[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"locally-advanced-colorectal-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:locally-advanced-colorectal-cancer":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,45,78,100,127,149,174],{"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},"100576299","phase-3-efficacy-of-the-use-of-neoadjuvant-withwithout-hyperthermic-intraperitoneal-chemotherapy-in-the-treatment-of-locally-advanced-colon-cancer-100576299",false,"NCT06783491","Efficacy of the Use of Neoadjuvant With\u002FWithout Hyperthermic Intraperitoneal Chemotherapy in the Treatment of Locally Advanced Colon Cancer","Efficacy of the Use of Neoadjuvant With\u002FWithout Hyperthermic Intraperitoneal Chemotherapy in the Treatment of Locally Advanced Colon Cancer: A Phase III Multi-arm, Randomized and Controlled Clinical Trial (FOXHIPECT4)","FOXHIPECT4","Inclusion Criteria:\n\n* Patients of both sexes, aged ≥18 years and ≤75 years (patients between 70-75 years old will be discussed in committee).\n* Adenocarcinoma of the colon, sigmoid colon and rectum-sigmoid junction that is cT4a\u002Fb according to the American Joint Committee on Cancer (AJCC) TNM eight edition. Pre-treatment diagnosis by imaging test (CT scan or MRI). High-risk cT3 with invasion into surrounding fat greater than 5mm may be included.\n* Nodal extension: cN0, the presence of cN1\u002F2 according to AJCC TNM 8th edition is allowed as long as they can be resected. Pre-treatment diagnosis by imaging test (CT scan or MRI).\n* Metastatic extension: cM0. Patients with cM1 are not allowed to be included.\n* ECOG 0-1.\n* Microsatellite stability (pMMR).\n* Informed consent duty completed.\n\nExclusion Criteria:\n\n* Presence of metastases (M1). If liver or peritoneal metastases are present at the time of surgery, the patient will be excluded from the study and treated according to the new stage.\n* Presence of un-resectability criteria in the pretreatment work-up, un-resectability will be discussed in MDT with expert oncologic surgeons.\n* Presence of microsatellite instability (dMMR).\n* Presence of deficit of DPD.\n* Urgent intervention due to obstruction or perforation if the primary tumour is removed. Bridge interventions such as transit shunts without removal of the primary tumour or percutaneous drainage of collections prior to neoadjuvant treatment or scheduled surgery will be accepted.\n* Extraperitoneal rectal cancer (medium-low) (avoiding alterations due to neoadjuvant radiotherapy).\n* Coexistence of another relevant malignant neoplastic disease (synchronous colon and rectum-sigmoid tumours are accepted as long as the stage is equal or lower than the treated tumour), it will be discussed in steering committee.\n* Severely impaired hepatic, renal or cardiovascular function.\n* Intolerance to treatment.\n* Gestational or lactating women.","ALL","18 Years","75 Years",{"count":21,"type":22},1083,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","The main objective of this randomized and controlled trial is to determine whether the use of a proactive strategy, systemic neoadjuvant treatment (FOLFOX) with or without hyperthermic intraperitoneal chemoterapy (HIPEC) with mitomycin C followed by postoperative systemic adjuvant treatment, increases disease-free survival at 36 months in patients with locally advanced colon cancer compared to standard treatment. Therefore, a phase III, randomized, academic, multicenter, controlled trial will be conducted. Patients with locally advanced colon adenocarcinoma (cT4, cT3 with invasion \\>5mm) Nx and no metastases will be included. Control group (n=361) will receive standard treatment (surgery and adjuvant chemotherapy FOLFOX x 12 based); Experimental group 1 (n=361) = Neoadjuvant chemotherapy (FOLFOX x6) + surgery (associating HIPEC) and FOLFOX x 6; Experimental group 2 (n=361): Neoadjuvant chemotherapy (FOLFOX x6) + surgery and FOLFOX x 6. Randomization will be 1:1:1, stratified and centralized. The primary outcome will be disease-free survival at 36 months. Secondary outcomes will be tumor regression rate, ctDNA negativization, peritoneal relapse rate at 36 months, pattern of relapse, toxicity, morbidity and overall survival. Considering the results obtained with these two independent strategies (FOLFOX and HIPEC), a new trial is justified in order to provide strong evidence for this proactive treatment. The aim is to combine both to obtain a better benefit, which opens the direct possibility of increasing the current percentage of disease-free survival. The results of this study will have important scientific and social impact, since is aimed at improving the outcomes of one subpopulation of patients with locally advanced colon cancer whose current treatment, is not enough to avoid the recurrence of disease.",[28],"Locally Advanced Colorectal