[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"esophagogastric-juction-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:esophagogastric-juction-cancer":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,49,78],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100639523","phase-2-tafolecimab-combined-with-sintilimab-and-sox-in-the-treatment-of-pmmrmss-gastric-cancer-100639523",false,"NCT07621562","Tafolecimab Combined With Sintilimab and SOX in the Treatment of pMMR\u002FMSS Gastric Cancer","Efficacy and Safety of a PCSK9 Inhibitor (Tafolecimab) Combined With Sintilimab and SOX in the Treatment of pMMR\u002FMSS Gastric Cancer: A Multicenter, Prospective, Single-Arm Exploratory Study","Inclusion Criteria:\n\n1. Fully understood the study and voluntarily signed the Informed Consent Form (ICF);\n2. Aged 18-75 years, male or female;\n3. Histopathologically confirmed pMMR\u002FMSS type gastric\u002Fgastroesophageal junction adenocarcinoma;\n4. Initially unresectable, advanced gastric\u002Fgastroesophageal junction adenocarcinoma;\n5. ECOG performance status 0-1;\n6. Life expectancy exceeding 3 months;\n7. Presence of measurable disease as confirmed by the investigator according to RECIST 1.1 criteria;\n8. Patients currently taking statin lipid-lowering medications must discontinue for ≥4 days before enrollment in this study;\n9. Adequate major organ function meeting the following requirements (laboratory values must meet the following criteria within 7 days before enrollment):\n\n   * Hematology (no transfusion, no granulocyte colony-stimulating factor \\[G-CSF\\], no medication correction within 14 days before screening):\n   * Neutrophils ≥ 1.5 × 10⁹\u002FL;\n   * Platelets ≥ 75 × 10⁹\u002FL;\n   * Hemoglobin ≥ 90 g\u002FL;\n   * Biochemistry (no albumin infusion within 14 days before screening):\n   * Serum creatinine ≤ 1.5 × upper limit of normal (ULN), or creatinine clearance \\> 50 mL\u002Fmin;\n   * Serum total bilirubin ≤ 1.5 × ULN (subjects with Gilbert's syndrome are allowed total bilirubin ≤ 3 × ULN);\n   * Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 × ULN; for subjects with liver metastases, ALT and AST ≤ 5 × ULN;\n\n   Coagulation function:\n\n   \\- International Normalized Ratio (INR) ≤ 2.3 or Prothrombin Time (PT) exceeding normal control by ≤ 6 seconds;\n10. No severe concomitant diseases leading to a life expectancy \\\u003C 5 years;\n11. Agree to provide blood and tissue samples for molecular biology testing;\n12. For patients with active Hepatitis B Virus (HBV) infection: HBV-DNA must be \\\u003C 500 IU\u002FmL (if the study center only uses copy\u002FmL units, must be \\\u003C 2500 copies\u002FmL), and willing to receive antiviral therapy throughout the study period; Hepatitis C Virus (HCV) RNA-positive patients must receive antiviral therapy according to local standard treatment guidelines and have liver function elevations within CTCAE Grade 1;\n13. Within 28 days before enrollment, females of childbearing potential must have a confirmed negative serum pregnancy test and agree to use effective contraception during study drug administration and for 60 days after the last dose. For this protocol, females of childbearing potential are defined as sexually mature women who: 1) have not undergone hysterectomy or bilateral oophorectomy; 2) have not been naturally postmenopausal for at least 24 consecutive months (cancer treatment-induced amenorrhea does not rule out childbearing potential) (i.e., have had menstruation at any time in the preceding 24 consecutive months). Male subjects' female partners of childbearing potential should also follow the above contraceptive requirements.\n\nExclusion Criteria:\n\n1. HER2 positive (IHC 3+, or IHC 2+ with positive in situ hybridization);\n2. EBER positive;\n3. CLDN18.2 positive (≥ 75% of tumor cells with membranous staining of IHC intensity 2+\u002F3+);\n4. Currently participating in other interventional clinical studies;\n5. Low-density lipoprotein cholesterol (LDL-C) controlled below 30 mg\u002FdL (≈ 0.78 mmol\u002FL);\n6. History of allergic reaction to PCSK9 inhibitors;\n7. Concurrent other active malignancy within the last 5 years besides gastric\u002Fgastroesophageal junction adenocarcinoma that has not recovered; Patients preparing for or having previously received organ or allogeneic bone marrow transplantation;\n8. Received major surgery (excluding diagnostic) within 4 weeks before start of study treatment or expected to require major surgery during the study (excluding radical gastrectomy);\n9. Currently have interstitial pneumonia or interstitial lung disease, or a history of interstitial pneumonia or interstitial lung disease requiring steroid therapy, or other pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), pneumoconiosis, drug-related pneumonia, idiopathic pneumonia that might interfere with the judgment and management of immune-related pulmonary toxicity, or evidence of active pneumonitis on chest computed tomography (CT) scan during the screening period, or severely impaired pulmonary function.Subjects with radiation pneumonitis in the radiation field are allowed; active tuberculosis;\n\n11\\. Presence of active autoimmune disease or a history of autoimmune disease that may recur (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism \\[subjects controlled by hormone replacement therapy alone can be included\\]); subjects with skin diseases not requiring systemic treatment such as vitiligo, psoriasis, alopecia, controlled Type I diabetes mellitus receiving insulin therapy, or childhood asthma that has completely resolved and requires no intervention in adulthood can be included; asthma patients requiring bronchodilators for medical intervention cannot be included; 12. History of uncontrolled epilepsy, central nervous system disease, or mental disorders, judged by the investigator as to whether clinical severity interferes with signing informed consent or affects patient compliance with medication; 13. Clinically significant (i.e., active) heart disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) Class II or more severe congestive heart failure, or severe arrhythmia requiring medical intervention, or history of myocardial infarction within the last 12 months; 14. Severe uncontrolled recurrent infections, or other severe uncontrolled concomitant diseases; 15. Allergy or contraindication to the components of the study drugs (PCSK9 inhibitor, PD-1 monoclonal antibody, or chemotherapeutic agents); 16. Prior receipt of any anti-tumor therapy for gastric\u002Fgastroesophageal junction adenocarcinoma, including radiotherapy, chemotherapy, systemic therapy, etc.; 17. Use of immunosuppressants or systemic hormone therapy for immunosuppressive purposes (dose \\> 10 mg\u002Fday prednisone or equivalent) within 14 days before the start of study treatment; 18. Patients with congenital or acquired immunodeficiency (e.g., HIV infection); 19. Co-infection with Hepatitis B and Hepatitis C; 20. Prior receipt of other anti-PD-1 antibody therapy or other immunotherapy targeting PD-1\u002FPD-L1, or prior receipt of PCSK9 monoclonal antibody therapy; 21. Receipt of live attenuated vaccine within 28 days before start of study treatment, or expected need for such vaccination during PD-1 monoclonal antibody treatment or within 60 days after the last dose of PD-1 monoclonal antibody; 22. Receipt of investigational drug (i.e., participating in another trial), anti-tumor cytotoxic drug therapy, biological drug therapy (e.g., monoclonal antibodies), immunotherapy (e.g., interleukin-2 or interferon) within 4 weeks before study enrollment; 23. Judged by the investigator, patients have other factors that may affect the study results or lead to premature termination of the study, such as alcoholism, drug abuse, other severe diseases (including mental illness) requiring concurrent treatment, severe laboratory abnormalities, family or social factors, etc., that might affect subject safety or compliance; 24. Subjects with active tuberculosis (TB), receiving anti-tuberculosis treatment, or having received anti-tuberculosis treatment within 1 year before screening; 25. Pregnant or breastfeeding women.","ALL","18 Years","75 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Background:\n\nGastric cancer remains a significant health burden globally, particularly in China, where the majority of patients present with advanced disease at diagnosis. While immune checkpoint inhibitors (ICIs) targeting PD-1 have revolutionized treatment for various malignancies, their efficacy in proficient mismatch repair (pMMR) or microsatellite stable (MSS) gastric cancer-which constitutes over 85% of cases-remains limited. Recent Phase III trials (CheckMate 649, ATTRACTION-04, Orient-16) have demonstrated that combining PD-1 inhibitors with chemotherapy improves outcomes in advanced gastric cancer, leading to approved indications. However, the benefit in pMMR\u002FMSS populations is modest, highlighting an urgent need for novel combination strategies to overcome immunotherapy resistance.