[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07475286":3,"trial-entities:NCT07475286":135,"trial-summary:NCT07475286":140},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":41,"secondary_outcomes":46,"sex":70,"minimum_age":71,"maximum_age":72,"healthy_volunteers":73,"eligibility_criteria":74,"std_ages":98,"locations":101,"central_contacts":127,"overall_officials":131,"references":133,"see_also_links":134},"NCT07475286","HCC 25-124","Combined Systemic and Intraperitoneal Chemotherapy for Synchronous Gastric and\u002For Gastroesophageal Peritoneal Carcinomatosis","A Phase II Single Arm Study of Combined Systemic and Intraperitoneal Chemotherapy for Synchronous Gastric and\u002For Gastroesophageal Peritoneal Carcinomatosis","RECRUITING","2034-06-30","2026-06","2026-07-02","2026-06-12","Mohammad Haroon Asif Choudry","OTHER",true,"This trial will administer laparoscopic hyperthermic intraperitoneal chemotherapy (HIPEC) to patients with peritoneal carcinomatosis from gastric cancer (GPC) who are receiving standard of care systemic chemotherapy.","Patients with peritoneal carcinomatosis from gastric cancer (GPC) have dismal oncologic outcomes, with median survival duration of 6-12 months and 2-year overall survival rate of \\\u003C 10%. Despite advancements in systemic therapy, survival remains poor and most patients succumb to the disease within 4-11 months following diagnosis. Therefore, there is a substantial need for novel treatment strategies to improve oncologic outcomes in GPC. The primary intervention is the addition of iterative laparoscopic HIPEC to the ongoing standard systemic chemotherapy regimen (or at least the backbone regimen), based on discussion with their treating medical oncologist. Laparoscopic HIPEC will be performed using a combination of cisplatin (100 mg\u002Fm2) and mitomycin C (30 mg total, administered in 2 divided doses of 15 mg each, 45 minutes apart), in 3-liters of normal saline perfusate, at 42°C for 90 minutes, with continuous manipulation of the abdomen to ensure even distribution. Systemic chemotherapy will be administered every two weeks while laparoscopic HIPEC procedures will be performed every 6 weeks in place of the scheduled biweekly systemic therapy cycle. The trial will include a maximum of 3 laparoscopic HIPEC procedures.",[19,20],"Synchronous Gastric Peritoneal Carcinomatosis","Gastroesophageal Peritoneal Carcinomatosis",[22],"Hyperthermic Intraperitoneal Chemotherapy (HIPEC)","INTERVENTIONAL","TREATMENT",[26],"PHASE2",{"count":28,"type":29},22,"ESTIMATED",[31,37],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DRUG","Cisplatin","Cisplatin interferes with DNA replication, which kills the fastest proliferating cells.",[36],"Hyperthermic intraperitoneal chemotherapy (HIPEC)",{"type":32,"name":38,"description":39,"armGroupLabels":40},"Mitomycin C","A drug that slows down the growth of cancer cells by making them less able to create the DNA, RNA, and proteins they need to multiply.",[36],[42],{"measure":43,"description":44,"timeFrame":45},"1-year Progression-free Survival (PFS)","The proportion of patients alive without progression at one year from the date of the first laparoscopic HIPEC treatment. Per RECIST v1.1, Progressive Disease is defined as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.","At 1 year",[47,51,54,58,61,64,67],{"measure":48,"description":49,"timeFrame":50},"Treatment-related Adverse Events","Frequency and severity (grade) of adverse events (AE) related to study treatment per CTCAE v5.0.","Up to 5 years",{"measure":52,"description":53,"timeFrame":50},"Progression-free Survival (PFS)","Median time from first laparoscopic HIPEC procedure to progression or death from any cause. Per RECIST v1.1, Progressive Disease is defined as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.",{"measure":55,"description":56,"timeFrame":57},"Overall Survival (OS)","Median time from first laparoscopic HIPEC procedure to death from any cause.","Up to 8 years",{"measure":59,"description":60,"timeFrame":50},"Objective Response Rate (ORR)","ORR is defined as the proportion of patients achieving a complete response (CR) or partial response (PR). Per RECIST v1.1, Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (target or non-target) with reduction in short axis to \\\u003C10 mm. Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.",{"measure":62,"description":63,"timeFrame":50},"Objective Response Rate (ORR) Peritoneal Cancer Index (PCI)","ORR per Peritoneal Cancer Index (PCI) score extracted from diagnostic laparoscopy procedures (in all patients), defined as the proportion of patients who achieve a reduction in PCI score. This scoring system quantifies the extent of peritoneal metastases in patients with abdominal cancers. It ranges from 0 to max score of 39, with lower scores indicating less disease burden and better surgical outcomes. The abdomen is divided into 13 regions, each scored from 0 to 3 based on the size and extent of tumor involvement. The total score is the sum of these individual scores, providing a clear picture of the disease's spread.",{"measure":65,"description":66,"timeFrame":50},"EQ-5D-5L scores","The EQ-5D-5L self-administered questionnaire captures health status across five key dimensions: Mobility: Ability to walk about; Self-Care: Ability to wash or dress oneself; Usual Activities: Ability to perform usual activities (work, study, housework, family, or leisure activities); Pain\u002FDiscomfort: Level of pain or discomfort experienced; Anxiety\u002FDepression: Level of anxiety or depression experienced. A 5-level\u002Fpoint scale is used: 1: No problems, 2: Slight problems, 3: Moderate problems, 4: Severe problems, 5: Extreme problems. Scores from each key dimension are added to yield a total score ranging from 5 to 25. Higher scores indicate worse health status. A Visual Analogue Scale (VAS) is also included: Patients rate their overall health on a scale from 0 (worst imaginable health) to 100 (best imaginable health).",{"measure":68,"description":69,"timeFrame":50},"Rate of Cytoreductive Surgery (CRS)\u002FHIPEC","Percentage of patients with unresectable locoregional disease prior to enrollment who undergo CRS\u002FHIPEC.","ALL","18 Years",null,false,{"inclusion":75,"exclusion":88,"raw_text":97},[76,77,78,79,80,81,82,83,84,85,86,87],"Histologically proven, synchronous gastric and\u002For gastroesophageal junction (Siewert 3) adenocarcinoma with either positive peritoneal cytology (micPC) or macroscopic carcinomatosis (macPC) (stage IV), diagnosed by imaging or laparoscopy or laparotomy.","Patients must be 18 years of age or older at time of informed consent.","ECOG performance status of ≤ 2\\*","Must have normal organ and marrow function following completion of 4-6 months systemic therapy and prior to enrollment as assessed on basic laboratory tests:","Patient should have a life expectancy of \\>6 months per the discretion of the treating surgical oncologist and\u002For medical oncologist in relation to comorbidities and volume of disease.","Patients must have received at least 4 months (maximum 6 months) of 1st or 2nd line systemic therapy at the discretion of the treating medical oncologist and\u002For surgical oncologist and exhibit no evidence of extraperitoneal disease progression prior to enrollment.","Patients with stable oligometastatic liver only metastasis (≤ 3 lesions, each \\\u003C 3 cm in maximum dimension), ovarian-only metastases, or lung-only metastases (≤ 5 lesions, each \\\u003C 1 cm) that are amenable to curative intent surgical resection and\u002For thermal ablation and\u002For SBRT will be eligible for enrollment.","Sexually active fertile subjects and their partners must agree to use highly effective method of contraception prior to study entry and during the course of the study. An additional contraceptive method, such as a barrier method (e.g., condom), is required. In addition, men must agree not to donate sperm and women must agree not to donate eggs (ova, oocyte) for the purpose of reproduction during these same periods.","Female subjects of childbearing potential must not be pregnant or breastfeeding at screening. Female subjects are considered to be of childbearing potential unless one of the following criteria is met:","Permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of