[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100495629":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":67,"centralContacts":72,"locations":80,"responsibleParty":99,"collaborators":102,"id":106,"slug":107,"hasResults":108,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":29,"eligibilityCriteria":112,"healthyVolunteers":108,"sex":113,"minAge":114,"maxAge":29,"enrollmentInfo":115,"targetDuration":29,"studyType":118,"phases":119,"briefSummary":121,"conditions":122,"keywords":29,"overallStatus":83,"whyStopped":29,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},{"fullName":5,"class":6},"University of California, Irvine","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Neoadjuvant chemotherapy with ctDNA testing","EXPERIMENTAL","The patients will be treated with one of the standard neoadjuvant protocols (FLOT or FOLFOX.) If patient response to their treatment, as measured by CT Scans or MRI results or blood tests done to look tumor markers such as carcinoembryonic antigen (CEA) and Carbohydrate antigen 19-9 (CA19-9) a change in adjuvant treatment will be made.",[13,14,15,16,17,18,19,20,21,22],"Combination Product: FLOT","Combination Product: FOLFOX","Combination Product: FOLFIRI","Combination Product: FOLFIRINOX","Combination Product: PACLITAXEL with or without CARBOPLATIN","Combination Product: DOCETAXEL and IRINOTECAN (alone or combined)","Drug: NIVOLUMAB (alone or when added to a regimen above)","Drug: PEMBROLIZUMAB (alone or when added to a regimen above)","Drug: Durvalumab","Drug: Trastuzumab",[24,30,34,38,42,46,50,55,59,63],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"COMBINATION_PRODUCT","FLOT","* Oxaliplatin 85 mg\u002Fm2 IV on Day 1\n* Docetaxel 50 mg\u002Fm2 IV on Day 1\n* Leucovorin 200 mg\u002Fm2 IV on Day 1\n* Fluorouracil 2600 mg\u002Fm2 continuous infusion over 24 hours daily on Day 1 Every 14 Days",[9],null,{"type":25,"name":31,"description":32,"armGroupLabels":33,"otherNames":29},"FOLFOX","* Oxaliplatin 85 mg\u002Fm2 IV on Day 1\n* Leucovorin 400 mg\u002Fm2 IV on Day 1\n* Fluorouracil 400 mg\u002Fm2 IV Push on Day 1\n* Fluorouracil 1200 mg\u002Fm2 continuous infusion over 24 hours daily on Days 1 and 2 Every 14 Days",[9],{"type":25,"name":35,"description":36,"armGroupLabels":37,"otherNames":29},"FOLFIRI","* Irinotecan 180 mg\u002Fm2 IV on Day 1\n* Leucovorin 400 mg\u002Fm2 IV on Day 1\n* Fluorouracil 400 mg\u002Fm2 IV Push on Day 1\n* Fluorouracil 1200 mg\u002Fm2 continuous infusion over 24 hours daily on Days 1 and 2 Every 14 Days",[9],{"type":25,"name":39,"description":40,"armGroupLabels":41,"otherNames":29},"FOLFIRINOX","* Oxaliplatin 85 mg\u002Fm2 IV on Day 1\n* Irinotecan 150 mg\u002Fm2 IV on Day 1\n* Leucovorin 200 mg\u002Fm2 IV on Day 1\n* Fluorouracil 1200 mg\u002Fm2 continuous infusion over 24 hours daily on Days 1 and 2 Every 14 days",[9],{"type":25,"name":43,"description":44,"armGroupLabels":45,"otherNames":29},"PACLITAXEL with or without CARBOPLATIN","* Paclitaxel 200 mg\u002Fm2 IV on Day 1\n* Carboplatin AUC 5 IV on day 1 Every 21 Days\n\nOR\n\n\\- Paclitaxel 80mg\u002Fm2 IV on Days 1,8,15 Every 28 Days",[9],{"type":25,"name":47,"description":48,"armGroupLabels":49,"otherNames":29},"DOCETAXEL and IRINOTECAN (alone or combined)","* Docetaxel 35 mg\u002Fm2 IV on Days 1 and 8\n* Irinotecan 50 mg\u002Fm2 IV on Days 1 and 8 Every 21 Days\n* Docetaxel 75 mg\u002Fm2 IV on Day 1 Every 21 Days\n* Docetaxel 150 mg\u002Fm2 IV on Day 1 Every 14 Days",[9],{"type":51,"name":52,"description":53,"armGroupLabels":54,"otherNames":29},"DRUG","NIVOLUMAB (alone or when added to a regimen above)","* 240 mg IV on Day 1 every 14 days, or\n* 360 mg IV on Day 1 every 21 days, or\n* 480 mg IV on Day 1 every 28 days",[9],{"type":51,"name":56,"description":57,"armGroupLabels":58,"otherNames":29},"PEMBROLIZUMAB (alone or when added to a regimen above)","* 200 mg IV on Day 1 every 21 days, or\n* 400 mg IV on Day 1 every 42 days",[9],{"type":51,"name":60,"description":61,"armGroupLabels":62,"otherNames":29},"Durvalumab","\\- 1500 mg IV on Day 1 every 28 days",[9],{"type":51,"name":64,"description":65,"armGroupLabels":66,"otherNames":29},"Trastuzumab","* 8 mg\u002Fkg on Day 1, then 6 mg\u002Fkg IV every 21 days, or\n* 6 mg\u002Fkg on Day 1, then 4 mg\u002Fkg IV every 14 days",[9],[68],{"name":69,"affiliation":70,"role":71},"Farshid