[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"rectal-neoplasms-malignant\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:rectal-neoplasms-malignant":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,40,71,93],{"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":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"100622412","phase-2-capox-and-bevacizumab-with-or-without-primary-tumor-radiotherapy-and-iparomlimab-and-tuvonralimab-as-first-line-treatment-for-ras-mutantmss-metastatic-rectal-cancer-100622412",false,"NCT07383285","CAPOX and Bevacizumab With or Without Primary Tumor Radiotherapy and Iparomlimab and Tuvonralimab as First-line Treatment for RAS-Mutant\u002FMSS Metastatic Rectal Cancer","CAPOX and Bevacizumab With or Without Primary Tumor Radiotherapy and Iparomlimab and Tuvonralimab as First-line Treatment for RAS-Mutant\u002FMSS Metastatic Rectal Cancer: An Open-label, Randomized, Multi-center Phase II Study","Inclusion Criteria:\n\n1. The subjects were able to understand the informed consent form, voluntarily participated and signed the informed consent form;\n2. On the day of signing the informed consent form, the subjects were aged between 18 and 75 years old, regardless of gender;\n3. Pathological tissue diagnosis confirmed rectal adenocarcinoma (including signet ring cell carcinoma and mucinous adenocarcinoma);\n4. The lower boundary of the lesion was within 15 cm from the anal verge;\n5. The clinical stage was stage IV;\n6. The genetic test results were KRAS or NRAS mutations, without BRAF V600 mutations, and the immunohistochemical results were pMMR;\n7. The subjects had not received palliative drug treatment, or had received 1 cycle of FOLFOX\u002FCAPOX and had not undergone tumor efficacy assessment;\n8. According to the RECIST 1.1 standard, there was at least 1 measurable lesion or assessable lesion at the baseline;\n9. The primary lesion existed and had not undergone radiotherapy previously;\n10. The ECOG score was 0 or 1 (Appendix 4);\n11. The expected survival period was ≥ 6 months;\n12. Female subjects with fertility or male subjects whose partner had fertility agreed to adopt effective contraceptive measures starting from 7 days before the first administration until 120 days after the last administration (refer to Appendix 3);\n13. The subjects were capable and willing to comply with the visit, treatment plan, laboratory tests and other research-related procedures stipulated in the research protocol;\n14. Within 7 days before the first administration, they had good organ function\n\nExclusion Criteria:\n\n(1) Subjects with untreated active brain metastases or meningeal metastases; if the brain metastases of the subject have been treated and the condition of the metastases is stable (brain imaging examination at least 4 weeks before the first administration shows stable lesions, and there are no new neurological symptoms or the neurological symptoms have recovered to baseline levels), and there is no evidence of new onset or enlargement of the metastases, they are allowed to be enrolled; (2) Have the following cardiovascular conditions:\n\n1. Active coronary heart disease with angina pectoris or patients who need to take medication to prevent angina attacks;\n2. NYHA II-IV grade chronic heart failure;\n3. Uncontrolled hypertension after drug treatment (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg);\n4. Major vascular diseases (such as aortic aneurysm, aortic dissection aneurysm, internal carotid artery stenosis);\n5. Has had thromboembolic or cerebrovascular embolic events within 6 months. (3) Have the following digestive system diseases:\n\n1\\) Within 6 months, there has been abdominal fistula, gastrointestinal perforation or abdominal abscess or active gastrointestinal bleeding. If the perforation or fistula has been treated by resection or repair, and the disease has been judged by the investigator to have recovered or alleviated, it is allowed to be enrolled; 2) Have gastric, duodenal ulcers or ulcer malignancy, intestinal obstruction\u002Fobstruction with incomplete obstruction; 3) Have chronic enteritis and\u002For inflammatory bowel disease; (4) Have abnormal coagulation conditions:\n\n1. Have bleeding (including hemoptysis) or coagulation disorders;\n2. Are taking warfarin, aspirin (except for small doses of less than 100 mg per day), low molecular weight heparin and other antiplatelet aggregation Chinese and Western drugs.