Cancer",[30,31],"colorectal cancer","hyperthermic intraperitoneal chemotherapy","RECRUITING","2026-06-04",{"date":35,"type":36},"2026-06-08","ACTUAL",{"date":38,"type":36},"2026-05-26",{"date":40,"type":22},"2030-12-31",{"name":42,"class":43},"Maimónides Biomedical Research Institute of Córdoba","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":57,"conditions":58,"keywords":62,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100638163","phase-1-study-evaluating-the-safety-feasibility-and-efficacy-of-odi-2001-vaccine-a-personnalized-immunotherapy-in-patients-with-metastatic-or-locally-advanced-colon-cancer-or-pancreatic-cancer-100638163","NCT07587827","Study Evaluating the Safety Feasibility and Efficacy of ODI-2001 Vaccine, a Personnalized Immunotherapy in Patients With Metastatic or Locally Advanced Colon Cancer or Pancreatic Cancer","A Phase 1, Open-label, Dose-escalation and Dose-expansion Study Evaluating the Safety Feasibility and Efficacy of ODI-2001 Vaccine, a Personnalized Immunotherapy in Patients With Metastatic or Locally Advanced Colon Cancer or Pancreatic Cancer","ODI-2001-01","Inclusion Criteria:\n\n* Patient capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n* Male or female of \\> 18 years of age\n* Histologically confirmed diagnosis of metastatic or locally advanced solid tumour: • Colorectal carcinoma with MicroSatellite Stable colorectal carcinoma (MSS) not eligible for surgery or other ablative therapies. • Pancreatic adenocarcinoma not eligible for surgery or other ablative therapies.\n* ECOG performance status 0 or 1\n* Baseline Tumoral evaluation (thoraco-abdomino-pelvic computed tomography) performed before the initiation of the standard first line-chemotherapy with at least one measurable lesion according to RECIST 1.1 criteria that can be accurately assessed at baseline and is suitable for repeated assessment.\n* Eligible to start a standard first line chemotherapy indicated in colorectal cancer (FOLFOX\u002FFOLFIRI\u002FFOLFIRINOX or FOLFOXIRI +\u002F- anti-VEGF\u002FEGF) pancreatic cancer (FOLFIRINOX\u002FNabPaclitaxel-Gemcitabine).\n* Adequate haematological, renal and hepatic laboratory requirements : • Haemoglobin \\> 9.0 g\u002FdL • White Blood Cells (WBC) \\> 2.5x109\u002FL including, absolute neutrophils count (ANC) \\> 1.5x109\u002FL, total lymphocytes count \\> 0.5x109\u002FL • Platelet's count \\> 100x109\u002FL• Serum alkaline phosphatase (PAL) ≤ 3 x ULN in the absence of liver or bone metastases and ≤ 5 x ULN in patients with documented bone or liver metastases• Serum transaminases (alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN in the absence of liver metastases and ≤ 5 x ULN in case of liver metastases\n\n  • Total bilirubin ≤ 1.5 x ULN• Albumin ≥ 30 g\u002FL • Glomerular Filtration Rate ≥ 50 mL\u002Fmin (according to Modification of the Diet in Renal Disease \\[MDRD\\] formula or Cockroft \\& Gault formula)\n* Adequate cardiac function with QTc \\\u003C 450 msec on baseline ECG, using the Fridericia correction cQTcF formula\n* Life expectancy of at least 6 months\n* Patient willing and able to comply with scheduled visits and exams during the follow-up and treatment compliance of the protocol, for the duration of the study including : • mandatory blood sampling (3 blood sampling) • mandatory biopsy of the tumor following enrolment in STEP 1 if no archived material dated less than 2 years is available in sufficient quality or quantity and a mandatory biopsy at 2 months after the initiation of ODI-2001 vaccine administration.\n* Men who are sexually active with women of childbearing potential must agree to use contraceptive method during the ODI-2001 treatment period and for at least 4 months after the last ODI-2001 administration. The individual methods of contraception may be determined in consultation with the investigator and it must have a failure rate of less than 1% per year.\n* A female participant is eligible to participate if she is not pregnant (negative urinary or serum pregnancy test), not breastfeeding, and at least one of the following conditions applies: • Not a woman of childbearing potential OR • Women of childbearing potential who agrees to apply effective contraception method during the treatment period and for at least 4 months after the last dose of study treatment. Effective contraception methods include a combination of any of the following (unless method is abstinence or sterilization, in which only one method is required): - Use of oral, injected, or implanted hormonal methods of contraception, or other forms of hormonal contraception that have comparable efficacy (failure rate \\\u003C 1%). In case of use of oral contraception, women should have been stable on the same pill for a minimum of 6 months before taking study treatment. - Placement of an intrauterine device or intrauterine system. - Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical\u002Fvault caps) with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fvaginal suppository. - Total abstinence - Female sterilization at least eight weeks before taking study treatment. - Male sterilization (at least six months prior to screening)\n* Patient must be affiliated to a social health insurance regimen\n\nInclusion criteria for ENROLMENT STEP 1 :\n\nFirst tumoral evaluation shows disease response with the following definition:\n\n* Colorectal carcinoma: A decrease of at least 30% or more in the sum of the diameters of target lesions compared to the initial sum of diameters (Baseline assessment) = at least partial response definition according to RECIST 1.1 definition.\n* Pancreatic carcinoma: A decrease of at least 20% or more in the sum of the diameters of target lesions compared to the initial sum of diameters (Baseline assessment) = adaptative RECIST 1.1 definition.\n\n  * Availability of tumoral material in sufficient quality and quantity in FFPE to performed dB209 manufacturing (5-10 slides according to tissue surface area) + tumoral microenvironment assessment (10 slides). In case of lack of tumoral material to performed the mandatory 2 analysis, a new biopsy should be organized.\n\nInclusion criteria for ENROLMENT STEP 2\n\n* Second tumoral evaluation shows disease response with the following definition:\n\n  * Colorectal carcinoma: A decrease of at least 30% or more in the sum of the diameters of target lesions compared to the initial sum of diameters (Baseline assessment) = at least partial response definition according to RECIST 1.1 definition.\n  * Pancreatic carcinoma: A decrease of at least 20% or more in the sum of the diameters of target lesions compared to the initial sum of diameters (Baseline assessment) = adaptative RECIST 1.1 definition.\n* Patient eligible for a 6-week chemotherapy break, with the start of maintenance treatment beginning in week 7.\n\nExclusion Criteria:\n\n* Patients with \\>10% hepatic involvement as per investigator\n* Exposure to any investigational agent within 30 days of enrolment.\n* Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study\n* History of any second malignancy within 2 years with the exception of malignancies with a negligible risk of metastasis or death (e.g. adequately treated carcinoma-in situ of the breast or the cervix, melanoma-in-situ, prostate cancer with Gleason grade ≤6 and prostate specific antigen within normal range).\n* Known or suspected history of immunosuppression (severe auto-immune or immunodeficiency disease) including history of invasive opportunistic infections (e.g tuberculosis, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystis, aspergillosis) despite infection resolution. Presence or suspicion of active bacterial, fungal or viral infections, or uncontrolled fever\n* Patients with major surgery within 4 weeks from enrolment\n* Previous vaccination (either therapeutic and\u002For prophylactic) against cancer\n* Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, ototoxicity, vitiligo, and the laboratory values defined in the inclusion criteria.\n* Patients under chronic treatment with systemic corticoids or other immunosuppressive drugs (e.g., cyclosporine) unless used at dose levels that are not immunosuppressive (e.g. Prednisone at 10 mg\u002Fday or less or as inhaled steroid at doses used for the treatment of asthma) up to 14 days before pre-enrolment.\n* Is receiving growth factors including, but not limited to, granulocyte colony stimulating factor (G-CSF), granulocyte macrophage-colony stimulating factor (GM-CSF), erythropoietin, etc. within 4 weeks from enrolment\n* Known history of Positive serology for Human Immunodeficiency Virus (HIV) or Hepatitis C Virus (HCV); presence of HBs antigen in the serum\n* History of severe auto-immune or immunodeficiency disease\n* Known allergy to any of the components of ODI-2001 (e.g. egg or gentamycin)\n* Known allergy, or history of serious adverse reaction to vaccines such as anaphylaxis, hives, or respiratory difficulty\n* Planned to receive yellow fever or other live (attenuated) vaccines during the course of the study\n* Recent or active clinically significant infection requiring therapy at the time of first dose\n* Any persistent or unresolved drug-related toxicity following previous treatment\n* Myocardial infarction or stroke within previous 6 months, unstable angina, serious uncontrolled cardiac arrhythmia, history of myocarditis, or congestive heart failure\n* Known symptomatic malignant brain lesion\n* Patients with any serious uncontrolled disease or psychiatric condition that, in the opinion of the Investigator, might interfere with the patient's participation in the trial or interfere with the interpretation of trial results",{"count":54,"type":22},77,[56],"PHASE1","This