[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pathologic-stage-iv-gastric-cancer-ajcc-v8\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pathologic-stage-iv-gastric-cancer-ajcc-v8":45},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,72,116],{"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":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":71},"100442420","early-phase-1-pembrolizumab-and-lenvatinib-for-the-treatment-of-advanced-unresectable-or-metastatic-gastroesophageal-adenocarcinoma-100442420",false,"NCT05041153","Pembrolizumab and Lenvatinib for the Treatment of Advanced, Unresectable, or Metastatic Gastroesophageal Adenocarcinoma","A Pilot Study of Pembrolizumab and Lenvatinib Combination Therapy in Patients With Previously Treated Advanced Gastroesophageal Adenocarcinoma","Inclusion Criteria:\n\n* The subject (or legally acceptable representative if applicable) provides written informed consent for the trial\n* Male and female subjects who are at least 18 years of age on day of signing informed consent with histologically and cytologically documented diagnosis as gastric or gastroesophageal adenocarcinoma\n* Has a documented, previously treated, advanced (unresectable and\u002For metastatic) gastroesophageal adenocarcinoma that is incurable and for which prior first-line or later-line standard of care (SOC) treatments have failed. Prior neoadjuvant or adjuvant therapy included in initial treatment may not be considered first- or later-line SOC treatment unless such treatments were completed less than 12 months prior to the current tumor recurrence\n* Has submitted an evaluable tissue sample for biomarker analysis from a newly obtained irradiated. The tumor tissue submitted for analysis must be from a single tumor tissue specimen and of sufficient quantity and quality to allow biomarker study (see laboratory manual). A \"newly obtained\" tumor specimen, defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on day 1, for biomarker characterization will be required for enrollment of all subjects. Tissue from tumor progressing at a site of prior radiation (at least 6 weeks interval after last radiation) may be allowed for biomarker characterization upon agreement from Merck. Subjects for whom newly-obtained samples cannot be provided (e.g., inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the Merck\n* Has measurable disease based on RECIST 1.1 as assessed by the Investigator. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions\n* Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale within 5 days of starting study treatment\n* Has a life expectancy of greater than 3 months per the judgment of the investigators\n* Has adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP =\\\u003C 150\u002F90 mm Hg at screening and no change in antihypertensive medications within 1 week of cycle 1 day 1\n* Absolute neutrophil count (ANC) \\>= 1,500\u002FuL (specimens must be collected within 5 days prior to the start of study treatment)\n* Platelets \\>= 100,000\u002FuL (specimens must be collected within 5 days prior to the start of study treatment)\n* Hemoglobin \\>= 9 g\u002FdL or \\>= 5.6 mmol\u002FL without transfusion or EPO dependency (within 7 days of assessment) (specimens must be collected within 5 days prior to the start of study treatment)\n* Serum creatinine =\\\u003C 1.5 x upper limit of normal (ULN) OR measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) \\>= 60 mL\u002Fmin for subject with creatinine levels \\> 1.5 x institutional ULN (specimens must be collected within 5 days prior to the start of study treatment)\n\n  * Creatinine clearance should be calculated per institutional standard\n* Total bilirubin \\\u003C 1.5 x ULN OR direct bilirubin =\\\u003C ULN for subjects with total bilirubin levels \\> 1.5 x ULN (specimens must be collected within 5 days prior to the start of study treatment)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) =\\\u003C 2.5 x ULN OR =\\\u003C 5 x ULN for subjects with liver metastases (specimens must be collected within 5 days prior to the start of study treatment)\n* Albumin \\>= 2.5 mg\u002FdL (specimens must be collected within 5 days prior to the start of study treatment)\n* International normalized ratio (INR) or prothrombin time (PT) activated partial thromboplastin time (aPTT) =\\\u003C 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants (specimens must be collected within 5 days prior to the start of study treatment)\n* Male subjects are eligible to participate if they agree to the following during the intervention period and for at least 30 days after the last dose of lenvatinib\n\n  * Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR\n  * Must agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause) as detailed below:\n\n    * Agree to use a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a women of child birth potential (WOCBP) who is not currently pregnant. Note: Men with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penile-vaginal penetration.