\n\n(5) Within 28 days before the first administration or 5 half-lives (whichever is shorter, but at least 2 weeks) have received any other interventional clinical trials or received other anti-tumor treatment for the purpose of alleviating symptoms of bone metastases is allowed; (6) Within 28 days before the first administration have received major surgical treatment (such as major surgeries through the abdomen or thorax; excluding drainage, diagnostic punctures or peripheral vascular access replacement surgeries); (7) Within 14 days before the first administration need to receive continuous 7 days of systemic corticosteroid treatment (≥ 10 mg\u002Fday prednisone, or equivalent other corticosteroids) or immunosuppressant treatment; except for inhalation or local application of corticosteroids, or receiving physiological replacement doses of corticosteroids due to adrenal insufficiency; allowed for short-term (≤ 7 days) corticosteroids for prevention (for example, contrast agent allergy) or treatment of non-autoimmune diseases (for example, delayed-type hypersensitivity reaction caused by exposure to allergens); (8) Within 28 days before the first administration have received live vaccines (including attenuated live vaccines); (9) Have interstitial lung disease, or have a history of non-infectious pneumonia requiring oral or intravenous administration of glucocorticoids; (10) Within 2 years before the start of the study treatment need systemic treatment for active autoimmune diseases, or the investigator judges that there is a possibility of recurrence or planned treatment for autoimmune diseases. The following are excluded: a) Skin diseases that do not require systemic treatment (such as: vitiligo, alopecia, psoriasis or eczema); b) Hypothyroidism caused by autoimmune thyroiditis, only requiring stable doses of hormone replacement therapy; c) Type I diabetes that only requires stable doses of insulin replacement therapy; d) Childhood asthma has completely resolved, and no intervention is needed after adulthood; e) The investigator judges that the disease will not recur without external triggering factors. (11) Within 5 years prior to the first administration, having another malignant tumor, except for cured skin squamous cell carcinoma, basal cell carcinoma, non-invasive bladder cancer, localized low-risk prostate cancer (defined as stage ≤ T2a, Gleason score ≤ 6, and PSA ≤ 10 ng\u002FmL at the time of prostate cancer diagnosis (if measured), patients who have received radical treatment and have no biochemical recurrence of prostate-specific antigen (PSA)), and in situ cervical\u002Fbreast cancer; (12) Having uncontrolled comorbidities, including but not limited to the following conditions: a) Active HBV or HCV infection; b) Subjects with positive HBsAg and\u002For HCV antibody during the screening period, must undergo HBV DNA and\u002For HCV RNA testing. Subjects with HBV DNA ≤ 500 IU\u002FmL (or ≤ 2000 copies\u002FmL) and\u002For negative HCV RNA can be enrolled; during the trial, the study investigator decides to monitor HBV DNA based on the subject's condition; c) Known HIV infection or AIDS history; d) Active tuberculosis; e) Active infection or systemic use of anti-infective drugs for more than 1 week before the first administration of this study and within 28 days before the first administration; fever of unknown origin occurred within 2 weeks before administration; f) Uncontrolled hypertension (resting blood pressure ≥ 160\u002F100 mmHg), symptomatic heart dysfunction (NYHA II-IV), unstable angina pectoris or myocardial infarction within 6 months, or QTc prolongation or risk of arrhythmia (baseline QTc \\> 470 msec corrected by Fridericia method, refractory hypokalemia, long QT syndrome, resting heart rate \\> 100 bpm atrial fibrillation or severe valvular heart disease); g) Active bleeding that cannot be controlled by medical treatment; (13) Toxicity from previous anti-tumor therapy has not recovered to CTCAE ≤ 1 grade (NCI-CTCAE v5.0) or baseline level, except alopecia, skin pigmentation (allowing any grade), and immune-related adverse reactions that require physiological dose substitution (such as hypothyroidism, pituitary insufficiency, type I diabetes, etc.); (14) Previous history of allogeneic bone marrow or organ transplantation; (15) Previous history of allergic reactions to antibody drugs, hypersensitivity reactions, or intolerance (such as severe allergic reactions, immune-mediated liver toxicity, immune-mediated thrombocytopenia or anemia); (16) Pregnant and\u002For lactating women; (17) Other situations that the investigator considers to affect the safety or compliance of the treatment with the study