[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100622260":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":64,"centralContacts":69,"locations":75,"responsibleParty":87,"collaborators":73,"id":90,"slug":91,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":92,"sex":98,"minAge":99,"maxAge":100,"enrollmentInfo":101,"targetDuration":73,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":111,"overallStatus":116,"whyStopped":73,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"Sixth Affiliated Hospital, Sun Yat-sen University","OTHER",[8,18],{"label":9,"type":10,"description":11,"interventionNames":12},"H101 + SBRT + PD-1 Antibody + Targeted Therapy + Chemotherapy","EXPERIMENTAL","The treatment regimen is administered sequentially as follows. Following stereotactic body radiotherapy (SBRT), a peritumoral injection of H101 is administered one week later. Three days after the H101 injection, combination therapy with chemotherapy and the PD-1 monoclonal antibody is initiated. This is followed by four cycles of a combined regimen consisting of peritumoral H101 injection, PD-1 monoclonal antibody, chemotherapy, and targeted therapy, with each cycle administered every 21 days.",[13,14,15,16,17],"Radiation: SBRT","Drug: PD-1 Antibody","Drug: H101","Drug: Target Therapy","Combination Product: Chemotherapy",{"label":19,"type":20,"description":21,"interventionNames":22},"Folfiri + Targeted Therapy","ACTIVE_COMPARATOR","Patients will receive four cycles of the FOLFIRI chemotherapy regimen combined with targeted therapy selected based on genetic testing results, with each cycle administered every 21 days.",[16,23],"Combination Product: FOLFIRI",[25,32,39,45,51,58],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"RADIATION","SBRT","Stereotactic Body Radiotherapy",[9],[31],"stereotactic body radiotherapy",{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"DRUG","PD-1 Antibody","PD-1 Antibody every 21 days",[9],[38],"PD-1 Monoclonic Antibody",{"type":33,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"H101","Peritumoral Injection of oncolytic virus (H101)",[9],[44],"oncolytic virus",{"type":33,"name":46,"description":47,"armGroupLabels":48,"otherNames":49},"Target Therapy","Targeted agents selected based on genetic testing results",[19,9],[50],"Target agents",{"type":52,"name":53,"description":54,"armGroupLabels":55,"otherNames":56},"COMBINATION_PRODUCT","FOLFIRI","FOLFIRI is a standard biweekly chemotherapy regimen for metastatic colorectal cancer. It consists of irinotecan, leucovorin, and fluorouracil (5-FU) administered sequentially over a 46-hour infusion period per cycle.",[19],[57],"irinotecan, leucovorin, and fluorouracil",{"type":52,"name":59,"description":60,"armGroupLabels":61,"otherNames":62},"Chemotherapy","Fluorouracil-based chemotherapy regimens, such as FOLFOX, CAPOX, or FOLFIRI.",[9],[63],"Fluorouracil-based chemotherapy",[65],{"name":66,"affiliation":67,"role":68},"Jun Huang","Sun Yat-sen University","PRINCIPAL_INVESTIGATOR",[70],{"name":66,"role":71,"phone":72,"phoneExt":73,"email":74},"CONTACT","+86-13926451242",null,"huangj97@mail.sysu.edu.cn",[76],{"facility":5,"status":73,"city":77,"state":78,"zip":73,"country":79,"countryCode":80,"cosmosGeoPoint":81,"geoPoint":86,"contacts":73},"Guangzhou","Guangdong","China","CN",{"type":82,"coordinates":83},"Point",[84,85],113.25,23.11667,{"lat":85,"lon":84},{"type":88,"investigatorFullName":66,"investigatorTitle":89,"investigatorAffiliation":5,"oldNameTitle":73,"oldOrganization":73},"SPONSOR_INVESTIGATOR","Professor","100622260","phase-2-oncolytic-virus-h101--sbrt--chemotherapy--targeted-therapy--immunotherapy-for-unresectable-crlm-100622260",false,"NCT07381309","Oncolytic Virus (H101) + SBRT + Chemotherapy + Targeted Therapy + Immunotherapy for Unresectable CRLM","Oncolytic Virus (H101) Peritumoral Injection Combined With SBRT, Chemotherapy, Targeted Therapy, and Immunotherapy for Unresectable MSS\u002FpMMR Colorectal Cancer Liver Metastases (CRLM)","VVSHIP","Inclusion Criteria:\n\n1. The patient or their legal representative understands and signs the informed consent form.\n2. Patients with pMMR\u002FMSS colorectal adenocarcinoma.\n3. Aged 18-75 years.\n4. Patients with histologically or cytologically confirmed colorectal cancer liver metastases. There must be at least one injectable lesion in the liver, which must also meet the criteria for a measurable target lesion according to RECIST version 1.1 (≥10 mm in the longest diameter on spiral CT\u002FMRI scan with a slice thickness of no greater than 5 mm).\n5. Patients with definitively unresectable metachronous liver metastases; OR patients deemed surgically resectable but who refuse surgery, provided the liver metastases meet the following requirements: ① The number of metastatic lesions must be no more than 5, and the sum of the longest diameters of all metastatic lesions must be ≤100 mm; ② The longest diameter of a single lesion must be ≤100 mm; ③ The longest diameter of the lesion to be injected must be ≥10 mm and ≤80 mm.