\n  * Please note that 30 days after lenvatinib is stopped, if the subject is on pembrolizumab only, no male contraception measures are needed\n* A female subject is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:\n\n  * Is not a WOCBP OR\n  * Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of \\\u003C 1% per year) and has a low user dependency, or is abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis), as described in Appendix 12.8 during the intervention period and for at least 120 days post pembrolizumab or 30 days post lenvatinib, whichever occurs last. The investigator should evaluate the potential for contraceptive method failure (i.e., noncompliance, recently initiated) in relationship to the first dose of study intervention\n  * A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours before the first dose of study intervention\n  * If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the subject must be excluded from participation if the serum pregnancy result is positive\n  * The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy\n\nExclusion Criteria:\n\n* Is currently participating in or has participated in a study of an investigational agent or used an investigational device within 4 weeks prior to the first dose of study treatment.\n\n  * Note: Subjects who have entered the follow-up phase of an investigational trial may participate as long as it has been 4 weeks after the last dose of the previous investigational agent\n* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment\n* Has had major surgery within 3 weeks prior to first dose of study interventions.\n\n  * Note: Adequate wound healing after major surgery must be assessed clinically, independent of time elapsed for eligibility\n* Has preexisting \\>= grade 3 gastrointestinal or non-gastrointestinal fistula\n* Has urine protein \\>= 1 g\u002F24 hours.\n\n  * Note: subjects with proteinuria \\>= 2+ (\\>= 100 mg\u002FdL) on urine dipstick testing\u002Furinalysis will undergo 24-hour urine collection for quantitative assessment of proteinuria\n* Has significant gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of lenvatinib\n* Has radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation.\n\n  * Note: The degree of proximity to major blood vessels should be considered because of the potential risk of severe hemorrhage associated with tumor shrinkage\u002Fnecrosis following lenvatinib therapy\n* Has clinically significant hemoptysis or tumor bleeding within 2 weeks prior to the first dose of study drug\n* Significant cardiovascular impairment within 12 months of the first dose of study drug: such as history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or cerebrovascular accident (CVA) stroke, or cardiac arrhythmia associated with hemodynamic instability\n* Prolongation of corrected QT (QTc) interval to \\> 480 ms\n* Has left ventricular ejection fraction (LVEF) below the institutional (or local laboratory) normal range as determined by multi-gated acquisition scan (MUGA) or echocardiogram (ECHO)\n* Has known intolerance or severe hypersensitivity (grade \\>= 3) to pembrolizumab, lenvatinib, or any of their excipients\n* Has received prior therapy with lenvatinib, an anti-PD-1, anti-PD-L1, or anti PD-L2 agent, a VEGFR2 agent, or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137)\n* Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks or 5 times the half-life time, whichever is shorter prior to allocation.\n\n  * Note: Subjects must have recovered from all adverse events (AEs) due to previously therapies to =\\\u003C grade 1 or baseline. Subjects with =\\\u003C grade 2 neuropathy may be eligible\n* Has received prior radiotherapy within 2 weeks prior to study day 1.\n\n  * Note: Subjects must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (=\\\u003C 2 weeks of radiotherapy) to non-central nervous system (CNS) disease\n* Has a known additional malignancy that is progressing or requires active treatment.\n\n  * Note: Subjects with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded\n* Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are radiological stable (i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to the first dose of trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability\n* Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed\n* Has symptomatic ascites or pleural effusion. A subject who is clinically stable following treatment for these conditions (including therapeutic thoraco- or paracentesis) is eligible\n* Has a history of (non-infectious) pneumonitis that required treatment with steroids or has current pneumonitis\n* Has an active infection requiring systemic therapy\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator\n* Has known psychiatric or substance-abuse disorders that would interfere with cooperation with the requirements of the trial\n* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment\n* Has a known history of human immunodeficiency virus (HIV) (HIV 1\u002F2 antibodies).