[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"rectal-cancer-adenocarcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:rectal-cancer-adenocarcinoma":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,46,77,113,142],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100629394","scrt-nalirixeloxsintilimab-as-tnt-for-high-risk-larc-100629394",false,"NCT07474103","SCRT-NALIRIXELOX+Sintilimab as TNT for High-Risk LARC","Short-Course Radiotherapy Followed by Liposomal Irinotecan, Oxaliplatin, Capecitabine, and Sintilimab as Total Neoadjuvant Therapy in High-Risk Locally Advanced Rectal Cancer: A Single-Arm, Single-Center, Exploratory Study","Inclusion Criteria:\n\n* Voluntary Participation: Subjects voluntarily participate in the study, sign the informed consent form, and have good compliance.\n* Age and Gender: Age between 18 and 75 years, any gender.\n* Pathological Diagnosis: Histologically or cytologically confirmed rectal adenocarcinoma; confirmed mismatch repair proficient (pMMR) or microsatellite stable (MSS) by genetic testing or immunohistochemistry.\n* Disease Stage: Assessed as high-risk, mid-low (distance from the anal verge ≤10 cm) locally advanced rectal cancer by colonoscopy, digital rectal exam, or MRI. High-risk definition: Meeting at least one of the following: cT4, extramural vascular invasion (EMVI), tumor deposits, involvement of the mesorectal fascia or intersphincteric plane.\n* Prior Treatment: No prior anti-tumor therapy for this rectal cancer (including surgery, radiotherapy, chemotherapy, immunotherapy, or targeted therapy).\n* Measurable Lesion: At least one measurable lesion according to RECIST v1.1 criteria.\n* Tumor Tissue Sample: Must provide tumor tissue samples for biomarker analysis.\n* Adequate Organ Function (within 7 days before the first dose): 1) Hematological: Hemoglobin ≥90 g\u002FL; White Blood Cell count ≥3.0 x 10⁹\u002FL; Absolute Neutrophil Count ≥1.5 x 10⁹\u002FL; Platelets ≥100 x 10⁹\u002FL. 2) Hepatic: Total Bilirubin \\\u003C1.5 x ULN; AST and ALT ≤2.5 x ULN; Albumin ≥30 g\u002FL. 3) Renal: Serum Creatinine ≤1.5 x ULN OR Creatinine Clearance ≥50 mL\u002Fmin. 4) Coagulation: INR ≤1.5 x ULN (or ≤3 x ULN if on stable anticoagulant therapy); PTT or aPTT ≤1.5 x ULN (or ≤3 x ULN if on stable anticoagulant therapy).\n* Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Life Expectancy: Expected survival time ≥3 months.\n* Good organ function.\n* Contraception: Subjects of childbearing potential must agree to use effective contraception during the treatment period and for 6 months after the last dose.\n\nExclusion Criteria:\n\n* Other Malignancies: Diagnosis of another malignancy within 5 years prior to the first dose, except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, carcinoma in situ, localized prostate cancer, or papillary thyroid cancer, etc.\n* Allergy: Known or suspected allergy to the study drugs or any of their excipients.\n* Pregnancy and Lactation: Pregnant or lactating women, or women planning to become pregnant during the study or within 6 months after the last dose.\n* Central Nervous System Disease: Known active epilepsy, active central nervous system (CNS) metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease.\n* Significant Cardiovascular Disease: Clinically significant uncontrolled cardiovascular disease.\n* History of Allergic Disease: History of allergic diathesis, asthma, or atopic dermatitis.\n* Pleural Effusion\u002FAscites: Presence of significant pleural effusion or ascites.\n* Active Autoimmune Disease: Active autoimmune disease requiring systemic treatment within 2 years prior to the first dose (replacement therapy is allowed).\n* Immunosuppressant Use: Use of systemic corticosteroids (\\>10 mg\u002Fday prednisone equivalent) or other immunosuppressants within 2 weeks prior to enrollment.\n* Interstitial Lung Disease: History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or evidence of active pneumonia on screening chest CT scan.\n* Transplantation History: History of allogeneic organ transplantation or hematopoietic stem cell transplantation.\n* Active Infection: Positive HIV test result; Active Hepatitis B (HBV DNA ≥10⁴ copies\u002FmL); Active Hepatitis C (HCV RNA ≥10³ copies\u002FmL); Active Tuberculosis.\n* Gastrointestinal Risk: History of bowel obstruction within 28 days prior to the first study dose; High risk of gastrointestinal perforation.