{"id":"p53-gene-with-surgery","safety":{"commonSideEffects":[{"rate":null,"effect":"Fever"},{"rate":null,"effect":"Local injection site reactions"},{"rate":null,"effect":"Transient elevation of liver enzymes"},{"rate":null,"effect":"Immune-related inflammatory responses"}]},"_chembl":{"chemblId":"CHEMBL3347606","moleculeType":"Small molecule","molecularWeight":"2109.47"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"This is a gene therapy product (Gendicine) that delivers functional p53 gene into tumor cells to restore apoptosis and cell cycle arrest in p53-deficient cancers. When combined with surgery, it aims to reduce recurrence by targeting residual disease and preventing tumor progression. The p53 protein acts as a 'guardian of the genome,' inducing cell death in malignant cells that would otherwise evade standard therapies.","oneSentence":"A p53 gene therapy that restores wild-type p53 tumor suppressor function in cancer cells, typically administered intratumorally in combination with surgical resection.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-27T23:59:30.770Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Head and neck squamous cell carcinoma (in combination with surgery)"},{"name":"Other solid tumors with p53 mutations (off-label use in some regions)"}]},"trialDetails":[{"nctId":"NCT04541654","phase":"","title":"Li-Fraumeni & TP53 (LiFT UP): Understanding and Progress","status":"RECRUITING","sponsor":"Dana-Farber Cancer Institute","startDate":"2020-09-15","conditions":"Li-Fraumeni Syndrome, TP53 Gene Mutation, Hereditary Cancer Syndrome","enrollment":1500},{"nctId":"NCT07424560","phase":"","title":"Multiplex Mutation Detection Using Mass Spectrometry in Bladder Cancer","status":"RECRUITING","sponsor":"Zhilong Dong","startDate":"2026-02-25","conditions":"Bladder Cancer, Bladder Cancer Recurrence, Adjuvant Therapy for Bladder Cancer","enrollment":400},{"nctId":"NCT03217266","phase":"PHASE1","title":"Navtemadlin and Radiation Therapy in Treating Patients With Soft Tissue Sarcoma","status":"COMPLETED","sponsor":"National Cancer Institute (NCI)","startDate":"2018-06-20","conditions":"Resectable Soft Tissue Sarcoma, Soft Tissue Sarcoma","enrollment":39},{"nctId":"NCT00898755","phase":"","title":"Collecting and Storing Tissue From Young Patients With Cancer","status":"COMPLETED","sponsor":"Children's Oncology Group","startDate":"2007-03-05","conditions":"Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Central Nervous System Neoplasm","enrollment":213},{"nctId":"NCT00003649","phase":"PHASE1","title":"Gene Therapy in Treating Patients With Non-small Cell Lung Cancer That Cannot Be Surgically Removed","status":"COMPLETED","sponsor":"Eastern Cooperative Oncology Group","startDate":"1998-11-17","conditions":"Lung Cancer","enrollment":""},{"nctId":"NCT00280761","phase":"","title":"Biomarkers in Patients With Rectal Cancer Undergoing Chemotherapy and Radiation Therapy","status":"COMPLETED","sponsor":"UNC Lineberger Comprehensive Cancer Center","startDate":"2003-12","conditions":"Colorectal Cancer","enrollment":47},{"nctId":"NCT02140723","phase":"","title":"p53 and Response to Preoperative Radiotherapy for T2 and T3","status":"UNKNOWN","sponsor":"Medical University of Vienna","startDate":"2011-08","conditions":"Rectal Cancer","enrollment":60},{"nctId":"NCT02340156","phase":"PHASE2","title":"Phase II Study of Combined Temozolomide and SGT-53 for Treatment of Recurrent Glioblastoma","status":"TERMINATED","sponsor":"SynerGene Therapeutics, Inc.","startDate":"2014-12","conditions":"RECURRENT GLIOBLASTOMA","enrollment":1},{"nctId":"NCT00004041","phase":"PHASE1","title":"Gene Therapy in Treating Patients With Recurrent Malignant Gliomas","status":"COMPLETED","sponsor":"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins","startDate":"1999-02-25","conditions":"Brain and Central Nervous System Tumors","enrollment":""},{"nctId":"NCT00686842","phase":"PHASE1, PHASE2","title":"PTC299 in Treating Patients With HIV-Related Kaposi Sarcoma","status":"TERMINATED","sponsor":"AIDS Malignancy Consortium","startDate":"2008-09","conditions":"Kaposi's Sarcoma","enrollment":17},{"nctId":"NCT00423865","phase":"PHASE1","title":"Cisplatin and Everolimus in Treating Patients With Advanced Solid Tumors","status":"COMPLETED","sponsor":"Memorial Sloan Kettering Cancer Center","startDate":"2006-11","conditions":"Unspecified Adult Solid Tumor, Protocol Specific","enrollment":30},{"nctId":"NCT00017095","phase":"PHASE3","title":"Biomarker (p53 Gene) Analysis and Combination Chemotherapy Followed by Radiation Therapy and Surgery in Treating Women With Large Operable or Locally Advanced or Inflammatory Breast Cancer","status":"COMPLETED","sponsor":"European Organisation for Research and Treatment of Cancer - 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Used for Head and neck squamous cell carcinoma (in combination with surgery), Other solid tumors with p53 mutations (off-label use in some regions).","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}