[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"adjuvant-chemotherapy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:adjuvant-chemotherapy":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,46,71,95,122,153,178,201],{"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":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100343195","adjuvant-chemotherapy-in-clinical-local-advanced-crc-following-preoperational-therapies-and-pt0-3n0m0-diagnosis-100343195",false,"NCT03748485","Adjuvant Chemotherapy in Clinical Local Advanced CRC Following Preoperational Therapies and pT0-3N0M0 Diagnosis","Comparing the Treatment Efficacy in Clinical Local Advanced Colorectal Cancer (cTxN1\u002F2M0) Following Preoperational Adjuvant Therapies and Pathologically Proved StageⅡ(pT0-3N0M0)With or Without Adjuvant Chemotherapy","CANWATCH","Inclusion Criteria:\n\n* preoperative clinical tumor stage III （TxN1-2M0）CRC\n* pathological proved CRC adenocarcinoma by endoscopic biopsy\n* Post operational pathological T0-3N0M0 without high risk factors of recurrence\n* Patient able to understand and sign written informed consent\n\nExclusion Criteria:\n\n* Other malignant tumors history.\n* Complications need emergency surgery (occlusion, sub-occlusion, massive hemorrhage and abscesses).\n* Colorectal tumor extension towards abdominal wall and\u002For adjacent organ making liver R0 resection impossible immediately.\n* Non resectable lymph node metastasis.\n* American Society of Anesthesiologists (ASA) grading≥ IV and\u002For, Eastern Cooperative Oncology Group(ECOG) score≥ 2.\n* Physical or psychological dependence.\n* Pregnant or breast feeding women.\n* Not controlled pre-operational infection.\n* Enrolled in other clinical trials within 4 weeks.\n* Other clinical or laboratorial condition not recommended by investigators.","ALL","18 Years","75 Years",{"count":21,"type":22},650,"ESTIMATED","INTERVENTIONAL",[25],"NA","Adjuvant chemotherapy was unnecessary in pathological stage Ⅱ colorectal cancer following initial treatment of surgery without high risk factors of recurrences. The treatment efficacy of adjuvant chemotherapy for pT1-3N0M0 colorectal cancer following preoperational chemotherapy or chemoradiotherapy remains unclear. Part of clinical local advanced colorectal cancer(cTxN1-2M0), which turn out to be pT0-3N0M0 after preoperational chemotherapy or chemoradiotherapy, might not really need adjuvant chemotherapy due to the down-stage efficacy of the preoperational treatments, or the misleading by lymph nodes false-positive imaging diagnosis.",[28,29],"Colorectal Cancer","Adjuvant Chemotherapy",[31,32],"local advanced colorectal cancer","adjuvant chemotherapy","RECRUITING","2026-06-05",{"date":36,"type":37},"2026-06-09","ACTUAL",{"date":39,"type":37},"2019-04-30",{"date":41,"type":22},"2030-12-30",{"name":43,"class":44},"Sixth Affiliated Hospital, Sun Yat-sen University","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":54,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":45},"100603404","phase-2-a-phase-2-trial-of-fruquintinib-and-tislelizumab-in-ctdna-defined-minimal-residual-disease-in-colorectal-cancer-after-completion-of-adjuvant-chemotherapy-100603404","NCT07136077","A Phase 2 Trial of Fruquintinib and Tislelizumab in ctDNA-defined Minimal Residual Disease in Colorectal Cancer After Completion of Adjuvant Chemotherapy","Eligibility Criteria\n\n* Participants must have histologically or cytologically confirmed microsatellite stable (MSS) colorectal adenocarcinoma.\n* Participants must have completed curative intent treatments of stages II, III, or IV colorectal cancer that must include ≥ 3 months of oxaliplatin containing chemotherapy.\n* No evidence of radiographic disease within 28 days (before or after) a positive ctDNA assay.\n* Participants must have minimal residual disease as defined by positive ctDNA assay by Signatera MRD assay.\n* Participants must have adequate organ and marrow function as defined below:\n\n  * Absolute neutrophil count of ≥1.0×109\u002FL\n  * Platelet count of ≥100×109\u002FL\n  * Hemoglobin ≥9 g\u002FdL\n  * Serum total bilirubin ≤1.5× upper limit of normal (ULN) (total bilirubin must be \\\u003C3× ULN for participants with documented Gilbert's syndrome).\n  * Participants must have ALT and AST ≤5× ULN.\n  * Urine protein ≤1+ by dipstick or 24-hour urine protein \\\u003C1 g\u002F24 hours. Participants with 2+ proteinuria by dipstick must undergo 24-hour urine collection to assess urine protein level.\n  * Creatinine creatinine clearance (CrCl) ≥30 mL\u002Fmin per Cockcroft-Gault.\n  * International normalized ratio (INR) and activated prothrombin time (aPTT) ≤1.5 ULN unless the participant is receiving anticoagulation therapy and INR and aPTT values are within the intended therapeutic range.\n* ECOG performance status (PS) of 0 or 1.\n* Age ≥ 18 years.\n* 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 4 months after the end of study treatment. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female patients, between the onset of menses and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:\n\n  * Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n  * History of hysterectomy or bilateral salpingo-oophorectomy.\n  * Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n  * History of bilateral tubal ligation or another surgical sterilization procedure.\n* Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. 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.\n* Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of study treatment administration.\n* Is able to understand and is willing to sign a written informed consent document.