is a phase 1, open-label, multicentric study evaluating the safety, feasibility and efficacy of ODI-2001, a personnalized therapeutic cancer vaccine composed of DNA neoantigen vaccine, Modified Vaccinia virus Ankara (MVA) viral adjuvant and anti-CTLA4 (ipilimumab), in patients with metastatic or locally advanced colorectal or pancreatic cancer. The study includes a dose-escalation phase to determine the maximum tolerated dose (MTD) followed by an expansion phase to evaluate efficacy in terms of progression-free survival",[59,28,60,61],"Metastatic Colorectal Cancer (CRC)","Metastatic Pancreatic Cancer","Locally Advanced Pancreatic Cancer",[63,64,65,66],"vaccine","pancreas","colorectal","phase 1","NOT_YET_RECRUITING","2026-05-11",{"date":70,"type":36},"2026-05-14",{"date":72,"type":22},"2026-11-01",{"date":74,"type":22},"2031-05-01",{"name":76,"class":43},"Centre Georges Francois Leclerc",2,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":85,"targetDuration":4,"studyType":23,"phases":87,"briefSummary":89,"conditions":90,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":4},"100631665","phase-2-umbrella-trial-of-neoadjuvant-therapy-for-locally-advanced-colorectal-cancer-100631665","NCT07503639","Umbrella Trial of Neoadjuvant Therapy for Locally Advanced Colorectal Cancer","An Exploratory Umbrella Trial of Neoadjuvant Therapy for Locally Advanced Colorectal Cancer Based on Molecular Subtypes","Inclusion Criteria:\n\n1. Age 18-75 years old, female and male;\n2. Pathological confirmed adenocarcinoma;\n3. Stage II\u002FIII colon cancer, or stage II\u002FIII rectal cancer located less than 10 cm from the anal verge;\n4. Treatment-naïve and no distance metastases;\n5. KPS ≥ 70;\n6. No radiotherapy, chemotherapy, immunotherapy, or any other anti-tumor therapy had been administered prior to enrollment;\n7. Baseline blood and biochemical indicators meet the following criteria: neutrophils ≥ 1.5 × 10\\^9\u002FL, Hb ≥ 90 g\u002FL, PLT ≥ 100 × 10\\^9\u002FL, ALT\u002F AST ≤ 2.5 ULN, Cr ≤ 1 ULN;\n8. With good compliance and signed the consent form.\n\nExclusion Criteria:\n\n1. Pregnancy or breast-feeding women;\n2. Known history of other malignancies within 5 years;\n3. Known history of severe neurological or mental illness (such as schizophrenia, dementia or epilepsy);\n4. Current severe cardiac disease (cardiac dysfunction and arrhythmia), renal dysfunction and liver dysfunction;\n5. Acute cardiac infarction or cerebral ischemic stroke occurred within 6 months before recruitment;\n6. Uncontrolled infection which needs systemic therapy;\n7. Active autoimmune disease or immunodeficiencies, known history of organ transplantation or systematic use of immunosuppressive agents;\n8. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1 to 2 antibody positive), active syphilis infection, active pulmonary tuberculosis infection;\n9. Allergic to any component of the therapy.",{"count":86,"type":22},134,[88],"PHASE2","This is a prospective, open-label, single-center, phase II umbrella trial designed to evaluate the efficacy and safety of neoadjuvant therapy for locally advanced colorectal cancer. Patients will be stratified into four cohorts based on microsatellite instability (MSI) status, KRAS mutation status, and the consensus molecular subtypes (CMS). Six arms are included across four cohorts and each arm will be assigned to a specific treatment regimen. The primary endpoint is the complete response rate. Secondary endpoints include safety, organ preservation rate (for rectal cancer only), R0 resection rate, surgical complications, treatment compliance, 3-year survival, and quality of life (QoL) score.",[28],"2026-03-25",{"date":93,"type":36},"2026-03-31",{"date":95,"type":22},"2026-04",{"date":97,"type":22},"2030-04",{"name":99,"class":43},"Fudan University",{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":17,"minAge":107,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":23,"phases":110,"briefSummary":111,"conditions":112,"keywords":113,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":44},"100581127","phase-2-neoadjuvant-adg126-and-pembrolizumab-in-locally-advanced-colorectal-cancer-100581127","NCT06846268","Neoadjuvant ADG126 and Pembrolizumab in Locally Advanced Colorectal Cancer","Phase II Trial of Neoadjuvant ADG126 and Pembrolizumab in Locally Advanced Colorectal Cancer","Inclusion Criteria:\n\n1. Willing and able to provide written informed consent for the trial.\n2. Be ≥ 21 years of age on the date of signing informed consent.\n3. ECOG performance status of 0 or 1.\n4. Histologically confirmed colorectal adenocarcinoma. Rectal cancers allowed if the treatment plan was upfront surgery with no need for any neoadjuvant chemotherapy or radiation.\n5. Clinical stage II (T3-4, N-) or stage III (Tany, N+).\n6. No evidence of distant metastases.