The effect of anti-programmed cell death 1 (PD-1) antibody in Epstein-Barr virus-associated gastric cancer (EBVaGC) was debatable, and no predictive biomarkers for efficacy have been reported. Public reports on anti-PD-1 antibody monotherapy-treated EBVaGC with available programmed death ligand-1 (PD-L1) expression status were summarized and analyzed. Relevance with clinicopathologic characteristics of PD-L1 expression by immunohistochemistry was analyzed in 159 patients diagnosed with EBVaGC. Relevance with genomic transcriptome and mutation profile of PD-L1 status in EBVaGC was assessed with three datasets, the cancer genome atlas (TCGA), Gene Expression Omnibus (GEO) GSE51575, and GSE62254. Based on the data from 8 reports, patients with positive PD-L1 expression (n = 30) had significantly superior objective response rate (ORR) than patients with negative PD-L1 expression (n = 9) (63.3% vs. 0%, P = .001) in EBVaGC receiving anti-PD-1 antibody monotherapy. PD-L1 positivity was associated with less aggressive clinicopathological characteristics and was an independent predictor for a longer disease-free survival (hazard ratio [HR] and 95% CI: 0.45 [0.22–0.92], P = .03) and overall survival (HR and 95% CI: 0.17 [0.06–0.43], P < .001). Analysis of public EBVaGC transcriptome and mutation datasets revealed enhanced immune-related signal pathways in PD-L1^high EBVaGC and distinct mutation patterns in PD-L1^low EBVaGC. PD-L1 positivity indicates a subtype of EBVaGC with ‘hot’ immune microenvironment, lower aggressiveness, better prognosis, and higher sensitivity to anti-PD-1 immunotherapy.

Background: Ovarian metastasis from colorectal cancer (CRC) is rare and lacks standard treatment. The benefit of metastatectomy remains to be elucidated. This study was conducted to assess the impact of metastatectomy on survival outcome and explore prognostic factors in ovarian metastatic CRC patients. Methods: Information of ovarian metastatic CRC patients between January 2008 and December 2017 were collected retrospectively from database of West China Hospital, Sichuan University. Kaplan–Meier method was used to estimate disease-specific survival (DSS) after diagnosis of ovarian metastasis, and multivariate Cox regression analysis was applied to identify prognostic factors. Results: Totally, 68 female patients from a cohort of 2170 cases were eligible. The median age at diagnosis was 46.5 years. The median DSS was 25.0 months (95% confidence interval (CI): 21.0– 29.0 months). Kaplan–Meier analysis and Log rank test showed that complete resection of ovarian metastases (median DSS: 33.0 months) could significantly prolong patients’ survival time, compared with palliative and no resection (median DSS: 20.0 months and 22.0 months, respectively), regardless of systemic chemotherapy (P< 0.05). Multivariate analysis demonstrated regional lymph nodes metastasis of primary tumor (hazard ratio (HR): 3.438, 95% CI: 1.094– 10.810, P=0.035), primary tumor resection (HR: 6.436, 95% CI: 1.770– 23.399, P=0.005), differentiation grade (HR: 0.272, 95% CI: 0.107– 0.693, P=0.006), complete resection of ovarian metastases (vs palliative resection: HR: 17.091, 95% CI: 3.040– 96.099, P=0.001; vs no resection: HR: 9.519, 95% CI: 1.581– 57.320, P=0.014), and systemic chemotherapy (HR: 3.059, 95% CI: 1.089– 8.595 P=0.034) were independent prognostic factors. Conclusion: Complete resection of ovarian metastases could independently predict favorable survival in ovarian metastatic CRC, while palliative resection could not improve patients’ prognosis compared with no resection.

Background: Pancreatic ductal adenocarcinoma (PDAC) is still a highly fatal malignancy among the most common cancers. More powerful treatments are expecting to bring hope for patients. Biweekly gemcitabine/nab-paclitaxel/S-1 (GAS) was proved safe and effective for patients with locally advanced pancreatic cancer in Japan. The objective of this study is to evaluate the feasibility and toxicity of GAS (repeated every 3 weeks) in the treatment of locally advanced or advanced pancreatic cancer and determine the recommended dose of S-1 in this combination. Methods: This is an open-label, single-arm, and single-center phase I trial. Patients who have been diagnosed with locally advanced or advanced PDAC pathologically without previous systemic treatments will be enrolled and be treated with GAS chemotherapy every 3 weeks (nab-paclitaxel 125 mg/m ², ivgtt, day1, 8; gemcitabine 1000 mg/m², day1, 8; different doses of S-1 within a dose escalation scheme) until the presence of disease progression (PD), intolerable adverse events (AEs), or requirement of patients and researchers. The primary endpoints are maximum tolerated dose (MTD) and dose-limiting toxicity (DLT). The secondary endpoints include safety, objective response rate (ORR), progression-free survival (PFS) and overall survival (OS). Discussion: This trial will adjust the administration of GAS to make it more effective for Chinese patients, while exploring the toxicity and feasibility of this adjustment. Trial registration: ChiCTR, (ChiCTR1900027833). Registered 30 November 2019.

Background Neoadjuvant radiochemotherapy followed by radical surgery is the standard treatment strategy for local advanced rectal cancer (LARC). However, the efficacy of neoadjuvant radiochemotherapy is limited, especially for patients with DNA mismatch repair-deficient (dMMR)/microsatellite instability-high (MSI-H) rectal cancer. Considering the amazing therapeutic effect of immune check point inhibitors for metastatic colorectal cancer, we conduct this multicenter, phase Ib study to investigate the safety and efficacy of anti-PD-1 antibody, sintilimab combined with hypofractionated radiotherapy in MSI-H/dMMR rectal cancer patients. Methods Patients with MSI-H/dMMR LARC will receive hypofractionated radiotherapy (5 Gy x 5) and three cycles of sintilimab 200 mg IV every 2 weeks. Radical surgery will be performed 6-8 weeks after radiotherapy. The primary endpoint is adverse reaction after neoadjuvant treatment and perioperative complications. Secondary endpoints include pathological response rate, complete resection rate, and quality of life. Discussion This is the first study to investigate the safety and effectiveness of neoadjuvant radiotherapy combined with immunotherapy for MSI-H/dMMR LARC. It is expected that this study will propose a brand new and effective treatment strategy for MSI-H/dMMR LARC.