\n\nExclusion Criteria\n\n* Has other concomitant active, invasive malignancies that may interfere with ctDNA analysis (known clonal hematopoesis of unknown potential allowed).\n* Has serum electrolytes, potassium, calcium, or magnesium levels outside of the normal laboratory reference range which are clinically significant in the investigator's judgment.\n* Has significant concomitant health conditions including but not limited to severe autoimmune or cardiovascular disorders that may interfere with participation in the study.\n* Active autoimmune diseases or history of autoimmune diseases that may worsen or relapse per treating providers' evaluation.\n* Has a persistent adverse event from previous treatment, except alopecia and neuropathy, greater than or equal to grade 2 of the Common Toxicity Criteria for Adverse Events (CTCAE) v. 5.0\n* Systemic anti-neoplastic therapies or any investigational therapy within 4 weeks prior to the first dose of study drug, including chemotherapy, radical radiotherapy, hormonotherapy, biotherapy, and immunotherapy.\n* Systemic small molecule-targeted therapies (eg, tyrosine kinase inhibitors) within 5 halflives or 4 weeks (whichever is shorter) prior to the first dose of study drug.\n* Mean QT interval corrected by the method of Fridericia (QTcF) ≥480 ms.\n* Has another disease, metabolic disorder, physical examination anomaly, abnormal laboratory result, or any other condition that investigators suspect may (a) prohibit use of the investigational product, (b) affect interpretation of study results, or (c) put the participant at undue risk of harm\n* Has known hypersensitivity to the trial drugs or their excipients or is at risk of allergic of anaphylactic reaction to drug product according to the Investigator's judgement.\n* Is pregnant or lactating.\n* Is unable to take medication orally or has any other condition that investigators believe may affect absorption of the investigational product.\n* Is receiving any other investigational agent.\n* Any condition that requires systemic treatment with either corticosteroid (\\>10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤14 days before the first dose of study drug(s), with the following exceptions:\n\n  * Adrenal replacement (dose of ≤10 mg daily of prednisone or equivalent).\n  * Topical, ocular, intra-articular, intranasal, or inhalational corticosteroid with minimal systemic absorption.\n  * Short course (≤7 days) of corticosteroid prescribed prophylactically (eg, for contrast dye allergy) or for the treatment of a non-autoimmune condition (eg, delayed-type hypersensitivity reaction caused by contact allergen)\n* Live vaccine ≤28 days before the first dose of study drug(s). Seasonal vaccines for influenza are generally inactivated vaccines and are allowed. Intranasal vaccines are live vaccines and are not allowed.\n* Known untreated or inadequately treated active hepatitis C, or chronic hepatitis B.\n* Known untreated or inadequately treated human immunodeficiency virus (HIV) infection.\n* Major surgery within 30 days before the first drug administration. Participants must have recovered adequately from the toxicity and\u002For complications from the intervention prior to the first dose of study drug(s).\n* Prior allogeneic stem cell transplantation or organ transplantation.\n* Any of the following cardiovascular risk factors:\n\n  * Acute myocardial infarction ≤6 months before the first dose of study drug(s).\n  * Heart failure meeting New York Heart Association Function Classification III or IV ≤6 months before the first dose of study drug(s)\n  * Ventricular arrhythmia Grade ≥2 in severity ≤6 months before the first dose of study drug(s).\n  * Cerebrovascular accident ≤12 months before the first dose of study drug(s).\n  * Uncontrolled hypertension that cannot be managed by standard antihypertension medications, which is specified as systolic pressure ≥140 mmHg and\u002For diastolic pressure ≥90 mmHg. The participant must have blood pressures below both limits. Repeated assessments are permitted.\n  * Syncope or seizure ≤28 days before the first dose of study drug(s).\n* Received strong inducers of cytochrome P450, family 3, subfamily A (CYP3A) taken within 2 weeks (or 5 times the t1\u002F2 of the drug, whichever is longer) prior to the first study treatment.\n* Active gastrointestinal and duodenal ulcers, ulcerative colitis, and other gastrointestinal disease: other conditions that the investigator determines to possibly cause gastrointestinal bleeding, perforation, and other conditions; or prior gastrointestinal perforation or gastrointestinal fistula that has not recovered after surgical treatment.\n* History or presence of clinically significant hemorrhage from any site (such as clinically significant melena, hematemesis, hemoptysis, fresh in stool) within 2 months before the screening.