[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":110},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,39,63,89],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":4},"100640741","phase-2-a-prospective-single-arm-phase-ii-clinical-trial-of-becotatug-vedotin-for-injection-combined-with-pucotenlimab-injection-as-a-first-line-treatment-for-platinum-intolerant-advanced-head-and-neck-squamous-cell-carcinoma-100640741",false,"NCT07628855","A Prospective, Single-arm, Phase II Clinical Trial of Becotatug Vedotin for Injection Combined With Pucotenlimab Injection as a First-line Treatment for Platinum-intolerant Advanced Head and Neck Squamous Cell Carcinoma","1. Histologically or cytologically diagnosed as squamous cell carcinoma, with the lesion site located in the oral cavity, oropharynx, hypopharynx, larynx, etc.;\n2. Recurrence and metastasis occurred after previous local treatment (surgery, radiotherapy, or concurrent chemoradiotherapy), with no possibility of cure, and no systemic treatment had been received previously, or previous induction or adjuvant treatment had been received, but the time from the end of the above treatment was ≥ 6 months;\n3. Existence of distant metastasis at the time of initial treatment, or extensive local lesion range, and not curable after MDT assessment;\n4. Patients who cannot tolerate platinum-based chemotherapy or do not accept cisplatin-based chemotherapy; Definition of cisplatin intolerance: Any of the following criteria met: age ≥ 70 years; mild or above hearing impairment; creatinine clearance rate \\\u003C 50 ml\u002Fmin (calculated according to the Cockcroft and Gault formula);\n5. PS score ≤ 2 points;\n6. At least one evaluable lesion according to the RECIST V1.1 standard;\n7. Normal organ function is sufficient:\n\nBone marrow: Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL, platelet count ≥ 100 × 109\u002FL, hemoglobin ≥ 90 g\u002FL, and no blood transfusion or biological response modifiers (such as granulocyte and erythropoietin growth factors) treatment within 14 days before the first administration; Liver: ALT and AST ≤ 2.5 times the upper limit of normal value (for subjects with liver metastasis, AST and ALT ≤ 5 × ULN), total bilirubin ≤ 1.5 times the upper limit of normal value (for subjects with liver metastasis or confirmed\u002Fsuspected Gilbert syndrome, TBIL ≤ 3 × ULN); serum albumin ≥ 30 g\u002FL; Kidneys: Creatinine clearance rate (Ccr) ≥ 30 mL\u002Fmin (calculated according to the Cockcroft and Gault formula)\n\nPatients with any of the following conditions are not eligible to be included in this study:\n\n1. Have a history of other primary malignant tumors within the past 3 years, except for skin basal cell carcinoma, superficial bladder cancer, skin squamous cell carcinoma, or in situ cervical cancer that have been completely resected;\n2. Have peripheral neuropathy of grade ≥ 2 (according to CTCAE v5.0);\n3. Have received any of the following treatments:\n4. Received intravenous antibiotic treatment within 7 days before the first administration;\n5. Received the study drug in another clinical trial within 4 weeks before the first administration;\n6. Have received attenuated live vaccines within 4 weeks before the first administration, or have been vaccinated with inactivated seasonal influenza vaccine or approved live virus-free COVID-19 vaccine;\n7. Have received systemic immunostimulatory drug treatment (including but not limited to interferons, interleukin-2, etc.) within 4 weeks before the first administration;\n8. Have undergone major surgical treatment (such as abdominal, thoracic surgeries, etc., excluding diagnostic punctures, infusion device implantation, or digestive tract implantation, etc.) within 4 weeks before the first administration, or are expected to undergo major non-tumor-related surgical treatment during the new adjuvant therapy period;\n9. Have clinically significant (i.e., active) cardiovascular diseases: cerebrovascular accidents\u002Fstrokes\u002F myocardial infarction within 6 months before enrollment, unstable angina pectoris, congestive heart failure (NYHA II grade and above), or require drug treatment for severe arrhythmias;\n10. Have evidence of active infections including hepatitis B (requiring both HBsAg positive, HBV DNA ≥ 2000 IU\u002Fml, and exclusion of hepatitis caused by other factors), hepatitis C (requiring both anti-HCV antibody