Abstract 1503TiP
Background
Oesophageal cancer is a seventh most commonly diagnosed carcinoma and sixth leading cause of death in both sexes, and 5-year survival rate is only 19%. To improve the prognosis of locally advanced oesophageal cancer patients, recent studies have focused on neoadjuvant regiments. CROSS-trial demonstrated a standard of care with neoadjuvant chemoradiotherapy (nCRT) followed by surgery for patients with operable oesophageal cancer, and patients who received nCRT achieved 23% and 49% of pathological complete response (pCR) rates for adenocarcinoma and squamous cell carcinoma, respectively. Apatinib is a VEGFR-2 inhibitor that selective compete for intracellular VEGFR-2 binding sites highly, which blocks downstream signal transduction and inhibit neoangiogenesis in tumor. In order to improve pCR rate further, we conduct a prospective trial of apatinib in combination with neoadjuvant concurrent chemoradiotherapy in locally advanced esophageal squamous cell carcinoma (ESCC).
Trial design
This is a single-arm exploratory study. Subjects will be scheduled for apatinib (250mg, po, qd, d1-35) with concurrent nCRT. Paclitaxel and Cisplatin are delivered with 50mg/m2 and 30mg/m2, respectively, d18,15,22 and 29. Patients are planed to receive the intensity modulated radiotherapy (IMRT) with the total dose of 41.4Gy/23fx. Esophagectomy will be performed 6-8 weeks after the completion of neoadjuvant treatment. Key eligibility criteria included as follows: patients diagnosed with operable locally advanced ESCC with 18-70 years old; patients with the clinical stage of II-III (T2-4N0/+M0) (According to 8th version of UICC); ECOG performance status is 0-2; patients with measurable lesions (according to the criteria in RECIST1.1) and organ function is in the normal range. The primary endpoint is pCR rate, and secondary endpoints include R0 resection rate, disease-free survival, overall survival and toxicity. Enrollment is currently ongoing.
Clinical trial identification
Clinical trial information: NCT03857763.
Editorial acknowledgement
Legal entity responsible for the study
Jun Wang.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.