\n* Recent Major Surgery: Major surgical procedure within 4 weeks prior to enrollment.\n* Other Exclusionary Conditions: Any other acute or chronic disease, mental disorder, or laboratory abnormality that, in the investigator's judgment, may increase the risk associated with study participation or drug administration, or interfere with the interpretation of study results.","ALL","18 Years","75 Years",{"count":20,"type":21},49,"ESTIMATED","INTERVENTIONAL",[24],"NA","This is a single-center, exploratory clinical study for patients with newly diagnosed, high-risk, locally advanced rectal cancer. The study aims to evaluate the effectiveness and safety of a comprehensive pre-surgery (neoadjuvant) treatment strategy.\n\nAll participants will receive a short course of radiation therapy (25 Gy in 5 fractions) over one week. This will be followed by a combination of chemotherapy (Liposomal Irinotecan, Oxaliplatin, and Capecitabine) and immunotherapy (Sintilimab). This combined treatment is administered for six cycles.\n\nFor patients who achieve a complete response, the option to avoid immediate surgery and enter a close monitoring program (\"Watch and Wait\") will be considered.",[27],"Rectal Cancer, Adenocarcinoma",[29,30,31,32],"total neoadjuvant therapy","Short-Course Radiotherapy","Liposomal Irinotecan","rectal cancer","RECRUITING","2026-03-11",{"date":36,"type":37},"2026-03-16","ACTUAL",{"date":39,"type":37},"2025-11-30",{"date":41,"type":21},"2028-12-31",{"name":43,"class":44},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":58,"conditions":59,"keywords":65,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":45},"100628199","phase-2-neoadjuvant-chemoradiotherapy-plus-tislelizumab-with-or-without-probio-m9-in-pmmrmss-locally-advanced-rectal-cancer-100628199","NCT07458529","Neoadjuvant Chemoradiotherapy Plus Tislelizumab With or Without Probio-M9 in pMMR\u002FMSS Locally Advanced Rectal Cancer","Neoadjuvant Chemoradiotherapy Combined With Tislelizumab With or Without Probio-M9 in pMMR\u002FMSS Locally Advanced Middle and Low Rectal Cancer: A Single-Center, Prospective, Randomized Controlled Trial (NCRIT-PM9 Trial)","NCRIT-PM9","Inclusion Criteria:\n\n* Age ≥ 18 years\n* ECOG performance status 0-2\n* Biopsy-proven rectal adenocarcinoma\n* Distal tumor margin within 10 cm of the anal verge\n* No distant metastasis\n* Clinical stage II or III based on MRI (T4b excluded)\n* Maximum diameter of rectal tumor ≥ 10 mm on baseline CT or MRI (measurable lesion according to RECIST 1.1)\n* Willing and able to comply with the study protocol\n* Willing to provide blood and tissue specimens for research purposes\n* No prior anti-tumor treatment (e.g., radiotherapy, chemotherapy, immunotherapy, biological therapy, or herbal therapy)\n* No history of immune system disorders (e.g., systemic lupus erythematosus, rheumatoid arthritis, systemic vasculitis, scleroderma, pemphigus, dermatomyositis, mixed connective tissue disease, autoimmune hemolytic anemia, thyroid autoimmune disease, ulcerative colitis, HIV infection, etc.)\n* No significant dysfunction of major organs (heart, lung, liver, kidney)\n* No jaundice or gastrointestinal obstruction\n* No acute or ongoing infection\n* Adequate hematologic and biochemical function including:\n\n  * Neutrophils ≥ 1.5 × 10\\^9\u002FL\n  * Hemoglobin ≥ 80 g\u002FL\n  * Platelets ≥ 100 × 10\\^9\u002FL\n  * Serum creatinine ≤ 1.5 × ULN\n  * Total bilirubin ≤ 1.5 × ULN\n  * ALT and AST ≤ 2.5 × ULN\n* No social or psychiatric disorders that may interfere with study participation\n* Women of childbearing potential must have a negative pregnancy test before enrollment and must use effective contraception from study entry until 60 days after the last dose of study drug\n\nExclusion Criteria:\n\n* History of multiple primary cancers or concomitant malignant tumors other than rectal cancer\n* Receipt of any anti-cancer treatment (e.g., surgery, chemotherapy, radiotherapy, or other systemic therapies) within the past 5 years\n* History of recent major surgery\n* Conditions that may affect the gastrointestinal absorption of capecitabine (e.g., inability to swallow, persistent nausea or vomiting, chronic diarrhea)\n* Uncontrolled or severe concomitant diseases of any kind\n* Known allergy or hypersensitivity to any components of the study drugs\n* Estimated life expectancy ≤ 5 years due to any cause\n* Planned or prior organ or bone marrow transplantation\n* Use of immunosuppressive therapy or systemic