[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-rectal-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-rectal-cancer":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,40,63,88],{"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},"100642682","phase-2-short-course-rt-followed-by-nalirifox-plus-pucotenlimab-as-neoadjuvant-therapy-for-high-risk-locally-advanced-rectal-cancer-with-msspmmr-100642682",false,"NCT07651007","Short-course RT Followed by NALIRIFOX Plus Pucotenlimab as Neoadjuvant Therapy for High-risk Locally Advanced Rectal Cancer With MSS\u002FpMMR","A Phase II Clinical Study of Short-course Radiotherapy Followed by NALIRIFOX Plus Pemolivimab as Neoadjuvant Therapy for High-risk Locally Advanced Rectal Cancer With MSS\u002FpMMR","Inclusion Criteria:\n\n1. Age: 18-70 years;\n2. ECOG PS score: 0-1;\n3. Pathologically confirmed rectal adenocarcinoma with immunohistochemistry and\u002For genetic testing showing MSS\u002FpMMR status;\n4. Lesion located ≤10 cm from the anal verge, confirmed by colonoscopy or digital rectal examination;\n5. According to the 8th edition of the 2018 AJCC Cancer Staging Manual and the 2008 ESMO staging criteria for lower rectal cancer: patients with stage II\u002FIII rectal cancer staged by MRI or endorectal ultrasound, who have at least one of the following high-risk factors: cT4a with more than half the circumference of the bowel invaded (measured by MRI), cT4b (resectable), cT3 with tumor penetration ≥5 mm beyond the muscularis propria (T3c\u002Fd) and positive extramural venous invasion (EMVI+) (for mid-upper rectal tumors), cN2, MRF+ (≤2 mm); for lower rectal tumors located on the anterior wall, additional criteria include T3 stage and tumor occupying \\>50% of the bowel circumference; for tumors primarily located on the lateral-posterior wall in the lower rectum, tumor penetration through the bowel wall (internal anal sphincter) ≥5 mm; for tumors invading the external anal sphincter or levator ani muscle (staged as stage IV). Preoperative T staging is based on endorectal ultrasound and rectal MRI; N staging on abdominal CT; M staging on abdominal and chest CT. If symptoms are present, appropriate imaging studies (brain MRI or whole-body bone scan) should be performed. Patients with MRI contraindications may be cautiously included based on CT and endorectal ultrasound staging. All patient staging must be reviewed and confirmed by a multidisciplinary team (MDT).\n6. No evidence of distant metastasis confirmed by comprehensive evaluation;\n7. Primary rectal cancer patients who have not received prior surgery (except palliative stoma formation), radiotherapy, systemic chemotherapy, or other anti-tumor treatments before enrollment;\n8. Normal organ function, meeting the following laboratory criteria: Hemoglobin (HB) ≥9 g\u002FdL, white blood cell count (WBC) ≥3.5×10⁹\u002FL, neutrophil count ≥1.5×10⁹\u002FL, platelet count (PLT) ≥100×10⁹\u002FL. Biochemical tests must meet the following standards: creatinine (Crea) and bilirubin (BIL) ≤1.0×ULN, ALT and AST ≤2.5×ULN, alkaline phosphatase (ALP) ≤2.5×ULN, total bilirubin (Tbil) ≤1.5×ULN;\n9. No history of hypersensitivity to 5-FU class drugs or platinum-based agents;\n10. No prior radiation therapy to the planned irradiation site;\n11. Female participants of childbearing potential must undergo a pregnancy test (serum or urine) within 7 days prior to enrollment, with a negative result, and agree to use an effective method of contraception during the study and for 8 weeks after the last dose. Male participants must agree to use an effective method of contraception during the study and for 8 weeks after the last dose;\n12. Participants must voluntarily enroll in the study, sign informed consent, demonstrate good compliance, and cooperate with follow-up visits.