[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"capecitabine\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:capecitabine":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,46,76,106,141,167,195,218],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100636301","total-neoadjuvant-therapy-with-additional-consolidation-chemotherapy-followed-by-local-excision-versus-total-neoadjuvant-therapy-followed-by-local-excision-at-stage-i-rectal-cancer-100636301",false,"NCT07563907","Total Neoadjuvant Therapy With Additional Consolidation Chemotherapy Followed by Local Excision Versus Total Neoadjuvant Therapy Followed by Local Excision at Stage I Rectal Cancer","Safety and Efficacy of Organ Preservation Treatment for Stage I Rectal Cancer: Optimization of Consolidation Chemotherapy Before Local Excision After Neoadjuvant Chemoradiotherapy (OPTION); A Multi-center, Prospective, Randomized Trial","OPTION","Inclusion Criteria:\n\n* Histologically confirmed rectall adenocarcinoma\n* Low rectal cancer (AV \\\u003C 15cm)\n* cT2N0 disease, or pathologic stage T1N0 disease after endoscopic resection with at least one high-risk feature, including: Positive resection margin Lymphovascular invasion Tumor budding ≥5\n* Ability to understand and comply with the requirements of the clinical trial\n\nExclusion Criteria:\n\n* Patients who prefer radical rectal resection\n* Prior history of surgery for rectal cancer\n* Recurrent rectal cancer\n* Synchronous metastatic rectal cancer\n* Evidence of lymph node metastasis or distant metastasis on abdominopelvic CT or chest CT, including para-aortic, common iliac, or external iliac lymph node metastasis\n* Uncontrolled active infection or other uncontrolled medical condition\n* Known hypersensitivity to chemotherapy\n* Patients considered unsuitable for participation in the clinical trial by the principal investigator or study personnel","ALL","19 Years","79 Years",{"count":21,"type":22},292,"ESTIMATED","INTERVENTIONAL",[25],"NA","Safety and Efficacy of Organ Preservation Treatment for Stage I Rectal Cancer: Optimization of Consolidation Chemotherapy Before Local Excision After Neoadjuvant Chemoradiotherapy (OPTION); A Multi-center, Prospective, Randomized Trial\n\nThe goal of this clinical trial is to find out if adding consolidation chemotherapy with capecitabine after total neoadjuvant chemoradiotherapy (TNT) works to improve oncologic outcomes in patients with stage I rectal cancer. It will also comparethe safety of adding consolidation chemotherapy before local excision.\n\nThe main questions it aims to answer are:\n\n* Does adding consolidation chemotherapy increase the rate of pathologic complete response?\n* What medical problems or side effects do participants have during and after treatment?\n\nResearchers will compare TNT followed by local excision to TNT followed by consolidation chemotherapy with capecitabine and then local excision to see if adding consolidation chemotherapy improves tumor response and treatment outcomes.\n\nParticipants will:\n\n* Receive TNT for stage I rectal cancer\n* Be randomly assigned to one of two treatment groups\n* Undergo local excision after preoperative treatment\n* Visit the clinic for checkups and tests to evaluate tumor response, side effects, recurrence, survival, quality of life, bowel function, urinary function, sexual function, circulating tumor DNA, and treatment-related costs",[28,29,30,31,32],"Organ Preservation","Rectal Cancer Stage I","Total Neoadjuvant Treatment","Consolidation Therapy","Capecitabine","NOT_YET_RECRUITING","2026-04-26",{"date":36,"type":37},"2026-05-04","ACTUAL",{"date":39,"type":22},"2026-06-01",{"date":41,"type":22},"2035-12-31",{"name":43,"class":44},"Seoul National University Hospital","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":45},"100480394","phase-1-utd1-combined-with-capecitabine-in-metastatic-her2-negative-breast-cancer-patients-with-brain-metastases-100480394","NCT05535413","UTD1 Combined With Capecitabine in Metastatic HER2-negative Breast Cancer Patients With Brain Metastases","A Single-arm, Multicenter, Open-labeled Clinical Study of UTD1 Combined With Capecitabine in Metastatic HER2-negative Breast Cancer Patients With Brain Metastases","Inclusion Criteria:\n\n* Patients aged 18 to 70 years\n* With histologically confirmed HER2 negative recurrent and metastatic breast cancer\n* have at least one measurable lesion in the central nervous system (the longest diameter ≥ 10mm)\n* ECOG score (PS) of 0-2\n* According to screening brain MRI, patients with CNS must meet the following conditions:\n\n  1. untreated brain metastases of breast cancer;\n  2. do not need immediate local treatment;\n  3. brain metastases of breast cancer which was treated in the past:\n\n     1. There are no clinical manifestations that have progressed after the previous local treatment of the central nervous system and require immediate local treatment.