\n* History of arterial thrombus within the last 12 months.",{"count":53,"type":22},20,[55],"PHASE2","To find out if a combination of fruquintinib and tislelizumab can control CRC in patients who have received treatment for the disease but still have \"positive\" ctDNA tests for MRD (meaning there is evidence of MRD based on this test).",[58,29,28,59,60,61],"Minimal Residual Disease","Fruquintinib","Tislelizumab","ctDNA","2026-05-28",{"date":64,"type":37},"2026-06-01",{"date":66,"type":37},"2025-09-18",{"date":68,"type":22},"2028-04-01",{"name":70,"class":44},"M.D. Anderson Cancer Center",{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":23,"phases":82,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":45},"100636205","phase-2-randomized-controlled-study-of-plasma-ctdna-methylation-guided-adjuvant-chemotherapy-in-stage-ilow-risk-stage-ii-colorectal-cancer-100636205","NCT07562659","Randomized Controlled Study of Plasma ctDNA Methylation-Guided Adjuvant Chemotherapy in Stage I\u002FLow-Risk Stage II Colorectal Cancer","A Randomized Controlled Trial of Plasma ctDNA Methylation-Guided Adjuvant Chemotherapy Decisions in Postoperative Stage I or Low-Risk Stage II Colorectal Cancer Patients","CLEAR-01","Inclusion Criteria:\n\nParticipants must meet all of the following criteria:\n\n1. Age ≥18 years, regardless of sex;\n2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, with an expected survival of \\>3 months;\n3. Histologically confirmed postoperative pTNM stage high-risk stage II colorectal cancer;\n4. Positive ctDNA status at 1 month after surgery;\n5. Expected survival of \\>12 months;\n6. Ability to understand and willingness to sign a written informed consent form (personally or via a legally authorized representative\u002Fguardian), indicating that the subject understands the study objectives and required procedures and agrees to participate.\n\nExclusion Criteria:\n\n1. Receipt of neoadjuvant therapy prior to surgery;\n2. Blood transfusion during surgery or within 2 weeks prior to surgery;\n3. Pregnant or breastfeeding women, or individuals of reproductive potential who are not using adequate contraception;\n4. History of other malignancies within the past 5 years, except for adequately treated carcinoma in situ of the cervix or non-melanoma skin cancer;\n5. Uncontrolled primary brain tumors or central nervous system metastases, or presence of significant intracranial hypertension or neuropsychiatric symptoms;\n6. Presence of severe or uncontrolled comorbidities, including but not limited to:Severe cardiac disease that remains unstable despite treatment, including myocardial infarction, congestive heart failure, unstable angina, symptomatic pericardial effusion, or unstable arrhythmia within 6 months prior to enrollment; Clearly diagnosed neurological or psychiatric disorders, including dementia or seizure disorders;Severe or uncontrolled infections;Active disseminated intravascular coagulation (DIC) or significant bleeding tendency;Significant impairment of major organ function; Any other condition that, in the opinion of the investigator, would make the patient unsuitable for participation in this study.","80 Years",{"count":81,"type":22},80,[55],"This study will utilize ctDNA methylation detection to evaluate patients with stage I or low-risk stage II colorectal cancer who are ctDNA-positive one month after surgery. It aims to investigate the impact of different adjuvant chemotherapy regimens on ctDNA clearance rates and their prognostic significance. By using postoperative ctDNA status to identify patients at high risk of recurrence, the study seeks to implement intensified chemotherapy strategies (treatment escalation) at an early stage, thereby improving ctDNA clearance and ultimately enhancing patient outcomes.",[61,85,29],"Colorectal Cancer (CRC)","2026-04-25",{"date":88,"type":37},"2026-05-01",{"date":90,"type":37},"2024-11-01",{"date":92,"type":22},"2027-12-31",{"name":94,"class":44},"Fudan University",{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":79,"enrollmentInfo":102,"targetDuration":4,"studyType":23,"phases":104,"briefSummary":106,"conditions":107,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":121},"100621123","phase-3-adjuvant-oxaliplatin-plus-s-1-versus-docetaxel-plus-s-1-for-stage-iii-gastric-cancer-100621123","NCT07366528","Adjuvant Oxaliplatin Plus S-1 Versus Docetaxel Plus S-1 for Stage III Gastric Cancer","Adjuvant Oxaliplatin Plus S-1 Versus Docetaxel Plus S-1 for Stage III Gastric Cancer After D2 Gastrectomy (DRAGON-Adjuvant): a Multicenter, Open-label, Phase 3, Randomized, Non-inferiority Study","Inclusion Criteria:\n\n1. age 18 to 80 years old, male and female\n2. histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction\n3. patients underwent standard D2 gastrectomy and achieved R0 resection, and had no systemic therapy like neoadjuvant therapy\n4. American Joint Committee on Cancer stage IIIA (T2N3a, T3N2, T4aN1, T4aN2, T4bN0), IIIB (T1N3b, T2N3b, T3N3a, T4aN3a, T4bN1, T4bN2), IIIC (T3N3b, T4aN3b, T4bN3a, T4bN3b), and has Lauren classification\n5. with no evidence of metastatic disease\n6. ECOG 0 to 1\n7. Enough organ functions that can tolerate treatment: Absolute neutrophil count (ANC) ≥1.5x109\u002FL, White blood count ≥3.5x109\u002FL, Platelets ≥75x109\u002FL, Hemoglobin (Hb) ≥80g\u002FL, ALT\u002FAST ≤2.5x ULN (for patient with liver metastasis ALT\u002FAST ≤5x ULN), Serum bilirubin ≤1.5x ULN, Serum creatinine ≤1.5x ULN.\n8. Woman of childbearing age should contracept for at least one month before screening and commit to using contraception throughout the entire study period and for the specified time after the study ends.\n9. Signed informed consent and willing to follow the study protocol\n\nExclusion Criteria:\n\n1. other primary malignancies, except for cured skin tumors or cervical carcinoma in situ\n2. severe complications that may lead to an expected survival time less than 5 years\n3. uncontrollable comorbidities, such as infectious disease, chronic diseases like hypertension, diabetes, heart diseases.