[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635224":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":27,"centralContacts":40,"locations":27,"responsibleParty":46,"collaborators":27,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":54,"acronym":27,"eligibilityCriteria":55,"healthyVolunteers":52,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":27,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":71,"overallStatus":76,"whyStopped":27,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":27},{"fullName":5,"class":6},"Sun Yat-sen University","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Neoadjuvant Iparomlimab\u002FTuvonralimab + CAPEOX","EXPERIMENTAL","Participants will receive neoadjuvant Iparomlimab\u002FTuvonralimab in combination with CAPEOX for 4 cycles (Q3W). Iparomlimab\u002FTuvonralimab will be administered 5 mg\u002Fkg intravenously on Day 1 of each 3-week cycle. CAPEOX consists of oxaliplatin 130 mg\u002Fm² IV on Day 1 plus capecitabine 1,000 mg\u002Fm² orally twice daily on Days 1-14 of each 3-week cycle. Tumor assessments will be performed per protocol during neoadjuvant treatment. Curative-intent surgery will be planned after completion of neoadjuvant therapy. Postoperative adjuvant treatment will be provided at the investigator's discretion according to standard clinical practice and pathological findings.",[13,14,15],"Drug: Iparomlimab\u002FTuvonralimab","Drug: Capecitabine","Drug: Oxaliplatin",{"label":17,"type":10,"description":18,"interventionNames":19},"Neoadjuvant Iparomlimab\u002FTuvonralimab + CAPEOX + Propranolol","Participants will receive neoadjuvant Iparomlimab\u002FTuvonralimab in combination with CAPEOX plus propranolol for 4 cycles (Q3W). Iparomlimab\u002FTuvonralimab will be administered 5 mg\u002Fkg intravenously on Day 1 of each 3-week cycle. CAPEOX consists of oxaliplatin 130 mg\u002Fm² IV on Day 1 plus capecitabine 1,000 mg\u002Fm² orally twice daily on Days 1-14 of each 3-week cycle. In addition, propranolol 10 mg orally three times daily (TID) will be given on Days 1-14 of each 3-week cycle. Tumor assessments will be performed per protocol during neoadjuvant treatment. Curative-intent surgery will be planned after completion of neoadjuvant therapy. Postoperative adjuvant treatment will be provided at the investigator's discretion according to standard clinical practice and pathological findings.",[13,14,15,20],"Drug: Propranolol",[22,28,32,36],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Iparomlimab\u002FTuvonralimab","Iparomlimab\u002FTuvonralimab will be administered 5 mg\u002Fkg intravenously on Day 1 of each 3-week cycle.",[9,17],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Capecitabine","Capecitabine 1,000 mg\u002Fm² orally twice daily on Days 1-14 of each 3-week cycle.",[9,17],{"type":23,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"Oxaliplatin","oxaliplatin 130 mg\u002Fm² IV on Day 1 of each 3-week cycle.",[9,17],{"type":23,"name":37,"description":38,"armGroupLabels":39,"otherNames":27},"Propranolol","propranolol 10 mg orally three times daily (TID) will be given on Days 1-14 of each 3-week cycle",[17],[41],{"name":42,"role":43,"phone":44,"phoneExt":27,"email":45},"Rongxin Zhang, MD, PhD","CONTACT","+86 020 87343920","zhangrx@sysucc.org.cn",{"type":47,"investigatorFullName":48,"investigatorTitle":49,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"PRINCIPAL_INVESTIGATOR","Gong Chen","Vice Director, Department of Colorectal Surgery, Chief Surgeon.","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":60,"type":61},45,"ESTIMATED","INTERVENTIONAL",[64],"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.",[67,68,69,70],"Colon Cancer (Stage II &Amp; III)","Immunotherapy","Beta Blocker","Neoadjuvant Chemoimmunotherapy",[72,73,24,74,75],"Colon Cancer","Neoadjuvant chemoimmunotherapy","propranolol","CAPEOX","NOT_YET_RECRUITING","2026-04-17",{"date":79,"type":80},"2026-04-24","ACTUAL",{"date":82,"type":61},"2026-04-20",{"date":84,"type":61},"2026-12-31",{"name":5,"class":6}]