[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"microsatellite-stable-colorectal-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:microsatellite-stable-colorectal-carcinoma":39},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,57,86,111,135],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":40,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":56},"100447533","phase-1-a-study-of-nx-1607-in-adults-with-advanced-malignancies-100447533",false,"NCT05107674","A Study of NX-1607 in Adults With Advanced Malignancies","A Phase 1a, Dose Escalation, Safety and Tolerability Study of NX-1607, a Casitas B-lineage Lymphoma Proto-oncogene (CBL-B) Inhibitor, in Adults With Advanced Malignancies, With Phase 1b Expansion in Select Tumor Types","Key Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Measurable disease per disease-specific response criteria.\n* Patients must have disease that is metastatic or unresectable and have received standard treatment options, are not candidates for standard treatment options, or will otherwise be prevented from receiving any standard treatment options.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Minimum of 3 weeks or 5 half-lives (whichever is shorter) since last dose of systemic cancer therapy (unless otherwise specified) or minimum of 2 weeks since last radiotherapy, or minimum of 6 weeks since last systemic therapy with nitrosoureas, antibody-drug conjugate, or radio immuno-conjugate therapy.\n* Adequate organ and bone marrow function, in the absence of growth factors (with limited exception for DLBCL), as defined by laboratory parameters.\n* Patients of child-bearing potential must use adequate contraceptive measures to avoid pregnancy for the duration of the study as defined in the protocol.\n* Patient must be willing and able to adhere to the prohibitions and restrictions specified in the protocol.\n* Each patient must sign an informed consent form (ICF).\n* Histological or cytological diagnosis of platinum-resistant EOC, including primary peritoneal and fallopian tube carcinoma; gastric\u002FGEJ cancer; HNSCC; recurrent and either metastatic or unresectable melanoma; NSCLC; mCRPC; MPM; TNBC; locally advanced or metastatic urothelial cancer; cervical cancer; MSS CRC; or DLBCL (including DLBCL-RT)\n* Accessible tumor (for all cohorts) or lymph node (DLBCL only) for biopsy (Phase 1b only).\n\nKey Exclusion Criteria:\n\n* Active untreated brain metastases.\n* Patient has any of the following:\n* Uncontrolled intercurrent illness including, but not limited to, poorly controlled hypertension or diabetes, or ongoing active infection requiring systemic therapy.\n* Patients with primary refractory EOC defined as patients who do not respond to their first platinum-containing regimen or who relapse less than 6 months after completion of that first platinum-containing regimen\n* Psychiatric illness that would limit compliance with study requirements.\n* Treatment with any of the following prior to the first dose of NX-1607: CPI (anti-PD-1, PD-L1, cytotoxic T-lymphocyte-associated protein 4, etc) within 3 weeks; autologous or allogeneic stem cell transplant within 100 days; prior systemic cancer therapy within 3 weeks or 5 half-lives (whichever is shorter) (unless otherwise specified) (including hormonal therapy except for hormonal prophylaxis for a prior malignancy); prior radiotherapy within 2 weeks; prior systemic therapy with nitrosoureas, antibody-drug conjugate, or radio-immuno-conjugate therapy within 6 weeks; use of strong or moderate CYP3A4 inducers or inhibitors within 14 days or 7 days, respectively, or 5 half-lives (whichever is longer)\n* History of CAR-T therapy within 30 days prior to the first dose of NX-1607.\n* Toxicities from previous anti-cancer therapies that have not resolved to baseline levels or to Grade 1 or less except for Grade 2 alopecia and Grade 2 peripheral neuropathy or patients receiving endocrine replacement therapy\n* Patients who experienced Grade 3 or higher irAEs with prior immunotherapy.\n* History of uveitis, or an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.\n* Unable to swallow capsules or has malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction likely to interfere with the delivery, absorption, or metabolism of NX-1607.\n* Known allergies, hypersensitivity, or intolerance to components of NX-1607.