[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"msi-h\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:msi-h":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,44,73,112],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100542694","phase-3-combination-of-immune-checkpoint-in-locally-advanced-or-metastatic-msidmmr-esogastric-adenocarcinomas-100542694",false,"NCT06346197","Combination of Immune Checkpoint in Locally Advanced or Metastatic MSI\u002FdMMR Esogastric Adenocarcinomas","A Multicenter, Randomised, Comparative, Open-label Phase III Aiming to Compare the Survival of Patients With Locally Advanced or Metastatic MSI\u002FdMMR Esogastric Adenocarcinomas Treated by a Combination of Immune Checkpoint Inhibitors (Botensilimab + Balstilimab) Versus the Standard of Care (FOLFOX\u002FXELOX + Nivolumab)","CIME","Inclusion Criteria:\n\n* Male or female patient ≥18 years of age at time of informed consent form signature.\n* Patient with MSI-H\u002FdMMR, HER2 negativeadvanced or metastatic gastric, gastro-oesophageal junction or oesophageal adenocarcinoma whose tumours express PD-L1 with a combined positive score (CPS) ≥ 5. Note :The claudin 18.2 status must be known and documented before inclusion.\n* Patient to be treated with a first line therapy for locally advanced\u002Fmetastatic disease.\n* No prior treatment with chemotherapy for locally advanced\u002Fmetastatic disease.\n\n  o Note - adjuvant or neoadjuvant chemotherapy is allowed providing that 6 months have relapsed between completion of adjuvant chemotherapy and recurrence.\n* Measurable disease (outside any previous irradiated field within the past 6 months) defined as at least one unidimensional lesion that can be accurately measured as ≥ 10 mm with CT scan according to RECIST V1.1 (Appendix 01).\n\n  * Note: Lesions intended to be biopsied should not be defined as target lesions.\n  * Note: previously irradiated lesions can be selected as target lesion only if recurrence\u002FPD is documented after RT.\n* Patient with PS ECOG 0 or 1 (Appendix 02).\n* Adequate hematologic and end-organ function, defined by the following laboratory test results:\n\nAbsolute neutrophil count ≥ 1.5 109\u002FL (without growth factor support within 14 d) Platelets ≥ 100 109\u002FL (without transfusion for platelets within 7 d) Hemoglobin ≥ 9 g\u002FdL (without transfusion within 7 d) Creatinine clearance according to CKD-EPI ≥ 30 mL\u002Fmin\u002F1.73 m2 Serum total bilirubin ≤ 1.5 x ULN (except for patients with Gilbert disease for whom a total serum bilirubin ≤ 3 x ULN is acceptable) ASAT and ALAT ≤ 3 x ULN (or up to 5 x ULN in case of liver metastasis or hepatic infiltration)\n\n* Availability of a representative formalin-fixed paraffin-embedded (FFPE) sample of the primary or metastatic tumor tissue (resection or biopsy) with an associated pathology report must be available. This tumor sample must meet the following quality\u002Fquantity control criteria: ≥30 % of tumor cells and a tumor surface area ≥ 5mm2 or biopsiable disease (see next inclusion criteria).\n* Tumor lesion visible by medical imaging and accessible to repeatable percutaneous or endoscopic sampling that permits core needle biopsy without unacceptable risk of a significant procedural complications, and suitable for retrieval of a minimum of 4 cores with a needle minimum diameter :16-gauge.\n\n  * Note 1: Fine needle aspirates, bone biopsies do not satisfy the requirement for tumor tissue.\n  * Note 2: Tumor lesions used for biopsy should not be lesions used as RECIST 1.1 target lesions unless there are no other lesions suitable for biopsy. If a RECIST target lesion is used for biopsy, the lesion must be ≥ 2 cm in longest diameter.\n* Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at the Screening Visit (within 72 hours of first dose of study drugs) and must agree to use highly effective contraceptive measures starting with the Screening Visit through\n\n  * 9 months after the end of the treatment with oxaliplatin\n  * 6 months after the end of the treatment with fluorouracil\n  * 5 months after the end of the treatment with nivolumab or botensilimab or Balstilimab\n  * 6 months for capecitabine\n\n    * Highly effective contraception is defined in Appendix 03.