must be independent of blood product administration)\n  8. Surgically sterile patients or patients of childbearing potential (CBP) who agree to use highly effective methods of contraception during study dosing and for 6 months after last dose of study drug\n  9. All other relevant medical conditions must be well-managed and stable, in the opinion of the investigator, for at least 28 days prior to administration of study drug\n\nExclusion Criteria:\n\n1. Has received prior TLR9 therapy\n2. Has received chemotherapy, radiotherapy, or biological cancer therapy within 21 days or 5 half-lives (whichever is shorter) of the start of treatment\n3. Has received an investigational agent within 28 days of the start of treatment\n4. Has received a commercial vaccine (flu, COVID, etc.) within 2 weeks of C1D1\n5. Has any unresolved toxicity ≥ Grade 2 from previous anti-cancer therapy, except for stable chronic toxicities (≤ Grade 3) that are not expected to resolve\n6. Has a history of histologically confirmed metastases outside of the peritoneal cavity, liver, or lungs\n7. Has high volume liver or lung metastases, defined as \\> 50% replacement of the liver volume by metastatic disease or \\> 5 lung lesions greater than 1 cm in size\n8. Tumor causing biliary obstruction not amenable to stenting or percutaneous drainage\n9. Ongoing or untreated intra-abdominal infection or bowel obstruction\n10. Has known, clinically active Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV) (Note: Testing is not required)\n11. Receiving continuous systemic corticosteroid therapy (≥ 10 mg\u002Fday of prednisolone or equivalent)\n12. Clinically significant cardiac disease or impaired cardiac function, including any of the following:\n\n    * A history of newly diagnosed transmural myocardial infarction, cerebral infarction, or pulmonary embolism within 6 months, except those approved by the medical monitor\n    * A history of newly diagnosed deep vein thrombosis (DVT) within 3 months\n    * Left ventricular ejection fraction (LVEF) \\\u003C 50%\n    * QTc \\>480 msec\n13. Active bacterial, viral, or fungal infection: patients with ongoing use of prophylactic antibiotics, antiviral agents, or antifungal agents remain eligible as long as there is no evidence of active infection\n14. Other active malignancy within 2 years excluding cutaneous squamous or basal cell carcinomas\n15. Any medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns, compliance with clinical study procedures or interpretation of study results\n16. History of hypersensitivity to TLR9 agonists\n17. Pregnant, likely to become pregnant, or lactating women (where pregnancy is defined as the state of a female after conception and until the termination of gestation)",{"count":51,"type":20},24,[53],"PHASE1","The goal of this clinical trial is to determine the safety and efficacy of of ACM-CpG for inoperable peritoneal metastases or malignant ascites. The main questions it aims to answer are:\n\n• To determine the safety and maximum tolerated dose (MTD) or optimal biologic dose (OBD) of intraperitoneal injection(s) of ACM-CpG for inoperable peritoneal metastases or malignant ascites? Researchers will assign treatment levels using escalating doses of ACM-CpG Therapy.\n\nParticipants will:\n\n* Will receive at least one dose of ACM-CpG therapy on Day 1 of a 28-day treatment cycle.\n* May receive up to 2 additional injections if they have clinically stable or responsive disease.\n* Must visit the clinic on Days 1, 4, 7, 10, 14, 21, and 28 for checkups and tests.\n* Will have a CT scan or MRI performed every 8 weeks for 3 scans and then continue to receive scans every 12 weeks to monitor their disease.",[56,57,27,58],"Malignant Ascites","Colorectal Adenocarcinoma","Appendiceal Adenocarcinoma",[60,61,62,56,63,58,64],"Metastatic disease must be primarily located in the peritoneal cavity","ACM-CpG","TLR9","Peritoneal Carcinomatosis,","CRC","NOT_YET_RECRUITING","2026-06-16",{"date":68,"type":33},"2026-06-18",{"date":70,"type":20},"2026-07",{"date":72,"type":20},"2030-07",{"name":74,"class":40},"Brown University",1,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":21,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":106},"100630880","to-evaluate-the-feasibility-and-safety-of-combining-surgery-pancreatectomy-and-cytoreduction-with-hipec-for-treating-pancreatic-cancer-with-peritoneal-involvement-100630880","NCT07493421","To