[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Jun Huang\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":104},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,74],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100577114","phase-3-sbrt--pd-1-monoclonal-antibody-in-unresectable-colorectal-liver-metastases-100577114",false,"NCT06794086","SBRT + PD-1 Monoclonal Antibody in Unresectable Colorectal Liver Metastases","SBRT Combined With PD-1 Monoclonal Antibody in Unresectable Colorectal Liver Metastases: A Prospective, Multicenter, Single-arm, Phase II Clinical Study (SPARKLE-L)","SPARKLE-L","Inclusion Criteria:\n\n1. Written informed consent, voluntarily signed and dated by the subject, must be obtained in accordance with regulatory and institutional guidelines before any procedures related to the study protocol that are not part of routine care are performed.\n2. Patients with pMMR\u002FMSS colorectal adenocarcinoma;\n3. Age 18-75 years;\n4. Patients with histologically or cytologically confirmed colorectal cancer liver metastasis, with or without extrahepatic oligometastatic lesions, who are deemed by the hepatobiliary surgeon within the multidisciplinary team (MDT) to be ineligible for upfront R0 resection of liver metastases (unresectability is defined as one or more of the following conditions: ① Involvement of both left and right branches of the portal vein at the first hepatic hilum; ② Involvement of ≥2 hepatic veins at the second hepatic hilum; ③ No indication for upfront R0 resection\u002Fablation after MDT discussion);\n5. Liver metastases are measurable by imaging (based on RECIST 1.1 criteria), with a maximum diameter of ≤6 cm;\n6. Patients who have not previously received radiotherapy for liver metastases, or whose liver tissue near the planned irradiation site has not been previously irradiated, and who have at least 700 cc of liver volume outside the treatment area;\n7. Previous hepatectomy, systemic chemotherapy, or local ablation therapy, or hepatic arterial infusion pump chemotherapy is allowed, with a washout period of 2 weeks;\n8. Child-Pugh score Class A ;\n9. ECOG performance status 0-1;\n10. Peripheral blood counts and liver and renal function within allowable ranges (tested within 15 days before the start of treatment);\n11. No history of other malignancies, not pregnant or breastfeeding, and effective contraception should be used during the study period and for 6 months after the last dose;\n12. Life expectancy of ≥6 months.\n\nExclusion Criteria:\n\n1. Active hepatitis, cirrhosis, or Child-Pugh score Class B or C;\n2. Extrahepatic metastases: bone or brain metastases, or ≥3 unresectable lung metastases (according to the 8th edition of the UICC);\n3. Unmeasurable liver metastases;\n4. History of severe drug allergies (including allergies to platinum agents, 5-FU, LV, and 5-HT3 receptor antagonists);\n5. Patients who have participated in or are currently participating in other clinical trials within the past 4 weeks;\n6. History of prior treatment with anti-PD-1, PD-L1, PD-L2, CTLA-4, or any other specific T-cell costimulatory or checkpoint pathway-targeted therapies;\n7. Severe electrolyte abnormalities;\n8. Presence of gastrointestinal diseases, such as active gastric or duodenal ulcers, ulcerative colitis, or unresected tumors with active bleeding; or other conditions that may lead to gastrointestinal bleeding or perforation (Note: Gastrointestinal fistulas that have not healed after surgical treatment, such as rectovesical, rectourethral, or rectovaginal fistulas, are exclusionary unless a stoma has been created and there are no active symptoms);\n9. History of arterial thrombosis or deep vein thrombosis within 6 months; history of bleeding or evidence of bleeding tendency within 2 months;\n10. Pregnant or breastfeeding women, or women of childbearing potential with a positive pregnancy test before the first dose; or female participants unwilling to strictly practice contraception during the study, as well as their partners;\n11. Patients with active autoimmune deficiency diseases requiring systemic treatment within the past 2 years (i.e., use of immunomodulators, corticosteroids, or immunosuppressive drugs);\n12. Presence of other active malignancies (except for malignancies that have