Trial reportBMC medicine2022
A multi-center, single-arm, phase II study of anlotinib plus paclitaxel and cisplatin as the first-line therapy of recurrent/advanced esophageal squamous cell carcinoma.
Trial report in BMC medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04063683 (Paclitaxel and DDP Combined With Anlotinib in the First-line Treatment for Patients With Advanced Esophageal Squamous Cell Carcinoma), which is not on this map. Cited by 8 papers.
What it found
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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.
Paclitaxel and DDP Combined With Anlotinib in the First-line Treatment for Patients With Advanced Esophageal Squamous Cell Carcinoma: a Single Arm, Multicentre Trial.
Who cites it
8 citing papers in PubMed, 13 citations in OpenAlex.
- First-line benmelstobart plus anlotinib and chemotherapy in advanced or metastatic/recurrent esophageal squamous cell carcinoma: a multi-center phase 2 study.Signal transduction and targeted therapy · 2024Trial
- Cost-effectiveness of PD-1 inhibitors combined with chemotherapy for first-line treatment of oesophageal squamous cell carcinoma in China: a comprehensive analysis.Annals of medicine · 2025Article
- Safety and feasibility of anlotinib in children with high risk, recurrent or refractory sarcomas: an open-label, single-centre, single-arm, phase Ia/Ib trial.EClinicalMedicine · 2025Article
- Off-label use of anlotinib in malignancies' treatment: efficacy and management of adverse reactions.Pharmacological reports : PR · 2025Review
- Chemoradiotherapy with or Without Anlotinib for Postoperative Lymph Node Recurrence of Esophageal Squamous Cell Carcinoma: A Real-World Observational Study.Drug design, development and therapy · 2025Observational
- Review
- Case Report: Efficacy of anlotinib and sintilimab in treating lung adenocarcinoma with RET fusion and PD-L1 expression.Frontiers in pharmacology · 2024Article
- Efficacy and safety of anlotinib plus XELOX regimen as first-line therapy for mCRC: a single-arm, multicenter, phase II study (ALTER-C-001).Frontiers in oncology · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 5 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAnlotinib, a tyrosine kinase inhibitor, has shown encouraging anti-tumor activity in esophageal squamous cell carcinoma (ESCC). This study was designed to assess the efficacy and safety of anlotinib plus paclitaxel and cisplatin (TP) as first-line therapy for advanced ESCC.
methodsIn a multi-center, single-arm, phase II clinical trial, patients (aged > 18 years) with ESCC, which was judged to be locally advanced, recurrent, or metastatic, received 10 mg oral anlotinib once daily on days 1-14, 135 mg/m
resultsForty-seven patients were enrolled in this study between October 2019 and March 2021. The median follow-up was 14.04 months (IQR, 9.30-19.38). Of 46 with assessable efficacy, the median PFS and median overall survival were 8.38 months (95% CI, 6.59-10.17) and 18.53 months (95% CI, 13.11-23.95), respectively. The objective response rate was 76.1% (95% CI, 61.2-87.4%), with 4 (8.7%) complete responses and 31 (67.4%) partial responses. The disease control rate was 91.3% (95% CI, 79.2-97.6%). The median duration of response was 6.80 months (95% CI, 4.52-9.08), and 1 patient had an ongoing response for 23 months. Subgroup analysis revealed no association between clinical factors and survival or response. Of the 47 patients with assessable safety, the main grade ≥ 3 treatment-emergent adverse events (TEAEs) were neutropenia (17.0%), bone marrow suppression (12.8%), and vomiting (10.6%). No treatment-related deaths or serious TEAEs were observed. Notably, higher c-Kit levels were an independent factor for superior PFS (HR = 0.032; 95% CI, 0.002-0.606; P = 0.022).
conclusionsThe study demonstrated a manageable safety profile and durable clinical response of anlotinib plus TP as first-line therapy in advanced ESCC, which suggested a potential therapeutic option for this population.
trial registrationClinicalTrials.gov NCT04063683. Registered 21 August 2019.
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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.