\n4. allergic to study medication\n5. bowel obstruction or other conditions affecting oral administration\n6. organ functions that cannot tolerate study treatment\n7. other conditions that patients are unsuitable for this study assessed by the investigators",{"count":103,"type":22},387,[105],"PHASE3","This is a multicenter, open-label, phase 3, randomized, non-inferiority study aimed to investigate the effect on disease-free survival of adjuvant chemotherapy with oxaliplatin plus S-1 compared with adjuvant chemotherapy with docetaxel plus S-1 after D2 gastrectomy in patients with stage III gastric cancer.",[108,29,109,110,111],"Gastric Cancer (GC)","Stage 3 Cancer","Docetaxel","Oxaliplatin","2026-01-16",{"date":114,"type":37},"2026-01-26",{"date":116,"type":37},"2025-12-15",{"date":118,"type":22},"2030-10-31",{"name":120,"class":44},"Ruijin Hospital",5,{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":126,"acronym":4,"eligibilityCriteria":127,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":128,"targetDuration":4,"studyType":23,"phases":130,"briefSummary":131,"conditions":132,"keywords":138,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":152},"100589024","phase-3-neoadjuvant-cadonilimab-combined-with-perioperative-oxaliplatin-plus-s1-for-diffuse-or-mixed-type-of-locally-advanced-gastricgastroesophageal-junction-adenocarcinoma-100589024","NCT06949033","Neoadjuvant Cadonilimab Combined With Perioperative Oxaliplatin Plus S1 for Diffuse or Mixed Type of Locally Advanced Gastric\u002FGastroesophageal Junction Adenocarcinoma","Inclusion Criteria:\n\n1. Type of Participant and Disease Characteristics\n\n   1. Patients must have a pathologically confirmed diagnosis of HER-2 negative tumor and diffuse or mixed type gastric or gastroesophageal junction adenocarcinoma according to Lauren's histological subtypes.\n   2. Patients must have previously untreated locally advanced gastric or gastroesophageal junction adenocarcinoma (stage cT2, cT3, cT4), with lymph nodes ranging from N1 to N3 and no evidence of metastatic disease (M0).\n   3. Patients with Siewert type 2 or 3 tumors are eligible. Enrollment of participants with Siewert type 1 tumors will be limited to those for whom the planned treatment is perioperative chemotherapy and resection.\n2. Demographics\n\n   1. Male or female subjects must be between the ages of ≥ 18 and ≤ 75 years at the time of signing the informed consent.\n   2. Expected Survival: The expected survival time must be ≥ 12 weeks.\n   3. Performance Status: Subjects must have an ECOG performance status of 0 or 1 (refer to Appendix 1).\n   4. Male Contraception: Non-sterilized male subjects who are sexually active with a female partner of childbearing potential must use an effective method of contraception from Day 1 through 120 days after receipt of the final dose of the investigational product. It is strongly recommended for the female partner of a male subject to also use an effective method of contraception throughout this period.\n   5. Female subjects of childbearing potential must be willing to use adequate contraception methods throughout the study and for 120 days after the last dose of the study drug. The decision to discontinue contraception after this time point should be discussed with the attending physician. Periodic abstinence, contraceptive rhythm methods, and withdrawal are not acceptable forms of contraception.\n\n      * Females of childbearing potential are defined as those who are not surgically sterile (e.g., bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal (defined as 12 months with no menses without an alternative medical cause).\n      * Highly effective contraception methods, resulting in a low failure rate (i.e., less than 1% per year) when used consistently and correctly, are required. Acceptable methods include a combination of a hormonal method (e.g., contraceptive pill) and a barrier method (e.g., male condom plus spermicide) to prevent pregnancy.\n      * Barrier methods include male condom plus spermicide, copper T intrauterine device, and levonorgestrel-releasing intrauterine system.\n      * Hormonal methods include implants, hormone injection, combined pill, minipill, and patch.\n      * If a female subject becomes pregnant or suspects pregnancy during her participation in the study or her partner's participation, she must promptly inform her treating physician.\n3. Organ Function\n\n   1. Blood Routine (no blood transfusion within 14 days): WBC ≥ 3.0 × 10\\^9\u002FL; ANC ≥ 1.5 × 10\\^9\u002FL; PLT ≥ 100 × 10\\^9\u002FL; HGB ≥ 80 g\u002FL.\n   2. Hepatic Function: Total bilirubin (TBIL) ≤ 1.5 × ULN, or direct bilirubin ≤ ULN for those with total bilirubin levels 1.5 × ULN and ALT\u002FAST levels ≤ 2.5 × ULN.\n   3. Renal Function: Creatinine (Cr) ≤ 1.5 × ULN or Creatinine Clearance (CrCl) ≥ 60 mL\u002Fmin for those with Cr \\> 1.5 × ULN.\n   4. Coagulation Function: INR ≤ 1.5 × ULN, APTT ≤ 1.5 × ULN.\n   5. Cardiac Function: Cardiac function will be assessed using electrocardiogram and color Doppler ultrasound, and subjects must have had no myocardial infarction within the last six months. Hypertension and other coronary heart diseases must be controllable.\n\n      * Females of childbearing potential are defined as those who are not surgically sterile (e.g., bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal (defined as 12 months with no menses without an alternative medical cause).\n      * Highly effective contraception methods, resulting in a low failure rate (i.e., less than 1% per year) when used consistently and correctly, are required. Acceptable methods include a combination of a hormonal method (e.g., contraceptive pill) and a barrier method (e.g., male condom plus spermicide) to prevent pregnancy.\n      * Barrier methods include male condom plus spermicide, copper T intrauterine device, and levonorgestrel-releasing intrauterine system.