Evaluate the Feasibility and Safety of Combining Surgery (Pancreatectomy and Cytoreduction) With HIPEC for Treating Pancreatic Cancer With Peritoneal Involvement.","Cytoreductive Surgery and HIPEC for Pancreatic Cancer With Peritoneal Metastasis - IGNIS Trial","Inclusion Criteria:\n\n* Pancreatic adenocarcinoma\n* Histologically confirmed peritoneal metastasis\n* Excluded other sites of metastasis (except ovary)\n* PCI less than or equal to 6\n* Age \\> 18 years\n* ECOG performance status 0-1\n* Written informed consent\n\nExclusion Criteria:\n\n* Pregnancy\n* Intestinal obstruction\n* Renal insufficiency (GFR \\\u003C 45 ml\u002Fmin)",{"count":84,"type":20},20,[86],"NA","The goal of this clinical trial is to evaluate the safety and feasibility of a combined surgical and chemotherapy approach (pancreatectomy with cytoreductive surgery and HIPEC) in patients aged 18 and older with pancreatic ductal adenocarcinoma and synchronous peritoneal metastases. The main questions it aims to answer are:\n\nIs the 90-day mortality rate for this intensive combined procedure lower than 5%? What are the postoperative morbidity and complication rates (as measured by the Clavien-Dindo classification) for these patients? How does this treatment impact the patient's quality of life 12 months after the procedure?\n\nParticipants will:\n\nComplete at least 6 months of systemic chemotherapy to ensure the disease is stable or responding (biomarker CA19-9 must decline by \\>20%).\n\nUndergo a major surgical procedure involving the removal of the pancreatic tumour (total Pancreatectomy or RAMPS) and any visible abdominal metastases (Cytoreductive Surgery).\n\nReceive Hyperthermic Intraperitoneal Chemotherapy (HIPEC), where heated Cisplatin and Paclitaxel are circulated in the abdominal cavity for 90 minutes during the operation.\n\nParticipate in long-term follow-up to monitor recurrence-free and overall survival.",[89,27],"Pancreatic Adenocarcinoma",[91,92,93,94,95],"Pancreatic Cancer","Cytoreduction Surgical Procedures","Hyperthermic Intraperitoneal Chemotherapy","Peritoneal Metastasis","Peritoneal Carcinomatosis","2026-03-20",{"date":98,"type":33},"2026-03-25",{"date":100,"type":33},"2026-03-01",{"date":102,"type":20},"2028-10-01",{"name":104,"class":105},"Unidade Local de Saúde São João","OTHER_GOV",3,{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":114,"enrollmentInfo":115,"targetDuration":4,"studyType":117,"phases":4,"briefSummary":118,"conditions":119,"keywords":122,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":75},"100629388","integrating-peritoneal-histological-growth-patterns-into-preoperative-decision-making-for-colorectal-peritoneal-metastses-100629388","NCT07474025","Integrating Peritoneal Histological Growth Patterns Into Preoperative Decision-Making for Colorectal Peritoneal Metastses","Integrating Peritoneal Histological Growth Patterns Into Preoperative Decision-Making for Colorectal Peritoneal Metastses: A Prospective Study","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Histologically confirmed colorectal adenocarcinoma\n* Suspected or confirmed peritoneal metastases from colorectal cancer based on imaging or prior clinical evaluation\n* Patients undergoing staging laparoscopy and\u002For cytoreductive surgery (CRS) ± hyperthermic intraperitoneal chemotherapy (HIPEC) as part of standard clinical care\n* Availability of peritoneal metastasis tissue samples suitable for histopathological analysis\n* Written informed consent provided for participation in the study\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* Peritoneal metastases originating from non-colorectal primary tumors\n* Absence of available or adequate peritoneal metastasis tissue samples for histological growth pattern analysis\n* Patients who decline or withdraw informed consent\n* Patients unable to provide informed consent","100 Years",{"count":116,"type":20},30,"OBSERVATIONAL","Colorectal cancer (CRC) remains the third most commonly diagnosed malignancy worldwide and the second leading cause of cancer-related death, with approximately 15% of patients presenting with synchronous liver metastases (LM) and 7% with peritoneal metastases (PM) at diagnosis. Despite curative-intent resection of the primary tumor, 16-20% of patients subsequently develop metachronous LM and up to 19% develop PM within three years \\[1-5\\].