\n7. Radiologically measurable or clinically evaluable disease.\n8. Negative pregnancy test done 72 hours before registration, for women of childbearing potential.\n\n   Subjects of childbearing potential must be willing to use an adequate method of contraception. Appropriate methods of birth control include abstinence, oral contraceptives, implantable hormone contraceptives, or double barrier method (diaphragm plus condom). Contraception, for the course of the study starting with the first dose of study medication through 150 days after the last dose of study medication. Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.\n\n   Non-childbearing potential is defined as follows:\n   * ≥45 years of age and has not had a menstrual period for \\>1 year\n   * Patients who have been amenorrhoeic for \\\u003C2 years without a history of hysterectomy and oophorectomy must have a follicle-stimulating hormone value in the postmenopausal range upon screening evaluation\n   * Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure; otherwise, the patient must be willing to use 2 adequate barrier methods throughout the study.\n9. Demonstrate adequate organ function as defined below, all screening labs should be performed within 28 days of treatment initiation.\n\n   1. Haematological\n\n      * Absolute neutrophil count (ANC) greater than or equal to 1,500\u002FmcL.\n      * Platelets greater than or equal to 100,000\u002FmcL.\n      * Haemoglobin greater than or equal to 9 g\u002FdL.\n   2. Renal\n\n      · Serum creatinine OR Measured or calculated creatinine clearance (by Cockcroft-Gault equation), Serum creatinine less than or equal to 1.5 x upper limit of normal (ULN) OR creatinine clearance greater than or equal to 60 mL\u002Fmin for subject with creatinine levels greater than 1.5 x ULN\n   3. Hepatic\n\n      * Serum total bilirubin less than or equal to 1.5 x ULN OR Direct bilirubin less than or equal to ULN for subjects with total bilirubin levels greater than 1.5 x ULN.\n      * AST and ALT less than or equal to 2.5 x ULN.\n   4. Coagulation · International Normalised Ratio (INR) or Prothrombin Time (PT) or Activated Partial Thromboplastin Time (aPTT). For patients not taking warfarin: INR less than or equal to 1.5 or PT less than or equal to 1.5 x ULN; and either PTT or aPTT less than or equal to 1.5 x ULN. Patients on warfarin may be included on a stable dose with a therapeutic INR less than 3.5.\n\nExclusion Criteria:\n\n1. Recurrent colorectal cancer.\n2. Prior radiation therapy, chemotherapy, immunotherapy, or surgery for colorectal cancer.\n3. Tumour is causing symptomatic bowel obstruction (patients who have a temporary diverting stoma are eligible).\n4. Other invasive malignancy ≤5 years prior to registration.\n5. Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of non-physiologic dose immunosuppressive therapy within 7 days prior to first dose of trial treatment.\n6. Active autoimmune disease requiring systemic treatment within the past 2 years or documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents at non-physiologic doses.\n7. Active infection requiring systemic therapy.\n8. Received prior therapy with an antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.\n9. Experienced ≥ Grade 3 immune-related adverse event with prior immunotherapy, with the exception of non-clinically significant lab abnormalities.\n10. Other anticancer or experimental therapy. No other experimental therapies (including chemotherapy, radiation, hormonal treatment, antibody therapy, immunotherapy, gene therapy, vaccine therapy, angiogenesis inhibitors, or other experimental drugs) of any kind are permitted while the patient is receiving study treatment.\n11. Known history of Human Immunodeficiency Virus.\n12. Known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \\[qualitative\\] is detected).\n13. Women who are pregnant or breastfeeding, or men expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening visit through 150 days after the last dose of study medication.\n14. Concurrent medical or psychiatric condition or disease which, in the investigator's judgement, would make them inappropriate candidates for entry into the study. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 90 days) myocardial infarction, chronic obstructive pulmonary disease, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent.\n15. Received a live vaccine within 30 days of planned start of study medication.\n16. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrolment.\n17. History of interstitial lung disease.