positive and HCV RNA result greater than the detection limit), or human immunodeficiency virus (HIV) infection; Uncontrolled active bacterial, other viral, fungal, rickettsial or parasitic infections, unless treated and resolved before the administration of the study drug;\n11. Have a history of primary immunodeficiency or active autoimmune diseases, are using immunosuppressants or systemic hormone therapy (dose ≥ 10 mg\u002Fday of prednisone or equivalent hormone), and are still using it within 2 weeks before enrollment; Note: Type 1 diabetes, stable hypothyroidism due to hormone replacement therapy (including autoimmune thyroid disease-induced hypothyroidism), psoriasis, vitiligo or eczema patients can be enrolled, using local topical or inhaled glucocorticoids, or short-term (≤ 7 days) use of glucocorticoids for prevention or treatment of non-autoimmune and infrequent allergic diseases are excluded. ;\n12. Has a history of ≥ grade 3 allergic reaction to any component of Viberceptotota monoclonal antibody or Putilimab injection;\n13. Has a history of or is concurrently suffering from interstitial pneumonia, radiation pneumonia, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, symptomatic bronchospasm, etc.;\n14. Has a history of organ transplantation, including allogeneic peripheral stem cell or bone marrow transplantation. After careful assessment, patients who have undergone autologous hematopoietic stem cell transplantation for ≥ 5 years and have normal bone marrow function (not dependent on blood transfusion) can be considered to participate in the study; Other conditions that the investigator deems unsuitable for participation in this clinical trial, including but not limited to severe mental illness, central nervous system disorders, drug abuse, etc.","ALL","70 Years","105 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This study is a randomized, open-label, multi-center phase II trial evaluating the efficacy and safety of the becotatug vedotin in combination with pucotenlimab regimen in patients with advanced head and neck squamous cell carcinoma who are intolerant to platinum-based therapy.",[26],"HNPCC","NOT_YET_RECRUITING","2026-06-01",{"date":30,"type":31},"2026-06-05","ACTUAL",{"date":33,"type":20},"2026-05-14",{"date":35,"type":20},"2028-08-30",{"name":37,"class":38},"Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center","OTHER",{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":15,"minAge":46,"maxAge":16,"enrollmentInfo":47,"targetDuration":4,"studyType":21,"phases":49,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":62},"100606967","early-phase-1-exploratory-clinical-study-of-personalized-mrna-tumor-vaccine-rh125-in-patients-with-advanced-solid-tumors-100606967","NCT07182435","Exploratory Clinical Study of Personalized mRNA Tumor Vaccine RH125 in Patients With Advanced Solid Tumors","A Phase 1 Clinical Trial of Personalized mRNA Tumor Vaccine RH125 in Patients With Advanced or Metastatic Solid Tumors Evaluating the Safety, Tolerability, and Efficacy","Inclusion Criteria:\n\n1. Male or female, aged from 18 to 70 years old.\n2. Patients with histologically and radiologically confirmed locally advanced or metastatic solid tumors that are not suitable for curative surgical treatment, Eligible patients must have experienced disease progression following standard antitumor therapy or be unable or unwilling to receive standard treatments. Patients in the combination therapy group are suitable for PD-1 blockers therapy judged by the investigator .\n3. Patients must hava at least one measureble disease per RECIST 1.1.\n4. Patients must have a fresh tumor lession sample for sequencing and test of expression of PD-1(22c3,only for patients in the combination therapy group .)\n5. ECOG performance status of 0 or 1\n6. Life expectancy of at least 6 months.\n7. Adequate organ and hematologic function, with no severe dysfunction of the heart, lungs, liver, kidneys, or immune system, based on the following laboratory values:\n\n1). Hematology: ANC ≥ 1.5 × 10⁹\u002FL, PLT ≥ 100 × 10⁹\u002FL, HGB ≥ 100 g\u002FL. Within one week before screening, the subject must not have received blood or platelet transfusions, G-CSF, or erythropoietin (EPO); 2). Renal function: Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 60 mL\u002Fmin (calculated using the Cockcroft-Gault formula); 3). Liver function: AST and ALT ≤ 2.5 × ULN (≤ 5 × ULN for patients with liver cancer or liver metastases); TBIL ≤ 1.5 × ULN (patients with Gilbert's syndrome: TBIL \\\u003C 3 × ULN); 4). Coagulation: INR ≤ 1.5 × ULN or APTT ≤ 1.5 × ULN (except for patients on anticoagulants).