\n\nSurgery remains the only potentially curative treatment for patients with colorectal peritoneal metastases (CRPM), offering long-term (\\>10years) disease-free survival (DFS) in a subset of highly selected patients \\[6,7\\]. However, selecting candidates for cytoreductive surgery (CRS) ± hyperthermic intraperitoneal chemotherapy (HIPEC) remains challenging and requires balancing the potential oncologic benefit of complete cytoreduction against perioperative risks and postoperative morbidity \\[6-8\\].\n\nConsequently, strong prognostic markers-clinical, biological, or genetic-are crucial to refine surgical decision-making. Currently, the two most consistent clinical determinants of outcome are the extent of disease (Peritoneal Cancer Index, PCI) and the completeness of cytoreduction (CC-score) \\[6-8\\]. Over the last decade, surgical selection has become more restrictive (e.g., PCI threshold moving from 25 to 17), and molecular profiles such as BRAF mutations have been associated with poor outcomes, potentially guiding against aggressive surgery in selected cases \\[8,9\\]. Yet, these markers are insufficient to fully capture inter-patient heterogeneity and do not reliably individualize surgical benefit \\[8,9\\].\n\nIn colorectal liver metastases (CRLM), the histological growth pattern (HGP) at the tumor-liver interface has emerged as a robust prognostic biomarker, with the desmoplastic HGP (d-HGP) associated with superior survival compared with replacement or pushing patterns \\[10,11\\]. International consensus guidelines have standardized HGP scoring for CRLM, enabling reproducible assessment and cross-study comparison \\[12\\]. Large multicentric cohorts also suggest possible modulation of HGP by systemic chemotherapy, supporting its value as a marker of intrinsic tumor biology and treatment response \\[13,14\\].\n\nTransposing this concept to the peritoneum, our group identified two reproducible peritoneal HGP in colorectal peritoneal metastases: the pushing pattern (P-HGP) and the infiltrating pattern (I-HGP). Across two monocentric studies, a dominant P-HGP (\\>50-60% of the tumor-peritoneum interface) was strongly associated with prolonged disease-free and overall survival (OS) \\[15,16\\].\n\nTaken together, these findings support HGP of PM as a potential histological biomarker to refine patient selection for CRS ± HIPEC beyond current clinical and molecular criteria.\n\nHowever, existing data derive exclusively from retrospective single-center cohorts, underscoring the need for prospective validation to:\n\nConfirm the independent prognostic value of HGP of PM (for overall and disease-free survival) in contemporary clinical practice; Standardize sampling and pathological assessment (standard operating procedures, central review, and interobserver reproducibility studies); Develop and validate a histo-prognostic scoring system integrating PM HGP with relevant clinicopathological variables, aimed at predicting patient outcomes and supporting preoperative decision-making for CRS ± HIPEC candidacy.\n\nThis prospective cohort study is designed to address these objectives without modifying standard care. By collecting clinicopathological and survival data prospectively, it will provide robust evidence for the integration of HGP into a multivariable prognostic model capable of stratifying surgical candidates and guiding individualized treatment strategies.",[27,26,120,121],"Colorectal (Colon or Rectal) Cancer","Histopathological Growth Patterns (HGPs)",[123,124,125],"Peritoneal cancer","Colorectal cancer","Histopathological Growth Patterns","2026-03-11",{"date":128,"type":33},"2026-03-16",{"date":130,"type":20},"2026-03",{"date":132,"type":20},"2028-12",{"name":134,"class":40},"Jules Bordet Institute",{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":4,"eligibilityCriteria":141,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":142,"targetDuration":4,"studyType":21,"phases":144,"briefSummary":145,"conditions":146,"keywords":147,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":4},"100627853","phase-1-intraperitoneal-px-in-combination-with-nab-paclitaxel-in-patients-with-peritoneal-metastatic-mucinous-adenocarcinoma-100627853","NCT07454031","Intraperitoneal