\n     2. All records related to the treatment of the central nervous system must be provided.\n     3. All toxicities related to the previous anti-tumor treatment of patients who have not received chemotherapy, radiotherapy, surgical treatment, targeted therapy and immunotherapy within 4 weeks before enrollment must be restored to ≤ level 1 (CTCAE v50). However, patients with hair loss of any grade are allowed to be recruited.\n* Blood routine examination was basically normal within 1 week before enrollment.\n* White blood cell count (WBC) ≥ 30 × 109 \u002FL\n* Neutrophil counts (ANC) ≥ 15 × 109\u002FL\n* Platelet count (PLT) ≥ 100 × 109 \u002FL\n* Hemoglobin ≥ 90g\u002Fdl. Patients can receive blood transfusion or erythropoietin treatment to meet this standard.\n* Within 1 week before enrollment, the liver and kidney function tests were basically normal (based on the normal value of the laboratory of each research center).\n* Total bilirubin ≤ 15 × Upper limit of normal value (ULN)\n* Alanine aminotransferase (SGPT \u002F ALT) ≤ 25 x ULN (patients with liver metastasis ≤ 5 × ULN)\n* Glutamic oxaloacetic transaminase (SGOT\u002FAST) ≤ 25 × ULN (patients with liver metastasis ≤ 5 × ULN)\n* Creatinine clearance rate (Ccr) ≥ 60ml\u002Fmin patients\n* With fertility must agree to use effective contraceptive methods during the study period and within 90 days of the last study medication. Before enrollment, the blood or urine pregnancy test must be negative and the\n* Life expectancy \\> 12 weeks.\n* The patient must be able to participate in and follow the treatment and follow-up.\n\nExclusion Criteria:\n\n* Primary or metastatic lesions were HER2 positive (HER2 IHC or FISH positive)\n* Other malignant carcinomas (including primary brain or leptomeningeal related tumors) in the past 5 years, except for the cured basal cell carcinoma of the skin and carcinoma in situ of the cervix.\n* Anti tumor treatment, including chemotherapeutic radical radiotherapy, hormone therapy, biological therapy Immunotherapy or anti-tumor traditional Chinese medicine.\n* Patients who have received surgical operation on major organs (excluding puncture biopsy) or have suffered significant trauma within 4 weeks before the first use of the study drug, or who need to undergo elective surgery during the trial.\n* Patients with symptomatic peripheral neuropathy with grade evaluation ≥ 2 (CTCAE 5.0), who have previously used anti-microtubule drugs and have serious adverse reactions related to the nervous system of grade 3 or above.\n* Use capecitabine within 6 months before enrollment; No response to capecitabine in the past (including progression during capecitabine treatment, or duration of clinical response after treatment \\\u003C 3 months) or unable to tolerate to capecitabine.\n* For any brain lesions requiring immediate local treatment, such as increased lesion size or treatment-related edema at intracranial (but not limited to) anatomical sites may pose risks to patients (e.g., brainstem lesions)\n* Known or suspected leptomeningeal disease (LMD)\n* Other non malignant systemic diseases (cardiovascular, renal, liver, etc.) that are excluded from any treatment regimen or interfere with follow-up in pregnant or lactating women.\n* Known or suspected allergy to any study drug or accessories.\n* Brain MRI can not be performed for any other reason.\n* The investigator considers it inappropriate to participate in.\n* Other situations where corticosteroids are prohibited.","FEMALE","18 Years","70 Years",{"count":57,"type":22},30,[59,60],"PHASE1","PHASE2","This study is a single-arm, multicenter, open-labeled clinical study of UTD1 combined with Capecitabine in metastatic HER2-negative breast cancaner patients with brain metastases. This study aims to evaluate the efficacy and safety of UDT1 combined with capecitabine in metastatic HER2-negative breast cancer patients with brain metastases.",[63,64,32,65],"Metastatic HER2 Negative Breast Carcinoma","Brain Metastases","UDT1","RECRUITING","2025-04-23",{"date":69,"type":37},"2025-04-25",{"date":71,"type":37},"2023-01-01",{"date":73,"type":22},"2025-07",{"name":75,"class":44},"Hunan Cancer Hospital",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":23,"phases":84,"briefSummary":85,"conditions":86,"keywords":94,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":45},"100547247","phase-2-naliri-xeloxak104-for-first-line-treatment-of-advanced-pdac-100547247","NCT06405490","NALIRI-XELOX+AK104 for First-line Treatment of Advanced PDAC","Nanoliposomal Irinotecan and XELOX (NALIRI-XELOX) in Combination With Cadonilimab for First-Line Treatment of Patients With Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma : A Single-arm, Phase II Study","Inclusion Criteria:\n\n1. Age ≥18, male or female;\n2. Has histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC);\n3. Has not received prior systemic treatment for their locally advanced or metastatic PDAC;\n4. Has presence of measurable disease as defined by Response Evaluation Criteria in Solid Tumours (RECIST 1.1);\n5. Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status;\n6. Has a life expectancy of at least 3 months;\n7. Has adequate organ function;\n8. If female of childbearing potential, have a negative serum pregnancy test within 7 days prior to first trial treatment;\n9. If female of childbearing potential or a male subject with a partner with childbearing potential, be willing to use a highly effective method of contraception (with a failure rate of less than 1.0% per year) from first study treatment to 24 weeks after completion of the trial treatment.\n\nExclusion Criteria:\n\n1. Untreated active CNS metastasis or leptomeningeal metastasis.\n2. Is currently participating and receiving an investigational drug or has participated in a study of an investigational drug within 4 weeks or within 5 times of half-life (no less than 2 weeks), whichever is shorter prior to the first dose of trial treatment;\n3. Has received other anti-tumor treatment within 4 weeks or within 5 times of half-life (no less than 2 weeks), whichever is shorter prior to the first trial treatment;\n4. Major surgery for any reason, except diagnostic biopsy, within 4 weeks of the first administration of trial treatment and\u002For if the subject has not fully recovered from the surgery within 4 weeks of the first administration of trial treatment;\n5. Curative radiation within 3 months of the first dose of trial treatment. Radiation to more than 30% of the bone marrow or with a wide field of radiation should not be used within 4 weeks prior to the first administration of trial treatment;\n6. Subjects receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs before initiation of trial treatment (with the exception of subjects with adrenal insufficiency, who may continue corticosteroids at physiologic replacement doses, equivalent to \\\u003C 10 mg prednisone daily, inhaled steroids and topical use of steroids);\n7. Vaccination within 28 days of the first administration of trial treatment, except for administration of inactivated vaccines (e.g., inactivated influenza vaccines);\n8. Has interstitial lung disease, or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management;\n9. History or current active autoimmune disease that might deteriorate when receiving an immunostimulatory agent；\n10. Previous malignant disease History of uncontrolled intercurrent illness Prior therapy with any antibody\u002Fdrug targeting T cell coregulatory proteins Known severe hypersensitivity reactions to antibody drug；\n11. Is pregnant or breastfeeding;\n12. Other medical conditions that at the discretion of investigator interfere with the requirements of the trial in terms of safety or efficacy evaluation, or treatment compliance.",{"count":57,"type":22},[60],"This study is a single-center, Phase II Study to assess the efficacy and safety of the regimen of Nanoliposomal Irinotecan and XELOX (NALIRI-XELOX) in combination with Cadonilimab in subjects with advanced pancreatic ductal adenocarcinoma who have not previously received systemic treatment.",[87,88,89,32,90,91,92,93],"Nanoliposomal Irinotecan","Cadonilimab","Oxaliplatin","First-Line","Advanced Cancer","Pancreatic Adenocarcinoma","Drug Use",[92,87,88,95,96],"First-Line Treatment","Advanced Pancreatic Adenocarcinoma","2024-12-19",{"date":99,"type":37},"2024-12-24",{"date":101,"type":37},"2024-04-17",{"date":103,"type":22},"2026-12-30",{"name":105,"class":44},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences",{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":113,"sex":17,"minAge":54,"maxAge":114,"enrollmentInfo":115,"targetDuration":4,"studyType":23,"phases":117,"briefSummary":118,"conditions":119,"keywords":125,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":45},"100562361","electroacupuncture-combined-with-self-administered-acupressure-for-the-prevention-of-capecitabine-associated-hand-foot-syndrome-100562361","NCT06602167","Electroacupuncture Combined With Self-administered Acupressure for the Prevention of Capecitabine-Associated Hand-Foot Syndrome","Electroacupuncture Combined With Self-administered Acupressure for the Prevention of Capecitabine-Associated Hand-Foot Syndrome: a Randomized Controlled Trial","Inclusion Criteria:\n\n1. Sign a written informed consent form;\n2. Male or female ≥ 18 years old;\n3. Patients with gastrointestinal cancer or breast cancer who are diagnosed with cancer by pathology will receive capecitabine treatment for the first time according to the label;\n4. The performance status of the Eastern Cancer Collaboration Group is 0-2;\n5. Palliative or adjuvant chemotherapy with capecitabine (combination or monotherapy, minimum daily total dose of capecitabine 2000 mg\u002Fm\\^2);\n6. Expected lifespan ≥ 3 months;\n7. Laboratory requirements: platelet count ≥ 100 × 10\\^9\u002FL, white blood cell count\\>3.0 × 10\\^9\u002FL, hemoglobin ≥ 10.0 g\u002FdL, normal liver and kidney function;\n8. Adequate contraception.