\n\n8.. Male subjects with reproductive potential and female subjects of childbearing potential agree to use effective contraception from the time of informed consent until 6 months after the last dose of investigational drug.\n\nWomen of childbearing potential include premenopausal women and those within 2 years post-menopause.\n\nA negative serum pregnancy test is required within 7 days before the first dose of the investigational product.\n\nExclusion Criteria:\n\n1. Having active malignant tumors within 2 years before the first administration, except for any locally curable tumors that have received radical treatment (e.g., resected basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix or breast);\n2. Presecne of central nervous system metastases, carcinomatous meningitis, or primary central nervous system tumors.\n3. Results of predicted neoantigen epitopes is less than 5.\n4. Having received other anti-tumor treatments (such as chemotherapy, endocrine therapy, targeted therapy, immunotherapy, radiotherapy, or tumor embolization) within 4 weeks before the first vaccination; for oral fluoropyrimidines and small-molecule targeted drugs, the interval required is more than 2 weeks or 5 half-lives of the drug, whichever is longer.\n5. Clinically significant residual toxicity (≥ grade 2 per CTCAE v5.0) from previous treatment (including systemic therapy, radiotherapy, or surgery), except for alopecia, hyperpigmentation, or other AEs deemed by the investigator not to affect study safety and where recovery to grade ≤1 is not required.\n6. Prior one marrow transplantation, allogeneic hematopoietic stem cell transplantation or solid organ transplantation\n7. Patients who need to take immunosuppressants regularly within 4 weeks before the first vaccination and during the clinical study, including but not limited to the following situations: those with severe asthma, autoimmune diseases or immunodeficiency, those receiving immunosuppressive drug therapy, or those with a known history of primary immunodeficiency; however, subjects with the following diseases are allowed to undergo further enrollment screening: type I diabetes with good control, hypothyroidism with good control requiring only hormone replacement therapy, skin diseases that do not require systemic treatment (such as vitiligo, psoriasis or alopecia), or subjects whose condition is not expected to relapse without external triggers.\n8. Clinically diagnosed active bacterial or fungal infections; having active tuberculosis or a history of tuberculosis.\n9. Active hepatitis B virus (HBV) infection (defined as HBsAg positive and HBV-DNA \\> ULN), hepatitis C virus (HCV) infection (defined as HCV-Ab positive and HCV-RNA positive), human immunodeficiency virus (HIV) infection (HIV-Ab positive) or treponema pallidum(TP) infection.\n10. Severe cardiovascular diseases occurring within 2 years before the first administration, including but not limited to: stable angina pectoris with functional class III-IV; unstable angina pectoris or myocardial infarction; NYHA class III-IV congestive heart failure; severe arrhythmias requiring drug treatment.\n11. A history of substance abuse, or clinical, psychological, or social factors that may affect informed consent or the conduct of the study; a history of mental illness.\n12. A history of allergies to previous vaccinations, allergies to any component of the investigational product, a history of severe allergies to food or drugs, or other potential allergies to immunotherapy as deemed by the investigator.\n13. Pregnant or lactating women.\n14. Participation in other interventional clinical studies within 12 weeks before the first vaccination, except for participation in observational (non-interventional) clinical studies or being in the survival follow-up phase of interventional studies.\n15. Vaccination of any type within 28 days before administration.