\n      * Hormonal methods include implants, hormone injection, combined pill, minipill, and patch.\n      * If a female subject becomes pregnant or suspects pregnancy during her participation in the study or her partner's participation, she must promptly inform her treating physician.\n4. Informed Consent All subjects must provide written informed consent to participate in the study.\n5. Other Inclusions\n\n   1. Prior Treatment: Patients must not have previously received any anti-tumor treatments, including radiotherapy, chemotherapy, targeted therapy, or immunotherapy.\n   2. Plan to proceed to surgery following pre-operative chemotherapy based on standard staging studies per local practice.\n   3. Be willing to provide tissue and blood sample from a tumor lesion at baseline and at time of surgery\n\nExclusion Criteria:\n\n1. Medical Conditions\n\n   1. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.\n   2. Has a known additional malignancy that is progressing or has required active treatment within the past 5 years (except for cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, or carcinoma in situ that has undergone potentially curative therapy).\n   3. Has an active infection requiring systemic therapy.\n   4. Has an active autoimmune disease that has required systemic treatment in the past 2 years. (NOTE: Subjects with vitiligo, alopecia, Grave's disease, Type I diabetes mellitus, hypothyroidism (e.g., following Hashimoto's syndrome) only requiring hormone replacement on a stable dose (without adjustment in the first 4 weeks of study treatment), psoriasis or eczema not requiring systemic treatment (within the past 2 years), or conditions not expected to recur in the absence of an external trigger are not excluded.)\n   5. Has any complications requiring systemic treatment with corticosteroids such as prednisone (\\> 10mg\u002Fday) or other immunosuppressive medications within 14 days prior to the first administration. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is allowed.\n   6. History of primary immunodeficiency.\n   7. Has received a live vaccine or other immune-activating anti-tumor drugs (such as interferon, interleukin, thymosin, or immunotherapy) within 30 days prior to the first dose of study treatment.\n   8. Has a known history of active tuberculosis.\n\n      * Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.\n   9. Has a known severe allergy or hypersensitivity to cadonilimab or sintilimab or any of the study chemotherapy agents and\u002For to any of their excipients.\n   10. Presence of any of the following cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors:\n\n       * Grade II or higher myocardial ischemia or myocardial infarction, poorly controlled arrhythmia (including QTc interval ≥ 480 ms), grade III or IV cardiac insufficiency, or left ventricular ejection fraction (LVEF) \\\u003C 50.0% as determined by color Doppler echocardiography.\n       * Cerebrovascular accident, transient ischemic attack, or other arteriovenous thrombotic, embolic, or ischemic events.\n2. Prior\u002FConcomitant Therapy\n\n   1. Subjects who have already enrolled in another clinical study, unless it is an observational, non-interventional clinical study, or they are in the follow-up period for an interventional study (the time between the first dose of cadonilimab and the last dose in the previous clinical study should be more than 4 weeks or 5 times the half-life of the previous study drug).\n   2. Subjects who have received any systemic or curative anti-tumor therapy, including radiotherapy, chemotherapy, targeted therapy.\n   3. Subjects who have previously received any anti-PD-1, anti-PD-L1, anti-CTLA-4 antibody, or any other antibody or drug therapy targeting T-cell co-stimulation or checkpoint pathway, e.g. ICOS or agonists (e.g., CD40, CD137, GITR, and OX40, etc.).\n3. Other exclusion criteria\n\n   1. Confirmed HER-2 positive tumor will be excluded.\n   2. Patients could not provide tumor samples and blood samples.\n   3. Pregnant or lactating patients, as well as patients with childbearing potential who plan to be pregnant within 5 months after the study; Women of childbearing should receive a blood pregnancy test within 7 days before the study",{"count":129,"type":22},668,[105],"This study aims to investigate the efficacy and safety of neoadjuvant cadonilimab in combination with perioperative SOX chemotherapy, compared to perioperative SOX chemotherapy alone, in patients with diffuse or mixed-type locally advanced gastric or gastroesophageal junction adenocarcinoma. The main questions it seeks to answer are:\n\n1. Is neoadjuvant cadonilimab plus SOX chemotherapy superior to neoadjuvant placebo plus SOX chemotherapy in terms of the pathological complete response (pCR) rate at the time of surgery?\n2. To evaluate and compare the 3-year OS rate in patients receiving neoadjuvant cadonilimab plus SOX chemotherapy versus patients receiving placebo plus neoadjuvant SOX chemotherapy regimen.\n\nParticipants will be divided into two groups:\n\n1. Experimental group: Participants will receive intravenous cadonilimab (10 mg\u002Fkg) in combination with the SOX regimen (oxaliplatin 130 mg\u002Fm² and S-1, with the initial dose determined based on body surface area).\n2. Control group: Participants will receive a placebo in combination with the SOX regimen.