\n18. Known hypersensitivity to ADG126 or pembrolizumab components or excipients.","21 Years",{"count":109,"type":22},20,[88],"This is a single site, open-label, single-arm phase II study to determine feasibility, tolerability, and preliminary efficacy of neoadjuvant ADG126 and pembrolizumab in stage II or III colorectal cancer.",[28],[114,115,116,117],"ADG126","Pembrolizumab","Colorectal cancer","Neoadjuvant","2025-07-22",{"date":120,"type":36},"2025-07-25",{"date":122,"type":36},"2025-04-14",{"date":124,"type":22},"2027-12-31",{"name":126,"class":43},"National University Hospital, Singapore",{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":135,"targetDuration":4,"studyType":23,"phases":137,"briefSummary":138,"conditions":139,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":44},"100484267","phase-2-capeox-combined-with-bevacizumab-plus-anti-pd1-antibody-as-neoadjuvant-therapy-for-microsatellite-stable-locally-advanced-rectal-cancer-100484267","NCT05585814","CapeOX Combined With Bevacizumab Plus Anti-PD1 Antibody as Neoadjuvant Therapy for Microsatellite Stable Locally Advanced Rectal Cancer","CapeOX Combined With Bevacizumab Plus Pembrolizumab as Neoadjuvant Therapy for Microsatellite Stable Locally Advanced Rectal Cancer (COBP)","COBP","Inclusion Criteria:\n\n* Histologically confirmed rectal adenocarcinoma with cT3+N+M0\n* Immunohistochemistry and\u002For genetic testing confirmed pMMR\u002FMSS\n* Initial diagnosed or recurrent patients will be accepted, patients with recurrence should not have received any treatment include chemotherapy, targeted therapy or immunotherapy within 1 month or radiotherapy within 1 year\n* Measurable disease according to the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria and haven't received any local treatment.\n* Eastern Cooperative Oncology Group (ECOG) 0-1.\n* Absence of distant metastasis confirmed by CT, MRI or PET\u002FCT\n* Adequate hematologic and organ function, defined by protocol-specified laboratory test results, obtained within 7 days before first dose. Absolute neutrophil count ≥1500\u002Fmm3, platelet ≥100,000\u002Fmm3, Hb ≥10g\u002Fdl, serum creatinine ≤1.5 times ULN, creatinine clearance rate ≥50mL\u002Fmin, ALT and AST ≤2.5 times ULN, INR or aPTT ≤1.5 times ULN (INR ≤2 times ULN and aPTT in normal range for patients who are on prophylactic anticoagulant therapy within 14 days before study treatment), total bilirubin level ≤2 times ULN (within 7 days before study treatment).\n* Women of childbearing age should confirm that serum pregnancy test is negative and agree to use effective contraceptive methods during study treatment and the following 60 days.\n* Life expectancy\\> 3 months\n* Signed and written informed consent\n\nExclusion Criteria:\n\n* Previously received anti-PD1 or anti-PDL1 or anti-PDL2 or anti-CTLA4.\n* Uncontrolled active bleeding from the primary tumor or intestinal obstruction.\n* Contraindications of bevacizumab\n* Hypersensitivity to other monoclonal antibodies.\n* Any active, known or suspected autoimmune disease.\n* Uncontrolled pleural effusion, pericardial effusion, or ascites to a moderate or greater extent.\n* History of one of the following diseases: idiopathic pulmonary fibrosis, organized pneumonia (eg. bronchiolitis obliterans), drug-induced pneumonia, idiopathic pneumonia and interstitial pneumonia, or evidence of active pneumonia through enhanced chest CT screening.\n* Major surgery within 4 weeks before enrollment and haven't fully recovered from the previous surgery.\n* Active bleeding or abnormal coagulation (aPTT \\>43s or INR \\>1.5 times ULN), or having a tendency to bleed or receiving thrombolytic or anticoagulant therapy.\n* Previously received allogeneic stem cell or parenchymal organ transplantation.\n* Any significant clinical or laboratory abnormality that the investigator considers to influence the safety assessment, eg. uncontrolled active infection, uncontrolled diabetes, hypertension that cannot be reduced to normal range with monotherapy, grade II or above peripheral neuropathy, congestive heart failure, heart disease (class II or higher) as defined by the New York College of Cardiology, myocardial infarction within 3 months prior to enrollment, unstable arrhythmias, unstable angina pectinis, chronic kidney disease, abnormal thyroid function and previous or co-existing malignancies.\n* History of uncorrected serum electrolyte disturbances such as potassium, calcium and magnesium.\n* HIV infection.\n* Active hepatitis B or hepatitis C.\n* Pregnancy or lactation period, or unwilling to use contraception during the trial.\n* With other malignancy within 5 year, except cervical carcinoma in situ, basal or squamous skin cancer, local prostatic carcinoma and ductal carcinoma in situ.\n* Use corticosteroids (dose of prednisone or similar drugs\\> 10mg\u002Fday) or other immunosuppressive agents within 14 days before enrollment.\n* Patients with active tuberculosis (TB) who are receiving anti-TB treatment or have received anti-TB treatment within 1 year.\n* Active infection, or treatment with oral or intravenous antibiotics within the first 2 weeks prior to neoadjuvant therapy, except prophylactic administration.