corticosteroids for immunosuppressive purposes within 1 month prior to enrollment\n* History of central nervous system disorders that may impair the ability to provide informed consent or affect compliance with oral medication (investigator discretion)\n* Other conditions that may interfere with study results or lead to premature discontinuation of study treatment (e.g., alcoholism or drug abuse)\n* Pregnant or breastfeeding women, or women planning to become pregnant during the treatment period",{"count":55,"type":21},50,[57],"PHASE2","This prospective, single-center, randomized controlled trial aims to assessing the efficacy and safety of neoadjuvant chemoradiation plus Tislelizumab (PD-1 inhibitor) with or without Probio-M9 and subsequent TME surgery, by comparing assorted endpoints between two experiment groups (Experiment group 1: chemoradiation+PD-1 inhibitor+Probio-M9; Experiment group 2: chemoradiation+PD-1 inhibitor+placebo) with a control group (chemoradiation only).",[27,60,61,62,63,64],"Neoadjuvant Therapy","Immunotherapy","Probio-M9","Tislelizumab","Randomized",[62,66,67],"tislelizumab","locally advanced rectal cancer","2026-03-08",{"date":70,"type":37},"2026-03-10",{"date":72,"type":37},"2026-02-10",{"date":74,"type":21},"2030-12-01",{"name":76,"class":44},"Seventh Medical Center of PLA General Hospital",{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":22,"phases":87,"briefSummary":88,"conditions":89,"keywords":96,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":112},"100624271","phase-2-upfront-trastuzumab-deruxtecan-plus-capecitabine-and-bevacizumab-for-patients-with-her-2-positive-metastatic-colorectal-cancer-100624271","NCT07407465","Upfront Trastuzumab-Deruxtecan Plus Capecitabine and Bevacizumab for Patients With HER-2 Positive Metastatic Colorectal Cancer.","Phase II Single Arm Study of Upfront Trastuzumab-Deruxtecan Plus Capecitabine and Bevacizumab for Patients With HER-2 Positive Metastatic Colorectal Cancer: the CHIMERA Study.","CHIMERA","Inclusion Criteria:\n\n* Written informed consent obtained from the patient\u002Flegal representative before performing any protocol-related procedures, including screening evaluations.\n* Patient state to comply with all the study procedures and treatments. Patients must be accessible for treatment and follow-up. Patients registered for this trial must be treated and followed at the participating Centre.\n* Age ≥ 18 years at the time of informed consent.\n* ECOG Performance Status ≤ 2.\n* Life expectancy of ≥ 3 months.\n* Have histologically documented adenocarcinoma of the colon or rectum, which is initially metastatic or unresectable locally advanced.\n* Subjects must be willing to provide the most recently available formalin-fixed paraffin-embedded tumor tissue blocks (or at least 25 freshly sectioned slides) for translational analyses (sampled before 1st treatment course). If archival tissue is not available for HER2 testing or for exploratory aims, then a newly obtained baseline biopsy of an accessible tumor lesion is required before Cycle 1 Day 1 timeframe. Biopsy must contain adequate tissue for analysis; the following biopsy types are acceptable: resection, excision, punch (skin lesions only) and core needle biopsies.\n* Presence of locally determined HER2 overexpression\u002Famplification defined as IHC 3+ or 2+\u002FISH amplified on archival\u002Fnewly obtained tumor tissue, according to the American Society of Clinical Oncology\u002FCollege of American Pathologists (ASCO\u002FCAP) guidelines for gastric\u002Fgastroesophageal cancer.\n* Have RAS known status and pMMR\u002FMSS status by standard local testing.\n* Have radiographically measurable disease per RECIST v1.1.\n* Have adequate hematological, hepatic, renal, cardiac and coagulation function, as defined below, obtained ≤ 7 days prior to enrollment (Cycle 1 Day 1):\n\n  * Absolute neutrophil count (ANC) ≥ 1500\u002Fmm3. (Granulocyte-colony stimulating factor administration is not allowed within 1 week prior to C1D1).\n  * Platelet count ≥ 100000\u002Fmm3. (Platelet transfusion is not allowed within 1 week prior to C1D1)\n  * Hemoglobin ≥ 9.0 g\u002FdL\n  * Total bilirubin ≤ 1.5 x upper limit of normal (ULN) or ≤ 3 x ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastases at baseline.\n  * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN (≤ 5 x ULN if liver metastases are present).\n  * Serum albumin ≥ 2.5 g\u002FdL.