\n\nNote Non-childbearing potential is defined as:\n\n1. ≥ 50 years of age and has not had menses for greater than 1 year.\n2. Amenorrheic for ≥ 2 years without a hysterectomy and bilateral oophorectomy and a follicle-stimulating hormone value in the postmenopausal range upon pre-study (screening) evaluation.\n3. Status is post-hysterectomy, bilateral oophorectomy, or tubal ligation.\n\n   * Male patients with a female partner(s) of childbearing potential must agree to use highly effective contraceptive measures throughout the study starting with the screening visit through 6 months after the end of the treatment with oxaliplatine or 3 months after the last dose for other study treatments is received. Males with pregnant partners must agree to use a condom; no additional method of contraception is required for the pregnant partner.\n   * Patient should understand, sign, and date the written voluntary informed consent form prior to any protocol-specific procedures performed and should be able and willing to comply with study visits and procedures as per protocol.\n   * Patients must be covered by a medical insurance.\n\nExclusion Criteria:\n\n* Oesogastric cancer eligible to treatment with curative intent\n* Patients previously treated by anti-PD-1, anti-PD-L1, or anti-CTLA-4 or any other immunotherapy\n* Patients with surgery or radiotherapy within less than 4 weeks before C1D1\n* Patients with persistent AE Grade \\>1 related to previous anti-cancer treatment, except alopecia (all grades), laboratory value according to criteria I7.\n* Patients with: hypokalemia, hypomagnesemia, hypocalcemia less than normal\n* Patients with known prolongation QT\u002FQTc interval i.e. QT\u002FQTc interval longer than 450 msec for men and longer than 470 msec for women according to the inclusion ECG.\n* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.\n\nNote: Asymptomatic patients with treated CNS lesions are eligible, provided that all of the following criteria are met:\n\n* Measurable disease, per RECIST v1.1, must be present outside the CNS.\n* The patient has no history of intracranial hemorrhage or spinal cord hemorrhage.\n* Metastases are limited to the cerebellum or the supratentorial region (i.e., no metastases to the midbrain, pons, medulla, or spinal cord).\n* There is no evidence of interim progression between completion of CNS-directed therapy and initiation of study treatment.\n* The patient has not undergone stereotactic radiotherapy within 7 days prior to initiation of study treatment, whole-brain radiotherapy within 14 days prior to initiation of study treatment, neurosurgical resection within 21 days prior to initiation of study treatment.\n* The patient has no ongoing requirement for corticosteroids as therapy for CNS disease. Anticonvulsant therapy at a stable dose is permitted. A minimal wash-out period of 10days for corticosteroids is required.\n\n  * Patients with other malignancy unless this malignancy is not expected to interfere with the evaluation of study endpoints (basal or squamous cell carcinoma of the skin, in-situ carcinoma of the cervix, localized prostate cancer), or with no evidence of disease for ≥ 2 years.\n  * Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.\n  * of ILD or non-infectious pneumonitis requiring glucocorticoids.\n  * History of allogeneic organ transplant.\n  * Psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.\n  * Patient with peripheral sensory neuropathy with functional impairment.\n  * Patients with clinically significant active heart disease or myocardial infarction within 6 months, history of uncontrolled or symptomatic cardiac disease.\n  * Patient with recent (within 7d before C1D1) or concomitant treatment with brivudine.\n  * Patient with complete absence of dihydropyrimidine dehydrogenase (DPD) activity (blood uracil level ≥ 150 ng\u002FmL) or partial deficit in DPD (i.e. blood uracil level between ≥ 16 ng\u002Fml and \\\u003C 150 ng\u002FmL)\n  * Patients with a condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalent) within 14 days or another immunosuppressive medication within 30 days of the first dose of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses (≤ 10 mg daily prednisone equivalent) are permitted in the absence of active autoimmune disease.