scholarly journals The efficacy and safety of S-1-based regimens in the first-line treatment of advanced gastric cancer: a systematic review and meta-analysis

2016 ◽  
Vol 19 (3) ◽  
pp. 696-712 ◽  
Author(s):  
Emil ter Veer ◽  
Nadia Haj Mohammad ◽  
Paul Lodder ◽  
Lok Lam Ngai ◽  
Mary Samaan ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Systematic Review ◽  
Advanced Gastric Cancer ◽  
Meta Analysis ◽  
Line Treatment ◽  
Efficacy And Safety ◽  
First Line ◽  
First Line Treatment

scholarly journals Comparative efficacy and safety of anti-HGF/MET pathway agents plus chemotherapy versus chemotherapy alone as first-line treatment in advanced gastric cancer: a protocol for a systematic review and meta-analysis

BMJ Open ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. e049575
Author(s):  
Zhiyuan Jiang ◽  
Zhaolun Cai ◽  
Qin Ma ◽  
Chaoyong Shen ◽  
Yuan Yin ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Systematic Review ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Line Treatment ◽  
Efficacy And Safety ◽  
Comparative Efficacy ◽  
First Line ◽  
Effect Model ◽  
First Line Treatment

IntroductionPhase I/II clinical trials suggested that the hepatocyte growth factor (HGF)/mesenchymal-epithelial transition (MET) pathway-targeted agents were active in suppression of gastric cancer (GC). Randomised controlled trials (RCTs) were undertaken assessing whether the addition of anti-HGF/MET agent (rilotumumab or onartuzumab) to chemotherapy improves survival outcomes of advanced GC, but conflict conclusions were reached. Therefore, we plan to perform this systematic review and meta-analysis to synthesise evidence concerning efficacy and safety of anti-HGF/MET agents combined with chemotherapy as the first-line treatment to advanced GC.Methods and analysisSystematic searches of the PubMed, Embase and the Cochrane Central Register of Controlled Trials will be performed with no language restriction from inception to 31 January 2022 to identify RCTs exploring the comparative efficacy and safety of anti-HGF/MET agents plus chemotherapy as first-line treatment in advanced GC. The primary outcome will be the time-to-event progression-free survival and overall survival, and the secondary outcomes will be disease control rate, overall adverse events rate and grade 3–5 adverse events rate. Statistical heterogeneity will be assessed by visual inspection of forest plots and measured using the I2 statistics. A fixed-effect model will be used when heterogeneity is low otherwise, a random-effect model will be chosen. Publication bias will be assessed by funnel plots; subgroup analysis and sensitivity analysis will be performed in the right context. For each outcome, we will perform data synthesis using Rev Man V.5.3 software, and compile ‘summary of findings’ tables using GRADEpro software.Ethics and disseminationThere is no requirement for ethics approval because no individual data will be collected in this research. It is anticipated that the dissemination of results will take place at conferences and through publication in a peer-review journal, any adjustments from the protocol will be clearly documented and explained in its final report.PROSPERO registration numberCRD42020177404.

Camrelizumab combined with SOX regimen in the first-line treatment of unresectable advanced or recurrent gastric cancer: A single-arm, prospective, open clinical study.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e16017-e16017
Author(s):  
Zhengxiang Han
Keyword(s):  
Gastric Cancer ◽  
Clinical Study ◽  
Advanced Gastric Cancer ◽  
Gastroesophageal Junction ◽  
Line Treatment ◽  
Efficacy And Safety ◽  
First Line ◽  
Gastroesophageal Junction Adenocarcinoma ◽  
Recurrent Gastric Cancer ◽  
First Line Treatment