\n* Anti-infective vaccine (eg. influenza vaccine, varicella vaccine, etc.) injection within 4 weeks before neoadjuvant therapy.\n* Previous participation in other clinical trials within 4 weeks before neoadjuvant therapy.\n* Any other disease, metabolic disorder, abnormal physical examination or abnormal laboratory results that may constrain the use of trial drug, or affect the reliability of study results, or lead to high risk of treatment complications, or affect patient compliance.",{"count":136,"type":22},30,[88],"This prospective, single-arm study aims to investigate the efficacy and safety of pembrolizumab plus bevacizumab and chemotherapy as neoadjuvant treatment in pMMR\u002FMSS locally advanced rectal cancer patients",[28],"2025-03-12",{"date":142,"type":36},"2025-03-14",{"date":144,"type":36},"2023-05-01",{"date":146,"type":22},"2028-05-01",{"name":148,"class":43},"Shanghai Changzheng Hospital",{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":153,"acronym":4,"eligibilityCriteria":154,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":155,"targetDuration":4,"studyType":23,"phases":156,"briefSummary":158,"conditions":159,"keywords":160,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":44},"100558387","phase-4-safety-and-efficacy-of-pembrolizumab-in-combination-with-bevacizumab--capeox-in-the-neoadjuvant-treatment-of-ras-mutated-braf-wild-type-microsatellite-stabilized-locally-advanced-colorectal-cancer-100558387","NCT06550453","Safety and Efficacy of Pembrolizumab in Combination with Bevacizumab + CapeOX in the Neoadjuvant Treatment of RAS-mutated, BRAF Wild-type, Microsatellite-stabilized, Locally Advanced Colorectal Cancer","Inclusion Criteria:\n\n* Age: ≥18 years;\n* Confirmed RAS mutation and BRAF wild-type in LACRC by pathological histology or genetic sequencing.;\n* ECOG Performance Status (PS) score of 0 or 1;\n* Previously untreated;\n* Microsatellite-stable status;\n* Hematological parameters within normal limits: White blood cell count ≥4×10\\^9\u002FL; Absolute neutrophil count ≥1.5×10\\^9\u002FL; Platelets ≥100×10\\^9\u002FL. Hemoglobin ≥90g\u002FL;\n* Normal renal function: Serum creatinine ≤1.5× upper limit of normal (ULN) or creatinine clearance (CrCl) \\>60 mL\u002Fmin (calculated using Cockcroft-Gault formula): Female CrCl = (140 - age) × weight (kg) × 0.85 \u002F (72 × Scr mg\u002Fdl)；Male CrCl = (140 - age) × weight (kg) × 1.00 \u002F (72 × Scr mg\u002Fdl);\n* Normal liver function: Serum total bilirubin ≤1.5× ULN; Aspartate aminotransferase (AST) ≤2.5× ULN; Alanine aminotransferase (ALT) ≤2.5× ULN;\n* Female patients must have a negative pregnancy test before the study initiation (not applicable to bilateral oophorectomy and\u002For hysterectomy patients or postmenopausal patients);\n* Signed written informed consent form.\n\nExclusion criteria:\n\n* Receiving anti-tumor therapy prior to enrollment, including but not limited to PD-1 inhibitors, CTLA-4 antibodies, EGFR monoclonal antibodies, EGFR-TKI, and anti-angiogenic drugs;\n* History of autoimmune diseases, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome-associated vascular thrombosis, Wegener's granulomatosis, desiccation syndrome, Guillain-Barre syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. (Note: Vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune disease, psoriasis not requiring systemic therapy, or patients not expected to have a relapse without external triggers may be allowed to enroll);\n* Enrolled in another interventional clinical trial within 30 days prior to screening;\n* History of other malignancies (except cured basal cell carcinoma of the skin);\n* Presence of severe, poorly controlled co-morbidities such as heart failure, diabetes mellitus, hypertension, hepatic failure, renal failure, thyroid disease, psychiatric disorders, etc;\n* Known HIV infection or active viral hepatitis or tuberculosis;\n* Major surgery or planned surgery within 30 days prior to the first dose of the investigational drug;\n* Hypersensitivity to the drugs used in the trial or their components;\n* Pregnancy (confirmed by blood or urine HCG test) or breastfeeding women, or subjects of childbearing potential unwilling or unable to use effective contraception until at least 6 months after the last trial treatment;\n* Deemed inappropriate for participation in the study by the investigator.\n* Unwilling or unable to participate in the study or sign the informed consent form.",{"count":109,"type":22},[157],"PHASE4","To explore the efficacy and safety of pembrolizumab in combination with bevacizumab and CapeOX neoadjuvant therapy for the treatment of RAS-mutated, BRAF wild-type, microsatellite-stabilized, locally advanced colorectal cancer.