[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"resectable-esophageal-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:resectable-esophageal-cancer":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100622595","phase-2-neoadjuvant-chemoimmunotherapy-or-chemoradiotherapy-in-escc-100622595",false,"NCT07385664","Neoadjuvant Chemoimmunotherapy or Chemoradiotherapy in ESCC","A Phase II Study of Neoadjuvant Chemoimmunotherapy or Concurrent Chemoradiotherapy Guided by Post-Chemoimmunotherapy FAPI-PET\u002FCT","FAIR","Inclusion Criteria:\n\n* Be able to understand and voluntarily provide written informed consent before any procedures required for the study are performed.\n* Age between 18 and 75 years.\n* Eastern Cooperative Oncology Group (ECOG) performance status score 0-1.\n* Histologically confirmed esophageal squamous cell carcinoma.\n* T1N1-3M0 or T2-4aNanyM0 as determined by endoscopic ultrasound (EUS) or magnetic resonance imaging (MRI) and PET\u002FCT. All lesions, including tumor and lymph nodes, were required to be resectable.\n* Tumors with strong FAPI uptake on baseline PET\u002FCT scan should have a maximum standardized uptake value (SUVmax) ≥5.0.\n* Subjects were required to provide preoperative paraffin blocks or white slides of tumor tissue, or freshly collected samples, including at least 3 unstained FFPE pathological slides.\n* Female subjects of childbearing potential must have a urine or serum pregnancy test with a negative result within 3 days before the first dose. If urine testing could not confirm the negative result, serum testing was required. Participants who had sex with an unsterilized male partner were required to use an effective contraceptive method from the time of screening and to agree to continue using a contraceptive method for 120 days after the last dose. Discontinuation of contraception after 120 days was discussed with the investigator.\n* Unsterilized male subjects who have sex with a female partner of childbearing potential are required to use effective contraception from the time of screening until 120 days after the last dose; Discontinuation of contraception after 120 days is also discussed with the investigator.\n* Laboratory tests must meet the following criteria:\n\nAbsolute neutrophil count (ANC) ≥ 1500 \u002FµL Platelet count ≥ 100,000\u002FµL Total bilirubin ≤ 2.5 times the upper limit of normal Creatinine clearance (calculated by the following formula) ≥ 60 mL\u002F minute AST\u002FALT ≤ 1.5 times the upper limit of normal The modified Cockcroft-Gault equation was used to estimate creatinine clearance (Clcr) : \\*\\*\n\nFor serum creatinine concentration (Sr Cr) expressed in mg\u002FdL:\n\nClcr (mL\u002Fmin) = (140-age) × actual weight (kg)\u002F(72 × Sr Cr(mg\u002FdL)) Results for women were calculated using 85% of the Clcr values for men.\n\nExclusion Criteria:\n\n* A history of malignant tumors within the past five years prior to registration (excluding basal cell carcinoma, squamous cell skin cancer, carcinoma in situ of the bladder, or cervical cancer). Patients who have undergone surgical treatment and have remained disease-free for over five years are still eligible for inclusion.\n* Known contraindications include severe allergic reactions to taxanes, platinum-based drugs, 5-FU medications, etc.\n* Patients with a documented history of severe allergic reactions to sintilimab.\n* Patients who are unwilling or unable to adhere to visit schedules, treatment plans, laboratory tests, and other study requirements.\n* Previous radiotherapy administered to the chest or abdomen.\n* Patients who have received treatments involving platinum agents, taxanes, 5-FU drugs or PD-1 inhibitors.\n* T4 stage tumors exhibiting definite invasion into the spine, heart, major blood vessels or tracheobronchial tree.\n* Patients with confirmed cervical or supraclavicular lymph node metastasis or other metastatic lymph nodes that cannot be included in the radiotherapy field nor removed during esophagectomy.\n* Patients diagnosed with distant metastases through PET\u002FCT scans or other examinations indicating liver, lung or bone metastases.\n* Individuals suffering from significant uncontrolled cardiovascular diseases (such as heart failure), severe coronary artery disease or recent myocardial infarction; also includes those with serious conditions affecting liver or kidney function (e.g., renal insufficiency or liver cirrhosis).\n* History of severe central nervous system disorders or mental health issues that may impact treatment compliance and study monitoring.