Nctid:
NCT06235164
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000013274", "term"=>"Stomach Neoplasms"}], "ancestors"=>[{"id"=>"D000005770", "term"=>"Gastrointestinal Neoplasms"}, {"id"=>"D000004067", "term"=>"Digestive System Neoplasms"}, {"id"=>"D000009371", "term"=>"Neoplasms by Site"}, {"id"=>"D000009369", "term"=>"Neoplasms"}, {"id"=>"D000004066", "term"=>"Digestive System Diseases"}, {"id"=>"D000005767", "term"=>"Gastrointestinal Diseases"}, {"id"=>"D000013272", "term"=>"Stomach Diseases"}], "browseLeaves"=>[{"id"=>"M16064", "name"=>"Stomach Neoplasms", "asFound"=>"Gastric Cancer", "relevance"=>"HIGH"}, {"id"=>"M8886", "name"=>"Gastrointestinal Neoplasms", "relevance"=>"LOW"}, {"id"=>"M7256", "name"=>"Digestive System Neoplasms", "relevance"=>"LOW"}, {"id"=>"M8883", "name"=>"Gastrointestinal Diseases", "relevance"=>"LOW"}, {"id"=>"M7255", "name"=>"Digestive System Diseases", "relevance"=>"LOW"}, {"id"=>"M16062", "name"=>"Stomach Diseases", "relevance"=>"LOW"}, {"id"=>"T5486", "name"=>"Stomach Cancer", "asFound"=>"Gastric Cancer", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Digestive System Diseases", "abbrev"=>"BC06"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000077594", "term"=>"Nivolumab"}, {"id"=>"D000082082", "term"=>"Immune Checkpoint Inhibitors"}], "ancestors"=>[{"id"=>"D000074322", "term"=>"Antineoplastic Agents, Immunological"}, {"id"=>"D000000970", "term"=>"Antineoplastic Agents"}, {"id"=>"D000045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}], "browseLeaves"=>[{"id"=>"M1674", "name"=>"Oxaliplatin", "relevance"=>"LOW"}, {"id"=>"M8600", "name"=>"Fluorouracil", "relevance"=>"LOW"}, {"id"=>"M2342", "name"=>"Immune Checkpoint Inhibitors", "asFound"=>"Autogenous", "relevance"=>"HIGH"}, {"id"=>"M1854", "name"=>"Nivolumab", "asFound"=>"Syndrome", "relevance"=>"HIGH"}, {"id"=>"M19537", "name"=>"Paclitaxel", "relevance"=>"LOW"}, {"id"=>"M2853", "name"=>"Immunomodulating Agents", "relevance"=>"LOW"}, {"id"=>"M1668", "name"=>"Docetaxel", "relevance"=>"LOW"}, {"id"=>"M377", "name"=>"Capecitabine", "relevance"=>"LOW"}, {"id"=>"M231", "name"=>"Albumin-Bound Paclitaxel", "relevance"=>"LOW"}, {"id"=>"M1346", "name"=>"Antineoplastic Agents, Immunological", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"RETROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>585}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"ACTIVE_NOT_RECRUITING", "startDateStruct"=>{"date"=>"2019-01-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2025-12-30", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-23", "studyFirstSubmitDate"=>"2024-01-23", "studyFirstSubmitQcDate"=>"2024-01-23", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2022-12-30", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"pathological complete response", "timeFrame"=>"4 months", "description"=>"pathological complete response (pCR)"}], "secondaryOutcomes"=>[{"measure"=>"major pathological response", "timeFrame"=>"4 months", "description"=>"major pathological response#MPR"}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Locally Advanced Gastric Cancer"]}, "descriptionModule"=>{"briefSummary"=>"To evaluate the safety and effectiveness of laparoscopic gastrectomy (LG) following neoadjuvant immunochemotherapy (nICT)", "detailedDescription"=>"comparing the radiological response, pathological response rate, perioperative outcomes, and early recurrence between the two groups."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"85 years", "minimumAge"=>"18 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"patients with locally advanced gastric cancer who underwent neoadjuvant therapy", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Age: 18-85 years of age\n* Gastric adenocarcinoma was confirmed by pathology# including histology or cytology##\n* CT/MRI,PET-CT or laparoscopic exploration were used to confirm the diagnosis of gastric cancer staging as cT2-4a and/or N+ and M0 before operation.\n* measurable lesions at least should be detected by CT/MRI examination in accordance with the RECIST1.1.