[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"colon-cancer-stage-ii-amp-iii\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:colon-cancer-stage-ii-amp-iii":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":4},"100635224","phase-2-neoadjuvant-iparomlimabtuvonralimab-plus-capeox-versus-iparomlimabtuvonralimab-plus-capeox-and-propranolol-for-locally-advanced-pmmr-colon-cancer-a-prospective-single-center-multi-cohort-study-100635224",false,"NCT07549906","Neoadjuvant Iparomlimab\u002FTuvonralimab Plus CAPEOX Versus Iparomlimab\u002FTuvonralimab Plus CAPEOX and Propranolol for Locally Advanced pMMR Colon Cancer: A Prospective, Single-Center, Multi-Cohort Study","Inclusion Criteria\n\nParticipants must meet all of the following:\n\n1. Diagnosis \u002F Stage: Histologically confirmed and radiologically assessed colon adenocarcinoma that is T4, or T3 with lymph node metastasis, with tumor location ≥10 cm from the anal verge, and clinical TNM staging per AJCC\u002FUICC 8th edition.\n2. Measurable disease: At least one measurable lesion per RECIST v1.1 (non-lymph node lesion long axis ≥10 mm on CT; lymph node lesion short axis ≥15 mm on CT).\n3. pMMR\u002FMSS confirmation: pMMR by IHC on colonoscopy biopsy (MMR proteins by immunohistochemistry), or MSS\u002FMSS-L by PCR or NGS.\n4. Treatment-naïve for current colon cancer: No prior anti-tumor treatment for colon cancer. (If Lynch syndrome, no anti-tumor treatment for the current diagnosis.)\n5. Age: 18 to 75 years, any sex.\n6. Performance status \u002F organ function: ECOG 0-1 with adequate organ and bone marrow function.\n7. Informed consent: Written informed consent signed before enrollment.\n8. Life expectancy: Expected survival \\>12 weeks.\n9. Hematology and chemistry (without blood products or growth factors within 14 days):\n\n   * Hemoglobin ≥60 g\u002FL\n   * ANC ≥1.5 × 10⁹\u002FL\n   * Platelets ≥75 × 10⁹\u002FL\n   * Serum creatinine ≤1.5 × ULN or creatinine clearance ≥50 mL\u002Fmin (Cockcroft-Gault)\n   * Total bilirubin ≤1.5 × ULN\n   * AST or ALT ≤2.5 × ULN (if abnormal due to liver metastasis, ≤5 × ULN)\n   * Urine protein \\\u003C2+; if ≥2+, 24-hour urine protein ≤1 g\n10. Coagulation \u002F bleeding-thrombosis status: No active bleeding and no thrombotic disease; patients may be eligible if thrombosis is treated and stable for ≥3 months. Must meet:\n\n    * INR ≤1.5 × ULN\n    * APTT ≤1.5 × ULN\n    * PT ≤1.5 × ULN\n11. Thyroid function within normal range:\n\n    * Free T4 12-22 pmol\u002FL\n    * Free T3 2.8-7.1 pmol\u002FL\n    * TSH 0.27-4.2 mIU\u002FL\n12. Blood pressure requirement (screening): Average seated BP 100-150 \u002F 60-90 mmHg, and 24-hour ambulatory BP below the threshold for Grade I hypertension.\n13. Contraception \u002F pregnancy test (for women of childbearing potential): Must use medically approved contraception during treatment and for 3 months after; pregnancy test (serum or urine HCG negative within 7 days prior to enrollment); not breastfeeding.\n14. Compliance: Willing and able to comply with study procedures and safety\u002Fsurvival follow-up.\n\nExclusion Criteria\n\nParticipants meeting any of the following are excluded:\n\n1. History of allergic disease, severe drug allergy, known allergy to macromolecular protein products, or allergy to Iparomlimab\u002FTuvonralimab (protocol wording originally referenced the Chinese drug name).\n2. Cardiopulmonary insufficiency or hepatic\u002Frenal insufficiency such that CAPEOX cannot be tolerated; known allergy to oxaliplatin or capecitabine.\n3. Presence of distant metastasis.