Abstract 3371
Background
The prognosis of osteosarcoma at its metastatic stage remains unchanged over the last several decades. Although 60∼80% first pulmonary recurrences were reportedly to be resectable, it’s surprising that the vast majority of trials to date were designed for metastatic osteosarcoma that were considered inoperable. Apatinib, a VEGFR2 inhibitor, is marked by its superior overall response rate (ORR) of ∼55% compared with other anti-angiogenic agents. Therefore, we aim to assess the efficacy and safety of incorporating apatinib with second-line chemotherapy preoperatively for resectable pulmonary metastatic osteosarcoma, with the intent to shrink the lesions for easier resection and eradicate the micro-metastatic residue using the combination therapy.
Trial design
This study is a multicenter, open-label, randomized phase II trial (ClinicalTrials ID: NCT03742193) in which ∼180 participants were to be randomized to an active control arm and an intervention arm in 1:1 ratio. Patients in the intervention arm will receive 250mg apatinib twice daily combined with gemcitabine-docetaxel (GD) regimen before and after the pulmonary metastasectomy, while the control arm will receive gemcitabine-docetaxel (GD) regimen only. Osteosarcoma patients with pulmonary recurrence only, which are potentially resectable at baseline will be recruited in the trial. The primary endpoint is progression-free survival (PFS) and the pre-specified target is an at least 30% decrease of hazard rate of progression in the experimental arm compared with the control arm. Error rate level of the trial was set at an one-sided α value of 0.1 and a power (1-β value) of 0.8, with mid-term assessment for both early efficacy and futility. Secondary objectives are to analyze the effect of the new regimen on overall survival, total resectability, objective response rate, clinical benefit rate, tolerability, as well as the potential predictive biomarker(s).
Clinical trial identification
NCT03742193; release date: March 2018.
Editorial acknowledgement
Legal entity responsible for the study
An IIT trial by Ruijin Hospital, Orthopaedic oncology group.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
4228 - Clinical Evaluation of Drug-Eluting Bead Transcatheter Arterial Chemoembolization(D-TACE) versus Conventional TACE in Treatment of unresectable Hepatocellular Carcinoma
Presenter: Yi Chen
Session: Poster Display session 1
Resources:
Abstract
3930 - Safety profile of tepotinib in patients with advanced solid tumors: pooled analysis of phase I and II data
Presenter: Thomas Decaens
Session: Poster Display session 1
Resources:
Abstract
5373 - Drug-drug interaction profile of tepotinib with CYP3A and P-gp substrates
Presenter: Juergen Heuer
Session: Poster Display session 1
Resources:
Abstract
5455 - Bioavailability of tepotinib: impact of omeprazole and food
Presenter: Juergen Heuer
Session: Poster Display session 1
Resources:
Abstract
2618 - Tislelizumab Exposure-Response Analyses of Efficacy and Safety in Patients with Advanced Tumors
Presenter: Chi-Yuan Wu
Session: Poster Display session 1
Resources:
Abstract
2563 - Population Pharmacokinetics of Tislelizumab in Patients with Advanced Tumors
Presenter: Chi-Yuan Wu
Session: Poster Display session 1
Resources:
Abstract
2021 - The Addition of Metformin to Systemic Anticancer Therapy
Presenter: Jung Han Kim
Session: Poster Display session 1
Resources:
Abstract
5243 - Growth modulation index (GMI) as a comparative measure of clinical activity of larotrectinib versus prior systemic treatments in adult and pediatric TRK fusion cancer patients
Presenter: Antoine Italiano
Session: Poster Display session 1
Resources:
Abstract
598 - Analysis of the overall survival and main surrogates used for FDA approvals in solid and hematological malignancies.
Presenter: Maria Kleniewska-Wieczor
Session: Poster Display session 1
Resources:
Abstract
5381 - Comparison of intratumoral docetaxel exposure in cancer patients between nanoparticle entrapped docetaxel (CPC634) and conventional docetaxel (Cd): the CriTax study
Presenter: Ruben Van Eerden
Session: Poster Display session 1
Resources:
Abstract