\n\nExclusion Criteria:\n\n1. Previous use of capecitabine or liposome doxorubicin or any other tyrosine kinase inhibitor that may induce HFS (such as sorafenib, sunitinib, and apatinib) for chemotherapy;\n2. The initial dose of capecitabine is less than 800mg\u002Fm\\^2;\n3. Radiation therapy or surgery should be performed within 4 weeks before the start of treatment;\n4. Skin diseases that may interfere with clinical trial results;\n5. Known drug\u002Falcohol abuse;\n6. Pregnant women or lactating patients;\n7. Participate in another clinical trial and the patient has received the investigational drug within the last 30 days prior to the start of treatment (i.e. follow-up in the previous trial was not exclusive);\n8. Known patients who are afraid of electroacupuncture stimulation or allergic to stainless steel needles or any component of capecitabine;\n9. Receive any acupuncture and moxibustion treatment ,there is lymphedema in the area stimulated by acupuncture;\n10. Patients with any chemotherapy- or radiotherapy-related toxicities that have not subsided to grade 2 or lower will be excluded, except for stable sensory neuropathy.\n11. Any unresolved skin toxicity caused by previous chemotherapy or radiotherapy, except for hair loss, will also be grounds for exclusion.",true,"85 Years",{"count":116,"type":22},220,[25],"This study hypothesizes that electroacupuncture combined with self-administered acupressure plus doctor-prescribed treatment is effective in preventing Hand-Foot Syndrome (HFS) caused by capecitabine. It aims to explore the effectiveness of this combined approach in preventing HFS in patients with malignant tumors undergoing oral capecitabine treatment. Further exploration of prevention and treatment methods may enhance the quality of life for patients during the treatment process.",[32,120,121,122,123,124],"Hand-foot Syndrome","Electroacupuncture","Self-administered Acupressure","Breast Cancer","Gastrointestinal Cancers",[126,127,128,129,130,131],"electroacupuncture","capecitabine","self-administered acupressure","Hand-foot syndrome","Breast cancer","Gastrointestinal cancers","2024-12-09",{"date":134,"type":37},"2024-12-12",{"date":136,"type":37},"2024-10-08",{"date":138,"type":22},"2027-12-31",{"name":140,"class":44},"Affiliated Hospital of Qinghai University",{"id":142,"slug":143,"hasResults":11,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":147,"eligibilityCriteria":148,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":149,"targetDuration":4,"studyType":23,"phases":151,"briefSummary":153,"conditions":154,"keywords":157,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":45},"100563445","phase-3-first-line-treatment-of-mcapox--cetuximab-vs-mfolfox6--cetuximab-for-rasbraf-wild-type-mss-unresectable-left-sided-mcrc-a-multicenter-randomized-controlled-phase-iii-study-100563445","NCT06616259","First-line Treatment of MCapOX + Cetuximab Vs. MFOLFOX6 + Cetuximab for RAS\u002FBRAF Wild-type, MSS, Unresectable Left-Sided MCRC: a Multicenter, Randomized, Controlled, Phase III Study","First-line Treatment of MCapOX in Combination with Cetuximab Versus MFOLFOX6 in Combination with Cetuximab for RAS\u002FBRAF Wild-type, MSS, Unresectable Left-Sided Metastatic Colorectal Cancer: a Multicenter, Randomized, Controlled, Phase III Study","CAPCET-III","Inclusion Criteria:\n\n* Able to provide written informed consent and can understand and comply with the requirements of the study.\n* Men and women ≥ 18 years of age.\n* Patients with histologically or cytologically confirmed RAS and BRAF wild-type, MSS\u002FpMMR, metastatic left-sided colorectal adenocarcinoma.\n* Presence of at least one evaluable lesion, as defined in RECIST Version 1.1.\n* With an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* No palliative first-line chemotherapy, targeted, immunotherapy, or prior platinum-based adjuvant chemotherapy, relapse more than 12 months from the end of adjuvant chemotherapy.\n* According to the imaging findings and surgical assessment of initial unresectable, synchronous metastatic colorectal cancer, no serious complications of the primary tumor (obstruction, perforation, massive hemorrhage that cannot be treated in internal medicine, etc.) .\n* Requirements for lab indicators: neutrophils ≥ 1.5 × 10\\^9\u002FL, platelets ≥ 75 × 10\\^9\u002FL, hemoglobin ≥ 8 g\u002FdL; total bilirubin ≤ 1.5 × upper limit of normal (UNL); ASAT (SGOT) and\u002For ALAT (SGPT) ≤ 2.5 × UNL (≤ 5 × UNL if liver metastases); alkaline phosphatase ≤ 2.5 × UNL (≤ 5 × UNL if liver metastases, ≤ 10 × UNL if bone metastases); LDH \\< 1500 U\u002FL; creatinine clearance (calculated according to Cockcroft and Gault formula) \\> 50 mL\u002Fmin or serum creatinine ≤ 1.5 × UNL.