been treated with curative intent and have been disease-free for over 3 years, or in situ cancers that can be cured with adequate treatment);\n13. Presence of severe ECG abnormalities or active coronary artery disease within 12 months before study entry, severe\u002Funstable angina, newly diagnosed angina or myocardial infarction, or New York Heart Association (NYHA) Class II or higher congestive heart failure;\n14. Patients with active infections (fever above 38°C due to infection);\n15. Patients with poorly controlled hypercalcemia, hypertension, or diabetes;\n16. Patients with severe pulmonary diseases (interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc.);\n17. Patients with psychiatric disorders affecting clinical management or a history of central nervous system diseases;\n18. Patients with severe complications (intestinal obstruction, renal insufficiency, hepatic insufficiency, cerebrovascular disorders, etc.);\n19. Presence of any CTCAE Grade 2 or higher toxicity from prior treatments that has not resolved (except for anemia, alopecia, and skin pigmentation);\n20. Any unstable medical condition that may affect patient safety or compliance with the study;\n21. Patients deemed by the investigator to be unsuitable for participation in this clinical trial.","ALL","18 Years","75 Years",{"count":21,"type":22},24,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","To explore the efficacy and safety of stereotactic body radiation therapy (SBRT) combined with PD-1 monoclonal antibody in the treatment of unresectable colorectal cancer liver metastasis through a prospective study, providing high-level evidence-based medical evidence for the use of SBRT combined with PD-1 inhibitors in the treatment of unresectable colorectal cancer liver metastasis.",[28,29],"Colorectal Cancer","Liver Metastases",[31,32],"Stereotactic body radiation therapy","PD-1 Monoclonal Antibody","RECRUITING","2026-06-29",{"date":36,"type":37},"2026-06-30","ACTUAL",{"date":39,"type":37},"2025-04-10",{"date":41,"type":22},"2027-01-20",{"name":43,"class":44},"Jun Huang","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":58,"conditions":59,"keywords":62,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":45},"100622260","phase-2-oncolytic-virus-h101--sbrt--chemotherapy--targeted-therapy--immunotherapy-for-unresectable-crlm-100622260","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.",{"count":55,"type":22},114,[57],"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.",[60,61],"CRC","Liver Metastasis Colon Cancer",[31,63,32,64],"Targeting Therapy","Oncolytic Virus","NOT_YET_RECRUITING","2026-04-22",{"date":68,"type":37},"2026-04-28",{"date":70,"type":22},"2026-06-01",{"date":72,"type":22},"2029-02-01",{"name":43,"class":44},{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":23,"phases":85,"briefSummary":86,"conditions":87,"keywords":90,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":45},"100576916","phase-3-mfolfox6--bevacizumab--pd-1-monoclonal-antibody-vs-mfolfox6-in-locally-advanced-pmmrmss-crc-100576916","NCT06791512","mFOLFOX6 + Bevacizumab + PD-1 Monoclonal Antibody Vs. mFOLFOX6 in Locally Advanced pMMR\u002FMSS CRC","mFOLFOX6 + Bevacizumab + PD-1 Monoclonal Antibody Versus mFOLFOX6 as Neoadjuvant Therapy for Locally Advanced pMMR\u002FMSS Colorectal Cancer: A Prospective, Multicenter, Randomized Phase III Study (BASKETIII)","BASKETⅢ","Inclusion Criteria:\n\n1. Histologically confirmed adenocarcinoma of the colon or upper rectum.\n2. Tumor biopsy immunohistochemical (IHC) identified pMMR, including all of the MSH1,MSH2,MSH6 and PMS2 protein expression and diagnosed as proficient mismatch repair(pMMR), or microsatellite stable (MSS) identified through next-generation sequencing or polymerase chain reaction.\n3. Clinical staging of cT4NxM0, with or without positive mesorectal fascia (MRF), and with or without extramural vascular invasion (EMVI); imaging confirms that the lower margin of the tumor is located above the peritoneal reflection (colon or upper rectum).