\n* Pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 6 months after the last dose of NX-1607.\n* Patient is a man who plans to father a child while enrolled in this study or within 3 months after the last dose of NX-1607 and, as applicable, within 6 months after the last dose of paclitaxel.\n* Patient has had major surgery (e.g., requiring general anesthesia) within 4 weeks before the planned first dose of NX-1607, or will not have fully recovered from surgery, or has surgery planned during the time the patient is expected to participate in the study or within 4 weeks after the last dose of NX-1607. Note: Patients with minor planned surgical procedures to be conducted under local anesthesia may participate.\n* Vaccinated with a live vaccine within 28 days (with the exception of the annual inactivated influenza vaccine) or COVID-19 vaccination within 14 days prior to the first dose of NX-1607.\n* Active known second malignancy with the exception of any of the following:\n\n  * Adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or in situ cervical cancer.\n  * Adequately treated Stage I cancer from which the patient is currently in remission and has been in remission for ≥ 2 years.\n  * Low-risk prostate cancer with Gleason score \\\u003C 7 and PSA \\\u003C 10 ng\u002FmL.\n  * Any other cancer from which the patient has been disease-free for ≥ 2 years.\n* Infection with human immunodeficiency virus (HIV)-1 or HIV-2. Exception: Patients with well controlled HIV (e.g., CD4 \\> 350\u002Fmm3 and undetectable viral load) are eligible.\n* Current active hepatitis, including hepatitis A (hepatitis A virus immunoglobulin M \\[IgM\\] positive), hepatitis B (hepatitis B virus \\[HBV\\] surface antigen positive), or hepatitis C (hepatitis C virus \\[HCV\\] antibody positive, confirmed by HCV RNA). Patients with HCV with undetectable virus after treatment are eligible. Patients with prior exposure to HBV may be entered if quantitative PCR is negative.\n* Use of systemic corticosteroids (\\> 20 mg prednisone or equivalent) within 15 days (except for prophylaxis for radio diagnostic contrast reactions and\u002For prophylaxis for patients receiving paclitaxel), or other immunosuppressive drugs within 30 days, prior to the first dose of NX-1607.\n* Use of biotin (i.e., Vitamin B7) or supplements containing biotin higher than the daily adequate intake of 30 µg \\[NIH 2020\\] (Note: Patients who switch from a high dose to a dose of 30 µg\u002Fday or less at least 1 day prior to Screening assessments are eligible for study entry).\n* Receipt of an IP or has been treated with an investigational device within 3 weeks or 5 half-lives (whichever is shorter) prior to the first dose of NX-1607.\n* Any of the following within 6 months prior to the first dose of NX-1607 or ongoing:\n\n  * Myocardial infarction\n  * Unstable angina\n  * Unstable symptomatic ischemic heart disease\n  * New York Heart Association Class III or IV heart failure\n  * Thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events)\n  * Any other significant cardiac condition (e.g., pericardial effusion, restrictive cardiomyopathy, severe untreated valvular stenosis, or severe congenital heart disease)\n  * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating Investigator in consultation with the Medical Monitor.","ALL","18 Years",{"count":19,"type":20},345,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is a first-in-human Phase 1a\u002F1b multicenter, open-label oncology study designed to evaluate the safety and anti-cancer activity of NX-1607 in patients with advanced malignancies.",[26,27,28,29,30,31,32,33,34,35,36,37,38,39],"Ovarian Cancer, Epithelial","Gastric Cancer","GastroEsophageal Junction (GEJ) Cancer","Head and Neck Squamous Cell Carcinoma","Metastatic or Unresectable Melanoma","Non-small Cell Lung Cancer (NSCLC)","Metastatic Castration-resistant Prostate Cancer (mCRPC)","Malignant Pleural Mesothelioma (MPM)","Triple Negative Breast Cancer (TNBC)","Metastatic Urothelial Carcinoma","Cervical Cancer","Diffuse Large B Cell Lymphoma (DLBCL)","Richter Transformation","Microsatellite Stable Colorectal Carcinoma",[41,42,43],"Ubiquitin Ligase Inhibitor","Advanced Malignancies","T-cell Activation","RECRUITING","2025-09-05",{"date":47,"type":48},"2025-09-09","ACTUAL",{"date":50,"type":48},"2021-09-29",{"date":52,"type":20},"2028-02-28",{"name":54,"class":55},"Nurix