\n\nExclusion Criteria:\n\n* Patients with mCRC who were initially resectable with R0 resection or radiofrequency or SBRT were excluded.\n* Patients diagnosed with MSI-H or dMMR by PCR or immunohistochemistry\n* Hypersensitivity to any therapeutic agent.\n* Patients who received adjuvant chemotherapy containing oxaliplatin and fluorouracil within 12 months before entering the study.\n* Patients who have failed one or more palliative chemotherapy regimens.\n* Patients with uncontrolled hepatitis B virus.\n* Peripheral neuropathy ≥ CTC grade 2.\n* Neurological or psychiatric disorders affecting cognitive performance.\n* Patients with central nervous system metastasis could not be controlled with radiotherapy.\n* Previous enteritis, chronic diarrhea, or recurrent bowel obstruction; uncontrolled bleeding from internal medicine; bowel perforation.\n* Uncontrolled concomitant diseases within 6 months before the study, including unstable angina, acute myocardial infarction, cerebrovascular accident, etc.\n* Pregnant or lactating patients, or those of childbearing potential who do not take adequate contraceptive measures.\n* History of other malignancies, but no disease-free survival longer than 5 years.\n* Patients concurrently receiving other anti-tumor treatment or participating in other interventional clinical trials.\n* Patients who are unable to comply with this study for psychological, family or social reasons.\n* Patients with other serious diseases that the investigator considers not suitable.",{"count":150,"type":22},452,[152],"PHASE3","This multicenter, randomized, controlled, phase III study is conducted to evaluate the efficacy and safety of first line mCapOX plus Cetuximab versus mFOLFOX6 plus Cetuximab for RAS\u002FBRAF wild-type, MSS, Unresectable Left-Sided mCRC.",[155,32,156],"Colorectal Cancer (CRC)","Cetuximab",[147],"2024-09-24",{"date":160,"type":37},"2024-09-27",{"date":162,"type":22},"2024-09-26",{"date":164,"type":22},"2029-09-30",{"name":166,"class":44},"Meng Qiu",{"id":168,"slug":169,"hasResults":11,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":4,"eligibilityCriteria":173,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":174,"targetDuration":4,"studyType":23,"phases":176,"briefSummary":177,"conditions":178,"keywords":184,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":45},"100513809","phase-2-xelox-bev-tislelizumab-for-first-line-treatment-of-msspmmr-ras-mutated-mcrc-100513809","NCT05970302","XELOX +Bev +Tislelizumab for First-line Treatment of MSS\u002FpMMR RAS-mutated mCRC","XELOX and Bevacizumab in Combination With Tislelizumab for First-Line Treatment of Patients With MSS\u002FpMMR RAS-mutated Metastatic Colorectal Cancer (mCRC): A Single-arm, Phase II Study.","Inclusion Criteria:\n\n1. Histologically confirmed initially unresectable MSS\u002FpMMR-type RAS-mutant metastatic colorectal adenocarcinoma;\n2. ECOG score of 0 or 1;\n3. Ability to swallow oral medications;\n4. Have at least one measurable lesion (according to RECIST v1.1 standard);\n5. No anti-tumor treatment has been received after recurrence and metastasis;\n6. Neoadjuvant or adjuvant chemotherapy containing fluorouracil drugs is allowed before or after radical resection of colorectal cancer, but the treatment needs to be completed for ≥ 6 months; if oxaliplatin is used in neoadjuvant or adjuvant chemotherapy, it includes The oxaliplatin regimen needs to be completed for ≥12 months;\n7. Adequate organ function: On the premise of no component blood transfusion within 14 days: white blood cells ≥ 3.5\\*10\\^9\u002FL and neutrophils ≥ 1.5\\*10\\^9\u002FL, hemoglobin ≥ 90g\u002FL, platelets ≥ 100\\* 10\\^9\u002FL; serum bilirubin ≤ 1.5 times the normal value, alanine aminotransferase (ALT) ≤ 2.5 times the normal value, aspartate aminotransferase (AST) ≤ 2.5 times the normal value; Urinary protein \\\u003C2+. Or urine protein 2+ but 24-hour urine protein quantity ≤ 1 g; serum creatinine ≤ 1.5 times of normal value, creatinine clearance rate ≥ 60ml\u002Fmin; Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) ≥ lower limit of normal value (50%);\n8. Expected survival period ≥ 3 months;\n9. Patients fully understand this research, voluntarily participate in this clinical trial and sign an informed consent;\n10. Women with reproductive potential (\\\u003C 2 years after the last menstrual period) and men use effective contraceptive methods until half a year after the last treatment.