\n  * Patient with Live vaccines injection within 4 weeks before C1D1. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever and BCG. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however intranasal influenza vaccines (e.g. Flu-Mist®) are live attenuated vaccines, and are not allowed.\n  * Active autoimmune disease or history of autoimmune disease that required systemic treatment within 2 years of the start of study treatment (i.e., with use of disease-modifying agents or immunosuppressive drugs).\n  * History or current evidence of any condition, co-morbidity, therapy, any active infections, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator.\n  * Patients with documented:\n* Active hepatitis B (chronic or acute; defined as having a positive hepatitis B surface antigen \\[HBsAg\\] test at screening) unless their HBV is stably controlled on nucleoside analogs (eg entecavir or tenofovir) which will be continued for the duration of the study. Note: Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as the presence of hepatitis B core antibody \\[anti-HBc\\] and absence of HBsAg) are eligible. HBV DNA test must be performed in these patients prior to C1D1.\n* Active hepatitis C. Patients positive for hepatitis C virus (HCV) antibody are eligible only if PCR is negative for HCV RNA, or\n* HIV infection\n\n  * Prior organ or bone marrow transplant.\n  * Pregnant or lactating women.","ALL","18 Years",{"count":20,"type":21},132,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","CIME is a multicenter, randomised, comparative, open-label phase III study aiming to compare the survival of patients suffering from MSI-H\u002FdMMR locally advanced or metastatic oeasogastric adenocarcinoma treated by a bi-immunotherapy (experimental arm) versus standard current treatment (FOLFOX\u002FXELOX + nivolumab : standard arm).",[27,28,29,30],"Gastric Cancer","MSI-H","Metastatic Cancer","Advanced Cancer","RECRUITING","2026-06-23",{"date":34,"type":35},"2026-06-25","ACTUAL",{"date":37,"type":35},"2025-12-08",{"date":39,"type":21},"2028-05-15",{"name":41,"class":42},"Centre Leon Berard","OTHER",7,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":72},"100560701","phase-2-immune-checkpoint-inhibitors-for-organ-preservation-in-non-metastatic-dmmrmsi-h-gastric-or-colon-cancers-100560701","NCT06580574","Immune Checkpoint Inhibitors for Organ Preservation in Non-metastatic dMMR\u002FMSI-H Gastric or Colon Cancers","PD-1\u002FPD-L1 Antibody With Selective Combination of Sintilimab, IBI310 and Lenvatinib Used for Organ Preservation in Non-metastatic Gastric or Colon Cancers With Mismatch Repair Deficiency or High Microsatellite Instability","Inclusion Criteria:\n\n* Subjects are able to comprehend the informed consent form, and voluntarily sign the informed consent form.\n* Subjects are ≥18 years old on the day of signing the informed consent form, with no gender restrictions.\n* Histologically confirmed gastric cancer or colon cancer, without distant metastasis based on CR or MR.\n* ECOG performance status of 0-2.\n* dMMR confirmed by immunohistochemistry or MSI-H confirmed by PCR and NGS. If MSI status and MMR status were not consistent, whether to enroll this patient should be determine by investigators. Patients with MMR heterogeneity in tumors could not be included.\n* Patients who are about to receive or are receiving 24 weeks of PD1\u002FPDL1 antibody monothearpy and have not had the first efficacy assessment.\n* Archived tumor tissue samples or freshly obtained tumor tissue samples are available.\n* Female subjects of childbearing potential or male subjects with partners of childbearing potential agree to use highly effective contraception from 7 days before the first dose until 120 days after the last dose. Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days before the first dose.\n* Subjects have the ability and willingness to comply with the study protocol's visits, treatment plan, laboratory tests, and other study-related procedures.