e16017 Camrelizumab combined with SOX regimen in the first-line treatment of unresectable advanced or recurrent gastric cancer£ºA single-arm, prospective, open clinical study. Background: Gastric cancer is one of the most common malignant tumors of the digestive system. In China, 80% of patients with gastric cancer are already in advanced or locally advanced stage at the time of detection. Even after receiving radical gastrectomy, more than half of patients will have local recurrence or distant metastasis, and the 5-year survival rate of patients with gastric cancer with metastasis is less than 10%.In recent years, more and more evidence supports the application of immune checkpoint inhibitors in advanced gastric cancer.In 2020, PD-1 was approved for advanced gastric cancer receiving second-line or above treatment in China, which is an affirming of the efficacy of PD-1 in the clinical treatment of gastric cancer. Immunotherapy combined with conventional chemotherapy, this study aims to explore the efficacy and safety of PD1 combined with chemotherapy in the treatment of first-line gastric cancer. Methods: This was a single center, prospective clinical study conducted at the Affiliated Hospital of Xuzhou Medical University, Jiangsu Province.Patients with newly treated unresectable advanced or recurrent gastric or gastroesophageal junction adenocarcinoma were enrolled.All enrolled subjects were treated with camrelizumab combined with SOX regimen every 3 weeks.The primary endpoint was progression-free survival (PFS).Secondary endpoints were overall survival (OS), objective response rate (ORR), disease control rate (DCR), and safety.This study was registered at Chictr.org.cn with the number Chictr2000029691. Results: The study plans to enroll 30 patients, and 16 patients have been included in the study from March 2020 to December 2020. Among them, 7 patients can be evaluated, 14 males, 2 females, ECOG score 0 or 1. Of the 7 patients who can be evaluated for efficacy, 1 achieved PR and 5 achieved SD, ORR was 14.29%, and DCR was 85.71 %. This is the early stage of data analysis, PFS has not yet reached, and the side effects are mild, mainly with grade 1 adverse reactions. The most common AEs are neutropenia (3/7) and decreased appetite (2/7). There were no treatment-related deaths. Conclusions: This study provides preliminary evidence for the first-line treatment of unresectable advanced or recurrent gastric or gastroesophageal junction adenocarcinoma with camrelizumab combined with chemotherapy. The current number of enrolled cases is small, but the preliminary effect of immunotherapy combined with chemotherapy in first-line patients with advanced gastric cancer can still be seen. This trial will further explore the clinical efficacy and safety of immunotherapy in the first-line gastric cancer. Clinical trial information: ChiCTR2000029691.

Apatinib in combination with S-1 as first-line treatment in patients with advanced gastric cancer: A phase II clinical trial.

2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 71-71
Author(s):  
Chuantao Zhang ◽  
Zimin Liu ◽  
Na Zhou ◽  
Jianli Zhang ◽  
Jingjuan Zhu ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Clinical Trial ◽  
Advanced Gastric Cancer ◽  
Objective Response Rate ◽  
Response Rate ◽  
Objective Response ◽  
Line Treatment ◽  
Efficacy And Safety ◽  
First Line ◽  
First Line Treatment

71 Background: Apatinib is a standard therapy for advanced gastric cancer in third-line setting. However, the efficacy and safety of apatinib plus S-1 as first-line therapy is unknown. Here, we conducted a single center study to evaluate the efficacy and safety of it. Methods: In this phase II trial, chemotherapy-naive patients with advanced gastric cancer were enrolled between August 24, 2016 and Sept 25, 2017, at a single centers in P.R. China. The patients enrolled were assigned to S-1 plus apatinib, S-1 (40 mg m-2 depending on patient's body surface area) was given orally, twice daily for 2 consecutive weeks, followed by a 1-week rest period, and apatinib 500 mg was given once daily, every 3-week cycle. The primary endpoint was overall survival(OS). Secondary endpoints were progression-free survival(PFS), time to progress (TTP), objective response rate (ORR) and safety. On disease progression, patients had the option to receive single-agent apatinib every 3 weeks.This trial is registered with ClinicalTrials.gov , number NCT02525237. Results: Thirty eligible patients, median age 63 years (range 40-76) and median performance status 1 (ECOG 0-2) ,were enrolled, 9 patients have no evaluation or withdrew consent. Therefore, of the 21 patients the median PFS and TTP were 5.34±1.83 months [1.76–8.92] and 1.34±0.08 months[1.18–1.51], respectively. Additionally, one(4.76%) patient had a complete response, one (4.76%)patients had partial responses, 11 patients had stable disease, and 9 patients had progress of disease. The objective response rate(ORR)and the disease control rate(DCR) were 9.52%(2/21) and 57.14%(12/21),respectively. Until Sept 25.2017,the primary endpoint(OS) had not been reached. We recorded grade 3 or 4 adverse events including elevated bilirubin and/or transaminase, fatigue, abdominal pain, thrombocytopenia,et al. There were no treatment-related deaths. Conclusions: First-line chemotherapy with S-1 plus apatinib in patients with advanced gastric cancer did not reach its primary objective. However, it holds promise of becoming a standard first-line treatment for patients with advanced gastric cancer. Clinical trial information: NCT02525237.

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