[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627853":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":20,"responsibleParty":30,"collaborators":34,"id":37,"slug":38,"hasResults":39,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":20,"eligibilityCriteria":43,"healthyVolunteers":39,"sex":44,"minAge":45,"maxAge":20,"enrollmentInfo":46,"targetDuration":20,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":60,"whyStopped":20,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":20},{"fullName":5,"class":6},"Peking University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"PX in combination with nab-paclitaxel","EXPERIMENTAL","intraperitoneal PX in combination with nab-paclitaxel in patients with peritoneal metastatic mucinous adenocarcinoma",[13],"Drug: intraperitoneal PX in combination with nab-paclitaxel",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","intraperitoneal PX in combination with nab-paclitaxel","intraperitoneal PX in combination with nab-paclitaxel in patients with peritoneal metastatic mucinous adenocarcinoma,",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Lin Shen, Prof.","CONTACT","01088196088","oncogene@163.com",{"name":28,"role":24,"phone":29,"phoneExt":20,"email":26},"Jian Li, Dr.","861088196088",{"type":31,"investigatorFullName":32,"investigatorTitle":33,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Shen Lin","Prof.",[35],{"name":36,"class":6},"Shenzhen Bay Laboratory","100627853","phase-1-intraperitoneal-px-in-combination-with-nab-paclitaxel-in-patients-with-peritoneal-metastatic-mucinous-adenocarcinoma-100627853",false,"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.","ALL","18 Years",{"count":47,"type":48},22,"ESTIMATED","INTERVENTIONAL",[51],"PHASE1","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).",[54],"Peritoneal (Metastatic) Cancer",[56,57,58,59],"peritoneal adenocarcinoma","PX","nab-paclitaxel","intraperitoneal injection·","NOT_YET_RECRUITING","2026-03-11",{"date":63,"type":64},"2026-03-13","ACTUAL",{"date":66,"type":48},"2026-03-15",{"date":68,"type":48},"2027-12-31",{"name":5,"class":6}]