Trial reportMolecular cancer2025
Anlotinib combined with benmelstobart as a chemo-free first-line treatment in advanced esophageal squamous cell carcinoma: an exploratory multicenter, single-arm phase II clinical trial.
Trial report in Molecular cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05038813 (A Single-arm, Multi-center Exploratory Clinical Study of Anlotinib Combined With TQB2450), which is not on this map. Cited by 7 papers.
What it found
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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 Single-arm, Multi-center Exploratory Clinical Study of Anlotinib Combined With TQB2450 (PD-L1 Inhibitor) in the Treatment of Advanced Esophageal Squamous Cell Carcinoma
Who cites it
7 citing papers in PubMed.
- Long-term outcomes of patients with esophageal cancer recommended for surgery but treated non-surgically: a Surveillance, Epidemiology, and End Results analysis.Journal of thoracic disease · 2026Article
- Iparomlimab and tuvonralimab (QL1706) combined definitive chemoradiotherapy in patients with locally advanced esophageal squamous cell carcinoma (QL1706-IIT-02): a single arm, phase 2 trial.EClinicalMedicine · 2026Article
- Efficacy and safety of anlotinib combined with PD-1/PD-L1 inhibitors in malignant solid tumors: a meta-analysis and network meta-analysis.Frontiers in immunology · 2026Article
- Clonal tracing of rare anal metastasis in esophageal squamous cell carcinoma: a case report with whole-exome sequencing and multimodal therapy.Frontiers in immunology · 2026Article
- Advances and challenges in immunotherapy for advanced esophageal squamous cell carcinoma.Frontiers in immunology · 2026Review
- Outcomes and Safety of PD-1 Blockades Plus Anlotinib Regimen in Previously-Treated Metastatic Esophageal Squamous Cell Carcinoma: A Retrospective, Exploratory Study.Drug design, development and therapy · 2026Article
- Benmelstobart+anlotinib: an emerging therapeutic option in the targeted-immunotherapy era.Frontiers in oncology · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
28 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundNo combined antiangiogenic and PD-1/PD-L1 blockade therapy has been investigated as a chemo-free first-line treatment for advanced esophageal squamous cell carcinoma (ESCC). This study evaluates the efficacy and safety of anlotinib combined with benmelstobart as a chemo-free treatment in previously untreated advanced ESCC, and identifies potential predictive biomarkers using next-generation sequencing (NGS).
methodsALTER-E-003, a single-arm, open-label phase II trial, enrolled patients with advanced ESCC across five Chinese centers. Patients received oral anlotinib 12 mg daily on days 1-14 per three-week cycle, with benmelstobart 1200 mg infused on day 1 of each cycle for up to 24 months. Thereafter, patients received anlotinib maintenance therapy. Primary endpoint was objective response rate (ORR). Secondary endpoints included progression-free survival (PFS), overall survival (OS), disease control rate (DCR), duration of response (DOR), and safety. NGS and fluorescent multiplex immunohistochemistry (mIHC) were performed on tumor specimens.
resultsOf 53 screened patients, 46 completed the study. The confirmed ORR was 56.5% (95% CI 41.1-71.1), and DCR was 91.3% (95% CI 79.2-97.6). Median PFS was 15.74 months (95% CI 9.03-21.91). Treatment-related adverse events occurred in 93.5% of patients, with 28.3% experiencing grade 3 or higher events. NGS revealed a novel predictive mutational signature (TP53+/FAT1+/NOTCH3-) that was associated with better ORR (65.6% versus 11.1%, P < 0.001), longer median PFS (17.91 versus 5.32 months, P = 0.005) and improved OS (P = 0.006).
conclusionFirst-line anlotinib-benmelstobart combination demonstrated durable responses and acceptable safety in ESCC patients. Exploratory biomarker analyses identified a TP53+/FAT1+/NOTCH3- mutational signature potentially associated with improved outcomes, though further validation in randomized trials is warranted.
trial registrationNCT05038813.
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