\n* Had an allogenic tissue\u002Fsolid organ or hematologic transplant\n* Has a known history of hepatitis B virus (HBV; hepatitis B surface antigen \\[HBsAg\\] reactive) or known active hepatitis C virus (HCV ribonucleic acid \\[RNA\\] \\[qualitative\\] is detected) infection.\n* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed","ALL","18 Years",{"count":19,"type":20},15,"ESTIMATED","INTERVENTIONAL",[23],"EARLY_PHASE1","This early phase I trial studies the effect of pembrolizumab and lenvatinib in treating patients with gastroesophageal adenocarcinoma that has spread to other places in the body (advanced\u002Fmetastatic) or cannot be removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Lenvatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and lenvatinib may kill more tumor cells.",[26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58],"Advanced Gastric Adenocarcinoma","Advanced Gastroesophageal Junction Adenocarcinoma","Clinical Stage III Gastric Cancer AJCC v8","Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8","Clinical Stage IV Gastric Cancer AJCC v8","Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8","Clinical Stage IVA Gastric Cancer AJCC v8","Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8","Clinical Stage IVB Gastric Cancer AJCC v8","Clinical Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8","Metastatic Gastric Adenocarcinoma","Metastatic Gastroesophageal Junction Adenocarcinoma","Pathologic Stage III Gastric Cancer AJCC v8","Pathologic Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8","Pathologic Stage IIIA Gastric Cancer AJCC v8","Pathologic Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8","Pathologic Stage IIIB Gastric Cancer AJCC v8","Pathologic Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8","Pathologic Stage IIIC Gastric Cancer AJCC v8","Pathologic Stage IV Gastric Cancer AJCC v8","Pathologic Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8","Pathologic Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8","Pathologic Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8","Postneoadjuvant Therapy Stage III Gastric Cancer AJCC v8","Postneoadjuvant Therapy Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8","Postneoadjuvant Therapy Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8","Postneoadjuvant Therapy Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8","Postneoadjuvant Therapy Stage IV Gastric Cancer AJCC v8","Postneoadjuvant Therapy Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8","Postneoadjuvant Therapy Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8","Postneoadjuvant Therapy Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8","Unresectable Gastric Adenocarcinoma","Unresectable Gastroesophageal Junction Adenocarcinoma","RECRUITING","2026-01-09",{"date":62,"type":63},"2026-01-12","ACTUAL",{"date":65,"type":63},"2022-02-14",{"date":67,"type":20},"2026-12-30",{"name":69,"class":70},"M.D. Anderson Cancer Center","OTHER",1,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":21,"phases":81,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":5},"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":80,"type":20},49,[82],"PHASE1","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.",[30,32,34,85,86,87,88,89,90,91,45,92,53,93,94,95,96,97,98,99,100,101,102,103,104,105,106],"Malignant Uterine Neoplasm","Metastatic Appendix Carcinoma","Metastatic Colorectal Carcinoma","Metastatic Gastric Carcinoma","Metastatic Malignant Neoplasm in the Peritoneum","Metastatic Malignant Solid Neoplasm","Metastatic Ovarian Carcinoma","Peritoneal Carcinomatosis","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":109,"type":63},"2025-12-10",{"date":111,"type":63},"2020-08-21",{"date":113,"type":20},"2028-01-05",{"name":115,"class":70},"City of Hope Medical Center",{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":4,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":123,"targetDuration":4,"studyType":21,"phases":125,"briefSummary":127,"conditions":128,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":169},"100379539","radiation-therapy-for-the-treatment-of-metastatic-gastrointestinal-cancers-100379539","NCT04221893","Radiation Therapy for the Treatment of Metastatic Gastrointestinal Cancers","Phase II Study of Hypofractionated Radiation Therapy to Augment Immune Response in Patients With Metastatic GastroIntestinal Malignancies Progressing on Immune Therapy (ARM-GI)","Inclusion Criteria:\n\n1. Patients must have a histologically, cytologically, or radiographically confirmed metastatic gastrointestinal (GI) malignancy (esophageal, gastroesophageal, gastric, small intestine, hepatocellular, pancreaticobiliary, colorectal, or anal cancer).