\n\nExclusion Criteria:\n\n1. Prior pelvic radiotherapy;\n2. Active or progressive infection requiring systemic treatment, such as active tuberculosis or active hepatitis;\n3. Presence of uncontrolled systemic diseases, as determined by the investigator, including diabetes, hypertension, cirrhosis, rheumatological or autoimmune disorders, and severe pulmonary disease;\n4. Clinically significant thyroid dysfunction (based on serum thyroid hormone levels TT4, TT3, FT3, FT4, and serum thyrotropin TSH), deemed unsuitable for study participation by the investigator. (5) History of hemorrhagic or thromboembolic events within the past 6 months, such as cerebrovascular accidents (including transient ischemic attacks), pulmonary embolism, or spontaneous major bleeding from tumors;\n\n(6) Prior or concurrent diagnosis of other malignancies (including synchronous colorectal cancer), except for cured cases of cutaneous basal cell carcinoma and cervical carcinoma in situ; (7) Presence of any other disease, metabolic abnormality, physical examination abnormality, or laboratory abnormality that, in the investigator's judgment, raises concern about the patient's unsuitability for the investigational drug, may interfere with interpretation of study results, or places the patient at high risk; (8) Estimated insufficient compliance of the patient to participate in this clinical study; (9) History of gastrointestinal fistula, perforation, bleeding, severe peptic ulcer disease, or other serious gastrointestinal disorders; (10) Patients who have undergone solid organ or bone marrow transplantation, or those who have had an active autoimmune disease requiring systemic treatment within 2 years prior to the first dose.","ALL","18 Years","70 Years",{"count":20,"type":21},29,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The goal of this clinical trial is conducted to evaluate the neoadjuvant regimen of short-course radiotherapy (SCRT) followed by NALIRIFOX chemotherapy plus Pucotenlimab immunotherapy for high-risk locally advanced rectal cancer.\n\nThe main questions it aims to answer are:\n\n1. Does this regimen increase the complete response rate ?\n2. What medical problems (adverse events) do participants have when receiving this treatment? Researchers will evaluate this regimen compared to historical standard neoadjuvant chemoradiotherapy to see if it achieves a higher complete response rate and improves sphincter preservation.\n\nParticipants will:\n\n1. Receive short-course radiotherapy (25Gy\u002F5f) over 5 consecutive days.\n2. Then receive NALIRIFOX chemotherapy every 2 weeks for 9 cycles and Pucotenlimab immunotherapy every 3 weeks for 6 cycles (total treatment duration approximately 6 months).\n3. Regular checkups and tests during treatment.\n4. Keep a diary of their symptoms and the number of times they use a rescue inhaler.",[27],"Advanced Rectal Cancer","NOT_YET_RECRUITING","2026-06-11",{"date":31,"type":32},"2026-06-16","ACTUAL",{"date":34,"type":21},"2026-05-31",{"date":36,"type":21},"2029-12-31",{"name":38,"class":39},"Wang Xin","OTHER",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":54,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":62},"100614558","phase-2-liposomal-irinotecan-capecitabine-and-enlonstobart-with-short-course-radiotherapy-for-locally-advanced-rectal-cancer-100614558","NCT07281157","Liposomal Irinotecan, Capecitabine and Enlonstobart With Short-Course Radiotherapy for Locally Advanced Rectal Cancer","Liposomal Irinotecan, Capecitabine, and Enlonstobart Combined With Short-Course Radiotherapy as Neoadjuvant Therapy for Locally Advanced Rectal Cancer: A Prospective, Single-Center, Single-Arm Study","Inclusion Criteria:\n\n1. Age of 18-75 years old;\n2. rectal adenocarcinoma confirmed by histology and\u002For cytology;\n3. locally advanced rectal cancer cT3-4 or N+ confirmed by baseline examination (AJCC\u002FUICC TNM staging (8th edition, 2017);\n4. Distance from lower margin to anal margin ≤ 10 cm;\n5. Patients with at least one assessable lesion according to RECIST1.1 criteria;\n6. ECOG 0-1;\n7. the expected survival time was more than 12 months;\n8. had not received anti-tumor treatment for rectal cancer after diagnosis, including radiotherapy, chemotherapy, surgery, etc.