\n  * Creatinine clearance ≥ 60 mL\u002Fmin as determined by Cockcroft-Gault (using actual body weight).\n  * Left ventricular ejection fraction (LVEF) ≥ 50% within 28 days before enrollment.\n  * International normalized ratio or Prothrombin time and either partial thromboplastin or activated partial thromboplastin time ≤ 1.5 x ULN.\n* Have had adequate washout period from previous treatment before screening, defined as:\n\n  * ≥ 4 weeks from major surgery.\n  * ≥ 4 weeks from radiation therapy, including palliative stereotactic radiation therapy to the chest.\n  * ≥ 3 weeks from anti-cancer chemotherapy \\[immunotherapy (non-antibody-based therapy)\\], retinoid therapy, hormonal therapy.\n  * ≥ 4 weeks from antibody-based anti-cancer therapy\n  * ≥ 2 weeks or 5 half-lives (whichever is longer) from targeted agent- and small molecule-based therapy\n  * ≥ 6 weeks from nitrosureas or mitomycin C\n  * ≥ 1 week from TKIs approved for treatment of patients with non-small-cell lung cancer (baseline CT must be completed after discontinuation of TKI)\n  * \\> 2 weeks from chloroquine\u002Fhydroxychloroquine\n  * ≥ 2 weeks from cell-free and Concentrated Ascites Reinfusion Therapy (CART), peritoneal shunt or drainage of ascites, pleural or pericardial effusion.\n* Evidence of post-menopausal status or negative serum pregnancy test for females of childbearing potential who are sexually active with a non-sterilized male partner. For women of childbearing potential, a negative result for serum pregnancy test (test must have a sensitivity of at least 25 mIU\u002FmL) must be available at the screening visit and urine beta- human chorionic gonadotropin (β-HCG) pregnancy test prior to each administration of IP. Women of childbearing potential are defined as those who are not surgically sterile (i.e. underwent bilateral salpingectomy, bilateral oophorectomy, or complete hysterectomy) or post-menopausal. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause.\n* Female patients of childbearing potential who are sexually active with a non-sterilized male partner must use at least one highly effective method of contraception, presented in Table 1. From the time of screening and must agree to continue using such precautions for 7 months after the last dose of investigational product (IP). Not all methods of contraception are highly effective. Female patients must refrain from breastfeeding while on study and for 7 months after the last dose of IP. Complete heterosexual abstinence for the duration of the study and drug washout period is an acceptable contraceptive method if it is line with the patient's usual lifestyle (consideration must be made to the duration of the clinical trial); however, periodic, or occasional abstinence, the rhythm method, and the withdrawal method are not acceptable.\n* Female participants must not donate, or retrieve for their own use, ova from the time of enrolment and throughout the study treatment period, and for at least 7 months after the final study drug administration. They should refrain from breastfeeding throughout this time. Preservation of ova may be considered prior to enrollment in this study.\n* Non-sterilized male patients who are sexually active with a female partner of childbearing potential must use a condom with spermicide from screening to 4 months after the final dose of IP for T-DXd while 6 months for capecitabine and bevacizumab. Complete heterosexual abstinence for the duration of the study and drug washout period is an acceptable contraceptive method if it is in line with the patient's usual lifestyle (consideration must be made to the duration of the clinical trial); however, periodic or occasional abstinence, the rhythm method, and the withdrawal method are not acceptable. It is strongly recommended for the female partners of a male patient to also use at least one highly effective method of contraception throughout this period, by employing protocol-recommended methods. In addition, male patients should refrain from fathering a child, or freezing or donating sperm from the time of randomization\u002Fenrollment, throughout the study and for 4 months after the last dose of IP for T-DXd while 6 months for capecitabine and bevacizumab. Preservation of sperm should be considered prior to enrollment in this study.