\n\nAfter completing 3-4 cycles of treatment, patients in both the experimental and control groups will undergo radical surgery with D2 or D2+ lymphadenectomy. Following surgery, patients will receive 4 cycles of adjuvant SOX chemotherapy at 70% of the standard dosage, administered every 21 days, starting within 3-6 weeks post-surgery.",[133,134,29,135,136,137],"Gastric Cancer (Including Stomach and Gastroesophageal Junction [GEJ])","Neoadjuvant Therapy","pCR Rate","MPR","ORR,OS,PFS",[139,140,141,111,142],"gastric cancer","Diffuse or Mixed type","Cadonilimab","S1","2025-07-03",{"date":145,"type":37},"2025-07-10",{"date":147,"type":37},"2025-05-15",{"date":149,"type":22},"2030-12-31",{"name":151,"class":44},"Zuoyi Jiao",4,{"id":154,"slug":155,"hasResults":11,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":4,"eligibilityCriteria":159,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":160,"targetDuration":4,"studyType":23,"phases":162,"briefSummary":163,"conditions":164,"keywords":165,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":177,"locationsCount":152},"100587196","phase-3-neoadjuvant-apatinib-combined-with-sintilimab-and-perioperative-sox-versus-neoadjuvant-sintilimab-combined-with-perioperative-sox-for-intestinal-type-of-locally-advanced-gastricgastroesophageal-junction-adenocarcinoma-100587196","NCT06925243","Neoadjuvant Apatinib Combined With Sintilimab and Perioperative SOX Versus Neoadjuvant Sintilimab Combined With Perioperative SOX for Intestinal Type of Locally Advanced Gastric\u002FGastroesophageal Junction Adenocarcinoma","Neoadjuvant Apatinib Combined With Sintilimab and Perioperative SOX Versus Neoadjuvant Sintilimab Combined With Perioperative SOX for Intestinal Type of Locally Advanced Gastric\u002FGastroesophageal Junction Adenocarcinoma: A Prospective, Multicenter, Open-Label, Randomized Controlled Phase III Study","Inclusion Criteria:\n\n1. Type of Participant and Disease Characteristics\n\n   1. Patients must have a pathologically confirmed diagnosis of HER-2 negative tumor and intestinal type gastric or gastroesophageal junction adenocarcinoma according to Lauren's histological subtypes.\n   2. Patients must have previously untreated locally advanced gastric or gastroesophageal junction adenocarcinoma (stage cT2 to cT4), with lymph nodes ranging from N0 to N3 and no evidence of metastatic disease (M0).\n   3. Patients with Siewert type 2 or 3 tumors are eligible. Enrollment of participants with Siewert type 1 tumors will be limited to those for whom the planned treatment is perioperative chemotherapy and resection.\n2. Demographics\n\n   1. Male or female subjects must be between the ages of ≥ 18 and ≤ 75 years at the time of signing the informed consent.\n   2. Expected Survival: The expected survival time must be ≥ 12 weeks.\n   3. Performance Status: Subjects must have an ECOG performance status of 0 or 1.\n   4. Male Contraception: Non-sterilized male subjects who are sexually active with a female partner of childbearing potential must use an effective method of contraception from Day 1 through 120 days after receipt of the final dose of the investigational product. It is strongly recommended for the female partner of a male subject to also use an effective method of contraception throughout this period.\n   5. Female subjects of childbearing potential must be willing to use adequate contraception methods throughout the study and for 120 days after the last dose of the study drug. The decision to discontinue contraception after this time point should be discussed with the attending physician. Periodic abstinence, contraceptive rhythm methods, and withdrawal are not acceptable forms of contraception.\n\n      * Females of childbearing potential are defined as those who are not surgically sterile (e.g., bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal (defined as 12 months with no menses without an alternative medical cause).\n      * Highly effective contraception methods, resulting in a low failure rate (i.e., less than 1% per year) when used consistently and correctly, are required. Acceptable methods include a combination of a hormonal method (e.g., contraceptive pill) and a barrier method (e.g., male condom plus spermicide) to prevent pregnancy.\n      * Barrier methods include male condom plus spermicide, copper T intrauterine device, and levonorgestrel-releasing intrauterine system.\n\n   ii.Hormonal methods include implants, hormone injection, combined pill, minipill, and patch.\n   * If a female subject becomes pregnant or suspects pregnancy during her participation in the study or her partner's participation, she must promptly inform her treating physician.\n3. Organ Function\n\n   1. Blood Routine (no blood transfusion within 14 days): WBC ≥ 3.0 × 10\\^9\u002FL; ANC ≥ 1.5 × 10\\^9\u002FL; PLT ≥ 100 × 10\\^9\u002FL; HGB ≥ 80 g\u002FL.\n   2. Hepatic Function: Total bilirubin (TBIL) ≤ 1.5 × ULN, or direct bilirubin ≤ ULN for those with total bilirubin levels 1.5 × ULN and ALT\u002FAST levels ≤ 2.5 × ULN.\n   3. Renal Function: Creatinine (Cr) ≤ 1.5 × ULN or Creatinine Clearance (CrCl) ≥ 60 mL\u002Fmin for those with Cr \\> 1.5 × ULN.\n   4. Coagulation Function: INR ≤ 1.5 × ULN, APTT ≤ 1.5 × ULN.\n   5. Cardiac Function: Cardiac function will be assessed using electrocardiogram and color Doppler ultrasound, and subjects must have had no myocardial infarction within the last six months. Hypertension and other coronary heart diseases must be controllable.\n\n      * Females of childbearing potential are defined as those who are not surgically sterile (e.g., bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal (defined as 12 months with no menses without an alternative medical cause).