\n9. Bone marrow function: absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL, hemoglobin ≥90g\u002FdL, platelet (PLT) ≥100×10\\^9\u002FL, white blood cell (WBC) ≥3.0×10\\^9\u002FL;\n10. Liver function: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) ≤2.5 times the upper limit of normal (ULN), if there is liver metastasis ≤5×ULN, total bilirubin \\\u003C1.5 ULN;\n11. Renal function: serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (CCr) ≥60mL\u002Fmin (according to Cockcroft-Gault formula);\n12. Coagulation function: prothrombin time (PT), activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤1.5×ULN;\n13. exclude active or suspected infection;\n14. non-pregnant or lactating women; Women\u002Fmen of childbearing age should use effective contraception during the study and for 6 months after the end of study treatment;\n15. The patients had good compliance, understood the research process of this study, and signed the written informed consent.\n\nExclusion Criteria:\n\n1. patients with other malignant tumors (except cured carcinoma in situ and basal cell carcinoma) in the past 5 years;\n2. patients with mismatch repair deficiency (dMMR) or microsatellite instability high (MSI-H);\n3. obvious clinical bleeding symptoms or obvious bleeding tendency within 3 months before treatment (bleeding \\> 30 mL within 3 months, hematemesis, melena, hematochezia), hemoptysis (fresh blood \\> 5 mL within 4 weeks), etc. Or treatment for a venous\u002Fvenous thrombotic event within the previous 6 months, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism; Long-term anticoagulation with warfarin or heparin or long-term antiplatelet therapy (aspirin ≥300 mg\u002F day or clopidogrel ≥75 mg\u002F day) may be required.\n4. extensive distant metastasis (e.g., peritoneal metastasis, multiple bone\u002Fbrain metastases);\n5. patients who had used potent CYP3A4 inducers at the same time within 3 weeks before the first dose, or had used potent CYP3A4 inhibitors or potent UGT1A1 inhibitors within 3 weeks before the first dose;\n6. patients who underwent major organ surgery (excluding needle biopsy, central venous catheterization, port catheterization, stent placement to relieve biliary obstruction, percutaneous hepatobiliary drainage, cholecystostomy) or elective surgery within 4 weeks before treatment;\n7. tumor invasion of large vascular structures, such as pulmonary artery, superior vena cava or inferior vena cava, and there is a high risk of bleeding according to the investigator's judgment;\n8. Active heart disease (including myocardial infarction, severe\u002Funstable angina) within 6 months before treatment. Echocardiography showed that the left ventricular ejection fraction was less than 50% and the arrhythmia was not well controlled.\n9. have hypertension that is not well controlled with antihypertensive medication (systolic blood pressure ≥140 mmHg and\u002For diastolic blood pressure ≥90 mmHg);\n10. subjects with active infection or fever of unknown origin \\>38.5 degrees during screening or before the first dose of medication (according to the investigator's assessment, subjects with fever due to cancer could be enrolled);\n11. subjects with congenital or acquired immunodeficiency, such as HIV infection or active hepatitis (transaminase did not meet the inclusion criteria, hepatitis B reference: HBV DNA≥1000 IU\u002Fml; hepatitis C reference: HCV RNA≥1000 IU\u002Fml); Chronic hepatitis B virus carriers, HBV DNA \\\u003C 2000 IU\u002Fml, must receive antiviral therapy at the same time during the trial.\n12. any other medical condition, clinically significant metabolic abnormality, physical examination abnormality, or laboratory abnormality where there is reason to suspect that the patient has a disease or condition (such as having seizures requiring treatment) that would be inappropriate for the study drug, in the investigator's judgment, or that would affect interpretation of the study results or place the patient at high risk;\n13. intestinal obstruction (except incomplete intestinal obstruction requiring only enteral nutrition); Subjects at risk of intestinal perforation (including, but not limited to, a history of acute diverticulitis, abdominal abscess, or abdominal cancer); (14 ) History of wide bowel resection (partial colectomy or wide small bowel resection with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea.\n\n(15) Has received any other antibodies\u002Fdrugs (including PD-1, PD-L1, PD-L2, CTLA-4, OX40, CD137 inhibitors, etc.) acting on T cell co-stimulation or checkpoint pathway.