\n\nExclusion Criteria:\n\n* Have previously received any systemic anticancer therapy for CRC in the metastatic\u002Flocally advanced unresectable setting or have participated in any interventional clinical trial for CRC in the metastatic\u002Flocally advanced unresectable setting. Subjects may have received prior fluoropyrimidine with or without oxaliplatin for CRC in the adjuvant or neoadjuvant setting if it was completed \\> 6 months before enrollment.\n* Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. Subjects with clinically inactive brain metastases may be included in the study. Subjects with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy. A minimum of 2 weeks must have elapsed between the end of whole brain radiotherapy and study enrollment.\n* Have previously been treated with an anti-HER2 agent and\u002For a topoisomerase I inhibitor.\n* Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to take oral medications.\n* Have substance abuse or any other medical conditions such as clinically significant cardiac or psychological conditions, that may, in the opinion of the investigator, interfere with the subject's participation in the clinical study or evaluation of the clinical study results.\n* Patients with a medical history of myocardial infarction (MI) within 6 months before enrollment, symptomatic congestive heart failure (CHF) (New York Heart Association Class II to IV). Subjects with troponin levels above ULN at screening (as defined by the manufacturer) and without any myocardial-related symptoms should undergo a cardiologic consultation before enrollment to rule out MI.\n* Corrected QT interval (QTcF) prolongation to \\> 470 msec (females) or \\> 450 msec (males) based on average of the screening 12-lead ECG.\n* Symptomatic arterial hypertension or uncontrolled arterial hypertension, as determined by the investigator.\n* Have a history of (non-infectious) ILD\u002Fpneumonitis that required steroids, have current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.\n* Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (e.g., severe asthma, severe chronic obstructive pulmonary disease \\[COPD\\], restrictive lung disease, pleural effusion, etc.).\n* Any autoimmune, connective tissue, or inflammatory disorders (e.g., Rheumatoid arthritis, Sjögren's, sarcoidosis etc.) where there is documented, or a suspicion of, pulmonary involvement at the time of screening. Full details of the disorder should be recorded in the eCRF for patients who are included in the study.\n* Prior pneumonectomy (complete).\n* A pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART).\n* Have unresolved toxicities from previous anticancer therapy, defined as toxicity (other than alopecia) not yet resolved to Grade ≤ 1 or baseline. Subjects may be enrolled with chronic, stable Grade 2 toxicities (defined as no worsening to Grade \\> 2 for at least 3 months before enrollment\u002Fcycle 1 day 1 and managed with standard of care treatment) that the investigator deems related to previous anticancer therapy such as: chemotherapy-induced neuropathy and fatigue.\n* Patients with known hypersensitivity to the study drug or to its excipients.\n* Patients with known hypersensitivity to other monoclonal antibodies.\n* Pregnant or breastfeeding female patients, or patients who are planning to become pregnant. Sexually active men not willing to use adequate contraception during whole study period.\n* Previous or concurrent malignancy within 3 years of study entry. Exceptions are adequately resected non-melanoma skin cancer, curatively treated in-situ diseases, and other solid tumors that have been curatively treated.\n* Presence of any of the following dihydropyrimidine dehydrogenase (DPYD) polymorphism, based on local laboratory testing: DPYD 2a (c.1905+1G\\>A); DPYD13 (c.1679 T\\>G); DPYD D949V (c.2846 A\\>T). French and German patients may undergo baseline uracilemia assessment as detailed below in spite of polymorphism testing.\n* Have a history of transient ischemic attack, cerebrovascular accident, myocardial infarction, unstable angina, cardiac or other vascular stenting, angioplasty, or cardiac surgery within 6 months prior to enrollment (Cycle 1 Day 1).\n* Have a history of a significant bleeding event (e.g., bleeding needing medical intervention) within 6 months prior to enrollment (Cycle 1 Day 1) unless the source of bleeding has been definitively treated.\n* Have a history of GI perforation within 12 months prior to enrollment (Cycle 1 Day 1).