Therapeutics, Inc.","INDUSTRY",17,{"id":58,"slug":59,"hasResults":11,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":4,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":64,"targetDuration":4,"studyType":21,"phases":66,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":85},"100498509","phase-2-vitamin-e-combined-with-fruquintinib-and-tislelizumab-in-microsatellite-stabilized-metastatic-colorectal-cancer-patients-100498509","NCT05771181","Vitamin E Combined With Fruquintinib and Tislelizumab in Microsatellite Stabilized Metastatic Colorectal Cancer Patients","Phase II Clinical Study of Vitamin E Combined With Fruquintinib and Tislelizumab in Patients With Microsatellite Stabilized Metastatic Colorectal Cancer Who Failed Standard Therapy","Inclusion Criteria:\n\n1. Age ≥18 years old, both sexes;\n2. Patients with histologically or cytologically confirmed unresectable and metastatic CRC;\n3. Recist1.1-defined disease progression or intolerance to prior standard therapy during or after standard therapy. Standard therapy was required to include all the following agents: fluorouracilines, chemotherapy agents such as irinotecan, and oxaliplatin, with or without an anti-VEGF monoclonal antibody (e.g., bevacizumab). Left-sided KRAS\u002FNRAS\u002FBRAF wild-type subjects received combined anti-EGFR mAb (cetuximab or panitumumab).\n4. Before enrollment, the tumor tissue was pMMR by immunohistochemistry, or MSS or MSI-L by PCR or NGS;\n5. Patients with ECOG score of 0-1 and expected survival time ≥3 months, patients who can cooperate to observe adverse reactions and efficacy;\n6. At least one measurable tumor lesion according to RECIST 1.1 criteria;\n7. Good organ function:\n\n   1. neutrophil ≥1.5\\*109\u002FL; Platelet ≥100\\*109\u002FL; Hemoglobin ≥9g\u002Fdl; Serum albumin ≥3g\u002Fdl;\n   2. Thyroid stimulating hormone (TSH) ≤ 1 times the upper limit of normal, T3 and T4 in the normal range;\n   3. bilirubin ≤ 1.5 times the upper limit of normal value; ALT and AST≤ 2 times the upper limit of normal;\n   4. Serum creatinine ≤ 1.5 times the upper limit of normal, creatinine clearance ≥60ml\u002Fmin;\n   5. International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times the upper limit of the normal range, unless the patient is receiving anticoagulant therapy and the PT value is within the intended range for anticoagulant therapy;\n   6. Activated partial thromboplastin time (aPTT) ≤ 1.5 times the upper limit of normal;\n8. There were no serious concomitant diseases that could make the survival time less than 5 years;\n9. Negative pregnancy test in female subjects (for female patients of childbearing potential); Infertile female patients;\n10. Male patients of childbearing potential and female patients of childbearing potential and at risk of pregnancy must agree to use adequate contraception for the entire duration of the study and for 12 months after receiving treatment with the protocol;\n11. Signed and dated informed consent indicating that the patient has been informed about all relevant aspects of the study;\n12. Patients who are willing and able to comply with the visit schedule, treatment plan, laboratory tests, and other study procedures;\n13. Willing to comply with the arrangement during the study period can not participate in any other clinical research on drugs and medical devices.\n\nExclusion Criteria:\n\n1. Pathological diagnosis of other intestinal tumors, such as gastrointestinal stromal tumor;\n2. Tumor tissues were dMMR detected by immunohistochemistry, or MSI-H detected by PCR or NGS\n3. Prior treatment with PD-1 antibody, PD-L1 antibody, or CTLA-4 antibody;\n4. Previous or concurrent history of other malignant tumors, excluding adequately treated non-melanoma skin cancer, cervical carcinoma in situ and thyroid papillary carcinoma;\n5. Active autoimmune disease, history of autoimmune disease (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); It does not include autoimmune-mediated hypothyroidism treated with stable doses of thyroid replacement hormone; Type I diabetes on stable doses of insulin; Vitiligo or cured childhood asthma\u002Fallergy without any intervention in adulthood;\n6. A history of immunodeficiency, including HIV positive, other acquired or congenital immunodeficiency diseases, or organ transplantation or allogeneic bone marrow transplantation;\n7. Contraindications