\n\nPreclinical research published in Nature (Liu et al., 2020) revealed that inhibiting PCSK9 (Proprotein Convertase Subtilisin\u002FKexin type 9)-a key regulator of cholesterol metabolism-can potentiate immune checkpoint therapy through a novel mechanism independent of its lipid-lowering function. PCSK9 inhibition was shown to increase tumor cell surface expression of MHC class I molecules by preventing their lysosomal degradation, thereby enhancing tumor antigen presentation and promoting cytotoxic T lymphocyte infiltration. This mechanistic insight suggests that combining a PCSK9 inhibitor with PD-1 blockade could synergistically improve antitumor immunity, particularly in immunologically \"cold\" tumors like pMMR\u002FMSS gastric cancer.\n\nTafolecimab is the first domestically developed fully humanized PCSK9 monoclonal antibody approved in China for hypercholesterolemia, with a favorable safety profile and extended half-life. Based on this strong preclinical rationale and the established efficacy of PD-1 plus chemotherapy in gastric cancer, this investigator-initiated trial aims to clinically translate the concept of PCSK9 inhibition as an immunomodulatory strategy.\n\nStudy Population:\n\nThis study will enroll 30 patients with the following key eligibility criteria:\n\nInclusion: Adults aged 18-75 years with histologically confirmed pMMR\u002FMSS gastric or gastroesophageal junction adenocarcinoma; initially unresectable or advanced disease (including metastatic); ECOG performance status 0-1; measurable disease per RECIST v1.1; adequate organ function.\n\nExclusion: HER2-positive, EBER-positive, or CLDN18.2-positive tumors; prior systemic anticancer therapy for advanced disease; active autoimmune disease requiring immunosuppression; uncontrolled intercurrent illness; LDL-C \\\u003C30 mg\u002FdL; history of PCSK9 inhibitor allergy; prior exposure to anti-PD-1\u002FPD-L1 or PCSK9-targeted therapies.\n\nStudy Objectives:\n\nThis is a multicenter, prospective, single-arm exploratory trial with a safety run-in phase (first 6 patients monitored for dose-limiting toxicities). The treatment regimen consists of:\n\nSintilimab (PD-1 inhibitor): 200 mg IV, day 1, every 3 weeks (Q3W) Tafolecimab (PCSK9 inhibitor): 300 mg subcutaneous injection, day 1, Q3W (dose reduction to 150 mg if DLTs occur) SOX chemotherapy: Oxaliplatin 130 mg\u002Fm² IV, day 1 + S-1 40 mg\u002Fm² orally twice daily, days 1-14, Q3W cycles Treatment continues until disease progression, unacceptable toxicity, or withdrawal of consent.\n\nPrimary Endpoint:\n\nObjective Response Rate (ORR) assessed by RECIST v1.1\n\nSecondary Endpoints:\n\nProgression-Free Survival (PFS) Disease Control Rate (DCR) Conversion surgery rate and R0 resection rate Pathological Complete Response (pCR) and Major Pathological Response (MPR) rates in resected patients Overall Survival (OS) Safety and tolerability (incidence of TRAEs, ≥Grade 3 AEs, irAEs per CTCAE v5.0)\n\nExploratory Endpoints:\n\nAssociation between tumor biomarkers (including PD-L1 CPS, H. pylori infection status, and tumor PCSK9 expression) and treatment efficacy Multi-omics analyses using paired pre- and post-treatment tumor tissue, peripheral blood, and fecal samples\n\nSample Size and Duration:\n\nA fixed sample size of 30 patients will be recruited over approximately 12 months, with survival follow-up extending to 36 months. This exploratory study is designed to generate preliminary efficacy and safety signals to inform future larger-scale investigations. The safety run-in design ensures close monitoring for potential additive toxicities, particularly given the novel combination of PCSK9 inhibition with immunotherapy and chemotherapy.",[27,28,29],"Gastric Adenocarcinoma","Esophagogastric Juction Cancer","Proficient Mismatch Repair",[31,32,33,34,35],"Gastric adenocarcinoma","Esophagogastric junction cancer","Proficient mismatch repair","Tafolecimab","Sintilimab","NOT_YET_RECRUITING","2026-05-27",{"date":39,"type":40},"2026-06-02","ACTUAL",{"date":42,"type":21},"2026-06-05",{"date":44,"type":21},"2030-09-01",{"name":46,"class":47},"First