\n\nExclusion Criteria:\n\n1. Previously received bevacizumab or anti-CTLA4, anti-PD-1\u002FPD-L1 therapeutic antibodies or pathway-targeted drugs;\n2. Received radiotherapy within 4 weeks before the evaluation;\n3. Symptomatic peripheral neuropathy \\> grade 2 (CTCAE5.0 standard);\n4. Received live vaccine or systemic immune stimulant (including but not limited to interferon or interleukin 2) within 1 month;\n5. HIV-positive and other immunodeficiency diseases;\n6. Active hepatitis B or hepatitis C (except for those who have been infected or cured before, that is, HBsAg negative and hepatitis B core antigen anti-HBc antibody positive; except for hepatitis C patients whose HCV RNA is negative by PCR);\n7. Existing autoimmune diseases or other diseases that require immunosuppressant treatment, except for type 1 diabetes; except for hypothyroidism that only requires hormone replacement therapy; skin diseases that do not require systemic treatment (such as vitiligo, psoriasis, alopecia areata); inhaled or topical steroids or equivalent steroids in excess of 10 mg prednisone per day, except for inactive autoimmune disease on adrenal replacement therapy;\n8. Received systemic hormone therapy or treatment with a daily dose of more than 10 mg prednisone equivalent dose or other forms of immunosuppressive treatment within 7 days, but inhaled or topical steroids or daily application of more than 10 mg prednisone, etc. Except for inactive autoimmune diseases treated with adrenal replacement therapy with potent steroids;\n9. Have a history of organ transplantation;\n10. Uncontrolled central nervous system (CNC) metastasis (symptomatic or metastatic sites are midbrain, pons, medulla or spinal cord) or other central nervous system diseases;\n11. Those who have undergone major surgery, open biopsy or obvious traumatic trauma within 1 month, or who may need major surgery during the study period; those who have undergone open biopsy or obvious traumatic trauma, or may need major surgery during the study period;\n12. Combined with other malignant tumors other than intestinal cancer (except cured basal cell carcinoma or squamous cell carcinoma of the skin and carcinoma in situ of the cervix; the treatment of other malignant tumors has been completed for more than 1 year, and there is no clinical and imaging evidence of recurrence or progression except);\n13. Combined active and refractory infection;\n14. Cardiovascular diseases with clinical significance, such as cardiovascular accident (CVA) (≤ 6 months before treatment), myocardial infarction (≤ 6 months before treatment), unstable angina, chronic heart failure of NYHA ≥ 2 (CHF), uncontrolled arrhythmia; uncontrolled hypertension; thromboembolic or bleeding events within 6 months before treatment;\n15. Evidence of causing coagulation disease;\n16. With dysphagia, active peptic ulcer, complete or incomplete intestinal obstruction, active gastrointestinal bleeding, perforation, malabsorption syndrome or uncontrollable gastrointestinal inflammatory disease (such as Crohn's disease or ulcerative colon inflammation);\n17. Severe unhealed wounds\u002Fulcers or severe fractures;\n18. Any serious acute or chronic medical condition that may affect the patient's participation in the study or interfere with the interpretation of the study results;\n19. There are mental illnesses, serious social and psychological illnesses, or researchers believe that there are factors that may affect research compliance;\n20. Pregnant or lactating women;\n21. No therapeutic anticoagulant or antiplatelet drugs or NSAIDs (aspirin ≤ 325 mg\u002Fday allowed);\n22. Severe allergic reaction to the test drug;\n23. Reluctance to use alternative therapies such as (but not limited to) bisphosphonates if receiving RANKL inhibitors (eg, denosumab).",{"count":175,"type":22},52,[60],"The goal of this clinical trial is to compare XELOX +Bev +Tislelizumab with standard chemotherapy，in MSS\u002FpMMR-type RAS-mutated metastatic colorectal adenocarcinoma. The main questions it aims to answer are efficacy and safety of the regimen of XELOX +Bev +Tislelizumab. The investigators want to transform ras-mutated colorectal cancer into a \"hot tumor\" through the combination of anti-vascular therapy and chemotherapy, and then achieve better therapeutic effect through the combination with immunotherapy. Participants will receive the regimen of XELOX +Bev +Tislelizumab.",[179,180,89,32,181,182,183,90],"Tislelizumab","Bevacizumab","MSS\u002FpMMR","Metastatic Colorectal Cancer (mCRC)","RAS-mutated",[185,186],"Single-arm","Phase II","2023-07-21",{"date":189,"type":37},"2023-08-01",{"date":191,"type":37},"2023-07-07",{"date":193,"type":22},"2026-07",{"name":105,"class":44},{"id":196,"slug":197,"hasResults":11,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":4,"eligibilityCriteria":201,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":202,"enrollmentInfo":203,"targetDuration":4,"studyType":23,"phases":205,"briefSummary":206,"conditions":207,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":4},"100503889","phase-2-tislelizumab-combined-with-chemotherapy-capox-in-the-perioperative-treatment-of-msi-hdmmr-stage-ii-or-iii-colorectal-cancer-100503889","NCT05841134","Tislelizumab Combined With Chemotherapy (CAPOX) in the Perioperative Treatment of MSI-H\u002FdMMR Stage II or III Colorectal Cancer","Multicenter, Single-arm, Open-label Phase II Clinical Study of Tislelizumab Combined With Chemotherapy (CAPOX) in the Perioperative Treatment of MSI-H\u002FdMMR Stage II or III Colorectal Cancer","Inclusion Criteria:\n\n1. ECOG: 0\\~1;\n2. Patients with colon or rectal adenocarcinoma confirmed by histology or cytology;\n3. The tissue specimens are confirmed as MSI-H by PCR or NGS. If the patients are dMMR by immunohistochemistry, they need to be confirmed as MSI-H by PCR (2021 Expert Consensus on Immunotherapy for Patients with Colorectal Cancer);\n4. Patients with clinical stage II or III (cT3-T4 N0 M0 or Tany N+M0, clinically positive lymph nodes are defined as any lymph node ≥ 1.0 cm);\n5. Expected survival period ≥ 12 weeks;\n6. The subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with follow-up visits.