\n4. Staging method: All patients must undergo chest, abdominal, and pelvic contrast-enhanced CT, rectal palpation, and high-resolution MRI. Positive perienteric lymph nodes (LNs) are defined as LNs with a short diameter ≥10 mm or LNs exhibiting typical metastatic shape and MRI characteristics. When staging results are contradictory, clinical data must be re-evaluated and confirmed by the central evaluation group. Distant metastases must be excluded through chest and abdominal contrast-enhanced CT and pelvic contrast-enhanced MRI.\n5. No symptoms of intestinal obstruction, or obstruction successfully relieved by proximal colostomy.\n6. No history of colorectal surgery.\n7. No prior chemotherapy or radiotherapy.\n8. No history of biopharmaceutical treatments (e.g., monoclonal antibody ), immunotherapy (e.g., anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies), or treatment with investigational drugs.\n9. Endocrine therapy history: Not restricted.\n10. Signed informed consent obtained.\n\nExclusion Criteria:\n\n1. Arrhythmias requiring anti-arrhythmic treatment (except β-blockers or Digoxin), symptomatic coronary artery disease, myocardial ischemia (myocardial infarction within the past 6 months), or congestive heart failure (CHF) \\> NYHA Class II.\n2. Severe hypertension that is not well controlled by medication.\n3. History of HIV infection or active chronic Hepatitis B or C (with high viral DNA load).\n4. Active tuberculosis (TB), ongoing anti-TB treatment, or anti-TB treatment within 1 year prior to trial screening.\n5. Other active severe infections as defined by NCI-CTCAE v5.0.\n6. Evidence of distant metastasis beyond the pelvic region.\n7. Blood dyscrasias or organ dysfunction.\n8. History of pelvic or abdominal radiotherapy.\n9. Multiple colorectal cancer or multiple primary tumors.\n10. Epilepsy requiring treatment (e.g., steroids or anti-epileptic drugs).\n11. History of other malignancies within the past 5 years.\n12. History of drug abuse, or medical, psychological, or social conditions that could interfere with patient participation or the evaluation of study results.\n13. Any active autoimmune disease or a history of autoimmune disease (including but not limited to interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism, hypothyroidism, and asthma requiring bronchodilators).\n14. Administration of any live attenuated vaccine within 4 weeks prior to inclusion.\n15. Long-term use of immunosuppressants or systemic\u002Ftopical corticosteroids (dose \\>10 mg\u002Fday prednisolone or equivalent).\n16. Known or suspected allergy to any study-related drug.\n17. Any unstable condition that could compromise patient safety or compliance.\n18. Pregnant or breastfeeding women, or women of childbearing potential not using effective contraception.\n19. Refusal to provide signed informed consent.","80 Years",{"count":84,"type":22},166,[25],"Neoadjuvant immunotherapy has shown promising therapeutic effects in mismatch repair-deficient or microsatellite instability-high (dMMR\u002FMSI-H) colorectal cancer (CRC). However, for patients with mismatch repair-proficient or microsatellite stable (pMMR\u002FMSS) CRC, the efficacy of PD-1 monoclonal antibody remains limited. Enhancing the efficacy of immunotherapy in pMMR\u002FMSS CRC has become a key area of exploration. Additionally, for locally advanced (cT4NxM0) CRC patients, achieving R0 resection poses a significant challenge. Failure to achieve R0 resection often results in recurrence, severely impacting patient survival outcomes. Our previous phase II clinical study (BASKET Ⅱ) demonstrated that the neoadjuvant regimen of mFOLFOX6 combined with Bevacizumab and PD-1 monoclonal antibody significantly enhanced the immunotherapy sensitivity of locally advanced pMMR\u002FMSS CRC, leading to improved pathological complete response (pCR) rates and higher R0 resection rates. This prospective, multicenter, randomized phase III trial aims to evaluate whether the neoadjuvant regimen of mFOLFOX6 + Bevacizumab + PD-1 monoclonal antibody can further improve pCR rate, enhance survival outcomes, and maintain an acceptable safety profile compared to mFOLFOX6 alone in pMMR\u002FMSS locally advanced CRC patients.",[88,89],"Colorectal Cancer (CRC)","pMMR\u002FMSS Adenocarcinoma of the Colon or Rectum",[91,92,93,94,95],"Colorectal cancer","pMMR\u002FMSS","Neoadjuvant Therapy","PD-1 monoclonal antibody","mFOLFOX6","2025-12-17",{"date":98,"type":37},"2025-12-24",{"date":100,"type":37},"2025-01-18",{"date":102,"type":22},"2031-12-31",{"name":43,"class":44},""]