drug, including but not limited to moderate to large pleural\u002Fabdominal effusion\u002Fpericardial effusion, refractory pleural\u002Fabdominal effusion\u002Fpericardial effusion, intestinal obstruction or subacute intestinal obstruction, mental disorders, etc.; (18) Previous treatment with immune checkpoint blockers or T-cell co-stimulation drugs, including but not limited to immune checkpoint blockers such as PD-1, PD-L1, CTLA4, LAG3, etc., therapeutic vaccines, etc.","ALL","18 Years","75 Years",{"count":20,"type":21},106,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Research objective: To compare the efficacy and safety of Capox + Bev versus Capox + Bev combined with primary site radiotherapy + (Iparomlimab and Tuvonralimab) as the first-line treatment for RAS Mutation\u002FpMMR metastatic rectal cancer patients.\n\nStudy endpoint:\n\nPrimary endpoint: 12-month progression-free survival rate (PFSR)\n\nSecondary endpoints:\n\n* The objective response rate (ORR) and disease control rate (DCR) as determined by the investigator according to the RECIST 1.1 standard, time to response (TTR), duration of response (DOR), progression-free survival (PFS), 6-month progression-free survival rate (PFSR), overall survival (OS);\n* The frequency and severity of adverse events (AEs) during treatment (NCI CTCAE 5.0).\n\nThis study will enroll 106 patients (stratification factors: presence or absence of liver metastasis; whether NED could be achieved). They were randomly assigned in a 1:1 ratio to:\n\nThe treatment group: Capox + Bev combined with primary site radiotherapy and (Iparomlimab and Tuvonralimab), administered every 3 weeks (Q3w), up to a maximum of 8 cycles, followed by a maintenance treatment stage of Capecitabine + Bev + (Iparomlimab and Tuvonralimab), administered every 3 weeks (Q3w).\n\nThe control group: Capox + Bev, administered every 3 weeks (Q3w), up to a maximum of 8 cycles, followed by a maintenance treatment stage of Capecitabine + Bev, administered every 3 weeks (Q3w).",[27],"Rectal Neoplasms Malignant","NOT_YET_RECRUITING","2026-01-26",{"date":31,"type":32},"2026-02-03","ACTUAL",{"date":34,"type":21},"2026-02-01",{"date":36,"type":21},"2029-12-31",{"name":38,"class":39},"Peking University Cancer Hospital & Institute","OTHER",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":47,"targetDuration":4,"studyType":22,"phases":49,"briefSummary":51,"conditions":52,"keywords":54,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":70},"100283201","transanal-versus-laparoscopic-total-mesorectal-excision-for-rectal-cancer-100283201","NCT02966483","Transanal Versus Laparoscopic Total Mesorectal Excision for Rectal Cancer","Transanal Versus Laparoscopic Total Mesorectal Excision for Mid and Low Rectal Cancer (TaLaR): a Multicentre Randomised Clinical Trial","Inclusion Criteria:\n\nhistologically proven rectal adenocarcinoma;\n\ntumor located below the level of peritoneal reflection ;\n\ndiagnosis of rectal cancer amenable to curative surgery;\n\nno evidence of distant metastases;\n\npreoperative tumor stage within III;\n\nno threaten mesorectal fascia (MRF)after neoadjuvant therapy;\n\nno contraindication to laparoscopic surgery;\n\nwithout history of other malignancies;\n\nWritten informed consent\n\nExclusion Criteria:\n\ncould not perform sphincter preservation surgery (requiring a Mile's procedure);\n\nT4b tumor invading adjacent organs;\n\nT1 tumors that can be locally resected\n\nshould take neoadjuvant therapy but refuse it;\n\nrecurrent cancer;\n\nconcurrent or previous diagnosis of invasive cancer within 5 years;\n\nemergent surgery with intestinal obstruction or perforation;\n\nhistory of colorectal surgery;\n\nfecal incontinence;\n\nhistory of inflammatory bowel disease;\n\nwith contraindications to general anaesthesia(ASA class 4 or 5);\n\npregnant or breast-feeding;\n\nhistory of mental disorder",{"count":48,"type":21},1114,[50],"NA","Laparoscopic surgery for rectal cancer has been successfully proven to be a non-inferior alternative regarding resection quality, and oncological outcomes of patients as compared to open surgery in mangy clinical trails. Moreover, laparoscopic surgery is advantageous over open surgery with regard to operative invasiveness, patient's recovery, and wound related complications. Thus, laparoscopic surgery has gained great popularity over the past decades. However, specifically for mid and low rectal cancer, laparoscopic surgery is technically demanding, which sometimes leads to high morbidity and unsatisfactory resection quality, especially in challenging