#CT scan of tumor lesion length≥10mm#CT scan short diameter≥15mm#scan slice thicknes 5mm#\n* ECOG#Eastern Cooperative Oncology Group#PS#Performance Status#:0-1 scores;\n* the expected survival time is more than 12 weeks\n* the main organ function is normal, which should meet the following criteria:\n\n (1) blood routine examination standards should be met#no blood transfusion within 14 days#\n\n a#HB≥ 100g/L b. WBC≥3×109/L c. ANC≥1.5×109/L d. PLT≥100×109/L #2#biochemical examination shall comply with the following criteria#\n 1. BIL#1.5 normal upper limit ULN\n 2. ALT and AST#2.5 ULN,GPT≤1.5×ULN\n 3. Cr≤1 ULN#CCR#creatinine clearance rate#60ml/min(Cockcroft Gault formula)\n* women of childbearing age must have a pregnancy test in 7 days before entering the group (in serum), and the results were negative, and willing to use appropriate contraception during the study period and the last 8 weeks after giving drug test; men should have the surgical sterilization, or adopt the appropriate contraceptive methods during the test and the last 8 weeks after giving drug test#\n* No other clinical studies were conducted before and during the treatment\n* participants is willing to participate in this study, sign the informed consent, have good compliance, cooperate with follow-up.\n\nExclusion Criteria:\n\n* Previous history of chemotherapy, radiotherapy, targeted drug therapy or immunotherapy\n* Patients with contraindications for surgical treatment and chemotherapy or whose physical condition and organ function do not allow for larger abdominal surgery\n* patients with metastasis\n* Having any active autoimmune diseases or a history of autoimmune diseases (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); Patients with vitiligo or cured childhood asthma/allergies who did not need any intervention in adulthood were excluded; Autoimmune hypothyroidism treated with a stable dose of thyroid replacement hormone; Type 1 diabetes with stable doses of insulin\n* A history of immunodeficiency, including HIV testing positive, or other acquired or congenital immunodeficiency disorders, or a history of organ transplantation and allogeneic bone marrow transplantation\n* Accompanied by serious heart, lung, liver, kidney disease; Have nerve, mental disease; Jaundice or obstruction of the digestive tract with severe infection\n* pregnant or lactating women\n* The blood pressure of patients with hypertension cannot be reduced to the normal range by the antihypertensive drugs (systolic pressure \\>140 mmHg, diastolic pressure \\>90 mmHg)\n* With # magnitude of coronary heart disease, arrhythmia (including QTc protracted between male \\> 450 ms, women \\> 470 ms) and cardiac insufficiency\n* Patients have a clear tendency with gastrointestinal bleeding, including the following situation: local active ulcerative lesions, and fecal occult blood (+ +); with melena and hematemesis history in 2 months; and patients with fecal occult blood (+) and unresected gastric primary tumor; patients with the risk of bleeding should take the gastroscopy test, if it is the gastric cancer, and researchers believe that may results in massive digestive tract hemorrhage#coagulation dysfunction (INR(international normalized ratio)\\>1.5, APTT(activated partial thromboplastin time)\\>1.5 ULN), with bleeding tendency;\n* Subjects have failed to control good cardiovascular clinical symptoms or disease, including but not limited to: such as: (1) the NYHA class II heart failure (2) above unstable angina pectoris (3) occurred within 1 year (4) have clinical significance of myocardial infarction (mi) room sex or ventricular arrhythmias without clinical intervention on or after clinical intervention is still poorly controlled\n* History of interstitial lung disease (except radiation pneumonia without hormone therapy), and history of non-infectious pneumonia\n* Patients are positive of urine protein (urine protein detection 2+ or above, or 24 hours urine protein quantitative \\>1.0g);\n* A person who has previously been allergic to any component of camrilizumab or to any component of the drug under study\n* The researchers consider those who were not suitable for inclusion."