\n4. Any of the following complications:\n\n   * Major GI bleeding, perforation, or GI obstruction (including paralytic ileus)\n   * Symptomatic heart disease (including unstable angina, myocardial infarction, heart failure)\n   * Uncontrolled diabetes, hypertension, or hypotension\n   * Uncontrolled diarrhea that interferes with daily activities despite adequate treatment\n   * Use of immunosuppressants or systemic\u002Fabsorbable local steroids for immunosuppression (\\>10 mg\u002Fday prednisone equivalent) and still using within 2 weeks before enrollment\n5. Poorly controlled cardiac symptoms or clinically significant heart disease, including:\n\n   * NYHA class \\>II heart failure\n   * Unstable angina\n   * Myocardial infarction within 1 year\n   * Clinically significant supraventricular or ventricular arrhythmia requiring treatment\u002Fintervention\n6. Prior or current thyroid dysfunction that cannot be maintained within normal range despite medication.\n7. Use of traditional Chinese immune modulators within 2 weeks before treatment, or receipt of systemic anti-tumor therapy (chemotherapy, immunotherapy, biologic therapy, etc.) or TCM anti-tumor therapy within 4 weeks before treatment.\n8. Active infection, or unexplained fever \\>38.5°C during screening or before first dose (tumor-related fever may be allowed per investigator judgment).\n9. History or current objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, known active pulmonary tuberculosis, severely impaired lung function, etc.\n10. Congenital or acquired immunodeficiency, e.g., HIV infection (HIV 1\u002F2 antibody positive).\n11. Acute or chronic active HBV: HBsAg(+) or HBcAb(+) requires HBV DNA testing. Eligible only if HBV DNA \\\u003C2×10³ copies\u002FmL or \\\u003C200 IU\u002FmL or below LLOD; HBsAg(+) must receive anti-HBV therapy during study treatment; HBcAb(+)\u002FHBsAg(-)\u002Fanti-HBs(-) with negative viral load does not require prophylaxis but requires close monitoring.\n12. Acute or chronic active HCV: HCV antibody positive and HCV RNA above LLOD.\n13. Receipt of a live vaccine within 4 weeks prior to study drug or anticipated need for live vaccination during the study.\n14. Known history of psychoactive substance abuse, alcoholism, or drug abuse.\n15. Pregnant or breastfeeding women, or men\u002Fwomen unwilling to use contraception.\n16. History of allergy to β-blockers.\n17. Asthma, COPD, or other respiratory disease requiring bronchodilator therapy.\n18. Definite history of hypertension (without antihypertensives: non-same-day 3 measurements with SBP ≥140 mmHg and\u002For DBP ≥100 mmHg, or currently receiving antihypertensive therapy).\n19. Clear history of hypotension; baseline SBP \\\u003C90 mmHg or DBP \\\u003C60 mmHg.\n20. Any other condition judged by the investigator to warrant exclusion (e.g., factors that may force early termination of study participation).","ALL","18 Years","75 Years",{"count":19,"type":20},45,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The goal of this prospective, single-center, multi-cohort clinical trial is to evaluate the efficacy and safety of neoadjuvant Iparomlimab\u002FTuvonralimab combined with CAPEOX, with or without propranolol, in patients with locally advanced pMMR (MSS) colon cancer. The main questions it aims to answer are:\n\n* What is the major pathological response (MPR) rate after neoadjuvant treatment and curative surgery (e.g., ≤10% viable tumor cells in the resected primary tumor)?\n* What are the key secondary outcomes (e.g., R0 resection rate, tumor regression grade, objective response rate, disease-free survival) and the safety\u002Ftolerability profile of these neoadjuvant regimens? If there is a comparison group: Researchers will compare Cohort A (Iparomlimab\u002FTuvonralimab + CAPEOX) versus Cohort B (Iparomlimab\u002FTuvonralimab + CAPEOX + propranolol) to see whether adding propranolol improves pathological and clinical responses while maintaining acceptable safety.\n\nParticipants will:\n\n* Receive neoadjuvant Iparomlimab\u002FTuvonralimab + CAPEOX for a protocol-defined number of cycles, with or without propranolol depending on cohort assignment.