\n* For patients who are about to receive combination of Sintilimab, IBI310 and Lenvatinib. subjects should have good organ function within the first 7 days of initial dosing: HGB ≥ 80g\u002FL, NEU ≥ 1.0\\*10\\^9\u002FL, PLT ≥ 75\\*10\\^9\u002FL, Cr≤1.5×ULN or CrCl≥50mL\u002Fmin（Cockcroft-Gault method), TBiL ≤ 1.5×ULN, ALT and AST ≤3 ×ULN; urine protein \\\u003C2+; if urine protein ≥ 2+, 24 hour urinary protein quantity \\\u003C2g; INR, APTT, PT ≤ 1.5 ×ULN\n\nExclusion Criteria:\n\n* Distant metastasis;\n* Previous treatment including CTLA4 blockade;\n* Subjects with interstitial lung disease or a history of non-infectious pneumonia requiring oral or intravenous corticosteroid treatment.\n* Subjects with active autoimmune diseases requiring systemic treatment before the start of the study or those considered at risk of recurrence or planned treatment for autoimmune diseases as judged by the investigator. Except for these conditions: a) skin diseases that do not require systemic treatment (e.g., vitiligo, alopecia, psoriasis, or eczema); b) hypothyroidism caused by autoimmune thyroiditis, requiring stable doses of hormone replacement therapy; c) type 1 diabetes requiring stable doses of insulin replacement therapy; d) childhood asthma fully resolved with no need for intervention in adulthood; e) the investigator judges that the disease will not relapse without external triggering factors.\n* Subjects with a history of other malignant tumors within 5 years, excluding cured skin squamous cell carcinoma, basal cell carcinoma, non-invasive bladder carcinoma, localized low-risk prostate cancer (defined as stage ≤T2a, Gleason score ≤6, and prostate-specific antigen (PSA) ≤10 ng\u002FmL (if measured) in patients who have undergone curative treatment and have no biochemical recurrence of prostate-specific antigen (PSA)), in situ cervical\u002Fbreast carcinoma, or Lynch syndrome.\n* Subjects with uncontrolled comorbidities, including but not limited to: a) active HBV or HCV infection; b) subjects who are HBsAg positive and\u002For HCV antibody positive during screening must undergo HBV DNA and\u002For HCV RNA testing. Only subjects with HBV DNA ≤500 IU\u002FmL (or ≤2000 copies\u002FmL) and\u002For HCV RNA negative can be enrolled; HBV DNA monitoring will be at the discretion of the investigator based on the subject's condition during the trial; c) known HIV infection or AIDS history; d) active tuberculosis; e) uncontrolled hypertension (resting blood pressure ≥160\u002F100 mmHg), symptomatic congestive heart failure (NYHA II-IV), unstable angina or myocardial infarction within 6 months, or the presence of QTc prolongation or the risk of arrhythmia (baseline QTc \\>470 msec \\\u003CFridericia method correction\\>, refractory hypokalemia, long QT syndrome, atrial fibrillation with resting heart rate \\>100 bpm, or severe valvular heart disease); f) active bleeding that cannot be controlled after medical treatment.\n* History of allogeneic bone marrow or organ transplantation.\n* Previous history of allergic reactions, hypersensitivity reactions, or intolerance to antibody drugs (e.g., severe allergic reactions, immune-mediated hepatotoxicity, immune-mediated thrombocytopenia, or anemia).\n* Pregnant and\u002For lactating females.\n* For patients who are about to receive combination of Sintilimab, IBI310 and Lenvatinib: a) Subjects with a history of gastrointestinal perforation or fistula within 6 months before the first dose. If the perforation or fistula has been treated with resection or repair, and the disease is judged to be recovered or improved by the investigator, then enrollment is allowed. b) Subjects who have undergone major surgery within 28 days before the first dose (e.g., major abdominal or thoracic surgery; excluding drainage, diagnostic puncture, or peripheral vascular access replacement). c) Subjects who require systemic corticosteroids (≥10 mg\u002Fday prednisone or equivalent) or immunosuppressive therapy for a continuous 7-day period within 14 days before the first dose. Inhaled or locally applied steroids and physiological replacement doses of steroids due to adrenal insufficiency are allowed. Short-term (≤7 days) corticosteroids for prophylaxis (e.g., contrast dye allergy) or treatment of non-autoimmune diseases (e.g., delayed hypersensitivity reaction caused by exposure to allergens) are allowed. d) Toxicity from previous antitumor treatments has not recovered to Grade ≤2 (NCI-CTCAE v5.0) or baseline, except for alopecia, skin pigmentation (allowed at any level), and immune-related adverse reactions requiring physiological replacement (e.g., hypothyroidism, hypopituitarism, type 1 diabetes).",{"count":52,"type":21},34,[54],"PHASE2","This study intends to explore the role of PD1\u002FPDL1 antibody with selective combination of Sintilimab, IBI310 and Lenvatinib in organ preservation in non-metastatic dMMR\u002FMSI-H gastric or colon cancers with mismatch repair deficiency or high microsatellite instability",[27,57,28,58],"Colon Cancer","DMMR Cancer",[60,61,62],"Organ preservation","immunotherapy","anti-VEGF","2026-05-13",{"date":65,"type":35},"2026-05-15",{"date":67,"type":35},"2024-09-13",{"date":69,"type":21},"2029-06-01",{"name":71,"class":42},"Peking University",1,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":22,"phases":84,"briefSummary":86,"conditions":87,"keywords":98,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":72},"100593065","phase-1-intra-tumoral-it-injection-of-vvdd-hil2-2-rg-1-for-metastatic-gastrointestinal-and-peritoneal-tumors-100593065","NCT07001592","Intra-tumoral (IT) Injection of vvDD-hIL2-2-RG-1 for Metastatic Gastrointestinal and Peritoneal Tumors","A Phase I Dose-Escalation Trial of vvDD-hIL2-2-RG-1 (Vaccina Virus Double Deleted) Administered by Intra-tumoral (IT) Injection for Metastatic Gastrointestinal and Peritoneal Tumors","RIOT3","Inclusion Criteria:\n\n1. Males or females age, 18 to \\\u003C 70 years at the time of consent\n2. Histologically confirmed metastases from gastrointestinal tumors with molecular determinants for MSI and KRAS.\n3. For microsatellite stable (MSS) tumors, subjects must have failed (or be ineligible for) standard 1st and 2nd line chemotherapy. For microsatellite instability-high (MSI-H) tumors, subjects must also have failed (or be ineligible for) systemic immunotherapy.\n4. Karnofsky Performance Status (KPS) of \\> 70\n5. Anticipated survival of at least 12 weeks.\n6. Written informed consent in accordance with national, local, and institutional guidelines obtained prior to any study procedures (subject or subject's legally authorized representative (LAR) must have the ability to understand and willingness to sign a written informed consent).\n7. Adequate bone marrow function: WBC \\> 2,000 and \\\u003C50,000 cells\u002Fmm3, ANC \\> 1,000 cells\u002Fmm3, hemoglobin \\>8 g\u002FdL, and platelet count \\>100,000 cells\u002Fmm3.\n8. Adequate renal function: serum creatinine level ≤ 2xULN\n9. Adequate liver function: Serum bilirubin \\\u003C 1.5 x ULN\n10. Acceptable coagulation status: INR \\\u003C ULN +15%. All patients must be able to suspend anticoagulant therapy for study specific biopsies and intra-tumoral injection.\n11. Women of childbearing potential (defined as all women physiologically capable of becoming pregnant) must have negative serum or urine pregnancy test.\n12. If sexually active, to prevent pregnancy and to prevent the spread of virus, subject must use an acceptable method of contraception as well as barrier contraception from screening through 6 weeks following study treatment with vvDD-hIL-2-RG-1.\n13. Subjects must be willing to comply with all study procedures, requirements, adhere to post-treatment care instructions and follow-up examinations.\n14. Have measurable disease based on RECIST 1.1 criteria.\n15. Have at least one tumor at least 1 cm in diameter amenable to safe intra-tumoral injection.\n\nExclusion Criteria:\n\n1. Pregnant or nursing an infant.\n2. Systemic corticosteroid or other immunosuppressive medication use within 2 weeks of the study treatment.\n3. Significant immunodeficiency (e.g. due to underlying illness and\u002For medication) in subject or household contacts (must be able to avoid household contact with immunodeficient person for 3 weeks).\n4. Clinically significant active infection or uncontrolled medical condition (e.g., pulmonary, neurological, cardiovascular, gastrointestinal, genitourinary) considered high risk for investigational new drug treatment, per investigator discretion.