\n* Individuals presenting severe surgical contraindications that render them unable to tolerate surgery.","ALL","18 Years","75 Years",{"count":21,"type":22},66,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This study was a single-arm, two-cohort, phase II trial aimed at evaluating the efficacy and safety of FAPI-PET\u002FCT response for guiding the selection of neoadjuvant treatment modes after chemotherapy combined with immunotherapy.",[28],"Resectable Esophageal Cancer",[30,28,31],"FAPI-PET\u002FCT","Neoadjuvant Therapy","NOT_YET_RECRUITING","2026-01-26",{"date":35,"type":36},"2026-02-04","ACTUAL",{"date":38,"type":22},"2026-01-28",{"date":40,"type":22},"2028-02-01",{"name":42,"class":43},"Ji Yongling","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":54,"briefSummary":56,"conditions":57,"keywords":63,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":44},"100565999","evaluation-in-humans-of-the-correlation-between-hepatotoxicity-neurotoxicity-induced-by-oxaliplatin-and-blood-levels-of-hmgb1-100565999","NCT06649474","Evaluation, in Humans, of the Correlation Between Hepatotoxicity, Neurotoxicity Induced by Oxaliplatin, and Blood Levels of HMGB1","HEPATOXALI","Inclusion Criteria:\n\n* ECOG WHO Performance status = 0 or 1\n* Signed and dated informed consent\n* Patients with histological diagnosis of oesogastric or pancreatic adenocarcinoma\n* Resectable tumors\n* Patients able to have a laparoscopy\n* In case of absence of peritoneal invasion on the laparoscopy, patient candidate to a chemotherapy schedule by FLOT or FOLFOX in perioperative setting for oesogastric adenocarcinoma, or FOLFIRINOX in perioperative setting for pancreatic adenocarcinoma\n* Registration in a national health care system (CMU included)\n* Patient speak and understand the french\n\nExclusion Criteria:\n\n* Histology other than adenocarcinoma\n* Metastatic disease\n* History of previous treatment with oxaliplatine\n* History of systemic chemotherapy administration within 5 years prior to inclusion,\n* Patient with an non balanced progressive condition\u002Fdisease (liver failure, renal failure (creatinine clearance \\<30mL\u002Fmin), respiratory failure, congestive heart failure, myocardial infarction in the last 6 months, etc.),\n* Patient on curative dose anticoagulant,\n* Patient with complete dihydropyrimidine dehydrogenase deficiency (Uracilemia ≥ 150 ng\u002Fml),\n* Patient not operable for the pathology concerned,\n* Pregnant or breastfeeding woman, woman of childbearing age who has not performed a pregnancy test before the procedure,\n* Patient with legal incapacity (person deprived of liberty or under curatorship, stutorship, safeguard of justice),\n* Patient who, for psychiatric, social, family or geographical reasons, cannot be followed and\u002For comply with the requirements of the study,,\n* Discovery of peritoneal invasion during the peritoneal exploratory of the laparoscopy",{"count":53,"type":22},100,[55],"NA","Oesogastric and pancreatic adenocarcinomas are poor-prognosis cancers. Incidence of pancreatic cancer drastically increases to such an extent that it will become the second cause of cancer's mortality by 2030. A major challenge is to optimize the therapies for localized setting, when oxaliplatin-based chemotherapy is the standard, before and after surgical excision. Because in 50% of cases oxaliplatin triggers a grade 2-3 sinusoidal obstruction syndrome (SOS) which increases post-operative morbidity, decreases histological response to chemotherapy, increases tumor recurrence, and aggravates the risk of chemotherapy-induced peripheral neuropathy (CIPN).\n\nThere is an urgent need to better understand the biological processes involved in SOS, in order to prevent and treat it without stopping or reducing oxaliplatin administration.\n\nThe biological link between oxaliplatin and SOS has not been described, but recent murine experiments argue for HMGB1 to be the mediator released after exposure to oxaliplatin and inducing SOS, and thereafter CIPN. To date, no biomarker is established between murine and patient analyses, and the release of HMGB1 after oxaliplatin treatment and its effect on hepatic parenchyma is not described in patients. Investigators hypothesized is that HMGB1 would also been increased in patients after oxaliplatin treatment, and correlated to the development of SOS and CIPN. If confirmed, personalized treatment will be possible to target this pathway.\n\nTherefore, investigators propose to dynamically explore this hypothesis in localized oesogastric and pancreatic cancer patients who will be routinely managed by an initial laparoscopy and post-oxaliplatin surgical excision.",[58,59,60,28,61,62],"Pancreatic Cancer","Resectable Pancreatic Adenocarcinoma","Adenocarcinoma","Resectable Gastric or Gastroesophageal Junction Adenocarcinoma","Oesophagogastric Cancer",[64,65,66],"resecable pancreatic, oesophageal, gastric or gastroesophageal junction adenocarcinoma.","Patients able to have a laparoscopy","chemotherapy before surgery","RECRUITING","2024-10-17",{"date":70,"type":36},"2024-10-18",{"date":72,"type":36},"2024-09-06",{"date":74,"type":22},"2028-06-30",{"name":76,"class":43},"University Hospital, Clermont-Ferrand"]