\n* Undergo curative-intent surgical resection after completing neoadjuvant therapy.\n* Be followed for postoperative treatment, adverse events, and longer-term outcomes (e.g., recurrence and survival), and may contribute tumor\u002Fblood samples for exploratory biomarker analyses related to treatment response.",[26,27,28,29],"Colon Cancer (Stage II &Amp; III)","Immunotherapy","Beta Blocker","Neoadjuvant Chemoimmunotherapy",[31,32,33,34,35],"Colon Cancer","Neoadjuvant chemoimmunotherapy","Iparomlimab\u002FTuvonralimab","propranolol","CAPEOX","NOT_YET_RECRUITING","2026-04-17",{"date":39,"type":40},"2026-04-24","ACTUAL",{"date":42,"type":20},"2026-04-20",{"date":44,"type":20},"2026-12-31",{"name":46,"class":47},"Sun Yat-sen University","OTHER",{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":59,"conditions":60,"keywords":64,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":4},"100624708","neoadjuvant-capeox-versus-upfront-surgery-for-locally-advanced-colon-cancer-with-elevated-cea-a-single-center-open-label-randomized-controlled-trial-100624708","NCT07413146","Neoadjuvant CAPEOX Versus Upfront Surgery for Locally Advanced Colon Cancer With Elevated CEA: A Single-Center, Open-Label, Randomized Controlled Trial","Inclusion Criteria:\n\nParticipants must meet all of the following criteria:\n\nAge 18 to 70 years (inclusive) at the time of written informed consent. ECOG performance status 0-1, without deterioration within 2 weeks prior to enrollment; anticipated life expectancy ≥12 weeks.\n\nHistologically or cytologically confirmed colon adenocarcinoma, non-MSI-H\u002FdMMR, with pathologic stage (AJCC\u002FUICC TNM 8th edition) of:\n\nHigh-risk stage II, or Stage III. High-risk stage II features include: T4, poor\u002Fundifferentiated histology (high grade; excluding MSI-H), lymphovascular invasion, perineural invasion, preoperative bowel obstruction or tumor perforation, positive\u002Funknown margin status, insufficient margin clearance, \\\u003C12 lymph nodes examined, or high-grade tumor budding.\n\nTumor location consistent with colon cancer: distal tumor margin ≥12 cm from the anal verge on preoperative endoscopy.\n\nBaseline serum CEA \\>5 ng\u002FmL prior to treatment. No evidence of distant metastasis (distant organ and\u002For distant lymph node metastasis) based on comprehensive clinical evaluation.\n\nAbility to provide required clinical data for study collection. Ability to provide adequate fresh tumor tissue from endoscopy and\u002For surgery for WES\u002FNGS to develop an individualized ctDNA MRD panel, and ability to provide required blood samples for ctDNA testing (baseline, postoperative \\~day 7, postoperative \\~day 30).\n\nCandidate for curative-intent R0 resection. Willing and able to comply with the protocol schedule, including regular follow-up visits and necessary treatments, and provides written informed consent.\n\nExclusion Criteria:\n\nParticipants will be excluded if any of the following apply:\n\nPrior or concurrent other malignant tumor. Any severe comorbidity that, in the investigator's judgment, may significantly affect follow-up or short-term survival.\n\nAny other medical condition, or social\u002Fpsychological circumstance, that in the investigator's judgment makes the participant unsuitable for the study.\n\nMSI-H\u002FdMMR tumor. Evidence of metastatic disease by pathology, clinical assessment, or imaging, including isolated distant lesions, distant disease, or non-contiguous intraperitoneal metastasis.\n\nMultiple primary colon cancers. Underwent open surgery at a non-colon site within 14 days prior to enrollment. Unable to provide required tumor tissue for WES\u002FNGS or personalized MRD panel development, personalized MRD panel customization failure, or unable to provide required blood samples (baseline, postoperative \\~day 7, postoperative \\~day 30).