\n5. Active eczema or psoriasis or other inflammatory skin conditions\n6. Unstable cardiac disease which includes but is not limited to any of the following within 6 months prior to study entry: myocardial infarction (MI), unstable angina, congestive heart failure, myocarditis, ventricular arrhythmias diagnosed and requiring medication.\n\n   * New York Heart Association functional class III-IV heart failure on active treatment\n   * Pulse oximetry of \\\u003C 90% in room air at rest\n7. Subjects who have received radiation, chemotherapy or other potentially immunosuppressive therapy within 2 weeks prior to study screening and within 4 weeks prior to anticipated vvDD-hIL-2-RG-1 treatment.\n8. Experienced a severe systemic reaction or side-effect as a result of a previous smallpox vaccination.\n9. Subjects who, in the opinion of the Investigator, have a medical condition that would subject the subject to prohibitive risk by participation in this study, or who may be unable to safely complete the required tumor biopsies.\n10. Subjects with household contacts who are children \\\u003C 5 years old, have active eczema, psoriasis or other inflammatory skin conditions or have a significant immunodeficiency due to underlying illness (e.g. human immunodeficiency virus) and\u002For medication (e.g. systemic corticosteroids) will be excluded unless alternate living arrangements can be made during the subject's active dosing period and for three weeks following the study medication.\n11. Vaccination with a live virus in the previous 60 days prior to Day 0.\n12. Inability or unwillingness to give informed consent.\n13. Is unable or unwilling to comply with protocol follow-up requirements. -","69 Years",{"count":83,"type":21},18,[85],"PHASE1","This research study aims to evaluate the safety and determine the optimal dose of a new experimental drug, vvDD-hIL2 (vaccinia virus double-deleted human interleukin 2), in patients with advanced abdominal cancer. The study will involve three dose levels, with three to six patients enrolled at each level.\n\nvvDD-hIL2 is a genetically modified vaccinia virus, derived from the virus previously used for smallpox vaccination. The modification is intended to target and destroy tumors while minimizing harm to healthy tissues by stimulating the body's immune response.\n\nParticipants will receive an injection of vvDD-hIL2 directly into their abdominal tumors at AHN West Penn. The study team will monitor for side effects and assess tumor response to the treatment.\n\nActive participation will last up to two months, involving seven clinic visits and approximately four lab visits at AHN West Penn Hospital. Visits will include standard of care procedures as well as study-specific tests and exams. Most visits will last one to two hours, with some extending to two to three hours. The drug administration day will require a twelve-hour visit.\n\nEffectiveness and side effects will be evaluated through blood draws, oral swabs, urinalysis and tissue biopsies. Tissue samples will be used for genomic analysis and stored for potential future research. Data collected may also be used for future research purposes.\n\nPrevious human trials of vvDD-hIL2 have reported side effects such as pain, rash or inflammation at the injection site, low-grade fevers, flu-like symptoms, and fatigue. There is a rare risk of rash transmission to close contacts with skin openings, and information on limiting contact and managing rash development will be provided.",[88,89,90,91,92,93,94,95,96,97,28,27],"Gastric Neoplasms","Esophageal Cancer","Liver Cancer","Liver Metastasis","MSS-CRC","MSS","Gastric Adenocarcinoma","Peritoneal Cancer","Peritoneal Carcinoma","Peritoneal Metastases",[99,100,61,101,102],"Oncolytic virus","vaccinia","intra-tumoral","intra-peritoneal","2025-06-02",{"date":105,"type":35},"2025-06-03",{"date":107,"type":35},"2025-05-06",{"date":109,"type":21},"2028-05",{"name":111,"class":42},"Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)",{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":119,"targetDuration":4,"studyType":22,"phases":121,"briefSummary":122,"conditions":123,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":72},"100411321","phase-1-sintilimab-plus-hypofractionated-radiotherapy-for-msi-hdmmr-rectal-cancer-100411321","NCT04636008","Sintilimab