\n\nMethods and analysis: A prospective, open-label, single-arm, phase 2 clinical study protocol will enroll a total of 20 patients. The study is designed as a Simon II Optimal study involving 20 locally advanced rectal cancer (LACRC) patients. Initially, 9 patients will be recruited in the Simon I phase, and if more than 1 patient achieves a pathological complete response (pCR), the study will proceed to the II phase. Recruit up to 20 patients in Phase II, and if more than 4 patients achieve pCR, the trial will be considered successful. All enrolled patients will receive 2-4 cycles of neoadjuvant therapy with pembrolizumab + bevacizumab and CapeOX (bevacizumab + oxaliplatin + capecitabine). The primary efficacy endpoint is the pathological complete response (pCR) of the cancer following neoadjuvant therapy. Secondary efficacy endpoints include major pathological response (MPR), objective response rate (ORR), and assessment of adverse events (AEs).\n\nEthics: Ethics approval has been obtained from the Ethics Committee at the First Affliated Hospital (Xijing Hospital)(KY20232402-F-1)",[28],[161,162,163,164],"Locally advanced colorectal cancer (LACRC)","pembrolizumab","microsatellite-stabilized","CapeOX neoadjuvant","2024-11-09",{"date":167,"type":36},"2024-11-12",{"date":169,"type":36},"2024-09-01",{"date":171,"type":22},"2026-01-15",{"name":173,"class":43},"yangjianjun",{"id":175,"slug":176,"hasResults":11,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":4,"eligibilityCriteria":180,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":181,"targetDuration":4,"studyType":23,"phases":183,"briefSummary":184,"conditions":185,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":44},"100561913","phase-2-evaluating-the-benefits-of-personalized-traditional-chinese-medicine-in-postoperative-treatment-for-locally-advanced-colorectal-cancer-100561913","NCT06596343","Evaluating the Benefits of Personalized Traditional Chinese Medicine in Postoperative Treatment for Locally Advanced Colorectal Cancer","Study on the Value of Traditional Chinese Medicine Precision Treatment Based on Syndrome Differentiation in Postoperative Adjuvant Therapy for Locally Advanced Colorectal Cancer","Inclusion Criteria:\n\n* 1\\. Age between 18 and 75 years. 2. Diagnosed with colorectal cancer at Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, and underwent standard radical colorectal cancer surgery. Postoperative pathological staging is stage III (AJCC 8th edition: T4, any N+, M0, or any T, N2, M0), indicating the need for chemotherapy according to the CSCO 2023 colorectal cancer guidelines.\n\n  3\\. Willing to receive Traditional Chinese Medicine (TCM) treatment. 4. Voluntarily agree to participate in the study and sign the informed consent form. If the subject is unable to read or sign the consent due to incapacity, the informed consent must be obtained from a legal guardian. If the subject cannot read the consent (e.g., illiterate subjects), a witness must observe and sign the consent process.\n\n  5\\. Expected survival of ≥12 months. 6. ECOG performance status score of 0-1. 7. No prior anti-cancer, immunotherapy, or radiation treatment. 8. Laboratory tests meeting the following criteria:\n* White blood cell count ≥3.5 × 10\\^9\u002FL, absolute neutrophil count ≥1.8 × 10\\^9\u002FL, platelet count ≥100 × 10\\^9\u002FL, hemoglobin ≥100 g\u002FL.\n* INR ≤1.5 and APTT ≤1.5 times the upper limit of normal (ULN) or PTT ≤1.5 times ULN.\n* Total bilirubin ≤1.25 times ULN; ALT and AST ≤3 times ULN; serum albumin ≥28 g\u002FL.\n* 24-hour creatinine clearance rate ≥50 mL\u002Fmin or serum creatinine ≤1.5 times ULN.\n\nExclusion Criteria:\n\n* 1\\. Colorectal cancer patients with distant metastasis as indicated by preoperative evaluation.\n\n  2\\. Postoperative pathological results indicate that chemotherapy is not required according to the CSCO 2023 colorectal cancer guidelines.\n\n  3\\. Patients who have received neoadjuvant chemoradiotherapy before surgery. 4. Patients with severe heart, liver, kidney damage, or bone marrow dysfunction.\n\n  5\\. Pregnant or breastfeeding women. 6. Patients with known allergies to Traditional Chinese Medicine components. 7. Patients who refuse chemotherapy or TCM treatment. 8. Patients with a history of mental illness or cognitive impairment.",{"count":182,"type":22},80,[88],"This study aims to explore the role of Traditional Chinese Medicine (TCM) based on syndrome differentiation in reducing chemotherapy side effects, lowering the risk of metastasis and recurrence, and improving survival rates in postoperative colorectal cancer patients through a prospective, single-arm interventional clinical trial.",[28,186],"Postoperative Adjuvant Therapy","2024-09-10",{"date":189,"type":36},"2024-09-19",{"date":191,"type":22},"2024-10",{"date":193,"type":22},"2027-09-30",{"name":195,"class":43},"Sir Run Run Shaw Hospital"]