cases such as bulky mesorectum, enlarged prostate, irradiated pelvis, etc. Under this circumstance, transanal total mesorectal excision (TaTME) , the so called \"down-to-up\" alternative, has emerged as a promising solution to these problems in recent years and more and more small studies have proven the feasibility and advantages of this technique, making it become a hot topic among both literature and conferences. However, TaTME is still at early birth, higher-level evidences, either multicentric, or comparative study with conventional surgery is strikingly lacking. Thus the investigators conduct this multicentre randomised clinical trial, comparing transanal TME versus laparoscopic TME for mid and low rectal cancer, aiming to prove the hypothesis that TaTME may achieve better resection quality and result in non-inferior oncological outcome, as well as short term operative morbidity and mortality.",[27,53],"Surgery",[55,56,57,58,59],"Rectal cancer","Laparoscopic surgery","Total mesorectal excision","Transanal","Multicentre randomised clinical trial","RECRUITING","2025-01-15",{"date":63,"type":32},"2025-01-17",{"date":65,"type":32},"2016-04",{"date":67,"type":21},"2026-07",{"name":69,"class":39},"Sun Yat-sen University",16,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":81,"conditions":82,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":92},"100528184","fapi-in-rectal-cancer-tnt-100528184","NCT06157463","FAPI in Rectal Cancer TNT","68Ga FAPI in Total Neoadjuvant Therapy of Rectal Cancer","Inclusion Criteria:\n\n1. Biopsy proven newly detected adenocarcinoma of the rectum\n2. Clinical stage II-III rectal cancer\n3. Aged at least 18 years. No upper age limit.\n4. WHO\u002FECOG Performance Status 0-1\n5. Eligible for total neoadjuvant therapy\n\nExclusion Criteria:\n\n1. Distant metastases found on either CT, MR or FDG-PET\n2. Prior anticancer therapy for colorectal cancer\n3. Prior radiotherapy of the pelvic region\n4. Other concurrent antineoplastic therapy\n5. Major surgery within the last 4 weeks prior to inclusion\n6. Subjects pregnant or breast feeding\n7. Serious concurrent diseases not compatible with study entry, including active, uncontrolled infections, active, disseminated coagulation disorder, clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia within 6 months before enrolment)\n8. Neurologic or psychiatric disorders including dementia, uncontrolled seizures, substance abuses, severe depression\n9. Prior or concurrent malignancy within 3 years prior to enrolment (except non-melanoma skin cancer or cervical carcinoma FIGO stage 0-1)\n10. Allergic to contrast agents or to the main ingredients or excipients of the experimental radiopharmaceutical 68Ga FAPI, including acetate, ascorbic acid and normal saline\n11. Those deemed unsuitable for participation in the trial by the investigators.",{"count":79,"type":21},99,"OBSERVATIONAL","The goal of the trial is to observe the changes of 68Ga FAPI signal before and after total neoadjuvant therapy for rectal cancers, and the correlation between the image parameters, immune checkpoints expression as well as the patient outcome. The trial will recruit patients with biopsy-confirmed rectal cancer aged 18 years old or older, with WHO\u002FECOG Performance Status 0-1, and eligible for total neoadjuvant therapy at the clinicians' discretion. After signing the informed consent, the participants will undergo a standard staging work-up if not already done, including colonoscopy and cross-sectional images such as CT, MR, and FDG-PET. Kidney function (by serum creatinine) and liver function (by serum alanine aminotransferase) will also be assessed. Only patients with stage II-III rectal cancer will be recruited.\n\nIf patients meet the inclusion and exclusion criteria, they will undergo the first 68Ga-FAPI PET within 30 days before the beginning of total neoadjuvant therapy. At 22-24 weeks into the TNT, follow-ups for response evaluation will be conducted, including colonoscopy and cross-sectional images such as CT, MR, and FDG-PET. The second 68Ga-FAPI PET will be performed within one month of these exams. Afterward, participants will either undergo surgery or have image follow-ups every 3 months. The participants will be followed up for up to 2 years after the second 68Ga-FAPI PET, and immunochemical staining with CD47, CD73, PD-L1, and FAP on the biopsy or surgical specimens will be performed in one batch to avoid batch-to-batch variation.",[27],"2024-08-06",{"date":85,"type":32},"2024-08-07",{"date":87,"type":32},"2024-03-08",{"date":89,"type":21},"2028-07-31",{"name":91,"class":39},"Chang