Abstract 196TiP
Background
Concurrent chemoradiotherapy (cCRT) is the standard therapy for locally advanced gastric and GEJ adenocarcinoma with poor prognosis. Programmed cell death receptor-1 (PD-1) inhibitor has been approved to treat ≥3 line gastric and GEJ patients (pts). PACIFIC study demonstrated significant clinical benefits of PD-1 inhibitor in addition to cCRT in locally advanced lung cancer. Sintilimab, a humanized IgG4 monoclonal antibody with high affinity and specificity for PD-1, has shown promising efficacy with an overall response rate of 85% in combination with chemotherapy in gastric cancer in a phase Ib study (NCT02937116). A study was therefore designed to explore the efficacy and safety of perioperative cCRT in combination with sintilimab for pts with locally advanced gastric cancer.
Trial design
This is a prospective, open label, multicentric phase II trial which pts with locally advanced (cT3N2-3 or cT4aN+ or cT4bNany) gastric or GEJ adenocarcinoma will receive preoperative 4 cycles sintilimab in combination with S1, nab-paclitaxel (nab-PTX) and radiotherapy (RT) and post-operative 3 cycles sintilimab with S1 and nab-PTX. Sintilimab will be administered intravenously at flat dose of 200 mg every 3 wks. S1 orally at dose of 40 mg/m2 (bid) and nab-PTX intravenously at 100-120 mg/m2 (d1, d8) will be given for 2 cycles before surgery and 3 cycles after. A weekly nab-PTX (80-100 mg/m2,d1, d8, d15, d22) with concurrent RT (45Gy/1.8Gy*25f) will be given in between 2 cycles of S1 and nab-PTX combination. The primary endpoint is the pathological complete response (pCR), and a Simon optimal two-stage design will be employed to achieve the target at 35% from historical 15%. Secondary endpoints include safety, major pathological response (MPR) (defined by tumor residual ≤10%), R0 resection rate, and overall survival. Collateral translational studies explore the correlation of response with tumor mutational burden or genetic alterations, or biomarkers etc. The trial is now open to enrollment, 13 of planned 34 pts have been enrolled.
Clinical trial identification
ChiCTR1900024428.
Legal entity responsible for the study
Affiliated Drum Tower Hospital to Medical School of Nanjing University.
Funding
Innovent Biologics.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
424P - Hippocampus sparing in volumetric modulated arc therapy (VMAT) for brain tumour radiotherapy treatment
Presenter: Eva Yi Wah Cheung
Session: e-Poster Display Session
425P - The impact of obesity on treatment outcomes in patients with solid tumour malignancies treated with first-line (1L) immuno-oncology (IO) agents
Presenter: Chun Loo Gan
Session: e-Poster Display Session
426P - A multicenter, randomized, double-blind, phase II study of lenvatinib (LEN) in patients (pts) with radioiodine-refractory differentiated thyroid cancer (RR-DTC) to evaluate the safety and efficacy of a daily oral starting dose of 18 mg vs 24 mg
Presenter: Marcia S. Brose
Session: e-Poster Display Session
427P - On the clinical implications of systemic and local immune responses in human angiosarcoma
Presenter: Jason Yongsheng Chan
Session: e-Poster Display Session
428P - Prognostic value of clinico-pathological characteristics and peripheral monocyte counts in localised extra-meningeal solitary fibrous tumours treated with surgical resection
Presenter: Ryan Lim
Session: e-Poster Display Session
429P - Demographics, pattern of care, and outcome analysis of malignant melanoma cases from a tertiary care centre in India
Presenter: Anshul Agarwal
Session: e-Poster Display Session
430P - Teenagers and young adult cancers in rural central India: Access to age-appropriate care
Presenter: Runu Sharma
Session: e-Poster Display Session
431P - Quantitative study of two critical lncRNAs in patients with glioma tumours
Presenter: Kamal Mohammadian
Session: e-Poster Display Session
432P - Efficacy and tolerability of vismodegib treatment in locally advanced and metastatic basal cell carcinoma
Presenter: Mustafa Gürbüz
Session: e-Poster Display Session
433P - Association between aspirin and cancer risk: A Mendelian randomization analysis
Presenter: Yu Jiang
Session: e-Poster Display Session