\n16. Subjects deemed unsuitable for enrollment by the investigator or who may be unable to complete the trial for other reasons.","18 Years",{"count":48,"type":20},36,[50],"EARLY_PHASE1","This is a Phase 1 clinical study investigating RH125 as monotherapy or in combination therapy in patients with locally advanced or metastatic solid tumors who failed standard treatment, or were intolerant to standard treatment, or declined standard treatment. The aim of the study is to evaluate the tolerability, safety, immunogenicity, and preliminary efficacy of RH125 monotherapy or combination with PD-1 blocker.",[53],"Solid Tumor Malignancies","2025-09-17",{"date":56,"type":31},"2025-09-19",{"date":58,"type":20},"2025-09-15",{"date":60,"type":20},"2028-12-31",{"name":37,"class":38},1,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":15,"minAge":46,"maxAge":4,"enrollmentInfo":71,"targetDuration":4,"studyType":21,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":62},"100575783","phase-1-a-phase-ibii-study-of-adebrelimab-in-combination-with-capecitabine-and-oxaliplatin-in-cancer-100575783","NCT06776770","A Phase Ib\u002FII Study of Adebrelimab in Combination with Capecitabine and Oxaliplatin in Cancer","A Phase Ib\u002FII Study of Adebrelimab in Combination with Capecitabine and Oxaliplatin in Previously Untreated Advanced or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma","GC-Ib\u002FII","Inclusion Criteria:\n\n\\- 1. The patients voluntarily participated in the study and signed the informed consent; 2. ≥ 18 years old (calculated on the day of signing informed consent), both male and female; 3. Patients with pathologically confirmed gastric cancer (GC) or gastroesophageal junction cancer (GEJC) who were histologically confirmed to be adenocarcinoma and had not received antineoplastic therapy for GC or GEJC; 4. No prior systemic therapy for advanced or metastatic disease. Prior adjuvant or neoadjuvant chemotherapy for GC and GEJC,Radiotherapy or chemoradiotherapy, provided that the last dose of the last drug (based on the last dose) occurred at least 6 months prior to enrollment. Palliative radiotherapy is allowed, but it must be completed 2 weeks before enrollment; 5. Human epidermal growth factor receptor 2 negative or unknown; 6. At least one measurable lesion according to the solid tumor efficacy evaluation criteria (RECIST v1.1); 7. The Eastern Cooperative Oncology Group (ECOG) physical status score was 0-1. 8. Expected survival \\> 12 weeks; 9. Adequate organ and bone marrow function, as defined below: A) Neutrophil count (ANC) ≥ 1,500\u002Fmm3 (1.5 × 10 \\^ 9\u002FL); B) Platelet count (PLT) ≥ 75,000\u002Fmm3 (75 × 10 \\^ 9\u002FL); C) hemoglobin (Hb) ≥ 8 G\u002FdL (80 G\u002FL); D) Serum creatinine ≤ 1.5 times the upper limit of normal (ULN) or creatinine clearance ≥ 40 ml\u002Fmin; E) Total bilirubin (BIL) ≤ 1.5 times the upper limit of normal (ULN); F) Aspartate transaminase or Alanine transaminase ≤ 2.5 times the upper limit of normal (ULN), and ≤ 5 × ULN for patients with liver metastasis; G) International normalized ratio (INR) ≤ 1.5, prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 times ULN; H) Urine protein \\\u003C 2 +; if urine protein ≥ 2 +, 24-hour urine protein quantification shows that protein must be ≤ 1 G; I) Thyroid-stimulating hormone (TSH) ≤ upper limit of normal (ULN); if abnormal, T3 and T4 levels should be investigated, and normal T3 and T4 levels can be included.\n\n10.Female subjects of childbearing age must have a negative serum pregnancy test within 3 days prior to the start of study medication and be willing to use a medically approved highly effective contraceptive method (e.g., intrauterine device, contraceptive pill, or condom) for the duration of the study and for 3 months after the last dose of study medication; Male subjects with a female partner of childbearing age were surgically sterilized or agreed to use an effective method of contraception for the duration of the study and for 3 months after the last study dose.\n\nExclusion Criteria:\n\n* 1\\. Previous treatment with PD-1\u002FPD-L1 antibodies, cytotoxic T lymphocyte-associated antigen-4 antibodies, or other PD-1\u002FPD-L1 inhibitors; 2. Past hypersensitivity to monoclonal antibodies and inactive ingredients of this product; 3. Previous use of immunosuppressive drugs within 14 days prior to the first dose of study drug, excluding nasal and inhaled corticosteroids or physiologic doses of systemic steroid hormones (i.e., up to 10 mg\u002Fday of prednisolone or pharmacophysiologically equivalent doses of other corticosteroids).