amenorrhea in a woman \\> 45 years-of-age in the absence of other biological or physiological causes.) Note: Documentation may include review of medical records, medical examination, or medical history interview by study site staff.","Must have the ability to understand and the willingness to sign a written informed consent document.","Must be able to read and write in English.",[89,90,91,92,93,94,95,96],"Patients with MSI-H tumors, dMMR, TMB \\> 30, CPS \\> 40, POL-E mutation, Claudin 18.2 positive tumors, BRAFV600E, RET fusions, HER-2-neu (3+ on IHC) or positive on FISH will be excluded.","Extensive retroperitoneal lymph node involvement not amenable to surgical resection during gastrectomy.","Recurrent large or small bowel obstruction attributable to the cancer (except for gastric outlet obstruction).","Prior abdominal surgeries that preclude safe and effective laparoscopy\u002Flaparoscopic HIPEC.","Significant ascites requiring repeated drainage for symptomatic relief.","Other malignancy within the preceding 3 years (except for non-melanoma skin cancer, early-stage prostate cancer, or curatively treated cervical cancer in-situ).","Patients should have recovered to baseline from any clinically significant adverse events from prior treatment.","Has acute or chronic active hepatitis B and C virus infection or known history of untreated hepatitis B (defined as hepatitis B surface antigen \\[HBsAg\\] reactive) or known active hepatitis C virus (HCV) (defined as HCV RNA \\[qualitative\\]) or HIV infection (see note).","Inclusion Criteria:\n\n* Histologically proven, synchronous gastric and\u002For gastroesophageal junction (Siewert 3) adenocarcinoma with either positive peritoneal cytology (micPC) or macroscopic carcinomatosis (macPC) (stage IV), diagnosed by imaging or laparoscopy or laparotomy.\n* Patients must be 18 years of age or older at time of informed consent.\n* ECOG performance status of ≤ 2\\*\n\n  \\*Note: ECOG PS of 2 is allowed only if debilitation is caused by the gastric cancer and not by other comorbidities.\n* Must have normal organ and marrow function following completion of 4-6 months systemic therapy and prior to enrollment as assessed on basic laboratory tests:\n\nHemoglobin ≥ 8.0 g\u002FdL Leukocytes ≥ 3,000\u002FmcL Absolute neutrophil count ≥ 1,500\u002FmcL Platelet count ≥ 100,000\u002FmcL Total bilirubin \\\u003C 2mg\u002Fdl AST (SGOT) ≤ 2.5 X institutional upper limit of normal (ULN) ALT (SGPT) ≤ 2.5 X institutional ULN Serum creatinine within normal institutional limits\n\n* Patient should have a life expectancy of \\>6 months per the discretion of the treating surgical oncologist and\u002For medical oncologist in relation to comorbidities and volume of disease.\n* Patients must have received at least 4 months (maximum 6 months) of 1st or 2nd line systemic therapy at the discretion of the treating medical oncologist and\u002For surgical oncologist and exhibit no evidence of extraperitoneal disease progression prior to enrollment.\n* Patients with stable oligometastatic liver only metastasis (≤ 3 lesions, each \\\u003C 3 cm in maximum dimension), ovarian-only metastases, or lung-only metastases (≤ 5 lesions, each \\\u003C 1 cm) that are amenable to curative intent surgical resection and\u002For thermal ablation and\u002For SBRT will be eligible for enrollment.\n* Sexually active fertile subjects and their partners must agree to use highly effective method of contraception prior to study entry and during the course of the study. An additional contraceptive method, such as a barrier method (e.g., condom), is required. In addition, men must agree not to donate sperm and women must agree not to donate eggs (ova, oocyte) for the purpose of reproduction during these same periods.\n* Female subjects of childbearing potential must not be pregnant or breastfeeding at screening. Female subjects are considered to be of childbearing potential unless one of the following criteria is met:\n* Permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of amenorrhea in a woman \\> 45 years-of-age in the absence of other biological or physiological causes.) Note: Documentation may include review of medical records, medical examination, or medical history interview by study site staff.