Year: 2021
Type: article
Study design: Clinical Trial
Abstract: Purpose: There is limited standard treatment for patients with advanced cholangiocarcinoma after refractory of chemotherapy.Apatinib is a tyrosine kinase inhibitor targeting VEGFR-2, which exhibited broad-spectrum antitumor activities in previous studies.We aim to evaluate the efficacy and safety of apatinib as non-first-line treatment in patients with advanced cholangiocarcinoma.Methods: This was a prospective open-label phase II trial (NCT03251443).Patients with pathology-confirmed cholangiocarcinoma after prior systemic therapy were enrolled.Participants were treated with apatinib 500 mg orally once daily.The primary end point was overall response rate (ORR).Results: Between August 8, 2017 and November 13, 2018, 30 patients participated in this study, and 26 patients received apatinib treatment except 4 patients withdrew consent before the first dosage.For full analysis set, the ORR was 11.5% and the disease control rate was 50.0%.3 patients (11.5%) achieved partial response and no patients achieved complete response.The median progression free time was 2.0 (95% CI: 0.7-3.3)months and median overall survival was 9. 0 (95% CI: 4.6-13.4)months.The most common adverse events of any grade were fatigue (80.8%), hypertension (73.1%) and decreased appetite (38.5%).Grade 3 adverse events occurred in 23.1% patients and no grade 4 adverse events occurred.The most common grade 3 adverse events were hypertension (23.1%) and elevated transaminase (11.5%).Conclusion: Apatinib as non-first-line monotherapy has potential therapeutic efficacy in patients with advanced cholangiocarcinoma.
Source: Journal of Cancer
DOI: 10.7150/jca.53482
Language: English
Subfield: Surgery
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $1,337
Awards: G1980161380, G2332635585
OpenAlex ID: W3128052265