}, "identificationModule"=>{"nctId"=>"NCT06235164", "briefTitle"=>"The Safety and Efficacy of Neoadjuvant Immunochemotherapy Followed by Laparoscopic Gastrectomy for Gastric Cancer", "organization"=>{"class"=>"OTHER", "fullName"=>"Fujian Medical University"}, "officialTitle"=>"The Safety and Efficacy of Neoadjuvant Immunochemotherapy Followed by Laparoscopic Gastrectomy for Gastric Cancer: A Multicenter Real-world Clinical Study", "orgStudyIdInfo"=>{"id"=>"2023KY160"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"neoadjuvant immunochemotherapy group", "description"=>"The immune checkpoint inhibitors (ICIs) used for neoadjuvant immunotherapy in this study included sintilimab, nivolumab, and camrelizumab. Neoadjuvant chemotherapy regimens were primarily categorized into two- and three-agent regimens. The two-agent regimens included: SOX (S-1 + oxaliplatin), CapeOx (capecitabine + oxaliplatin), AS (S-1 + nab-paclitaxel), FOLFOX (oxaliplatin + fluorouracil) and DS (S-1 + docetaxel). The three-agent regimens included: FLOT (docetaxel + oxaliplatin + fluorouracil), DOS (docetaxel + oxaliplatin + S-1) and POF (paclitaxel + oxaliplatin + fluorouracil). Dosages were calculated based on drug monographs, guidelines, and patient body surface area. The patients underwent LG within 4-6 weeks after completing neoadjuvant therapy.", "interventionNames"=>["Drug: immune checkpoint inhibitors: sintilimab, nivolumab, and camrelizumab"]}, {"label"=>"neoadjuvant chemotherapy group", "description"=>"Neoadjuvant chemotherapy regimens were primarily categorized into two- and three-agent regimens. The two-agent regimens included: SOX (S-1 + oxaliplatin), CapeOx (capecitabine + oxaliplatin), AS (S-1 + nab-paclitaxel), FOLFOX (oxaliplatin + fluorouracil) and DS (S-1 + docetaxel). The three-agent regimens included: FLOT (docetaxel + oxaliplatin + fluorouracil), DOS (docetaxel + oxaliplatin + S-1) and POF (paclitaxel + oxaliplatin + fluorouracil). Dosages were calculated based on drug monographs, guidelines, and patient body surface area. The patients underwent LG within 4-6 weeks after completing neoadjuvant therapy."}], "interventions"=>[{"name"=>"immune checkpoint inhibitors: sintilimab, nivolumab, and camrelizumab", "type"=>"DRUG", "description"=>"Drug: Sintilimab, Nivolumab, and Camrelizumab，One course will last 21 days.Given once every 3 weeks at a dose of 200 mg. Drug: nab-paclitaxel nab-paclitaxel one course will last 21 days#Given twice every 3 weeks at a dose of 125 mg/m2. Drug:oxaliplatin Oxaliplatin one course will last 21 days#Given once every 3 weeks at a dose of 130 mg/m2.\n\nDrug:docetaxel docetaxel one course will last 21 days#Given once every 3 weeks at a dose of 40mg/m2.\n\nDrug:fluorouracil fluorouracil one course will last 14 days#Given once every 2 weeks at a dose of 2800mg/m2.\n\nDrug: Capecitabine Capecitabine was calculated according to body surface area every 3 weeks at a dose of 1000 mg/m2, P.O., bid, d1-d14 Drug: S1 S-1 was calculated according to body surface area, P.O., bid, d1-d14#And the dosage according body surface area:\\<1.25m2, 40mg everytime;1.25-1.5m2,50mg every time; \\>1.5m2, 60mg every time", "armGroupLabels"=>["neoadjuvant immunochemotherapy group"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"350001", "city"=>"Fuzhou", "state"=>"Fujian", "country"=>"China", "facility"=>"Fujian Medical University Union Hospital", "geoPoint"=>{"lat"=>26.06139, "lon"=>119.30611}}], "overallOfficials"=>[{"name"=>"Chang-Ming Huang", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Fujian Medical University Union Hospital"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Fujian Medical University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Fujian Medical University Union Hospital", "investigatorFullName"=>"Chang-Ming Huang, Prof.", "investigatorAffiliation"=>"Fujian Medical University"}}}}