； 4. Vaccination with live attenuated vaccine within 4 weeks before the first dose or planned during the study; 5. Patients with clinical signs and symptoms of central nervous system metastasis or other evidence that central nervous system metastasis has not been controlled are not suitable for inclusion according to the judgment of the investigator, and those with meningeal metastasis history or symptoms and signs need to be excluded; 6. Toxicity of previous antineoplastic therapy did not recover to the level of CTCAE v5.0 ≤ 1 or the level specified in the inclusion\u002Fexclusion criteria; except for other toxicities such as alopecia, which the investigator considered did not pose a safety risk to the patient; 7. Advanced patients with symptoms, dissemination to the viscera, and risk of life-threatening complications in the short term (including patients with uncontrollable massive exudates \\[thoracic, pericardial, abdominal\\], pulmonary lymphangitis, and liver involvement of more than 30%); 8. Presence of any active autoimmune disease or history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis,Hyperthyroidism, hypothyroidism; subjects with vitiligo or complete remission of asthma in childhood without any intervention in adulthood can be included; subjects with asthma requiring medical intervention of bronchodilators can not be included); 9. Any other malignancy diagnosed within 3 years prior to study entry, except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix; 10. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV DNA ≥ 500 IU\u002Fml), hepatitis C (hepatitis C antibody positive, and hepatitis C virus-RNA above the detection limit of the analytical method), or co-infection with hepatitis B and hepatitis C; 11.Myocardial infarction, severe\u002Funstable angina, NYHA class 2 or greater cardiac dysfunction, and poorly controlled arrhythmias (including Corrected QT Interval interval \\> 450 ms in men and \\> 470 ms in women) within 6 months prior to study entry. QTcF interval was calculated by Fridericia formula), symptomatic congestive heart failure, cerebrovascular accident (including transient ischemic attack or symptomatic pulmonary embolism); 12.Hypertension that is not well controlled by antihypertensive medication (systolic blood pressure \\> 140 mmHg or diastolic blood pressure \\> 90 mmHg); 13. Coagulation dysfunction (INR \\> 1.5 or APTT \\> 1.5 × ULN), bleeding tendency or receiving thrombolytic or anticoagulant therapy; 14. Known hereditary or acquired bleeding and thrombotic tendencies, such as hemophilia, coagulation disorders, thrombocytopenia, hypersplenism, etc; 15. Patients with obvious hemoptysis or daily hemoptysis volume of half a teaspoon (2.5 ml) or more within 2 months before entering the study; 16. There were clinically significant bleeding symptoms or definite bleeding tendency within 3 months before entering the study, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood + + and above, or vasculitis; 17. Arterial\u002Fvenous thrombotic events occurred within 6 months before entering the study, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism.\n\n  18\\. Known hereditary or acquired bleeding and thrombotic tendencies (such as hemophilia, coagulation dysfunction, thrombocytopenia, hypersplenism, etc.); 19. Long-term anticoagulation therapy with warfarin or heparin, or long-term antiplatelet therapy (aspirin ≥ 300 mg\u002Fday or clopidogrel ≥ 75 mg\u002Fday); 20. Complicated with severe infection within 4 weeks before the first medication (e.g., need for intravenous antibiotics, antifungal or antiviral drug), or unexplained fever \\> 38.5 ° C during screening\u002Fbefore first dose; 21. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 22. Participated in any other clinical study of the drug within 4 weeks prior to the first dose, or not more than 5 half-lives from the last study dose; 23. Known history of psychotropic substance abuse or drug use; 24. Patients with other serious physical or mental illnesses or laboratory abnormalities that may increase the risk of participating in the study or interfere with the results of the study, and who are not considered suitable for participation in the study by the investigator.",{"count":72,"type":20},52,[74,23],"PHASE1","In this study, the combination of Adebrelimab (PD-L1 monoclonal antibody) on the basis of standard treatment (two-drug chemotherapy regimen of fluorouracil and platinum drugs) may enhance the immune response in order to enhance the