\n* Must have the ability to understand and the willingness to sign a written informed consent document.\n* Must be able to read and write in English.\n\nExclusion Criteria:\n\n* Patients with MSI-H tumors, dMMR, TMB \\> 30, CPS \\> 40, POL-E mutation, Claudin 18.2 positive tumors, BRAFV600E, RET fusions, HER-2-neu (3+ on IHC) or positive on FISH will be excluded.\n* Extensive retroperitoneal lymph node involvement not amenable to surgical resection during gastrectomy.\n* Recurrent large or small bowel obstruction attributable to the cancer (except for gastric outlet obstruction).\n* Prior abdominal surgeries that preclude safe and effective laparoscopy\u002Flaparoscopic HIPEC.\n* Significant ascites requiring repeated drainage for symptomatic relief.\n* Other malignancy within the preceding 3 years (except for non-melanoma skin cancer, early-stage prostate cancer, or curatively treated cervical cancer in-situ).\n* Patients should have recovered to baseline from any clinically significant adverse events from prior treatment.\n* Has acute or chronic active hepatitis B and C virus infection or known history of untreated hepatitis B (defined as hepatitis B surface antigen \\[HBsAg\\] reactive) or known active hepatitis C virus (HCV) (defined as HCV RNA \\[qualitative\\]) or HIV infection (see note).\n\nNote: No testing for Hepatitis B, Hepatitis C, or HIV is required unless mandated by local health authority or clinically indicated.\n\nNote: Participants with a history of HIV infection are considered eligible if CD4+ T cell counts are ≥ 350 cells\u002FµL and the patient has had no opportunistic infections in the last 12 months.",[99,100],"ADULT","OLDER_ADULT",[102],{"facility":103,"status":8,"city":104,"state":105,"zip":106,"country":107,"contacts":108,"geoPoint":124},"UPMC Hillman Cancer Center","Pittsburgh","Pennsylvania","15232","United States",[109,114,118,121],{"name":110,"role":111,"phone":112,"email":113},"Debra Diecks, RN, BSN","CONTACT","412-623-8364","diecksda@upmc.edu",{"name":115,"role":111,"phone":116,"email":117},"Cole Stacy, RN, BSN","878-261-6872","colesl2@upmc.edu",{"name":119,"role":120},"Haroon Choudry, MBBS, FACS","PRINCIPAL_INVESTIGATOR",{"name":122,"role":123},"Samer AlMasri, MD","SUB_INVESTIGATOR",{"lat":125,"lon":126},40.44062,-79.99589,[128,129],{"name":110,"role":111,"phone":112,"email":113},{"name":130,"role":111,"phone":116,"email":117},"Stacy Cole, RN, BSN",[132],{"name":119,"affiliation":103,"role":120},[],[],{"nct_id":4,"conditions":136,"biomarkers":139},[137,138],"Gastric Carcinoma","Gastroesophageal Junction Adenocarcinoma",[],{"nct_id":4,"found":15,"summary":141,"prompt_version":151},{"design":142,"status":143,"heading":144,"summary":145,"follow_up":146,"word_count":147,"commitments":148,"compensation":149,"drugs_mentioned":150},"This study is an interventional study, meaning participants will receive a specific treatment. It plans to include 22 participants.","completed","Combined Chemotherapy for Gastric and Gastroesophageal Peritoneal Carcinomatosis","This study is looking into a new way to treat stomach (gastric) and\u002For food pipe (gastroesophageal) cancers that have spread to the lining of the abdomen (peritoneal carcinomatosis). It combines standard chemotherapy given through your veins with a procedure called laparoscopic hyperthermic intraperitoneal chemotherapy (HIPEC). During HIPEC, the drugs cisplatin and mitomycin C are warmed and washed directly inside your abdomen. The goal is to see if this combination can help people live longer without their cancer getting worse. You might be able to join if you are 18 or older and have been diagnosed with this type of cancer. The study plans to enroll 22 participants. We don't know the current enrollment status.","The study will measure how long participants live without their cancer progressing, at one year.",114,"You would receive standard chemotherapy every two weeks, and laparoscopic HIPEC procedures every six weeks, for a maximum of three HIPEC procedures.","Not stated in the trial record.",[33,38],"v2"]