PX in Combination With Nab-Paclitaxel in Patients With Peritoneal Metastatic Mucinous Adenocarcinoma","An Investigator-Initiated Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Intraperitoneal PX in Combination With Nab-Paclitaxel in Patients With Peritoneal Metastatic Mucinous Adenocarcinoma","Inclusion Criteria:\n\n* Age ≥ 18 years, regardless of sex;\n* Histologically confirmed peritoneal metastatic mucinous adenocarcinoma;\n* Considered suitable for intraperitoneal therapy based on investigator assessment;\n* ECOG performance status 0-2;\n* Adequate organ function confirmed by laboratory tests within 7 days prior to enrollment:\n* Hematology: ANC ≥ 1.5 × 10⁹\u002FL; PLT ≥ 100 × 10⁹\u002FL; Hb ≥ 85 g\u002FL; Liver function: TBIL ≤ 1.5 × ULN (≤ 3 × ULN for Gilbert's syndrome);AST\u002FALT ≤ 3 × ULN (≤ 5 × ULN in patients with liver metastases); Renal function: creatinine clearance ≥ 60 mL\u002Fmin (Cockcroft-Gault) or serum creatinine ≤ 1.5 × ULN; Coagulation: PT, INR, and APTT ≤ 1.5 × ULN;\n* Life expectancy ≥ 3 months;\n* Ability to understand and willingness to sign written informed consent.\n\nExclusion Criteria:\n\n* Planned concomitant systemic anti-tumor therapy during intraperitoneal treatment;\n* Massive ascites not expected to be adequately drained prior to dosing;\n* Chemotherapy or radiotherapy within 4 weeks prior to enrollment (≥ 6 weeks for nitrosoureas or mitomycin C);\n* Pregnancy or lactation, or unwillingness to use effective contraception;\n* Severe abdominal infection or gastrointestinal obstruction;\n* Known peritoneal adhesions deemed unsuitable for catheter placement;\n* Active bleeding, uncorrected coagulation disorders, or inability to safely interrupt therapeutic anticoagulation;\n* Known hypersensitivity to PX, nab-paclitaxel, or excipients;\n* Pre-existing ≥ Grade 2 peripheral sensory neuropathy;\n* Severe or uncontrolled comorbidities that may increase study risk or interfere with evaluation;\n* Active or severe autoimmune disease, or ongoing systemic immunosuppressive therapy;\n* Positive for HBsAg, anti-HCV, syphilis antibody, or HIV antibody;\n* Psychiatric or cognitive disorders affecting compliance;\n* Any other condition deemed unsuitable by the investigator.",{"count":143,"type":20},22,[53],"To evaluate the safety and tolerability of intraperitoneal PX in combination with nab-paclitaxel in patients with peritoneal metastatic mucinous adenocarcinoma, and to determine the maximum tolerated dose (MTD) and the recommended Phase II dose (RP2D).",[27],[148,149,150,151],"peritoneal adenocarcinoma","PX","nab-paclitaxel","intraperitoneal injection·",{"date":153,"type":33},"2026-03-13",{"date":155,"type":20},"2026-03-15",{"date":157,"type":20},"2027-12-31",{"name":159,"class":40},"Peking University",{"id":161,"slug":162,"hasResults":11,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":166,"eligibilityCriteria":167,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":168,"enrollmentInfo":169,"targetDuration":4,"studyType":21,"phases":171,"briefSummary":172,"conditions":173,"keywords":176,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":75},"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":170,"type":20},200,[23],"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.",[27,95,174,175],"Abdominal Cancer","Abdominal Cancer Patients",[177,178,179,180,181,182,183,184,185],"intraperitoneal","peritoneal cavity","mitomycin-C","PIPAC","HIPEC","Heated Intra-Peritoneal Chemotherapy","Pressurized Intraperitoneal Aerosol Chemotherapy","intra-abdominal","cytoreduction","2026-02-25",{"date":188,"type":33},"2026-02-27",{"date":190,"type":33},"2026-01-05",{"date":192,"type":20},"2040-11",{"name":194,"class":40},"Patrick Wagner, MD, FACS",{"id":196,"slug":197,"hasResults":11,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":4,"eligibilityCriteria":201,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":202,"enrollmentInfo":203,"targetDuration":4,"studyType":21,"phases":205,"briefSummary":206,"conditions":207,"keywords":211,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":4},"100624138","phase-2-lubiprostone-combined-with-maintenance-therapy-for-prevention-of-postoperative-recurrence-in-peritoneal-metastatic-colorectal-cancer-100624138","NCT07405736","Lubiprostone Combined With Maintenance Therapy for Prevention of Postoperative Recurrence in Peritoneal Metastatic Colorectal Cancer","Lubiprostone Combined With Maintenance Therapy for Prevention of Postoperative Recurrence in Peritoneal Metastatic Colorectal Cancer, A Randomized Controlled Phase II Study","Inclusion Criteria:\n\n* Voluntarily participates and provides written informed consent.