\n\n(16) patients with CTCAE 5.0 grade ≥ 3 immune-related adverse events (AE) after immunotherapy.\n\n(17) patients receiving glucocorticoid (prednisone \\>10mg\u002F day or equivalent dose of other drugs of the same kind) or other immunosuppressive therapy for some condition within 14 days before the first dose of the drug.\n\n(18) participated in other clinical investigators within 4 weeks before enrollment; (19) a documented history of allergy to study drugs, including Enlonstobart, capecitabine, liposomal irinotecan, and any component of the drug; (20) pregnant or lactating female subjects; Patients deemed by the investigator to be ineligible for trial participation.","75 Years",{"count":49,"type":21},30,[24],"This is a prospective, single-center, single-arm study evaluating the combination regimen of liposomal irinotecan, capecitabine, and enlonstobart combined with short-course radiotherapy as neoadjuvant therapy for locally advanced rectal cancer.",[27],"RECRUITING",{"date":55,"type":32},"2026-06-03",{"date":57,"type":32},"2025-11-01",{"date":59,"type":21},"2032-04-30",{"name":61,"class":39},"Tianjin Medical University Cancer Institute and Hospital",1,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":70,"targetDuration":4,"studyType":22,"phases":72,"briefSummary":73,"conditions":74,"keywords":75,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":62},"100456810","phase-2-modified-sandwich-therapeutic-regimen-for-locally-advanced-rectal-cancer-100456810","NCT05228431","Modified Sandwich Therapeutic Regimen for Locally Advanced Rectal Cancer","Single Arm and Phase II Clinical Trial of a Sandwich Regimen as XELOX Regimen and Capecitabine Alternate Administration Combined With Preoperative Intensity Modulated Radiation Therapy for pMMR Locally Advanced Rectal Cancer","Inclusion Criteria:\n\nPathological confirmed rectal adenocarcinoma.\n\nClinical stage T3-4 or T any N1.With or without MRF positivity, with or without EMVI positivity, R0 resection is estimated.\n\nNo metastasis\n\nNo signs of intestinal obstruction; or intestinal obstruction has been relieved after proximal colostomy surgery.\n\nAge ranged from 18 to 75\n\nNo previous radiotherapy，surgery and chemotherapy.\n\nExclusion Criteria:\n\nMultiple primary tumor\n\nCachexy",{"count":71,"type":21},121,[24],"In the treatment of locally advanced rectal cancer, the short-term and long-term efficacy of the traditional sandwich regimen has not reached satisfactory efficacy. For this reason, the concept of reducing the dose of postoperative chemotherapy or directly moving forward the full amount of postoperative chemotherapy was proposed, which is called total neoadjuvant therapy (TNT). However, TNT also includes the high toxicity of oxaliplatin in the whole process and the long time interval between the end of radiotherapy and the operation, which leads to fibrosis of the surrounding tissue, which increases the difficulty of surgical resection and makes it difficult to ensure good surgical specimen quality. In addition to this, there are issues that may increase the risk of potential disease progression in patients with poor treatment withdrawal. Therefore, appropriately reducing the intensity of chemotherapy and controlling the total duration of preoperative neoadjuvant therapy during radiotherapy is expected to alleviate the side effects of neoadjuvant therapy. Here, the investigators synthesized the characteristics of TNT and sandwich regimens and proposed a XELOX regimen and capecitabine alternate administration combined with preoperative intensity modulated radiation therapy.",[27],[76,77,78],"Rectal cancer","neoadjuvant chemoradiotherapy","optimization","2024-04-19",{"date":81,"type":32},"2024-04-22",{"date":83,"type":32},"2022-03-02",{"date":85,"type":21},"2028-05-01",{"name":87,"class":39},"Zhen-Hai Lu",{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":96,"targetDuration":4,"studyType":22,"phases":98,"briefSummary":99,"conditions":100,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":62},"100466872","phase-2-a-combination-therapy-including-anti-pd-1-immunotherapy-in-mss-rectal-cancer-with-resectable-distal-metastasis-100466872","NCT05359393","A