Affiliated Hospital of Zhejiang University","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":48},"100425581","phase-3-neoadjuvant-treatment-modalities-in-esophageal-cancer-100425581","NCT04821843","Neoadjuvant Treatment Modalities in Esophageal Cancer","Cohort Study of Neoadjuvant Treatment Modalities for Esophageal Cancer","Inclusion Criteria:\n\n* ≥18 years；\n* Esophageal or Esophagogastric cancer；\n* Histologically proven squamous cell carcinoma or adenocarcinoma in patients staged as I-IVa (AJCC 8th)；\n* Primary treatment performed in Cancer Hospital, Chinese Academy of Medical Sciences；\n* ECOG PS score: 0\\~1；\n* Estimated survival time ≥3 months；\n* Normal organ and marrow function as defined below:Hemoglobin: greater than or equal to 100g\u002FL ;Leukocytes: greater than or equal to 4,000 G\u002FL; Neutrophil: greater than or equal to 2,000 G\u002FL; Platelets: greater than or equal to 100,000\u002Fmm3 ; Creatinine: less than or equal to 1.5 times the upper limit or CCR greater than or equal to 60 ml\u002Fmin; AST\u002FALT: less than or equal to 2.5 times the upper limit; Total bilirubin: less than or equal to 1.5 times the upper limit; INR: less than or equal to 1.5 times the upper limit; APTT: less than or equal to 1.5 times the upper limit; PT: less than or equal to 1.5 times the upper limit；\n* Informed consent；\n\nExclusion Criteria:\n\n* With any distant metastasis out of regional lymphatic drainage or in liver, lung, bone, CNS, etc；\n* Patients with other cancer history in 5 years except cervical carcinoma in situ and non-malignant melanoma skin cancer；\n* Existing active infection such as active tuberculosis and hepatitis；\n* History of myocardial infarction within the past 6 months or history of ventricular arrhythmia；\n* Uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness History of allergic reactions attributed to paclitaxel, albumin or cisplatin；\n* Participation in other clinical trials currently or within 4 weeks of selection；\n* Pregnant or lactating females；\n* Absence of medical records.",{"count":57,"type":21},2000,[59],"PHASE3","Esophageal cancer is the most prevalent cancer globally with poor survival outcome. The prognosis with surgery alone is poor, accounting for 30-40% of overall survival at 5 year. Either neoadjuvant chemotherapy (nCT) or chemoradiotherapy (nCRT) has been shown as efficatious therapy to improve patients outcomes in esophageal or esophagogastric junction cancer as compared with surgery alone. The purpose of this study was to explore the optimal neoadjuvant treatment modalities including PD-1\u002FPD-L1 antibody or targeted drug for patients with esophageal or esophagogastric junction cancer.",[62,63,64,65,66,67,28],"Esophageal Cancer","Chemotherapy Effect","Chemoradiation","Surgery","Targeted Therapy","Immunotherapy","RECRUITING","2026-01-18",{"date":71,"type":40},"2026-01-21",{"date":73,"type":40},"2002-01-01",{"date":75,"type":21},"2030-12-31",{"name":77,"class":47},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences",{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":22,"phases":87,"briefSummary":89,"conditions":90,"keywords":94,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":109},"100576305","phase-1-a-first-in-human-escalation-and-expansion-study-of-patients-with-advanced-solid-tumors-100576305","NCT06783569","A First-in-Human Escalation and Expansion Study of Patients With Advanced Solid Tumors","A First-in-Human, Open-Label, Dose Escalation and Expansion Study of JR8603 in Patients With Advanced Solid Tumors","Inclusion Criteria\n\nPatients who meet ALL the following inclusion criteria will be eligible to participate in the study:\n\n1. ≥18 years of age.\n2. Histologically confirmed, locally advanced, or metastatic solid tumor which has progressed on, or patients intolerant to, all standard therapy, or no standard therapy available, or it is documented that the therapy is refused by the patient.\n3. Measurable disease per RECIST v1.1.\n4. Life expectancy ≥3 months.