killing effect on tumor cells and bring survival benefits to patients with advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma.",[77],"Gastric Cancer",[79],"Adebrelimab plus capecitabine and oxaliplatin","RECRUITING","2025-01-10",{"date":83,"type":31},"2025-01-15",{"date":85,"type":31},"2024-08-03",{"date":87,"type":20},"2026-12-31",{"name":37,"class":38},{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":15,"minAge":46,"maxAge":96,"enrollmentInfo":97,"targetDuration":4,"studyType":21,"phases":98,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":104,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":62},"100575782","phase-1-sintilimab-in-combination-with-cetuximab-and-chemotherapy-as-first-line-treatment-for-rasbraf-wild-type-advanced-colorectal-cancer-100575782","NCT06776757","Sintilimab in Combination with Cetuximab and Chemotherapy As First-line Treatment for RAS\u002FBRAF Wild-type Advanced Colorectal Cancer","Sintilimab in Combination with Cetuximab and Chemotherapy As First-line Treatment for RAS\u002FBRAF Wild-type Advanced Colorectal Cancer: an Open-label, Non-comparative, Phase 1b\u002F2 Dose Escalation and Expansion Trial","Inclusion Criteria:\n\n1.Sign a written informed consent before implementing any trial-related procedures.\n\n2.Age between 18 and 75 years old.\n\n3.No gender restrictions.\n\n4.Histologically or cytologically confirmed inoperable or recurrent metastatic colorectal cancer (AJCC 8th edition, Stage IV).\n\n5.No prior systemic antitumor treatment, or at least 6 months since the completion of adjuvant therapy.\n\n6.At least one measurable lesion as per the RECIST 1.1 criteria for solid tumors.\n\n7.Tumor tissue with both RAS and BRAF mutations being wild-type. 8.Tumor tissue with PD-L1 CPS ≥1, TPS ≥1%, or CD8+ TILs ≥2%. 9.ECOG performance status score of 0 or 1. 10.Expected survival time \\>3 months. 11.Sufficient organ function and bone marrow compensation function are required, and the subjects must meet the following laboratory criteria:\n\n1. .Neutrophil Absolute Count (ANC) ≥ 1.5 x 10\\^9\u002FL, provided that granulocyte colony-stimulating factor has not been used in the past 14 days.\n2. .Platelet count ≥ 90 x 10\\^9\u002FL, provided that no blood transfusion has been received in the past 14 days.\n3. .Hemoglobin \\> 9 g\u002FdL, provided that no blood transfusion or erythropoiesis-stimulating agents have been used in the past 14 days.\n4. .Total bilirubin ≤ 1.5× Upper Limit of Normal (ULN); or total bilirubin \\> ULN but direct bilirubin ≤ ULN.\n5. .Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5× ULN (patients with liver metastasis are allowed to have ALT or AST ≤ ULN).\n6. .Serum creatinine ≤ 1.5× ULN, and creatinine clearance (calculated using the Cockcroft-Gault formula) ≥ 60 ml\u002Fmin.\n7. .Normal coagulation function, defined as International Normalized Ratio (INR) or prothrombin time (PT) ≤ 1.5× ULN.\n8. .Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within the normal range. If baseline TSH is outside the normal range, subjects with normal total T3 (or FT3) and FT4 levels may also be included.\n9. .Normal myocardial enzyme levels (subjects with isolated laboratory abnormalities that the investigator determines to have no clinical significance may still be eligible for inclusion). (Optional) 12.For female subjects of reproductive potential, a urine or serum pregnancy test must be performed within 3 days prior to the first dose of study medication (Cycle 1, Day 1), and the result must be negative. If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Non-reproductive-aged females are defined as those who are at least 1 year postmenopausal or have undergone surgical sterilization or hysterectomy.\n\n13.If there is a risk of pregnancy, all subjects (male and female) must use a contraceptive method with a failure rate of less than 1% throughout the treatment period and for 120 days after the last dose of study drug (or for 180 days after the last dose of chemotherapy).