Combination Therapy Including Anti-PD-1 Immunotherapy in MSS Rectal Cancer With Resectable Distal Metastasis","Radiotherapy Followed by Chemotherapy and Anti-PD-1 Immunotherapy in MSS Rectal Cancer With Resectable Liver\u002F Pulmonary Metastasis(Miracle-1): A Prospective, Single Arm, Multi-Center, Phase II Clinical Trial","Miracle-1","Inclusion Criteria:\n\n* Age 18\\~75;\n* Patient signs informed consent;\n* ECOG score 0\\~1;\n* Initial colonoscopy and pathology: adenocarcinoma;\n* MRI: rectal cancer located less than 10cm from the anus;\n* Imaging confirms that there are measurable metastases in the liver or lung, which are evaluated as NED acceptable by MDT discussion;\n* no previous treatment;\n* Patients have adequate organ function;\n* No contraindications to surgery or chemoradiation;\n* The relevant test results within 7 days before the first dose must meet the following requirements:\n\n  1. Blood routine examination (no blood transfusion within 7 days before screening, no correction with hematopoietic stimulating factor drugs):\n\n     * Hb≥90g\u002FL\n     * ANC≥1.5×10\\^9\u002FL; LC≥0.5×10\\^9\u002FL;\n     * PLT≥100×10\\^9\u002FL;\n     * WBC≥3.0×10\\^9\u002FL, ≤15×10\\^9\u002FL;\n  2. Blood chemistry (no blood transfusion or albumin within 7 days prior to screening):\n\n     * ALT, AST≤1.5 ULN;\n     * ALP≤2.5 ULN;\n     * TBIL≤1.5 ULN;\n     * Cr≤1.5 ULN, CrCL≥50 mL\u002Fmin;\n     * PT, APTT≤1.5 ULN, INR≤1.5 ULN(not receiving anticoagulation);\n  3. TSH is within the normal range; if TSH is out of the normal range, FT3 and FT4 should be investigated. If the test results of FT3\u002FFT4 cannot be obtained, T3 and T4 can be accepted. If the level of T3\u002FT4 is normal, the patients can be selected.\n  4. Urine test: urine protein\\\u003C2+; if the urine protein≥2+, the 24-hour urine protein quantification must be≤1g;\n  5. Echocardiography: LVEF≥55%;\n  6. 12-lead ECG: Fridericia corrected QTcF\\\u003C470 msec.\n* Expected survival time \\>6 months;\n* The gene status of KRAS, NRAS, BRAF and HER2 is clear;\n* Patients with microsatellite stability or mismatch repair protein defects;\n* Patients are willing and able to follow the protocol during the study, including receiving treatment and scheduled follow-up and examination.\n\nExclusion Criteria:\n\nPatients will not be accepted into this study if they meet any of the following criteria:\n\n1\\. History of tumor-related disease and treatment:\n\n1. Age \\\u003C18 or \\>75 years;\n2. other malignancy within 5 years, except adequately treated carcinoma in situ of the cervix or squamous cell carcinoma of the skin, or largely controlled basal cell carcinoma of the skin;\n3. malignant pleural effusion or malignant ascites;\n4. patients with severe medical comorbidities that preclude radiotherapy and surgery;\n5. previously treated;\n6. clinical or radiological evidence of spinal cord compression or a tumor within 3mm of the spinal cord on MRI\n7. the presence of distant metastases besides the liver and lungs, including brain, bone, ovarian, peritoneal and retroperitoneal multiple lymph node metastases;\n8. Patients who are considered suitable for using intense systemic treatment to achieve conversion after MDT discussion;\n9. pathological diagnosis of indolent cell carcinoma;\n10. patients with microsatellite instability or dMMR;\n11. patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc. that require emergency surgical resection;\n\n2\\. Co-morbidities and treatment history:\n\n1. Presence of immunodeficiency disorders, including primary immunodeficiency disorders (e.g. caused by genetic factors) or secondary immunodeficiency disorders (e.g. caused by HIV infection or treatment related to immunological agents, etc.);\n2. Presence of any autoimmune disease that still requires treatment or a previous history of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, rheumatic heart valve disease, glomerulonephritis, etc. Excluding hypothyroidism due to autoimmune thyroiditis requiring only hormone replacement therapy and type I diabetes with manageable and stable blood glucose;\n3. known or suspected interstitial