\n5. Adequate organ and bone marrow function defined by:\n\n   1. Absolute neutrophil count (ANC) ≥1.5 × 109\u002FL (≥1500\u002Fmm3)\n   2. Platelet count ≥100 × 109\u002FL (≥100,000\u002Fmm3) (no platelet transfusion within 14 days prior to enrollment)\n   3. Total bilirubin ≤1.5 × upper limit of normal (ULN), unless known Gilbert syndrome (≤3 × ULN) has been diagnosed\n   4. AST and ALT ≤2.5 × ULN or ≤5 × ULN for patients with known liver metastases\n   5. Estimated creatinine clearance by the Cockcroft-Gault or estimated glomerular filtration rate (eGFR) of ≥60 mL\u002Fmin\n   6. International Normalized Ratio (INR), prothrombin time (PT), and activated partial thromboplastin time (aPTT) ≤1.5 × ULN. If a patient is receiving anticoagulant therapy, PT and aPTT must be within therapeutic range of intended use of anticoagulants\n6. Patients with treated, stable central nervous system (CNS) metastases (including leptomeningeal carcinomatosis) are allowed if there is no evidence of progression for at least 4 weeks after CNS-directed treatment as ascertained by clinical examination and brain imaging.\n7. Resolution of any clinically significant toxic effects of prior therapy to Grade ≤1 according to the NCI CTCAE v5.0 (exception of alopecia and Grade 2 peripheral neuropathy).\n8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n9. Willingness of men and women of reproductive potential to observe conventional and effective birth control methods with failure rates of \\\u003C1% for the duration of treatment and for at least 6 months for women and at least 3 months for men following the last dose of study treatment (this must include a barrier method such as condom or diaphragm with spermicidal gel). Women of reproductive potential are defined as following menarche and who are not postmenopausal (and 2 years of nontherapy-induced amenorrhea or surgically sterile). For male patients with a nonpregnant female partner of childbearing potential and a woman of childbearing potential, 1 of the following highly effective birth control methods with a failure rate of less than 1% per year when used consistently and correctly are recommended:\n\n   1. Combined estrogen and progestin containing hormonal contraception associated with inhibition of ovulation given orally, intravaginally, or transdermally\n   2. Progestin-only hormonal contraception associated with inhibition of ovulation given orally, by injection, or by implant\n   3. Intrauterine device\n   4. Intrauterine hormone-releasing system\n   5. Bilateral tubal occlusion\u002Fligation\n   6. Vasectomized partner\n   7. Sexual abstinence Note: Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study drug. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the patient. Birth control methods unacceptable for this study include the following:\n\n   \u003C!-- -->\n\n   1. Periodic abstinence (calendar, symptothermal, or post-ovulation methods)\n   2. Withdrawal (coitus interruptus)\n   3. Spermicide only\n   4. Lactational amenorrhea method Egg and sperm donation or banking is prohibited during the duration of participation on this protocol and for 90 days after the last dose of study drug. 10. A negative serum pregnancy test at screening and a negative (serum or urine) pregnancy test within 72 hours before the first dose of study drug (female patients of childbearing potential only). If the urine test is positive or cannot be confirmed negative, a serum pregnancy test will be required and must be negative for the patient to be eligible.\n\n11\\. Willing and able to provide informed consent and comply with protocol requirements for the duration of the study.\n\nSpecific Inclusion Criteria for Expansion Cohorts:\n\nTo be eligible during the dose expansion part of the study, patients must meet 1 of the following 2 criteria:\n\nExpansion Cohort 1: Documented locally advanced or metastatic gastric or\n\nEGJ cancer which has progressed on or after standard therapy or patient is intolerant to standard therapy or patient refuses therapy. Standard therapy options are described in (Wang,2024):\n\n* Prior systemic standard therapy for patients with HER2-positive gastric or EGJ cancer should include trastuzumab plus chemotherapy (fluorouracil plus platinum), mono-chemotherapy (eg., paclitaxel, docetaxel, irinotecan), and other monotherapy (eg., VEGF targeted agents, anti-PD-1 or PD-L1).\n* Prior system standard therapy for patients with HER2-negative gastric or EGJ cancer should include fluorouracil plus platinum or in combination with anti-PD-1, mono-chemotherapy (eg., paclitaxel, docetaxel, irinotecan) and VEGF targeted therapy.