\n6. The liver metastases have not received prior radiotherapy, OR the area of the liver near the planned radiotherapy site has not been previously irradiated. At least 700 cc of liver volume must be preserved outside the treatment area.\n7. Prior treatments such as hepatic resection, systemic chemotherapy, local ablation therapy, or hepatic artery infusion pump chemotherapy are allowed, provided a washout period of 2 weeks is observed. Patients must have recovered from prior anti-tumor therapy-related adverse events to baseline or Grade ≤1 (according to CTCAE version 5.0) (excluding alopecia and Grade 2 anemia).\n8. Child-Pugh score A or B\n9. ECOG Performance Status 0-1\n10. Peripheral blood counts and liver\u002Frenal function within the allowable ranges (tested within 15 days before treatment initiation)\n11. No prior history of other concomitant malignancies. Patients must not be pregnant or breastfeeding and should use effective contraception during the study and for 6 months after the last dose.\n12. Life expectancy ≥6 months.\n\nExclusion Criteria:\n\n1. Synchronous colorectal cancer liver metastases.\n2. Active hepatitis, cirrhosis, or Child-Pugh class C.\n3. Extralepatic metastases to: central nervous system \u002F bone marrow \u002F brain (UICC 8th edition).\n4. Liver metastases not measurable.\n5. Prior history of oncolytic virus therapy (e.g., T-VEC).\n6. Liver metastases not meeting the requirements for peritumoral injection volume or unsuitable for peritumoral injection.\n7. History of severe drug allergy (e.g., to oncolytic adenovirus, PD-1 monoclonal antibody, platinum agents, 5-FU, leucovorin, 5-HT3 receptor antagonists, bevacizumab, etc.).\n8. Antiviral therapy (e.g., acyclovir, ganciclovir, valacyclovir, vidarabine) within 4 weeks prior to the first dose of study treatment.\n9. Participation in another clinical trial within 4 weeks or ongoing participation.\n10. History of prior therapy targeting PD-1, PD-L1, PD-L2, CTLA-4, or any other T-cell co-stimulation or checkpoint pathway.\n11. Severe electrolyte abnormalities.\n12. Significant portal hypertension: history of upper gastrointestinal bleeding or severe hypersplenism.\n13. Arterial or deep venous thrombosis within the past 6 months; history or evidence of bleeding tendency within the past 2 months.\n14. Pregnant or breastfeeding women, or women with a positive pregnancy test before the first dose; or female participants and their partners unwilling to use strict contraception during the study.\n15. Active autoimmune disease requiring systemic treatment (e.g., immunomodulators, corticosteroids, immunosuppressants) within the past 2 years.\n16. Past or current other active malignancies (except malignancies cured \\>3 years ago or carcinoma in situ treated curatively).\n17. Severe ECG abnormalities; active coronary artery disease, severe\u002Funstable angina, newly diagnosed angina, or myocardial infarction within 12 months; New York Heart Association (NYHA) class II or higher congestive heart failure.\n18. Active infection (with fever \\>38°C).\n19. Poorly controlled hypercalcemia, hypertension, or diabetes.\n20. Severe pulmonary disease (interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc.).\n21. Psychiatric disorder affecting clinical treatment or history of central nervous system disease.\n22. Severe complications (intestinal obstruction, renal insufficiency, hepatic insufficiency, cerebrovascular disorders, etc.).\n23. Persistent toxicity ≥ Grade 2 (CTCAE v5.0) from prior therapy (except anemia, alopecia, skin pigmentation).\n24. Use of any other investigational drug or participation in another interventional trial within 14 days prior to study treatment.\n25. Pregnant, breastfeeding, or planning pregnancy during the study; men or women unwilling to use effective contraception.\n26. Any unstable medical condition that may affect patient safety or compliance, as judged by the investigator to be unsuitable for the trial.","ALL","18 Years","75 Years",{"count":102,"type":103},114,"ESTIMATED","INTERVENTIONAL",[106],"PHASE2","This prospective study aims to investigate the efficacy and safety of peritumoral injection of the oncolytic virus H101 in combination with stereotactic body radiotherapy (SBRT), PD-1 monoclonal antibody, chemotherapy, and targeted therapy for the treatment of patients with unresectable, microsatellite stable\u002Fmismatch repair proficient (MSS\u002FpMMR) colorectal adenocarcinoma liver metastases. The ultimate goal is to provide high-level evidence-based medical support for this combined modality approach.",[109,110],"CRC","Liver Metastasis Colon Cancer",[112,113,114,115],"Stereotactic body radiation therapy","Targeting Therapy","PD-1 Monoclonal Antibody","Oncolytic Virus","NOT_YET_RECRUITING","2026-04-22",{"date":119,"type":120},"2026-04-28","ACTUAL",{"date":122,"type":103},"2026-06-01",{"date":124,"type":103},"2029-02-01",{"name":66,"class":6},1]