\n2. Patients must be receiving immunotherapy (checkpoint inhibitor or CTLA4 inhibitor) with overall response of progressive disease by RECIST criteria.\n3. Patients must have at least two metastases which are individually progressing as per RECIST criteria, one of which can be safely unirradiated as adjudicated by the treating radiation oncologist (e.g. lesions for which small increases in dimensions are unlikely to precipitate significant symptoms).\n4. Patients must have 1-5 sites of disease meeting standard-of-care indications for palliative radiation therapy as adjudicated by the treating radiation oncologist. For example:\n\n   * Symptomatic disease causing pain, bleeding, dyspnea, dysphagia, or nausea\n   * At-risk for neurologic, respiratory, cardiovascular, gastrointestinal, musculoskeletal, or hepatobiliary compromise\n5. Evaluation by a radiation oncologist within 28 days of study registration.\n6. Must have adequate organ function to administer radiation therapy and immunotherapy as per standard of care.\n7. Age \\>= 18 years.\n8. Life expectancy exceeding 6 months.\n9. Eastern Cooperative Oncology Group (ECOG) 0-2 or Karnofsky performance status \\>= 50.\n10. Radiation therapy is known to be teratogenic and therefore women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of radiation therapy. 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 and for 3 months after completion of radiation therapy. Contraception requirements during the follow-up period of 6 months will be according to standard of care for immunotherapy administration.\n\n    a. If a woman is of child-bearing potential, a negative pregnancy test within 28 days prior to study enrollment is required.\n11. Ability to understand a written informed consent document, and the willingness to sign it.\n\nExclusion Criteria:\n\n1. Enrollment on immunotherapy clinical trial for which radiation therapy is not permitted.\n2. Administration of radiation therapy within 4 weeks prior to study enrollment.\n3. Treatment with systemic corticosteroids or other immunosuppressive medications which would significantly diminish the effect of immunotherapy as judged by the treating physician.\n4. Radiation therapy is contraindicated as adjudicated by the radiation oncologist.",{"count":124,"type":20},28,[126],"NA","This phase II trial studies how well radiation therapy works for the treatment of gastrointestinal cancer that are spreading to other places in the body (metastatic). Radiation therapy uses high energy x-rays to kill cancer cells and shrink tumors. This trial is being done to determine if giving radiation therapy to patients who are being treated with immunotherapy and whose cancers are progressing (getting worse) can slow or stop the growth of their cancers. It may also help researchers determine if giving radiation therapy to one tumor can stimulate the immune system to attack other tumors in the body that are not targeted by the radiation therapy.",[129,130,131,132,133,134,135,136,137,138,139,140,141,87,142,88,37,143,144,145,146,45,147,148,149,150,48,151,53,54,152,153,55,154,155,56,156,94,157,98,158,102,159,106],"Stage IV Esophageal Adenocarcinoma","Stage IV Esophageal Squamous Cell Carcinoma","Stage IV Gastric Cancer","Stage IV Adenocarcinoma of the Gastroesophageal Junction","Stage IVA Esophageal Adenocarcinoma","Stage IVA Esophageal Squamous Cell Carcinoma","Stage IVA Gastric Cancer","Stage IVA Adenocarcinoma of the Gastroesophageal Junction","Stage IVB Esophageal Adenocarcinoma","Stage IVB Esophageal Squamous Cell Carcinoma","Stage IVB Gastric Cancer","Stage IVB Gastroesophageal Junction Adenocarcinoma","Metastatic Anal Canal Carcinoma","Metastatic Esophageal Carcinoma","Metastatic Hepatocellular Carcinoma","Metastatic Malignant Digestive System Neoplasm","Metastatic Small Intestinal Carcinoma","Pancreatobiliary Carcinoma","Pathologic Stage IVA Esophageal Adenocarcinoma AJCC v8","Pathologic Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8","Pathologic Stage IVB Esophageal Adenocarcinoma AJCC v8","Pathologic Stage IVB Esophageal Squamous Cell Carcinoma AJCC v8","Postneoadjuvant Therapy Stage IV Esophageal Squamous Cell Carcinoma AJCC v8","Postneoadjuvant Therapy Stage IVA Esophageal Adenocarcinoma AJCC v8","Postneoadjuvant Therapy Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8","Postneoadjuvant Therapy Stage IVB Esophageal Adenocarcinoma AJCC v8","Postneoadjuvant Therapy Stage IVB Esophageal Squamous Cell Carcinoma AJCC V8","Stage IV Anal Cancer AJCC v8","Stage IV Hepatocellular Carcinoma AJCC v8","Stage IVA Hepatocellular Carcinoma AJCC v8","Stage IVB Hepatocellular Carcinoma AJCC v8","2025-09-30",{"date":162,"type":63},"2025-10-06",{"date":164,"type":63},"2020-08-07",{"date":166,"type":20},"2028-04-30",{"name":168,"class":70},"University of California, San Francisco",2]