\n\nExclusion Criteria:\n\n1. Previously received chemotherapy, cetuximab, or other anti-EGFR targeted therapies;\n2. Previously received any of the following therapies: anti-PD-L1, anti-PD-L2 drugs, or drugs targeting other stimulatory or co-inhibitory T cell receptors (e.g., CTLA-4, OX-40, CD137) (adjustable);\n3. Symptomatic or high-risk conditions such as obstruction, bleeding, perforation, pneumonia (including non-infectious pneumonia treated with corticosteroids or ongoing pneumonia treatment);\n4. Diagnosed with other malignant diseases outside of colorectal cancer within 5 years prior to the first dose (excluding surgically cured basal cell carcinoma, squamous cell carcinoma of the skin, and\u002For surgically resected carcinoma in situ);\n5. Currently participating in an interventional clinical trial or received other investigational drugs or devices within 4 weeks prior to the first dose;\n6. Received traditional Chinese medicine with antitumor indications or immune-regulating drugs (including thymosin, interferons, interleukins, excluding local use for pleural effusion) as systemic therapy within 2 weeks prior to the first dose;\n7. Experienced an active autoimmune disease requiring systemic treatment (e.g., disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapies (e.g., thyroid hormone, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) are not considered systemic treatments;\n8. Receiving systemic corticosteroid therapy (excluding nasal, inhaled, or other forms of localized corticosteroids) or any other form of immunosuppressive therapy within 7 days prior to the first dose of the study drug. Note: Physiological doses of corticosteroids (≤10 mg\u002Fday of prednisone or equivalent) are allowed;\n9. Received blood transfusion within 7 days prior to the first dose of treatment;\n10. Clinically uncontrolled pleural or peritoneal effusion (patients who do not require drainage or have stable effusion for 3 days after stopping drainage may be enrolled);\n11. Known history of allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;\n12. Known allergy to the study drug, sindilizumab, chemotherapy, targeted drug active ingredients, or excipients;\n13. Presence of multiple factors affecting oral drug absorption (e.g., difficulty swallowing, post-gastrointestinal resection, chronic diarrhea, intestinal obstruction, etc.);\n14. Not fully recovered from toxicity and\u002For complications caused by any previous interventions before starting treatment (i.e., ≤ Grade 1 or back to baseline, excluding fatigue or alopecia);\n15. Known history of HIV infection (i.e., HIV 1\u002F2 antibody positive).\n16. Untreated active hepatitis B (defined as HBsAg positive with detectable HBV-DNA copy numbers greater than the normal value upper limit in the testing laboratory of the research center); Note: Hepatitis B patients who meet the following criteria may also be included:\n\n1).HBV viral load \\\u003C1000 copies\u002Fml (200 IU\u002Fml) before the first dose; the participant should receive anti-HBV treatment throughout the study chemotherapy period to prevent viral reactivation.\n\n2).For participants who are anti-HBc (+), HBsAg (-), anti-HBs (-), and have a negative HBV viral load, prophylactic anti-HBV treatment is not required, but close monitoring for viral reactivation is necessary.\n\n17.Active HCV infection (HCV antibody positive and HCV-RNA level above the detection limit).\n\n18.Vaccination with live vaccines within 30 days before the first dose (Cycle 1, Day 1); Note: An inactivated seasonal flu vaccine is allowed within 30 days prior to the first dose. However, intranasal live attenuated flu vaccines are not permitted.\n\n19.Pregnant or breastfeeding women. 20.Presence of any serious or uncontrolled systemic diseases, such as:\n\n1. .Significant and symptomatic abnormalities in rhythm, conduction, or morphology on resting electrocardiogram that are difficult to control, such as complete left bundle branch block, second-degree or higher heart block, ventricular arrhythmias, or atrial fibrillation;\n2. .Unstable angina, congestive heart failure, or chronic heart failure with New York Heart Association (NYHA) classification ≥ 2.\n3. .History of any arterial thrombosis, embolism, or ischemia within 6 months prior to enrollment, such as myocardial infarction, unstable angina, cerebrovascular accidents, or transient ischemic attacks (TIA), etc.;\n4. .Poorly controlled blood pressure (systolic blood pressure \\> 140 mmHg, diastolic blood pressure \\> 90 mmHg);\n5. .History of non-infectious pneumonia requiring corticosteroid treatment within 1 year prior to the first dose, or currently has clinically active interstitial lung disease;\n6. .Active pulmonary tuberculosis;\n7. .Presence of active or uncontrolled infections requiring systemic treatment;\n8. .Presence of clinically active diverticulitis, intra-abdominal abscess, or gastrointestinal obstruction;\n9. .Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis;\n10. .Poorly controlled diabetes (fasting blood glucose (FBG) \\> 10 mmol\u002FL);\n11. .Urinalysis showing urine protein ≥ ++, and confirmed 24-hour urine protein quantification \\> 1.0 g;\n12. .Presence of psychiatric disorders that prevent the patient from cooperating with the treatment; 21.A history or evidence of diseases that may interfere with the trial results, hinder the subject's full participation in the study, abnormal treatment or laboratory test values, or any other situation the investigator deems unsuitable for inclusion, including potential risks considered by the investigator that would make the participant unsuitable for this study.","75 Years",{"count":19,"type":20},[74,23],"In 2018, global cancer incidence reached 18.1 million new cases, with 9.6 million cancer-related deaths. Colorectal cancer ranked as the third most common malignancy by incidence. Data from the U.S. NIH SEER database indicate a five-year survival rate for colorectal cancer of approximately 65%. Specifically, the survival rate is 90% for localized (non-metastatic) cases, 71% for regional (lymph node metastasis) cases, and only 14% for advanced metastatic cases. According to the China Society of Clinical Oncology (CSCO) guidelines, first-line therapy for advanced colorectal cancer typically involves chemotherapy combined with targeted agents, such as bevacizumab or cetuximab, yielding a median survival of 20-30 months. Prognosis is generally better for RAS wild-type patients compared to those with RAS mutations. In subsequent lines of therapy, chemotherapy combined with targeted therapy results in remission for approximately 22% of patients, although overall survival rarely exceeds 12 months.\n\nBasic research has demonstrated that cetuximab, when combined with chemotherapy, enhances the infiltration of NK cells, cytotoxic T cells, and other immune cells into the tumor microenvironment. In head and neck cancer, an increase in PD-1+ and TIM-3+ tumor-infiltrating lymphocytes (TILs) during cetuximab treatment was negatively correlated with treatment response. Blocking these immune checkpoints may improve cetuximab-based immunotherapy by reversing CD8+ TIL dysfunction, potentially enhancing clinical outcomes. The cetuximab-chemotherapy regimen increases tumor immunogenicity by inducing tumor cell death and antigen release. When combined with immune checkpoint inhibitors, cetuximab may convert \"cold tumors\" into \"hot tumors,\" thus synergistically improving tumor cell elimination. Additionally, cetuximab has been shown to activate tumor-promoting M2 macrophages, particularly CD163-positive macrophages in colorectal cancer, which produce high levels of Fc-γ receptors and PD-L1, supporting the theoretical basis for combining cetuximab with immune checkpoint inhibitors in colorectal cancer treatment.\n\nIn patients with locally advanced colorectal cancer, immune checkpoint inhibitors like PD-1 and CTLA-4 inhibitors have shown preliminary efficacy. The NICHE study reported a 100% pathological response in MSI-H patients and a 27% response in MSS-type patients, indicating potential benefits and safety of immunotherapy in both MSI-H sensitive and MSS\u002FpMMR populations. For first-line treatment of advanced colorectal cancer, the BBCAPX Phase II study showed that sintilimab combined with CapeOX and bevacizumab resulted in an objective response rate (ORR) of 84% and a 100% disease control rate in RAS-mutant, MSS-type metastatic colorectal cancer (mCRC) patients. Similarly, the AIO-KRK-0216 study found that a combination of Avelumab (PD-L1), cetuximab, and chemotherapy produced an ORR of 79.5% in first-line MSS-type metastatic colorectal cancer. In later-line therapy, the REGONIVO Phase II study reported a 36% ORR for PD-1 monoclonal antibody combined with anti-angiogenesis agents (chemotherapy, targeted therapy) in metastatic colorectal cancer, with a 33% ORR for MSS-type patients. The median progression-free survival (PFS) was 7.9 months, though median overall survival (OS) had not been reached.",[101],"Metastatic Colorectal Cancer",[103],"Sintilimab, Cetuximab, Chemotherapy, first-line, mCRC",{"date":83,"type":31},{"date":106,"type":31},"2023-12-25",{"date":108,"type":20},"2025-12-25",{"name":37,"class":38},""]