\n* Histologically confirmed colon\u002Frectal adenocarcinoma with molecular status confirmed as pMMR or MSS.\n* Cytoreductive surgery (CRS) achieves CC0\u002FCC1 cytoreduction.\n* No extraperitoneal metastasis prior to treatment.\n* ECOG performance status 0-1 with adequate organ function per protocol requirements.\n\nExclusion Criteria:\n\n* Extensive multisystem metastases on baseline imaging assessment.\n* Tumor carrying BRAF V600E mutation.\n* dMMR\u002FMSI-H, or confirmed pathogenic POLE\u002FPOLD1 mutation(s).\n* Cachexia or decompensated organ dysfunction.\n* History of another malignancy within the past 5 years.\n* Known or suspected hypersensitivity\u002Fallergy to the study drug or related formulations.\n* Multiple primary cancers.\n* Any serious disease or other medical, psychological, or social condition that, in the investigator's judgment, may compromise participant safety or affect study results.","75 Years",{"count":204,"type":20},124,[23],"The goal of this phase II randomized controlled clinical trial is to evaluate whether adding lubiprostone to standard postoperative maintenance therapy can delay disease progression and recurrence in adult patients with colorectal cancer and peritoneal metastases (PM-CRC) who have undergone cytoreductive surgery with or without HIPEC after systemic treatment. The main questions it aims to answer are:\n\nDoes lubiprostone plus maintenance therapy improve the 1-year progression-free survival (PFS) rate compared with maintenance therapy alone?\n\nIs lubiprostone safe and feasible for long-term use during the maintenance period in this PM-CRC population?\n\nResearchers will compare lubiprostone + maintenance therapy versus maintenance therapy alone to see if the addition of lubiprostone prolongs PFS, reduces the risk of distant metastasis, improves overall survival, and maintains or improves quality of life.\n\nParticipants will:\n\nBe randomly assigned to receive maintenance therapy with lubiprostone or maintenance therapy alone after surgery (CRS ± HIPEC) and prior systemic therapy, according to the study protocol.\n\nUndergo scheduled follow-up assessments for disease status (progression\u002Frecurrence), survival outcomes, treatment-related toxicity, and quality of life using the EORTC QLQ-C30 (v3.0) questionnaire.",[208,27,94,209,210],"Colorectal Cancer Metastatic","Colorectal Cancer (CRC)","MSS Metastatic Colorectal Cancer",[212,124,213,214,215,216],"Peritoneal metastasis","Maintenance therapy","Lubiprostone","Cytoreductive Surgery","Progression-free survival","2026-02-10",{"date":219,"type":33},"2026-02-12",{"date":221,"type":20},"2026-02-24",{"date":223,"type":20},"2028-06-01",{"name":225,"class":40},"Sun Yat-sen University",{"id":227,"slug":228,"hasResults":11,"nctId":229,"briefTitle":230,"officialTitle":231,"acronym":4,"eligibilityCriteria":232,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":233,"targetDuration":4,"studyType":21,"phases":235,"briefSummary":237,"conditions":238,"keywords":242,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":252,"locationsCount":75},"100579527","early-phase-1-allogeneic-b7h3-car-t-cell-therapy-for-advanced-solid-tumors-100579527","NCT06825455","Allogeneic B7H3 CAR-γδT Cell Therapy for Advanced Solid Tumors","Clinical Study of the Safety and Tolerability of B7H3 CAR-γδT Cell Injection in the Treatment of Advanced Solid Tumors","Inclusion Criteria:\n\n1. Age ≥18 years old, gender is not limited;\n2. Expected survival time ≥3 months;\n3. ECOG score 0\\~1;\n4. Patients who meet the clinical diagnostic criteria and have a clear pathological diagnosis of malignant solid tumors that have failed standard treatment;\n5. Tumor tissue samples (specimens within one year are recommended) positive for B7H3 by immunohistochemical (IHC) staining or flow assay;\n6. Presence of at least one evaluable lesion according to RECIST V1.1;\n7. Tumors limited to peritoneal (metastatic) and ovarian cancer in patients in the laparotomy group;\n8. Substantially normal bone marrow reserve function and normal liver and renal function (laboratory tests need to be fulfilled before the first treatment with cell injection):\n\n   Blood: white blood cell count (WBC) ≥3E9\u002FL, lymphocyte count (LY) ≥0.8E9\u002FL, hemoglobin (Hb) ≥80g\u002FL, platelet (PLT) ≥75E9\u002FL; Liver: ALT ≤ 3 × ULN; AST ≤ 3 × ULN; total bilirubin ≤ 3.0 × ULN; Kidney: serum creatinine ≤ 1.5 × upper limit of normal range (ULN); Heart: left ventricular ejection fraction ≥50% on echocardiography; lung: normal oxygen saturation without oxygen.