\n* Major surgical procedure or significant traumatic injury ≤ 28 days prior to enrollment (≤ 56 days for hepatectomy, open thoracotomy or major neurosurgery) or anticipation of need for major surgical procedure during the course of the study.\n* Serious, non-healing wound, ulcer, or bone fracture.\n* Prior organ transplantation, including allogenic stem-cell transplantation.\n* Known history of HIV infection.\n* Active infection including tuberculosis, hepatitis B, hepatitis C. Patients positive for hepatitis C (HCV) antibody are eligible only if HCV RNA polymerase chain reaction (PCR) is negative. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \\[anti-HBc\\] and absence of HBsAg) are eligible only if meeting the following criteria:\n\n  * HBsAg negativity (for more than 6 months off anti-viral treatment).\n  * Anti-HBc positivity (IgG or total Ig).\n  * Absence of cirrhosis or fibrosis on prior imaging or biopsy.\n  * Absence of HCV co-infection and no history of HCV co-infection.\n  * Access to a local HBV expert during and after the study Patients meeting all abovementioned criteria must be closely monitored for HBV reactivation.\n* Receipt of live, attenuated vaccine (mRNA and replication deficient adenoviral vaccines are not considered attenuated live vaccines) within 30 days prior to the first dose of trastuzumab deruxtecan. Note: Patients, if enrolled, should not receive live vaccine during the study and up to 30 days after the last dose of IMP\n* Any psychiatric condition that would prohibit the understanding or rendering of informed consent and that would limit compliance with trial requirements.\n* Use of any disallowed drugs (see Section 7.5).\n\nAdditional exclusion criteria for France and Germany:\n\n* Patients with dihydropyrimidine dehydrogenase (DPD) enzyme deficiency (uracilemia ≥ 16 ng\u002FmL)\n* Patient who is under judicial protection and patient who is legally institutionalized or under guardianship or not able to give consent.",{"count":86,"type":21},42,[57],"The aim of this study is to evaluate the activity of first-line trastuzumab-deruxtecan, capecitabine and bevacizumab in terms of overall response rate for patients with HER-2 positive metastatic\u002Flocally advanced unresectable colorectal cancer",[90,91,92,27,93,94,95],"Colorectal Cancer","Colorectal Adenocarcinoma","Rectal Adenocarcinoma","Rectal Cancer, Metastatic","Colon Cancer Metastatic","Colon Cancer Adenocarcinoma",[97,98,99,100,101,102],"colorectal cancer","HER-2 positive","Trastuzumab-deruxtecan","Capecitabine","Bevacizumab","mCRC","2026-02-15",{"date":105,"type":37},"2026-02-17",{"date":107,"type":37},"2025-10-20",{"date":109,"type":21},"2027-10-20",{"name":111,"class":44},"Gruppo Oncologico del Nord-Ovest",28,{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":120,"targetDuration":4,"studyType":22,"phases":122,"briefSummary":123,"conditions":124,"keywords":127,"overallStatus":132,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":45},"100623500","phase-2-short-course-radiotherapy-combined-with-chemotherapy-and-immunotherapy-in-mid-low-locally-advanced-rectal-cancer-100623500","NCT07397442","Short-Course Radiotherapy Combined With Chemotherapy and Immunotherapy in Mid-Low Locally Advanced Rectal Cancer","A Prospective, Phase II, Single-Arm Study on the Efficacy and Safety of Neoadjuvant Short-Course Radiotherapy Combined With Chemotherapy and Immunotherapy in Mid-Low Locally Advanced Rectal Cancer","Inclusion Criteria:\n\n1. Age 18-75 years.\n2. ECOG performance status score 0-2.\n3. Rectal adenocarcinoma confirmed by colonoscopic pathology, with pMMR or MSS.\n4. Imaging studies confirm no distant metastasis or lateral lymph node metastasis; MRI staging is II\u002FIII (excluding T4b, N1c, N2) and any positive lymph nodes (if present) are confined within the mesorectum.\n5. MRI shows the distal margin of the tumor is ≤10 cm from the anal verge, and the mesorectal fascia (MRF) is negative.\n6. The longest diameter of the rectal cancer lesion is ≥10 mm on baseline CT or MRI (meeting the definition of a \"measurable lesion\" per RECIST 1.1 criteria).\n7. Willing and able to comply with the study procedures.\n8. Consent to the use of tissue and blood samples by the investigator for medical research purposes.\n9. No prior history of radiotherapy or immunotherapy.\n10. No history of immune system diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis, systemic vasculitis, scleroderma, pemphigus, dermatomyositis, mixed connective tissue disease, autoimmune hemolytic anemia, ulcerative colitis, HIV infection, etc.).