\n      * Highly effective contraception methods, resulting in a low failure rate (i.e., less than 1% per year) when used consistently and correctly, are required. Acceptable methods include a combination of a hormonal method (e.g., contraceptive pill) and a barrier method (e.g., male condom plus spermicide) to prevent pregnancy.\n      * Barrier methods include male condom plus spermicide, copper T intrauterine device, and levonorgestrel-releasing intrauterine system.\n\n   iv.Hormonal methods include implants, hormone injection, combined pill, minipill, and patch.\n   * If a female subject becomes pregnant or suspects pregnancy during her participation in the study or her partner's participation, she must promptly inform her treating physician.\n4. Informed Consent All subjects must provide written informed consent to participate in the study.\n5. Other Inclusions\n\n   1. Prior Treatment: Patients must not have previously received any anti-tumor treatments, including radiotherapy, chemotherapy, targeted therapy, or immunotherapy.\n   2. Plan to proceed to surgery following pre-operative chemotherapy based on standard staging studies per local practice.\n\nBe willing to provide tissue and blood sample from a tumor lesion at baseline and at time of surgery\n\nExclusion Criteria:\n\n1. Medical Conditions\n\n   1. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.\n   2. Has a known additional malignancy that is progressing or has required active treatment within the past 5 years (except for cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, or carcinoma in situ that has undergone potentially curative therapy).\n   3. Has an active infection requiring systemic therapy.\n   4. Has an active autoimmune disease that has required systemic treatment in the past 2 years. (NOTE: Subjects with vitiligo, alopecia, Grave's disease, Type I diabetes mellitus, hypothyroidism (e.g., following Hashimoto's syndrome) only requiring hormone replacement on a stable dose (without adjustment in the first 4 weeks of study treatment), psoriasis or eczema not requiring systemic treatment (within the past 2 years), or conditions not expected to recur in the absence of an external trigger are not excluded.)\n   5. Has any complications requiring systemic treatment with corticosteroids such as prednisone (\\> 10mg\u002Fday) or other immunosuppressive medications within 14 days prior to the first administration. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is allowed.\n   6. History of primary immunodeficiency.\n   7. Has received a live vaccine or other immune-activating anti-tumor drugs (such as interferon, interleukin, thymosin, or immunotherapy) within 30 days prior to the first dose of study treatment.\n   8. Has a known history of active tuberculosis.\n   9. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.\n   10. Has a known severe allergy or hypersensitivity to sintilimab or apatinib or any of the study chemotherapy agents and\u002For to any of their excipients.\n   11. Presence of any of the following cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors:\n\n       * Grade II or higher myocardial ischemia or myocardial infarction, poorly controlled arrhythmia (including QTc interval ≥ 480 ms), grade III or IV cardiac insufficiency, or left ventricular ejection fraction (LVEF) \\\u003C 50.0% as determined by ultrasonic cardiography.\n       * Cerebrovascular accident, transient ischemic attack, or other arteriovenous thrombotic, embolic, or ischemic events.\n2. Prior\u002FConcomitant Therapy\n\n   1. Subjects who have already enrolled in another clinical study, unless it is an observational, non-interventional clinical study, or they are in the follow-up period for an interventional study.\n   2. Subjects who have received any systemic or curative anti-tumor therapy, including radiotherapy, chemotherapy, targeted therapy.\n   3. Subjects who have previously received any anti-PD-1, anti-PD-L1 antibody, or any other antibody or drug therapy targeting T-cell co-stimulation or checkpoint pathway, e.g. ICOS or agonists (e.g., CD40, CD137, GITR, and OX40, etc.).\n3. Other exclusion criteria\n\n   1. Confirmed HER-2 positive tumor will be excluded.\n   2. Patients could not provide tumor samples and blood samples.\n   3. Pregnant or lactating patients, as well as patients with childbearing potential who plan to be pregnant within 5 months after the study; Women of childbearing should receive a blood pregnancy test within 7 days before the study.",{"count":161,"type":22},682,[105],"This study aims to compare the efficacy and safety of neoadjuvant apatinib combined with sintilimab and perioperative SOX chemotherapy versus neoadjuvant sintilimab combined with perioperative SOX chemotherapy in locally advanced intestinal-type gastric cancer\u002Fgastroesophageal junction adenocarcinoma. The primary questions include:\n\n1. Whether the complete remission rate (pCR) of the apatinib combined with sintilimab and SOX regimen is higher than that of the sintilimab combined with SOX regimen.\n2. The safety of the apatinib combined with sintilimab and SOX regimen.\n\nParticipants will be divided into:\n\n1. Experimental Group: Participants will receive an intravenous injection of sintilimab (200 mg) combined with the SOX regimen (oxaliplatin 130 mg\u002Fm² and S-1, with the initial dose determined based on body surface area). Additionally, apatinib (250 mg) will be administered orally once daily during the first three neoadjuvant cycles.\n2. Control Group: Participants will receive treatment with the sintilimab combined with the SOX regimen.