\n\nExpansion Cohort 2: Documented locally advanced or metastatic colorectal cancer which has progressed on or after standard therapy or patient is intolerant to standard therapy, or patient refuses therapy. Standard treatment options are described in (Association NHCOTPROCSOOCM,2023):\n\n* Prior systemic standard therapy for patients with MMR-deficient (dMMR)\u002Fmicrosatellite instability-high (MSI-H): pembrolizumab for 1st line therapy, no standard therapy for 2nd and 3rd line therapy.\n* Prior system standard therapy for patients with microsatellite stability (MSS) or microsatellite instability-low (MSI-L)\u002Fproficient mismatch repair (pMMR), RAS and BRAF wild-type (WT) should include cetuximab or bevacizumab monotherapy or in combination with FOLFOX\u002FFOLFIRI\u002FCAPEOX, and monotherapy (eg., regorafenib, fruquintinib, trifluridine tipiracil).\n* Prior system standard therapy for patients with MSS or MSI-L\u002FpMMR, RAS and BRAF mutation: should include bevacizumab monotherapy or in combination with FOLFIRI, and monotherapy (eg., regorafenib, fruquintinib, trifluridine tipiracil).\n\nExclusion Criteria Patients who meet any of the following exclusion criteria will be excluded from participation in the study:\n\n1. Any condition that in the opinion of the Investigator would place the patient at an unacceptable risk or cause the patient to be unlikely to fully participate or comply with study procedures.\n2. Received systemic anticancer chemotherapy, targeted agents, antibody therapy for cancer, immunotherapy for cancer, hormonal therapy, or an investigational agent within 2 weeks or 5 half-lives (whichever is shorter) prior to start of study drug treatment.\n3. Major surgery within 3 weeks prior to start of study drug treatment.\n4. Radiation therapy within 4 weeks prior to start of study drug treatment (palliative radiation or stereotactic radiosurgery within 7 days prior to start of study drug treatment). Patients must have recovered from all acute radiotherapy-related toxicities.\n5. Severe or unstable cardiac conditions including, but not limited to, congestive heart failure (New York Heart Association Class III or IV), ischemic heart disease, uncontrolled hypertension, uncontrolled cardiac arrhythmia requiring medication (Grade ≥2, according to NCI CTCAE v5.0), myocardial infarction within 6 months prior to starting study drug treatment, congenital long QT syndrome or QT interval corrected for heart rate using Fridericia's formula (QTcF) \\>470 msec at screening, and any other significant or unstable concurrent cardiac illness.\n6. Severe or unstable medical condition including uncontrolled diabetes or unstable psychiatric condition.\n7. Has a history of another active malignancy (a second cancer) within the previous 2 years except for localized cancers that are not related to the current cancer being treated, are considered cured, and, in the opinion of the Investigator, present a low risk of recurrence. These exceptions include, but are not limited to, basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.\n8. Active infection requiring systemic therapy (including asymptomatic infections with positive virus titers and the Investigator's judgment that worsening of the condition is likely with study drug or the condition will impair or prohibit a patient's participation in the study).\n9. Known human immunodeficiency virus, hepatitis B virus (HBV) (i.e., hepatitis B surface antigen positive), or hepatitis C virus (HCV) (i.e., detectable HCV ribonucleic acid \\[RNA\\]). Note: Patients with a prior history of treated HBV infection who are antigen negative, patients with a prior history of treated HCV infection who are HCV RNA undetectable, or patients with HIV who are on stable anti-retroviral therapy and have an undetectable viral load may be enrolled.\n10. Pregnant (or intending to become pregnant) or breastfeeding.",{"count":86,"type":21},94,[88],"PHASE1","The goal of this clinical trial is to learn if the investigational drug (JR8603) is safe and effective in treating patients with solid tumors after their initial rounds of treatment with other drugs did not work.",[91,92,28,93],"Solid Tumors","Gastric Cancer","Colorectal Cancer",[95,96,97,98],"locally advanced solid tumors","metastatic solid tumors","intolerant to standard therapies","Mitomycin C","2025-09-02",{"date":101,"type":40},"2025-09-09",{"date":103,"type":40},"2024-12-31",{"date":105,"type":21},"2026-07",{"name":107,"class":108},"JiaRay Group","INDUSTRY",2]