\n\nExclusion Criteria:\n\n1. Have received anti-tumor therapy;\n2. Have received PD-(L)1 or CTLA-4 treatment;\n3. The patient has any active autoimmune disease or has a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis , hyperthyroidism; patients with vitiligo; asthma that has been completely remitted in childhood and does not require any intervention in adulthood can be included; patients with asthma requiring medical intervention with bronchodilators cannot be included);\n4. Patients are using immunosuppressants or systemic hormone therapy to achieve the purpose of immunosuppression (dose\\>10mg\u002Fday prednisone or other equivalent hormones), and continue to use within 2 weeks before enrollment;\n5. Patients with any severe and\u002For uncontrolled diseases\n6. Urine routine prompts urine protein ≥ ++, and confirmed 24-hour urine protein quantity \\> 1.0g;\n7. Pregnant or lactating women;\n8. Patients with other malignant tumors within 5 years (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);\n9. Those who have a history of psychotropic drug abuse and cannot quit or patients with mental disorders;","75 Years",{"count":204,"type":22},25,[60],"This study is a multi-center, single-arm, open-label phase II clinical trial, aiming to observe and evaluate the perioperative treatment of tislelizumab combined with chemotherapy (CAPOX) in stage II or III colorectal cancer with MSI-H\u002FdMMR Patient efficacy and safety.",[208,179,89,32],"MSI-H Colorectal Cancer","2023-05-05",{"date":211,"type":37},"2023-05-09",{"date":213,"type":22},"2023-06-01",{"date":215,"type":22},"2027-01-31",{"name":217,"class":44},"The First Affiliated Hospital of Zhengzhou University",{"id":219,"slug":220,"hasResults":11,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":4,"eligibilityCriteria":224,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":55,"enrollmentInfo":225,"targetDuration":4,"studyType":23,"phases":227,"briefSummary":228,"conditions":229,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":45},"100461556","phase-2-radiotherapy-combined-with-pd-1-monoclonal-antibody-and-capecitabine-in-the-treatment-of-nasopharyngeal-carcinoma-100461556","NCT05290194","Radiotherapy Combined With PD-1 Monoclonal Antibody and Capecitabine in the Treatment of Nasopharyngeal Carcinoma","Multi-target Radiotherapy Combined With PD-1 Monoclonal Antibody and Capecitabine Maintenance Therapy Treating Oligometastatic Nasopharyngeal Carcinoma: a Single-arm, Multicenter, Prospective, Open-label Phase II Clinical Trial","Inclusion Criteria:\n\n1. The patient was histologically or cytologically diagnosed with nasopharyngeal carcinoma;\n2. The patient was newly diagnosed with metastatic nasopharyngeal carcinoma (AJCC eighth edition), and after 4-6 cycles of gemcitabine plus cisplatin combined with PD-1 monoclonal antibody regimen, the efficacy reached more than stable disease;\n3. Except for the primary tumor and cervical lymph node metastasis, less than 5 distant organ metastases, and were suitable for SBRT radiotherapy;\n4. ECOG PS score 0-2 points;\n5. Aged 18-70 years old;\n6. Major organ function met the following criteria (14 do not allow the use of any blood components and cell growth factor):\n\n   1. Neutrophil ANC ≥ 2.0 × 10\\^9\u002FL; platelet count PLT ≥ 100 × 10\\^9\u002FL; hemoglobin HB ≥ 90 g\u002FL;\n   2. Serum albumin ≥ 28 g\u002FL;\n   3. Alanine aminotransferase ALT, aspartate aminotransferase AST ≤ 2.5 × ULN; if there is liver metastasis, ALT and AST ≤ 5 × ULN;\n   4. Serum creatinine ≤ 1.5 × ULN, Or creatinine clearance ≥ 60 mL\u002Fmin;\n   5. INR ≤ 1.5 × ULN, and APTT ≤ 1.5 × ULN;\n7. Life expectancy ≥ 12 weeks;\n8. The subject who voluntarily joins the study, sign informed consent, and coordinates with follow-up.