to antiangiogenic drugs (such as active bleeding, gastrointestinal bleeding, hemoptysis, etc.);\n8. History of interstitial lung disease (excluding radiation pneumonitis without steroid treatment) and non-infectious pneumonia;\n9. Patients with active pulmonary tuberculosis infection detected 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 more than 1 year before enrollment but without regular treatment;\n10. The subject has active hepatitis B (HBV DNA ≥2000 IU\u002FmL or 104 copies\u002FmL), hepatitis C (hepatitis C antibody positive and HCV-RNA above the detection limit of the assay)\n11. Severe cardiopulmonary and renal dysfunction;\n12. Have hypertension that is not well controlled with antihypertensive medication (systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg);\n13. A history of psychotropic substance abuse, alcohol or drug abuse;\n14. Other factors that may affect subject safety or trial compliance as judged by the investigator. Severe medical conditions requiring concomitant treatment (including mental illness), serious laboratory abnormalities, or other family or social factors.",{"count":65,"type":20},25,[67],"PHASE2","The goal of this clinical trial is to learn about efficacy of Vitamin E in combination with Fuquinitinib and Tirelizumab in patients with microsatellite stabilized mCRC who have failed standard therapy. The main question is to explore the survival time, safety and tolerability of the treatment. At the same time, the correlation between biomarkers (including PD-L1 expression, tumor mutation load, lymphocyte subpopulation, cytokines, TCR, intestinal microbes, and others) and the efficacy and drug resistance mechanism will be analyzed, so as to provide reference for the subsequent guidance of the screening of benefit groups.",[70,39],"Colorectal Cancer",[72,73,74],"Tirelizumab","Fuquinitinib","Vitamin E","2025-06-09",{"date":77,"type":48},"2025-06-12",{"date":79,"type":48},"2023-03-01",{"date":81,"type":20},"2027-02",{"name":83,"class":84},"Fudan University","OTHER",1,{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":21,"phases":96,"briefSummary":97,"conditions":98,"keywords":4,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":110},"100556270","phase-2-sequential-immunochemotherapy-treatment-with-pembrolizumab-plus-dendritic-cell-dc-vaccine-followed-by-trifluridinetipiracil-plus-bevacizumab-in-refractory-mismatch-repair-proficient-pmmr-or-microsatellite-stable-mss-metastatic-colorectal-cancer-100556270","NCT06522919","Sequential Immunochemotherapy Treatment with Pembrolizumab Plus Dendritic Cell (DC) Vaccine Followed by Trifluridine\u002FTipiracil Plus Bevacizumab in Refractory Mismatch-repair-proficient (pMMR) or Microsatellite-stable (MSS) Metastatic Colorectal Cancer","Sequential Immunochemotherapy Treatment with Pembrolizumab Plus Dendritic Cell (DC) Vaccine Followed by Trifluridine\u002FTipiracil (FTD\u002FTPI) Plus Bevacizumab in Refractory Mismatch-repair-proficient (pMMR) or Microsatellite-stable (MSS) Metastatic Colorectal Cancer (CombiCoR-Vax)","CombiCoR-Vax","Inclusion Criteria:\n\n* Be willing and able to provide written informed consent.\n* Histologically confirmed pMMR or MSS mCRC\n* Male or female, aged ≥ 18 years\n* Life expectancy greater than 12 weeks\n* ECOG performance status \\\u003C2\n* Patient suitable for the collection of biological material from leukapheresis: negative serological tests (HIV, HBV, HCV, Treponema pallidum); normal cardiological parameters (12-lead ECG and echocardiogram); evaluation by transfusionist to exclude possible contraindications to leukapheresis; recovered (grade 1 or less by CTCAE 5.0) from all the adverse events related to previous treatments.Exclusion Criteria:\n* Patients must have measurable disease by RECIST v 1.1 criteria on CT (or MRI) scan of the chest, abdomen and pelvis. See section 9.2 and Appendix D for the evaluation of measurable disease.\n* Prior treatment with 1-2 chemotherapy regimens in an advanced setting, including (if not contraindicated) fluoropyrimidines, irinotecan, oxaliplatin, an anti-VEGF monoclonal antibody and\u002For anti-EGFR monoclonal antibody for RAS wild-type tumors.