Dayyani, MD,PhD","Chao Family Comprehensive Cancer Center","PRINCIPAL_INVESTIGATOR",[73,78],{"name":74,"role":75,"phone":76,"phoneExt":29,"email":77},"Chao Family Comprehensive Cancer Center University of California, Irvine","CONTACT","1-877-827-8839","ucstudy@uci.edu",{"name":79,"role":75,"phone":29,"phoneExt":29,"email":29},"University of California Irvine Medical",[81],{"facility":82,"status":83,"city":84,"state":85,"zip":86,"country":87,"countryCode":88,"cosmosGeoPoint":89,"geoPoint":94,"contacts":95},"Chao Family Comprehensive Cancer Center, University","RECRUITING","Orange","California","92868","United States","US",{"type":90,"coordinates":91},"Point",[92,93],-117.85311,33.78779,{"lat":93,"lon":92},[96],{"name":97,"role":75,"phone":98,"phoneExt":29,"email":77},"Farshid Dayyani, MD, PhD","877-827-8839",{"type":71,"investigatorFullName":100,"investigatorTitle":101,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"Farshid Dayyani","Professor of Clinical Medicine",[103],{"name":104,"class":105},"BillionToOne Inc.","INDUSTRY","100495629","phase-1-response-adapted-neoadjuvant-therapy-in-gastroesophageal-cancers-rant-gc-trial-100495629",false,"NCT05733689","Response Adapted Neoadjuvant Therapy in Gastroesophageal Cancers (RANT-GC Trial)","Response Adapted Neoadjuvant Therapy in Gastroesophageal Cancers (RANT-GC Trial) - a Phase Ib Feasibility Trial","Inclusion Criteria:\n\n* Patients must have histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (GEA). Other GE histologies which are treated per NCCN guidelines for neoadjuvant treatment are eligible.\n* Must have Stage IB, II or Stage III GEA eligible for (neo)adjuvant doublet or triplet chemotherapy for up to 6 months.\n* Age ≥ 18 years Because the safety or efficacy of neoadjuvant chemotherapy for LGEA has not been tested or established for patients \\\u003C18 years of age, children are excluded from this study but will be eligible for future pediatric trials, if applicable.\n* Performance status: ECOG performance status ≤2\n* Life expectancy of greater than 6 months\n* Adequate organ and marrow function as defined below:\n\n  1. hemoglobin ≥ 7g\u002FdL\n  2. absolute neutrophil count ≥ 1,500\u002FmcL\n  3. platelets ≥ 80,000\u002Fmcl\n  4. total bilirubin within normal institutional limits\n  5. AST(SGOT)\u002FALT(SPGT) ≤ 5 X institutional upper limit of normal\n  6. creatinine \\\u003C2 X ULN\n* Docetaxel can cause fetal harm and irinotecan is known to be teratogenic. Since these compounds are part of the treatment regimens, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.\n\n  1\\. A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\n  1. Has not undergone a hysterectomy or bilateral oophorectomy; or\n  2. Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).\n* Ability to understand and the willingness to sign a written informed consent. 1. Both men and women and members of all races and ethnic groups are eligible for this trial. Non-English speaking, deaf, hard of hearing and illiterate individuals are eligible for this trial.\n\nExclusion Criteria:\n\n* Patients may not be receiving any other investigational agents.\n* Patients with known distant metastases from GEA.\n* History of allergic reactions attributed to agents used in study.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* History of another primary cancer which requires active treatment or is expected to require treatment within 12 months after enrollment.\n* Inability to comply with study and follow-up procedures as judged by the Investigator.\n* Patients who are pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.\n* Patients with prior organ\u002Fbone marrow\u002Fnon-autologous stem cell transplants","ALL","18 Years",{"count":116,"type":117},20,"ESTIMATED","INTERVENTIONAL",[120],"PHASE1","This is a phase 1b prospective, single arm, open-label trial determining the efficacy and feasibility of using a response-guided approach to help guide neoadjuvant chemotherapy in subjects with Stage IB, II or Stage III adenocarcinoma of the stomach or gastroesophageal junction (GEA).",[123],"Gastroesophageal Adenocarcinoma","2026-03-06",{"date":126,"type":127},"2026-03-10","ACTUAL",{"date":129,"type":127},"2025-06-27",{"date":131,"type":117},"2027-06",{"name":5,"class":6},1]