\n9. Pregnancy test should be negative for women of childbearing potential and both men and women agree to use effective contraception during treatment and for 1 year thereafter;\n10. Be able to understand the requirements and matters of the trial and be willing to participate in the clinical study as required;\n11. Sign the trial informed consent form.\n\nExclusion Criteria:\n\n1. Known hypersensitivity, allergy, intolerance, or contraindication to cell infusion or any of the drug components that may be used in the study, including fludarabine and cyclophosphamide;\n2. Patients who have been continuously using immunosuppressive drugs within 1 month prior to cell infusion;\n3. Cerebrovascular accident or seizure within 6 months prior to signing the informed consent form;\n4. Symptomatic brain metastases;\n5. a known psychiatric or substance abuse disorder that would interfere with cooperation with the trial requirements;\n6. Hepatitis B surface antigen (HBsAg) positivity or hepatitis B core antibody (HBcAb) positivity and a peripheral blood test for hepatitis B virus (HBV) DNA titer that is not within the normal reference range; hepatitis C virus (HCV) antibody positivity and peripheral blood hepatitis C virus (HCV) RNA positivity; human immunodeficiency virus (HIV) antibody positivity; syphilis Positive for syphilis;\n7. Serious cardiac disease: including, but not limited to, unstable angina pectoris, myocardial infarction (occurring within 6 months prior to screening), congestive heart failure (NYHA classification ≥ III), and severe arrhythmias;\n8. Presence of active or uncontrolled infections requiring systemic therapy (except for mild genitourinary and upper respiratory tract infections);\n9. has not recovered from acute toxic effects of prior therapy (prior therapy-induced hematologic or organ toxicity ≥ Grade 2, except for abnormalities related to study disease and medical history);\n10. have a confirmed diagnosis of an immunodeficiency\n11. suffering from an active infection requiring systemic therapy;\n12. a female subject of childbearing potential who plans to become pregnant within 2 years of cell infusion; or a male subject whose partner plans to become pregnant within 2 years of cell infusion;\n13. Participation in a clinical study of another innovative drug within 1 month prior to screening;",{"count":234,"type":20},18,[236],"EARLY_PHASE1","γδT cells can directly recognize non-peptide tumor antigens, such as IPP phosphorylated metabolites, without relying on specific major histocompatibility complexes (MHCs). This unique characteristic leads to a lower risk of graft-versus-host disease (GVHD). The clinical safety of γδT cells in allogeneic tumor therapies has been validated multiple times, highlighting their significant potential in developing universal CAR-T cell therapies.\n\nB7H3 (CD276), a member of the B7 negative co-stimulatory molecule family, is minimally expressed or absent in normal tissues but highly expressed in various tumor tissues. As a result, B7H3 is regarded as a highly promising tumor-associated antigen and a universal drug target with substantial therapeutic potential.\n\nBy utilizing γδT cells as carrier cells, the development of universal B7H3 CAR-γδT cell injections for advanced solid tumors can effectively address risks such as autologous cell preparation failure and treatment delays. This innovative approach offers a highly efficient solution for solid tumor treatment and holds great promise for advancing immunotherapy in this field",[239,240,241],"Advanced Solid Tumors","Ovarian Cancers","Peritoneal (metastatic) Cancer",[243,244,245],"cell therapy","γδT","CAR-T","2025-02-09",{"date":248,"type":33},"2025-02-13",{"date":250,"type":20},"2025-03-01",{"date":157,"type":20},{"name":159,"class":40}]