Gung Memorial Hospital",1,{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":100,"targetDuration":4,"studyType":22,"phases":102,"briefSummary":104,"conditions":105,"keywords":107,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":121},"100476445","phase-2-short-course-radiotherapy-followed-by-chemotherapy-and-pd-1-inhibitor-for-locally-advanced-rectal-cancer-100476445","NCT05484024","Short-course Radiotherapy Followed by Chemotherapy and PD-1 Inhibitor for Locally Advanced Rectal Cancer","Preoperative Short-course Radiotherapy Followed by Chemotherapy With or Without PD-1 Inhibitor for Locally Advanced Rectal Cancer: a Prospective, Multicenter, Randomized Controlled, Phase II\u002FIII Study (STELLAR II Study)","Inclusion Criteria:\n\n* Biopsy proven rectal adenocarcinoma;\n* Distance between tumour and anal verge≤ 10cm;\n* Locally advanced tumour;(8th edition AJCC\u002FUICC staging :cT3-T4N0\u002FcT2-4N+，M0) Cancer Staging must be based on pelvic MRI or Endoscopic ultrasound;\n* Eastern Cooperative Oncology Group(ECOG) performance score ≤ 1;\n* Mentally and physically fit for chemotherapy; Adequate blood counts: White blood cell count ≥3.5 x 109\u002FL Haemoglobin levels ≥100g\u002FL Platelet count ≥100 x 109\u002FL Creatinine levels ≤1.0× upper normal limit（UNL） Urea nitrogen levels ≤1.0× upper normal limit（UNL） Alanine aminotransferase(ALT) ≤1.5× upper normal limit（UNL） Aspartate aminotransferase(AST) ≤1.5× upper normal limit（UNL） Alkaline phosphatase(ALP) ≤1.5× upper normal limit（UNL） Total bilirubin(TBIL)\n\n  ≤1.5× upper normal limit（UNL）\n* No excision of tumor, chemotherapy or other anti-tumor treatment after the diagnosis.\n* No previous pelvic radiation history；\n* Written informed consent;\n\nExclusion Criteria:\n\n* Previous treatment with anti-PD-1\u002FL1 and anti-CTLA-4 or other immune experimental drugs.\n* Severe autoimmune disease: active inflammatory bowel disease (including Crohn's disease, ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (e.g. Wegener's granulomatosis)\n* Symptomatic interstitial lung disease or active infectious\u002Fnon-infectious pneumonia.\n* At risk for bowel perforation: active diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, abdominal cancer or other known risk factors for bowel perforation.\n* history of other malignancies, excluding curable non-melanotic skin cancer and cervix carcinoma in situ；\n* Active infection, heart failure, heart attack within 6 months, unstable angina or unstable arrhythmia.\n* Any condition investigator considered may interfere with the results or place the patient at increased risk of treatment complications, or other uncontrollable disease.\n* Pregnancy or breast feeding\n* Immunodeficiency disorders including human immunodeficiency virus (HIV), or history of organ transplantation, allogeneic stem cell transplantation\n* Active hepatitis B virus (HBV) hepatitis (HBV-DNA ≥ 2000 U\u002FmL), hepatitis C virus (HCV) hepatitis, active tuberculosis infection.\n* Oncology vaccination history or any vaccination within 4 weeks prior to the start of treatment.(Note: influenza vaccines are mostly inactivated and therefore allowed, intranasal preparations are usually live attenuated vaccines and therefore not allowed)\n* Concomitant other immune agents, chemotherapeutic agents, other drugs in clinical studies, and long term cortisol application",{"count":101,"type":21},588,[24,103],"PHASE3","This phase II\u002FIII trial studies how well neoadjuvant short-course radiotherapy and chemotherapy with or without PD-1 inhibitors works in treating patients with locally advanced rectal adenocarcinoma. Neoadjuvant short-course radiation therapy followed by two-drug regimen chemotherapy, such as CAPOX, were shown to be non-inferior to standard long-course chemoradiotherapy in our previous STELLAR study. Immune checkpoint inhibitors (ICIs) using monoclonal antibodies, such as PD-1 or PD-L1 inhibitor, show promising efficiency and reliable security in some limited sample prospective or retrospective studies. When treating patients with locally advanced rectal cancer, giving sequential neoadjuvant short-course radiotherapy and chemotherapy with PD-1 inhibitor may work better.",[27,106],"Radiotherapy",[108,109,110,111],"rectal cancer","short-course radiotherapy","total neoadjuvant therapy","PD-1 inhibitor","2022-07-29",{"date":114,"type":32},"2022-08-02",{"date":116,"type":21},"2022-08-06",{"date":118,"type":21},"2030-07-31",{"name":120,"class":39},"Chinese Academy of Medical Sciences",2]