Plus Hypofractionated Radiotherapy for MSI-H\u002FdMMR Rectal Cancer","The Safety and Efficacy of Sintilimab Combined With Hypofractionated Radiotherapy in MSI-H\u002FdMMR Rectal Cancer: a Prospective, Single-arm, Multicenter, Phase Ib Study","Inclusion Criteria:\n\n1. Histologically confirmed rectal adenocarcinoma;\n2. With DNA mismatch repair-deficient (dMMR) or microsatellite instability-high (MSI-H) status, whether or not being Lynch syndrome;\n3. Not received any anti-rectal cancer treatment previously; for patients with Lynch syndrome, not received any anti-tumor therapy about rectal cancer diagnosed this time;\n4. No distant metastasis except for lateral lymph nodes on thoracic and abdominal enhanced computed tomography (CT) scans; the distance between tumor's lower edge and anus within 15cm; clinical T stage ≥T2 on high-resolution pelvic magnetic resonance imaging (MRI)；\n5. Men and women ≥18 years of age;\n6. Eastern Cooperative Oncology Group performance status score 0 or 1;\n7. Adequate hematologic, hepatic, renal, thyroid and cardiac function: hemoglobin ≥90 g\u002FL, neutrophils ≥1500\u002Fmm3, platelets ≥75,000\u002Fmm3; aspartate aminotransferase and alanine aminotransferase ≤3.0 × upper limit of normal (ULN), bilirubin ≤1.5 × ULN; creatinine ≤1.5 × ULN, creatinine clearance ≥50 mL\u002Fmin; activated partial thromboplastin time, prothrombin time and international normalized ratio ≤1.5 × ULN; serum albumin ≥28 g\u002FL；thyroid stimulating hormone and free thyroxine within ±10% of normal levels; no obvious abnormality in electrocardiogram;\n8. Not received blood, blood products and hematopoietic growth factor (e.g. granulocyte colony-stimulating factor) within 2 weeks before inclusion;\n9. Informed consent form signed;\n10. Life expectancy of ≥3 months.\n\nExclusion Criteria:\n\n1. Allergic disease history, severe hypersensitivity to drugs, antibody products or Sintilimab;\n2. Other malignancy history with disease free survival \\\u003C5 years, except for curative in situ cervical cancer, curative skin basal cell carcinoma and curative gastrointestinal cancer by endoscopic mucoresection;\n3. Current or past history of autoimmune diseases, including but not limited to: interstitial lung disease, uveitis, enteritis，active hepatitis (HBV DNA≥103 copies\u002FmL after regular antiviral therapy)，nephritis, hyperthyroidism and hypothyroidism;\n4. Immunosuppressant or corticosteroid (systemic or local) use to suppress immune function within 2 weeks before inclusion;\n5. Severe infection needing intravenous antibiotics, antifungal agents or antiviral drugs, et al;\n6. Congenital or acquired immunodeficiency such as HIV infection; active Hepatitis B (HBV DNA≥103 copies\u002FmL after regular antiviral therapy);\n7. Having one of the following complications: massive gastrointestinal hemorrhage, gastrointestinal perforation or obstruction; symptomatic heart diseases including unstable angina, myocardial infarction and heart failure; uncontrollable diabetes mellitus or hypertension; uncontrollable diarrhea (interfering with daily activities although receiving adequate treatment);\n8. Bleeding tendency or receiving thrombolytic or anticoagulant therapy;\n9. Pregnant or breastfeeding female; male and female unwilling to take any contraceptive measures;\n10. Psychiatric disorders that would interfere with cooperation with the requirements of the study;\n11. Other conditions that investigators consider not suitable for this study.",{"count":120,"type":21},20,[85,54],"This prospective, single-arm study is conducted to investigate the safety and efficacy of Sintilimab combined with hypofractionated radiotherapy in patients with microsatellite instability-high (MSI-H)\u002F DNA mismatch repair-deficient (dMMR) non-metastatic rectal cancer.",[124,125,126,28,127],"Anti-PD-1 Antibody","Radiotherapy","Rectal Cancer","Mmr Deficiency","2024-08-03",{"date":130,"type":35},"2024-08-06",{"date":132,"type":35},"2020-08-14",{"date":134,"type":21},"2024-12",{"name":136,"class":42},"West China Hospital"]