\n11. No history of endocrine system diseases (e.g., hyperthyroidism, hypothyroidism, thyroid nodules, thyroiditis, type 1 diabetes, type 2 diabetes, gestational diabetes, other specific types of diabetes, Cushing's syndrome, primary aldosteronism, pheochromocytoma, adrenal insufficiency, pituitary adenoma, anterior pituitary hypofunction, acromegaly, gigantism, polycystic ovary syndrome, precocious puberty, hypogonadism, hyperparathyroidism, hypoparathyroidism, etc.).\n12. No severe cardiac, pulmonary, hepatic, or renal dysfunction.\n13. No jaundice or gastrointestinal obstruction.\n14. No concurrent acute infection.\n15. Subjects must undergo all required baseline laboratory assessments, and results must be obtained within 1 week before enrollment. Laboratory values must meet the following criteria (per CTCAE 5.0):\n\n    1. White blood cell count ≥2000\u002FμL.\n    2. Neutrophil count ≥1500\u002FμL.\n    3. Platelet count ≥100×10³\u002FμL.\n    4. Hemoglobin ≥9.0 g\u002FdL.\n    5. Creatinine: serum creatinine ≤1.5 × upper limit of normal (ULN) or creatinine clearance \\>50 mL\u002Fmin (calculated using the Cockcroft-Gault formula).\n    6. Creatinine clearance for females = \\[140 - age (years)\\] × weight (kg) × 0.85 ÷ \\[72 × serum creatinine (mg\u002FdL)\\].\n    7. Creatinine clearance for males = \\[140 - age (years)\\] × weight (kg) × 1.00 ÷ \\[72 × serum creatinine (mg\u002FdL)\\].\n    8. Aspartate aminotransferase (AST) ≤3 × ULN, alanine aminotransferase (ALT) ≤3 × ULN, total bilirubin ≤1.5 × ULN.\n16. No psychiatric\u002Fpsychological disorders affecting social functioning.\n17. Women of childbearing potential must have a negative serum pregnancy test (blood HCG) within 1 week before enrollment.\n18. Women of childbearing potential and men who are sexually active with women of childbearing potential must agree to use appropriate contraceptive methods.\n\nExclusion Criteria:\n\n1. Multifocal cancer, or concomitant other malignant tumors.\n2. Received any anti-tumor therapy for other malignant tumors within the past 5 years.\n3. Underwent major surgery recently (within 6 months).\n4. Presence of multiple factors affecting oral drug absorption (e.g., inability to swallow, nausea, vomiting, chronic diarrhea, intestinal obstruction, etc.).\n5. Any uncontrolled, severe comorbid diseases.\n6. Allergy to any component of the study medication.\n7. Life expectancy less than 5 years for any reason.\n8. Planning to undergo or previously underwent organ\u002Fbone marrow transplantation.\n9. Received immunosuppressive agents or glucocorticoid therapy aimed at suppressing immune responses within 1 month before enrollment.\n10. For patients with a history of central nervous system diseases, the investigator will determine whether their current condition allows them to provide informed consent or comply with the study procedures, and subsequently decide whether they can be enrolled.\n11. Other diseases or conditions that may prevent completion of the study treatment (e.g., alcoholism, drug addiction, etc.).\n12. Pregnant or lactating women.",{"count":121,"type":21},19,[57],"The goal of this clinical trial is to test a new combination treatment for locally advanced rectal cancer (cancer in the lower or middle part of the rectum that has not spread to distant organs). The study aims to increase the chance of making the tumor disappear completely (called \"complete response\") and improve the quality of life by increasing the rate of anal sphincter preservation (avoiding permanent colostomy bags).\n\nThe main questions it aims to answer are:\n\nDoes the combination of short-course radiation therapy, two types of immunotherapy drugs (Qibeian and Aike), and chemotherapy (XELOX) increase the complete response rate to over 50%? Is this combination treatment safe, and what are the side effects? Can this treatment help more patients keep their anal function and avoid permanent stomas?\n\nThis is a single-arm study, meaning all participants will receive the experimental treatment (there is no placebo or control group).\n\nParticipants will:\n\nReceive short-course radiation therapy (25 Gy total, given once daily for 5 consecutive days). The radiation will target only the tumor and visible lymph nodes, intentionally avoiding unaffected lymph node areas to protect the immune system.\n\nReceive Qibei'an (a dual immunotherapy drug targeting both PD-1 and CTLA-4) once, 2 days after completing radiation.