pneumonia; other moderate to severe lung disease that may interfere with the detection or management of drug-related pulmonary toxicity and severely affect respiratory function, including idiopathic pulmonary tissue fibrosis, mechanized pneumonia\u002Focclusive fine bronchitis, etc.;\n4. severe cardiovascular disease, including but not limited to conditions meeting NYHA criteria (Class III or higher), or myocardial infarction or cerebrovascular accident (cerebral ischaemia, symptomatic cerebral infarction, etc.) occurring within 3 months prior to the first dose, or unstable arrhythmia or unstable angina pectoris with coronary artery disease occurring within 1 month prior to the first dose, or congestive heart failure, or pre-existing symptomatic superior vena cava syndrome, etc.;\n5. an arteriovenous thrombotic event, such as deep vein thrombosis and pulmonary embolism, within the previous 3 months;\n6. history of live attenuated vaccination within 28 days prior to the first study dose or anticipated need for live attenuated vaccination during the study;\n7. active hepatitis B (defined as positive hepatitis B virus surface antigen \\[HBsAg\\] test result and HBV-DNA test value ≥ 500 IU\u002Fml);\n8. Hepatitis C (defined as a positive test result for hepatitis C virus antibody \\[HCV-Ab\\]) ;\n9. history of tuberculosis infection or treatment within 1 year prior to signing informed consent;\n10. presence of severe infection within 4 weeks prior to first dose, including but not limited to bacteremia requiring hospitalization, severe pneumonia, etc.; or active infection requiring systemic antibiotic therapy according to NCI-CTCAE v5.0 grade ≥ 2 within 2 weeks prior to first dose, or unexplained fever \\>38.5°C during screening\u002Fprior to first dose (at the investigator's discretion, due to oncologic causes fever due to tumor causes may be enrolled);\n11. previous allogeneic bone marrow transplantation or solid organ transplantation received or intended to be received;\n12. Hemoptysis with a maximum daily hemoptysis of approximately ≥2.5 ml within 2 months prior to signing informed consent; clinically significant bleeding symptoms or a clear bleeding tendency within 1 month prior to signing informed consent, e.g. gastrointestinal bleeding, bleeding gastric ulcer, fecal occult blood ++ at baseline, vasculitis; known hereditary or acquired bleeding and thrombotic tendencies, e.g. hemophilia, impaired coagulation skills, thrombocytopenia, hypersplenism, etc.;\n13. abnormal coagulation (INR \\> 1.5 or APTT \\> 1.5 × ULN) with bleeding tendency or undergoing thrombolysis or requiring long-term anticoagulation with warfarin or heparin, or requiring long-term antiplatelet therapy (aspirin ≥ 300 mg\u002Fday or clopidogrel ≥ 75 mg\u002Fday)\n14. peripheral neuropathy ≥ grade 2 according to NCI-CTCAE v5.0;\n15. Co-morbidities of other infectious diseases that are not suitable for participation in this study.",{"count":97,"type":21},52,[24],"Although patients with locally advanced rectal cancer and resectable liver\u002Fpulmonary metastasis could benefit from surgery resection, these patients still have a poorer prognosis compared to those without distal metastasis. Based on previous studies, there is no confirmation of whether these patients could benefit from preoperative immunotherapy combined with conventional chemoradiotherapy. This study proposes a combination therapy, preoperative short-course radiotherapy followed by neoadjuvant chemotherapy and anti-PD-1 immunotherapy, for microsatellite-stable patients with locally advanced rectal cancer and resectable liver\u002Fpulmonary metastasis, to assess its impact on tumor retreat, decline of postoperative metastasis and recurrence, and the disease-free survival and overall survival of patients. Besides, this study will provide high-level medical evidence for future clinical treatment of patients with advanced rectal cancer.",[27,101,102,103],"Liver Metastasis","Pulmonary Metastasis","Microsatellite Stable Colorectal Carcinoma","2022-11-09",{"date":106,"type":32},"2022-11-14",{"date":108,"type":21},"2022-12-01",{"date":110,"type":21},"2027-09-01",{"name":112,"class":39},"Fudan University"]