\n\nHistory of blood transfusion within 2 weeks prior to surgery or intraoperatively.\n\nUnable to undergo contrast-enhanced CT or MRI for routine clinical follow-up. Fever ≥38°C within the past 7 days, or clinically significant active infection (including active tuberculosis), or active fungal\u002Fbacterial\u002Fviral infection requiring systemic therapy.\n\nInadequate bone marrow reserve or organ function meeting any of the following laboratory abnormalities (within 1 week prior to testing without corrective treatment):\n\nANC \\\u003C 1.5 × 10⁹\u002FL Platelets \\\u003C 90 × 10⁹\u002FL Hemoglobin \\\u003C 90 g\u002FL (\\\u003C9 g\u002FdL) ALT \\> 3 × ULN AST \\> 3 × ULN or total bilirubin \\> 1.5 × ULN Creatinine \\> 1.5 × ULN or creatinine clearance \\\u003C 45 mL\u002Fmin (Cockcroft-Gault) Albumin \\\u003C 28 g\u002FL Pregnant or breastfeeding, or planning pregnancy during the study period. Any other condition that, in the investigator's judgment, indicates the participant should not participate.","70 Years",{"count":56,"type":20},100,[58],"NA","The goal of this interventional clinical trial is to compare the efficacy of neoadjuvant chemotherapy versus upfront surgery in adults aged 18-70 years with stage II (high-risk)-III, non-MSI-H colon adenocarcinoma and elevated baseline CEA (\\>5 ng\u002FmL) undergoing curative-intent treatment. This single-center, open-label, randomized controlled study will evaluate 2-year disease-free survival (2y-DFS) as the primary endpoint, with all study-related procedures-including longitudinal ctDNA-based molecular residual disease (MRD) monitoring, Immunoscore assessment, tumor tissue sequencing, and surveillance imaging-provided at no cost to participants. The main questions it aims to answer are:\n\n* Does a treatment strategy involving neoadjuvant CAPOX followed by surgery improve 2y-DFS compared with upfront surgery followed by standard adjuvant chemotherapy?\n* Do postoperative ctDNA-MRD status and its longitudinal dynamics predict 2y-DFS?\n* Does combining ctDNA-MRD with Immunoscore enhance prognostic risk stratification for recurrence beyond either biomarker alone?\n\nParticipants will:\n\n* Be randomized 1:1 (N=100) to one of two treatment pathways:\n\n  * Arm A: Neoadjuvant CAPOX × 4 cycles → curative surgery (R0 planned) → postoperative management per standard practice\n  * Arm B: Upfront curative surgery → postoperative standard adjuvant chemotherapy per guideline → routine surveillance\n* Undergo baseline assessments prior to treatment initiation, including blood draw, colonoscopy, primary tumor next-generation sequencing (for personalized ctDNA-MRD assay development), and Immunoscore testing-all provided free of charge as part of the study.\n* Provide postoperative blood samples for ctDNA-MRD testing at approximately postoperative day \\~7 and day \\~30 (before adjuvant therapy start, if applicable).\n* During follow-up, provide serial blood samples every 3 months, aligned with routine surveillance visits, for repeat ctDNA-MRD analysis.\n* Receive standard-of-care postoperative surveillance (including imaging and clinical evaluations) through 2 years, with all study-mandated assessments covered by the trial.\n\nThis trial integrates clinical intervention with comprehensive biomarker profiling to determine whether early systemic therapy alters MRD dynamics and improves outcomes in high-risk, CEA-elevated colon cancer.",[61,62,63,26],"Minimal Residual Disease","Immunoscore","Neoadjuvant Chemotherapy",[65,61,62,66,67],"advanced stage colon cancer","neoadjuvant chemotherapy","upfront surgery","2026-02-09",{"date":70,"type":40},"2026-02-17",{"date":72,"type":20},"2026-02-24",{"date":74,"type":20},"2027-07-31",{"name":46,"class":47}]