Trial reportBMC medicine2024
Efficacy and safety of tislelizumab plus lenvatinib as first-line treatment in patients with unresectable hepatocellular carcinoma: a multicenter, single-arm, phase 2 trial.
Trial report in BMC medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04401800 (A Phase 2 Study to Investigate the Preliminary Antitumor Activity, Safety and Tolerability of Tislelizumab in Combination With Lenvatinib in Patients With Unresectable Locally Advanced or Metastatic Hepatocellular Carcinoma), which is not on this map. Cited by 32 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 2 Study to Investigate the Preliminary Antitumor Activity, Safety and Tolerability of Tislelizumab in Combination With Lenvatinib in Patients With Unresectable Locally Advanced or Metastatic Hepatocellular Carcinoma
Who cites it
32 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Response Rate Correlates with the Conversion Rate in Patients with Advanced Hepatocellular Carcinoma Treated with Systemic or Hepatic Artery Infusion Chemotherapy: A Systematic Review.Digestive surgery · 2026Pooled it
- Adverse events associated with hepatic arterial infusion chemotherapy and its combination therapies in hepatocellular carcinoma: a systematic review.Frontiers in immunology · 2025Pooled it
- Adjuvant tislelizumab, lenvatinib, and capecitabine for resected biliary tract cancer: a prospective phase II trial.BMC medicine · 2026Trial
- Perioperative tislelizumab plus lenvatinib treatment for resectable hepatocellular carcinoma at high risk of recurrence: single-arm phase II trial.Nature communications · 2026Trial
- Trial
- Sorafenib Combined with Tislelizumab and Transarterial Chemoembolization for Advanced-Stage Hepatocellular Carcinoma: A Phase II Study.ImmunoTargets and therapy · 2025Trial
- Matching-adjusted indirect comparison of tislelizumab plus lenvatinib versus sintilimab plus bevacizumab biosimilar as first-line treatment for unresectable hepatocellular carcinoma.Frontiers in immunology · 2025Trial
- Dynamics changes of spleen volume predict survival outcomes in unresectable hepatocellular carcinoma treated with tislelizumab plus lenvatinib.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026Article
- Efficacy and safety of transarterial chemoembolization (TACE) with tislelizumab and tyrosine kinase inhibitors versus TACE for intermediate and advanced HCC.Journal of cancer research and clinical oncology · 2026Article
- Article
- TACE combined with tislelizumab and lenvatinib in the treatment of intermediate-to-advanced hepatocellular carcinoma: a retrospective real-world study.BMC cancer · 2026Article
- Article
- Comparative efficacy of postoperative adjuvant transcatheter arterial chemoembolization versus lenvatinib plus tislelizumab in patients with BCLC stage 0 -B hepatocellular carcinoma after radical resection.Frontiers in immunology · 2026Article
- Transarterial infusion chemotherapy combined with lenvatinib and tislelizumab versus intravenous chemotherapy for unresectable pancreatic ductal adenocarcinoma: a retrospective propensity score matching analysis.Frontiers in oncology · 2026Article
- Prognostic value of radiological and pathological complete response following immune-based conversion therapy in patients with unresectable hepatocellular carcinoma (GUIDANCE004).JHEP reports : innovation in hepatology · 2025Article
- Tislelizumab: Structural Innovations and Expanding Clinical Horizons in Next-Generation PD-1 Immunotherapy.Chronic diseases and translational medicine · 2025Review
- Review
- Prognostic comparison between pulmonary metastasectomy and combination immunotherapy with targeted molecular therapies for advanced hepatocellular carcinoma with pulmonary metastasis: A propensity score matching analysis.Liver research (Beijing, China) · 2025Article
- Real-world effectiveness and safety of TACE combined with lenvatinib plus immune checkpoint inhibitors in patients with BCLC-B stage hepatocellular carcinoma.Journal of gastrointestinal oncology · 2025Article
- Case report and literature review: tislelizumab combined with lenvatinib and polymeric micellar paclitaxel for thymic squamous cell carcinoma.Frontiers in immunology · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
20 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundLenvatinib is widely used in treatment of unresectable hepatocellular carcinoma (uHCC), but the benefit of its combination with immunotherapy needs to be verified. This study evaluated the efficacy and safety of tislelizumab plus lenvatinib in systemic treatment-naïve patients with uHCC.
methodsIn this multicenter, single-arm, phase 2 study, systemic treatment-naïve patients with uHCC received tislelizumab 200 mg every three weeks plus lenvatinib (bodyweight ≥ 60 kg: 12 mg; < 60 kg: 8 mg; once daily). Dose-limiting toxicities (DLTs) were evaluated in safety run-in phase to determine whether to enter the expansion phase. The primary endpoint was objective response rate (ORR) assessed by independent review committee (IRC) per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1). Based on Simon's two-stage design, > 6 responders were needed in stage 1 (n = 30) to continue the study, and ≥ 18 responders were needed by the end of stage 2 (n = 60) to demonstrate statistical superiority to a historical control of lenvatinib monotherapy.
resultsSixty-four patients were enrolled. No DLTs were reported. The study achieved statistical superiority (p = 0.0003) with 23 responders assessed by IRC per RECIST v1.1 in the first 60 patients of the efficacy evaluable analysis set (n = 62). After a median follow-up of 15.7 months, confirmed ORR and disease control rate were 38.7% (24/62, 95% confidence interval [CI], 26.6-51.9) and 90.3% (56/62, 95% CI, 80.1-96.4), respectively. Median progression-free survival was 8.2 months (95% CI, 6.8-not evaluable). Overall survival rate at 12 months was 88.6% (95% CI, 77.7-94.4). Grade ≥ 3 treatment-related adverse events occurred in 18 (28.1%) patients.
conclusionsTislelizumab plus lenvatinib demonstrated promising antitumor activity with favourable tolerability as first-line therapy for patients with uHCC.
trial registrationClinicalTrials.gov (NCT04401800).
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.