\n* Patients must have normal organ and marrow function as defined below:\n\nleukocytes \\>3,000\u002FμL, absolute neutrophil count \\>1,500\u002FμL, platelets \\>100,000\u002FμL, total bilirubin \\\u003C 1.5 X institutional upper limit of normal (ULN), AST(SGOT)\u002FALT(SGPT) \\\u003C2.5 X ULN, creatinine \\\u003C 1.5 X ULN OR creatinine clearance \\>30 mL\u002Fmin\u002F1.73 m2\n\n* The autologous surgical specimen needed for vaccine manufacturing must have been collected and sent to the Somatic Cell Therapy Lab of IRCCS IRST and must fulfill all the acceptance criteria prescribed by the GMP procedures\n* Recovery (grade 1 or less by CTCAE 5.0) from all the adverse events related to previous surgery.\n* A female participant is eligible to participate if she is not pregnant and not breastfeeding. Female patients of childbearing potential and all male patients must accept and be compliant with a highly effective contraceptive method\n* Participant is willing and able to give informed consent for participation in the study.\n\nExclusion Criteria:\n\nThe participant may not enter the study if ANY of the following apply:\n\n* Prior treatment with FTD\u002FTPI for mCRC\n* Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.\n* Participation in another clinical trial with any investigational agents within 30 days prior to study screening.\n* Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to Pembrolizumab, FTD\u002FTPI, Bevacizumab or components of the DC vaccine.\n* History of congenital or acquired immunodeficiency, including history of organ transplantation.\n* Any active inflammatory or autoimmune disease requiring systemic steroids or other immunomodulatory agents\n* Uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Other known malignant neoplastic diseases in the patient's medical history with a disease-free interval of less than 5 years (except for previously treated basal cell carcinoma and in situ carcinoma of the uterine cervix).",{"count":95,"type":20},36,[67],"Single-arm, open-label, multicenter phase 2 clinical trial evaluating the clinical and the immunological activity of an innovative strategy with an induction combo immunotherapy (Pembrolizumab plus DC Vaccine) followed by a maintenance chemotherapy (FTD\u002FTPI plus Bevacizumab) in patients with refractory MSS\u002FpMMR metastatic colorectal cancer.",[99,39,100],"Colorectal Cancer Metastatic","Refractory Mismatch-repair-proficient (pMMR) Metastatic Colorectal Cancer","2025-01-24",{"date":103,"type":48},"2025-01-28",{"date":105,"type":48},"2025-01-07",{"date":107,"type":20},"2026-09-01",{"name":109,"class":84},"Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS",2,{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":4,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":118,"enrollmentInfo":119,"targetDuration":4,"studyType":21,"phases":121,"briefSummary":122,"conditions":123,"keywords":4,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":85},"100532899","phase-2-cadonilimab-in-combination-with-bevacizumab-and-folfox-regimen-for-the-first-line-treatment-of-advanced-unresectable-mss-type-ras-mutated-metastatic-colorectal-cancer-100532899","NCT06218810","Cadonilimab in Combination With Bevacizumab and FOLFOX Regimen for the First-Line Treatment of Advanced Unresectable MSS-Type, RAS-Mutated Metastatic Colorectal Cancer","Cadonilimab in Combination With Bevacizumab and FOLFOX Regimen for the First-Line Treatment of Advanced Unresectable MSS-Type, RAS-Mutated Metastatic Colorectal Cancer: A Single-Arm, Open-Label, Multicenter Phase II Study","Inclusion Criteria:\n\n1. Voluntarily sign a written ICF.\n2. Age at enrollment: ≥ 18 years old, ≤ 75 years old, both male and female.\n3. The Eastern Cancer Collaborative Organization (ECOG) has a physical fitness score of 0 or 1.\n4. The expected survival period is ≥ 3 months.\n5. Subjects diagnosed with metastatic colorectal adenocarcinoma by histology or cytology.\n6. Colorectal cancer patients who have not received systematic anti-tumor therapy in the past and are not suitable for radical surgical resection or local treatment.\n7. Genetic testing results indicate pMMR or MSS; RAS mutation;\n8. According to RECIST v1.1, there is at least one measurable lesion that is suitable for repeated and accurate measurements. Note: Brain metastases cannot be used as target lesions; For lesions that have received radiation therapy before, it is not recommended to select them as target lesions. If there are no other lesions that meet the target lesion criteria, and the lesion can be measured according to RECIST v1.1 and there is objective evidence to prove significant progression after radiation therapy, the irradiated lesion can be considered as a target lesion.