\n\nExclusion Criteria:\n\n1. Recurrent and metastatic nasopharyngeal carcinoma after initial treatment;\n2. Patients received previous treatment of primary lesion or metastasis except for the standard first-line regimen (gemcitabine plus cisplatin combined with PD-1 monoclonal antibody regimen), including induction chemotherapy, adjuvant chemotherapy, concurrent chemoradiotherapy, surgery and other treatments;\n3. Central nervous system metastastic (confirmed or suspected);\n4. Allergy to PD-1 monoclonal antibody or other PD-1 monoantibody; intolerance or allergy to capecitabine; suffering any disease or extrinsic factors affecting oral drugs;\n5. Uncontrolled cardiac clinical symptoms or diseases, such as: ① heart failure of NYHA Grade II or higher ; ② unstable angina pectoris; ③ suffering myocardial infarction within 1 year; ④ patients with supraventricular or arrhythmia requiring clinical intervention;\n6. Severe infection (CTCAE 5.0 ≥ 2) 4 weeks before the first use of study drugs, such as severe pneumonia, bacteremia, infectious complications requiring hospitalization; baseline chest imaging examination suggests the presence of active pulmonary inflammation; symptoms and signs of infection or the need for oral or intravenous antibiotics (excluding the prophylactic use of antibiotics) 2 weeks before the first use of the study drug;\n7. History of other malignancies within 5 years or at the time,but except for cured cutaneous basal cell carcinoma and cervical carcinoma in situ, breast carcinoma in situ, superficial bladder tumors (Ta, Tis and T1) and papillary thyroid cancer as well as other cancers treated more than 3 years before the start of the study;\n8. Any of the following conditions is met:\n\n   1. Received any investigational drug before the first use of the study drug;\n   2. Participated in another clinical study at the same time, unless it is an observational (non-interventional) clinical study or interventional clinical study at the follow-up time;\n   3. Required systemic treatments with corticosteroids (the dose higher than the equivalent dose of 10 mg prednisone per day) or other immunosuppressive agents 2 weeks before the first use of the study drug, except for local inflammation and prevention of allergy and nausea and vomiting. In the absence of active autoimmune disease, inhaled or topical steroids and adrenocorticotropic hormone replacement at doses greater than 10 mg daily in prednisone efficacy dose are allowed;\n   4. Received anti-tumor vaccines or vaccinated live vaccines 4 weeks before the first dose of study drug;\n   5. Underwent excessive surgery or severe trauma 4 weeks before the first use of study drug;\n9. Patients had active autoimmune diseases and a history of autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases and syndromes) in the past 2 years; patients who did not require any intervention after adulthood are allowed;\n10. History of immunodeficiency, including HIV positive, or other acquired, congenital immunodeficiency diseases, or history of organ transplantation and bone marrow transplantation;\n11. Patients with active pulmonary tuberculosis infection found by medical history or CT examination, or with a history of active pulmonary tuberculosis infection within 1 year before enrollment, or with a history of active pulmonary tuberculosis infection 1 year ago but without regular treatment;\n12. Patients with active hepatitis (HBV ≥ 2000 IU\u002Fml or HBV DNA ≥ 10000\u002Fml), or hepatitis C (hepatitis C antibody positive, and HCV-RNA ≥ 1000\u002Fml);\n13. Patients with coagulation abnormalities (PT \\> 16s, APTT \\> 43s, TT \\> 21s, Fbg \\\u003C 2 g\u002FL), bleeding tendency or receiving thrombolytic or anticoagulant therapy; or patients with previous severe bleeding (bleeding \\> 30ml within 3 months), hemoptysis (bleeding \\> 5ml within 4 weeks) within 12 months due to thromboembolic events (including stroke events and\u002For transient ischemic attack);\n14. Uncontrolled hypertension (systolic blood pressure \\> 140 mmHg, or diastolic blood pressure \\> 90 mmHg); coronary heart disease, arrhythmia ≥ grade II (including QTc prolongation, male \\> 450 ms, female \\> 470 ms) and heart failure;\n15. Urine protein ≥ + +, or 24 hour urine protein ≥ 1.0 g;\n16. Current diarrhea-related diseases (e.g., ulcerative colitis, Crohn's disease, chronic diarrhea, etc.);\n17. Known history of psychotropic drug abuse, alcoholism and drug abuse; or current history of antiepileptic drug use;\n18. Pregnant or lactating;\n19. Patients considered unsuitable for inclusion by the investigator as assessed by the investigator.",{"count":226,"type":22},28,[60],"This is a single-arm, multicenter, prospective, open-label phase II clinical trial of multi-target radiotherapy combined with PD-1 monoclonal antibody and capecitabine maintenance therapy treating oligometastatic nasopharyngeal carcinoma, the main purpose of which is to evaluate the efficacy of multi-target radiotherapy combined with PD-1 monoclonal antibody and capecitabine maintenance therapy regimen in treating oligometastatic nasopharyngeal carcinoma.",[230,231,32,232],"Radiotherapy","PD-1 Inhibitor","Nasopharyngeal Carcinoma","2022-04-13",{"date":235,"type":37},"2022-04-14",{"date":237,"type":37},"2022-03-28",{"date":239,"type":22},"2027-01-01",{"name":241,"class":44},"Fifth Affiliated Hospital, Sun Yat-Sen University"]