{"preliminary_commentary":{"by_channel":{"x_thread":13,"podcast":3},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT03412773\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's free public preview; the full report is still bought."},"commentary_summary":null,"drugs_tested":[["tislelizumab"]],"indication":"first-line unresectable hepatocellular carcinoma","name":"RATIONALE-301","nct_id":"NCT03412773","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=rationale-301-nct03412773. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":1250,"size":"standard","size_rule":"Standard: 151–300 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Japanese participants received 200 mg intravenous tislelizumab every 3 weeks to assess preliminary safety and tolerability.","label":"Safety Run-In Sub-study","type":"EXPERIMENTAL"},{"description":"Participants received 200 mg of intravenous tislelizumab every 3 weeks until intolerable toxicity, withdrawal of consent, or the investigator determined no further benefit from the therapy.","label":"Arm A: Tislelizumab","type":"EXPERIMENTAL"},{"description":"Participants received 400 mg of oral sorafenib twice daily until intolerable toxicity, consent withdrawal, or the investigator deemed no further benefit.","label":"Arm B: Sorafenib","type":"ACTIVE_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2023-12-14","type":"ACTUAL"},"conditions":["Hepatocellular Carcinoma (HCC)"],"enrollment":{"count":684,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Tislelizumab","otherNames":["BGB-A317"],"type":"DRUG"},{"name":"Sorafenib","otherNames":["Nexavar","BAY43-9006"],"type":"DRUG"}],"last_update":"2025-10-14","lead_sponsor":"BeiGene","official_title":"A Randomized, Open-label, Multicenter Phase 3 Study to Compare the Efficacy and Safety of BGB-A317 Versus Sorafenib as First-Line Treatment in Patients With Unresectable Hepatocellular Carcinoma","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2022-07-11","type":"ACTUAL"},"primary_outcomes":[{"measure":"Safety Run-in Sub-study: Number of Participants With Treatment-emergent Adverse Events (TEAEs)","timeFrame":"From the first dose to 30 days after the last dose, new anticancer therapy, or the analysis cutoff of December 14th, 2023 (a maximum of 64 months)"},{"measure":"Safety Run-in Sub-study: Serum Concentration of Tislelizumab","timeFrame":"Cycle 1 and Cycle 5 at end of infusion, 24 hand 72 hours post-dose, and 8 days and 15 days post-dose (each cycle was 3 weeks)."},{"measure":"Main Study: Overall Survival (OS)","timeFrame":"Through the primary analysis data cut-off date of July 11th, 2022 (up to approximately 55 months)"}],"references":[{"citation":"Qin S, Finn RS, Kudo M, Meyer T, Vogel A, Ducreux M, Macarulla TM, Tomasello G, Boisserie F, Hou J, Li X, Song J, Zhu AX. RATIONALE 301 study: tislelizumab versus sorafenib as first-line treatment for unresectable hepatocellular carcinoma. Future Oncol. 2019 Jun;15(16):1811-1822. doi: 10.2217/fon-2019-0097. Epub 2019 Apr 10.","pmid":"30969136","type":"RESULT"},{"citation":"Qin S, Kudo M, Meyer T, Bai Y, Guo Y, Meng Z, Satoh T, Marino D, Assenat E, Li S, Chen Y, Boisserie F, Abdrashitov R, Finn RS, Vogel A, Zhu AX. Tislelizumab vs Sorafenib as First-Line Treatment for Unresectable Hepatocellular Carcinoma: A Phase 3 Randomized Clinical Trial. JAMA Oncol. 2023 Dec 1;9(12):1651-1659. doi: 10.1001/jamaoncol.2023.4003.","pmid":"37796513","type":"RESULT"},{"citation":"Finn RS, Kudo M, Barnes G, Meyer T, Boisserie F, Abdrashitov R, Chen Y, Li S, Zhu AX, Qin S, Vogel A. Tislelizumab versus Sorafenib in First-Line Treatment of Unresectable Hepatocellular Carcinoma: Impact on Health-Related Quality of Life in RATIONALE-301 Study. Liver Cancer. 2024 Feb 21;13(5):548-560. doi: 10.1159/000537966. eCollection 2024 Oct.","pmid":"39435268","type":"RESULT"}],"start_date":{"date":"2017-12-18","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of Tislelizumab Versus Sorafenib in Participants With Unresectable Hepatocellular Carcinoma (HCC)","url":"https://clinicaltrials.gov/study/NCT03412773"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.1","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/rationale-301-nct03412773"}