\n\nExclusion Criteria:\n\n1. Patients with known MSI-H or dMMR.\n2. Participants of RAS wild-type.\n3. Subjects suffered from other malignant tumors within 3 years before enrollment, except for cured local tumors (such as basal cell skin cancer, squamous cell skin cancer, superficial bladder cancer, cervical carcinoma in situ, etc.).\n4. Simultaneously enroll in another clinical study, unless it is an observational, non-interference clinical study or a follow-up period of an intervention study.\n5. Received systematic anti-tumor therapy (chemotherapy) within 3 weeks prior to the first administration; Palliative local treatment was performed on non target lesions within 2 weeks prior to the first administration; Received non-specific immunomodulatory therapy (such as interleukin, interferon, thymosin, etc., excluding IL-11 used to treat thrombocytopenia) within 2 weeks before the first administration; Chinese herbal medicine or traditional Chinese patent medicines and simple preparations with anti-tumor indications was received within 1 week before the first administration.\n6. Have received any immunotherapy against tumors in the past, including immune checkpoint inhibitors (such as anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-CTLA-4 antibodies, etc.), immune checkpoint agonists (such as ICOS, CD40, CD137, GITR, OX40 antibodies, etc.), immune cell therapy, and any treatment targeting the immune mechanism of tumors.\n7. Patients with active autoimmune diseases that require systematic treatment within the past two years (such as using medication to improve the condition, corticosteroids, immunosuppressive agents), and replacement therapy (such as thyroid hormone, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary dysfunction) are not considered as systematic treatment.\n8. A history of active or previous inflammatory bowel disease (such as Crohn's disease, ulcerative colitis, or chronic diarrhea).\n9. History of immunodeficiency; HIV antibody test positive individuals; Currently using systemic corticosteroids or other immunosuppressants for a long time.\n10. Subjects who are known to have active pulmonary tuberculosis (TB) and suspected to have active TB need to undergo clinical examination to exclude them; Known active syphilis infection.\n11. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.\n12. Previous or current non infectious pneumonia\u002Finterstitial lung disease requiring systemic glucocorticoid treatment.","75 Years",{"count":120,"type":20},53,[67],"The dual immunotherapy regimen significantly outperformed previous chemotherapy or immunomonotherapy for MSS type advanced CRC in two key efficacy indicators, ORR and PFS. Researchers have also conducted in-depth analysis of patient transcriptomics, immune microenvironment characteristics, and other related information, which is expected to guide more accurate immune combination therapy for CRC in the future. Our team plans to conduct a multicenter, prospective, single arm clinical trial in patients with RAS mutant MSS unresectable metastatic colorectal cancer, with a focus on observing the 1-year progression free survival rate of the combination of two chemotherapy drugs, bevacizumab and Cadonilimab, as well as ORR, perioperative safety, and long-term survival.",[124,39,125,126],"Metastatic Colorectal Cancer","RAS Mutation","Cadonilimab","2024-01-20",{"date":129,"type":48},"2024-01-23",{"date":131,"type":48},"2024-01-01",{"date":133,"type":20},"2026-12-31",{"name":83,"class":84},{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":141,"eligibilityCriteria":142,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":118,"enrollmentInfo":143,"targetDuration":4,"studyType":21,"phases":145,"briefSummary":146,"conditions":147,"keywords":4,"overallStatus":151,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":85},"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":144,"type":20},52,[67],"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.",[148,149,150,39],"Advanced Rectal Cancer","Liver Metastasis","Pulmonary Metastasis","NOT_YET_RECRUITING","2022-11-09",{"date":154,"type":48},"2022-11-14",{"date":156,"type":20},"2022-12-01",{"date":158,"type":20},"2027-09-01",{"name":83,"class":84}]