\n\nThis treatment will be administered for three to four cycles prior to surgery, followed by radical surgery, including D2 or D2+ lymph node dissection. Surgery is scheduled four weeks after the last neoadjuvant therapy (NAT) cycle. Within 3 to 6 weeks post-surgery, patients will begin adjuvant SOX chemotherapy. Postoperative patients will receive four cycles of adjuvant SOX chemotherapy, administered every three weeks.",[133,134,29,135,136,137],[166,167,168,169,139,170],"apatinib","sintilimab","SOX","Neoadjuvant therapy","intestinal type","2025-04-21",{"date":173,"type":37},"2025-04-22",{"date":175,"type":37},"2025-04-15",{"date":149,"type":22},{"name":151,"class":44},{"id":179,"slug":180,"hasResults":11,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":4,"eligibilityCriteria":184,"healthyVolunteers":11,"sex":17,"minAge":185,"maxAge":4,"enrollmentInfo":186,"targetDuration":4,"studyType":188,"phases":4,"briefSummary":189,"conditions":190,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":45},"100546024","long-term-observational-study-to-evaluate-the-dfs-and-os-of-adjuvant-folfirinox-regimen-in-pancreatic-cancer-patients-100546024","NCT06389552","Long-term Observational Study to Evaluate the DFS and OS of Adjuvant FOLFIRINOX Regimen in Pancreatic Cancer Patients","A Long-term Follow-up Study of FOLFIRINOX Regimen as Adjuvant Therapy in Pancreatic Cancer Patients After Curative Surgery: Multi-center, Prospective","Inclusion Criteria:\n\n* Age over 19 at the time of obtaining the informed consent form\n* Planning to FOLFIRINOX as adjuvant therapy after pancreatic cancer surgery\n* ECOG 0 or 1\n* Scheduled to RO or R1 resection\n* Organ function capable of chemotherapy\n\nExclusion Criteria:\n\n* FOLFIRINOX contraindications among the drug approval requirements\n* Palliative Therapy\n* Experienced toxic reactions or Hypersensitivity reactions of FOLFIRINOX","19 Years",{"count":187,"type":22},36,"OBSERVATIONAL","This study is designed to evaluate the safety and efficacy of adjuvant FOLFIRINOX regimen in pancreatic cancer patients after curative surgery.",[29],"2024-04-24",{"date":193,"type":37},"2024-04-29",{"date":195,"type":37},"2023-09-25",{"date":197,"type":22},"2027-12",{"name":199,"class":200},"HK inno.N Corporation","INDUSTRY",{"id":202,"slug":203,"hasResults":11,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":4,"eligibilityCriteria":207,"healthyVolunteers":11,"sex":208,"minAge":18,"maxAge":19,"enrollmentInfo":209,"targetDuration":4,"studyType":23,"phases":211,"briefSummary":212,"conditions":213,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":45},"100495741","phase-3-concurrent-chemoradiotherapy-combined-with-adjuvant-chemotherapy-treated-advanced-cervical-cancer-100495741","NCT05735145","Concurrent Chemoradiotherapy Combined With Adjuvant Chemotherapy Treated Advanced Cervical Cancer","A Prospective Randomized Controlled Trial for Concurrent Chemoradiotherapy Combined With Adjuvant Chemotherapy in the Treatment of Advanced Cervical Cancer at 2018 FIGO Staging","Inclusion Criteria:\n\n* Cervical cancer confirmed by histopathology incloud squamous cell carcinoma, adenocarcinoma and adenosquamous carcinoma\n* FIGO stage IB3, IIA2, IIB-IVA patients in 2018\n* Locally advanced cervical cancer patients received standard concurrent intensity-modulated chemoradiotherapy followed by three-dimensional afterloading treatment after diagnosis, and the effect reached CR after treatment\n* Aged 18-75 years\n* PS score 0-1\n* Serum hemoglobin \\>=100\\*10\\^9\u002FL, blood platelet \\>= 100000\u002FμL, absolute count of neutrophils\\>=1500\u002FμL; 7.Serum creatinine \\\u003C=1.5 UNL or creatinine clearance \\>= 60 ml\u002Fmin; 8.Serum bilirubin \\\u003C=1.5 UNL, AST (SGOT) and ALT (SGPT)\\\u003C= 1.5 UNL\n* Sign a formal informed consent to show that they understand that the study is in line with hospital and national policies .Estimated total survival \\> 6 months.\n\nExclusion Criteria:\n\n* Locally advanced cervical cancer patients received standard concurrent intensity-modulated chemoradiotherapy followed by three-dimensional afterloading treatment after diagnosis, and the effect unreached CR after treatment\n* Patients who have received neoadjuvant chemotherapy and surgery\n* Patients with cognitive impairment\n* Patients with any distant metastases\n* Patients with any other malignancy within 5 years\n* Any other disease or condition is contraindications to chemoradiotherapy (e.g., active infection, 6 months after myocardial infarction, symptomatic heart disease, including unstable angina, congestive heart failure or uncontrolled arrhythmias, immunosuppressive therapy, etc.); 5.Pregnant or lactating women, or fertile women who do not use contraception\n* Severe bone marrow dysfunction\n* Patients with bleeding tendency\n* Drug abusers or alcohol addicts\n* Those who are known to have a third or fourth degree allergic reaction to any treatment in the study","FEMALE",{"count":210,"type":22},108,[105],"This study carried out a prospective, randomized, controlled clinical study under the background of intensity-modulated radiation therapy and three-dimensional afterloading therapy. By comparing simultaneous intensity-modulated radiotherapy and chemotherapy combined with adjuvant chemotherapy and simultaneous intensity-modulated radiotherapy and chemotherapy alone, based on the 2018 FIGO staging The clinical efficacy of locally advanced cervical cancer further clarifies the role of adjuvant chemotherapy in locally advanced cervical cancer.",[214,215,29],"Uterine Cervical Neoplasms","Chemoradiotherapy","2023-02-16",{"date":218,"type":37},"2023-02-21",{"date":220,"type":37},"2022-07-01",{"date":222,"type":22},"2027-06-30",{"name":224,"class":44},"Fourth Affiliated Hospital of Guangxi Medical University"]