{"doi":"10.1080/07357907.2025.2484774","title":"A Phase I Study of the Naturally Occurring Bioactive, Opioid Growth Factor, in Patients with Unresectable Hepatocellular Cancer","abstract":"Hepatocellular cancer (HCC), one of the world’s most deadly tumors, and its incidence in the US continues to rise. Surgical resection/transplantation offers the only hope for cure; however, many patients are not candidates and have limited therapeutic options. Opioid growth factor (OGF) is a naturally occurring bioactive endogenous pentapeptide that inhibits growth of human HCC cell lines in vitro by a receptor-mediated mechanism and inhibits progression of tumors in nude mice. Based on these preclinical studies, we conducted a phase I clinical trial with dose escalation (standard 3 + 3 protocol) of OGF to determine the maximum tolerated dose in HCC patients with concomitant liver disease (NCT00706576). Fifteen doses were administered to 14 patients with a maximum 300 µg/kg dose. No Grade 3 toxicities were encountered in the study group. This dose exceeds the maximum tolerated dose reached in our previous phase I pancreatic cancer trial. We conclude that OGF can be safely administered to patients with HCC and concomitant liver disease without significant toxicities up to a dose of 300 µg/kg. The result of this trial provides data on toxicity and the pharmacokinetics of OGF in patients with HCC and liver disease and lays the groundwork for additional studies.","journal":"Cancer Investigation","year":2025,"id":563937,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":0,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9533,"is_data_producer":false,"deposit_databanks":null,"is_oa":false,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2025-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":772357,"name":"Jussuf T. Kaifi","orcid":"0000-0003-3425-2356","position":1,"is_corresponding":false},{"id":1466793,"name":"Yixing Jiang","orcid":"0000-0002-0013-1807","position":2,"is_corresponding":false},{"id":1466794,"name":"Guangfu Li","orcid":"0000-0002-1513-2466","position":3,"is_corresponding":false},{"id":1467112,"name":"Diego M. Avella","orcid":null,"position":4,"is_corresponding":false},{"id":236261,"name":"Niraj J. Gusani","orcid":"0000-0002-7695-5108","position":5,"is_corresponding":false},{"id":309540,"name":"Ian Schreibman","orcid":null,"position":6,"is_corresponding":false},{"id":1466795,"name":"Peter N. Waybill","orcid":"0000-0002-7784-9366","position":7,"is_corresponding":false},{"id":1467113,"name":"P. J. McLaughlin","orcid":null,"position":8,"is_corresponding":false},{"id":409622,"name":"Ian S. Zagon","orcid":"0000-0002-4221-6745","position":9,"is_corresponding":false},{"id":404341,"name":"Jill P. Smith","orcid":"0000-0002-0835-4802","position":10,"is_corresponding":false},{"id":482515,"name":"Kevin F. Staveley-O’Carroll","orcid":"0000-0003-2207-0379","position":11,"is_corresponding":false},{"id":476437,"name":"Eric T. Kimchi","orcid":"0000-0002-5046-1142","position":0,"is_corresponding":true}],"reference_count":63,"raw_metadata":null,"created_at":"2026-07-19T02:56:17.117043Z","pmid":"40196893","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}