\n\nReceive Camrelizumab (a PD-1 immunotherapy drug) three times, combined with XELOX chemotherapy.\n\nReceive XELOX chemotherapy (Oxaliplatin ivgtt on Day 1, plus Capecitabine pills taken twice daily for 14 days, for each cycle) for up to 3 cycles.\n\nUndergo detailed assessments after treatment, including MRI scans, colonoscopy with biopsies, and blood tests (including ctDNA tests), to determine if the tumor has disappeared or if surgery is needed.\n\nAttend regular follow-up visits for up to 5 years after treatment (or surgery) to monitor for recurrence and assess quality of life.\n\nThe study will enroll approximately 19 patients at Beijing Friendship Hospital, Capital Medical University. An independent safety monitoring board will regularly review the data to ensure participant safety.",[27,125,126],"Rectal Cancer Stage II","Rectal Cancer Stage III",[67,128,129,130,131],"short-course radiotherapy","anti-PD1","anti-CTLA4","complete response","NOT_YET_RECRUITING","2026-02-09",{"date":135,"type":37},"2026-02-11",{"date":137,"type":21},"2026-03-01",{"date":139,"type":21},"2033-02-28",{"name":141,"class":44},"Beijing Friendship Hospital",{"id":143,"slug":144,"hasResults":11,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":4,"eligibilityCriteria":148,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":149,"targetDuration":4,"studyType":22,"phases":151,"briefSummary":152,"conditions":153,"keywords":154,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":45},"100577041","phase-2-intestinal-microbiome-modulation-with-antibiotics-in-the-neoadjuvant-treatment-of-locally-advanced-rectal-cancer-100577041","NCT06793137","Intestinal Microbiome Modulation With Antibiotics in the Neoadjuvant Treatment of Locally Advanced Rectal Cancer","Phase II Trial for Intestinal Microbiome Modulation With Antibiotics in the Neoadjuvant Treatment of Locally Advanced Rectal Cancer","Inclusion Criteria:\n\n* Patients over 18 years old with middle and lower rectal adenocarcinoma, classified as locally advanced or where the tumor´s location necessitates rectal amputation surgery;\n* Tumors located below the peritoneal reflection, as determined by MRI, will be defined as middle and lower rectum;\n* Patients eligible for rectal amputation will be those with tumor whose distal margin is less than 2,0cm from the pectineal line, as determined by rectoscopy, or less than 2,0cm from the anorectal ring by palpation or MRI.\n* Patients with middle rectum cancer candidates for radiotherapy as part of neoadjuvant treatment will be included according to the following criteria: mesorectal fascia compromised by direct extension of the primary tumor or by an affected lymph node; cT4 tumors.\n\nExclusion Criteria:\n\n* Patients without performance status for total neoadjuvant treatment;\n* Histologies other than adenocarcinoma;\n* Adenocarcinomas with a microsatellite instability phenotype, as determined by immunohistochemistry;\n* Patients with middle rectal tumors who are not indicated for radiotherapy in the neoadjuvant treatment regimen, according to the institutional protocol (tumors cT3N0, with free mesorectal fascia; cT1-3 N+, with free mesorectal fascia).",{"count":150,"type":21},100,[57],"Colorectal cancer is the second most common malignancy worldwide and one-third of these tumors are located in the rectum. The treatment may involve up to three modalities: radiotherapy, chemotherapy, and surgery. For several years, thanks mainly to Brazilian researchers, subgroups of patients have been selected for non-surgical treatment when chemoradiotherapy induces a complete clinical response. These treatment regimens have reached a plateau leading researchers to seek strategies that can increase response rates. Intestinal microbiota studies have shown that an overpopulation of certain anaerobic bacteria is generally associated with poorer treatment response. No study has attempted to intervene in the gut microbiota to increase the complete response rate in rectal cancer. The proposal of the investigators aims to modulate the intestinal microbiota through a phase 2 clinical trial, with the use of metronidazole as the intervention .",[27],[155,156,157],"Total Neoadjuvant Therapy","Intestinal microbiota","Locally advanced rectal cancer","2025-01-27",{"date":160,"type":37},"2025-01-29",{"date":162,"type":37},"2024-07-22",{"date":164,"type":21},"2026-04-30",{"name":166,"class":44},"AC Camargo Cancer Center"]