PILGRIM: Phase III clinical trial in evaluating the role of hyperthermic intraperitoneal chemotherapy for locally advanced gastric cancer patients after radical gastrectomy with D2 lymphadenectomy(HIPEC-01).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 4538-4538
Author(s):  
Shu-zhong Cui ◽  
Han Liang ◽  
Yong Li ◽  
Yanbing Zhou ◽  
Kaixiong Tao ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Cancer Patients ◽  
Hyperthermic Intraperitoneal Chemotherapy ◽  
Locally Advanced ◽  
Control Group ◽  
Radical Gastrectomy ◽  
Node Dissection ◽  
D2 Lymph Node Dissection ◽  
Locally Advanced Gastric Cancer ◽  
Gastric Cancer Patients

4538 Background: Gastric cancer remains the 3rd leading cancer related death worldwide due to early disease recurrence. We hypothesize that hyperthermic intraperitoneal chemotherapy (HIPEC) may effectively prevent local regional recurrence for locally advanced gastric cancer patients who received curative intent surgery. Methods: Pathology proven gastric cancer patients with clinical T3/T4NxM0 disease are eligible for the study and will be randomized to either control group, who will receive standard radical gastrectomy and D2 lymph node dissection or HIPEC group, who will receive the same surgery and HIPEC with paclitaxel x 2 within the first week after surgery. All patients will receive either XELOX or SOX adjuvant chemotherapy. The primary end point is overall survival. Results: 648 patients from 16 high volume gastric medical centers were enrolled between May, 2015 and March, 2019. 331 and 317 patients were randomized to control and HIPEC groups respectively. The median follow-up time is 12.1 months. The common grade 3/4 toxicities ( > 5%) in control and HIPEC groups are anemia 6% vs. 4.1%, intraabdominal infection 5.4% vs. 3.8%, pneumonia 9.7% vs. 9.8%, fever 10.6% vs. 11.4% and hypoalbunemia 15.1% vs. 16.7% respectively. All three perioperative death (within 30 days after surgery) occurred in control group. One patient died from duodenum stump leak which led to multiple organ failure. One patient died from anastomotic led to intraabdominal infection and shock. The 3rd death was suicide caused by severe depression. At the time of this report, the number of event has not reached for final efficacy analysis. Conclusions: It is safe to administer HIPEC to patients received radical gastrectomy with D2 lymph node dissection within one week of surgery. The primary analysis will be expected in one year. Clinical trial information: NCT02356276 .

scholarly journals Neoadjuvant therapy for locally advanced gastric cancer patients. A population pharmacodynamic modeling

PLoS ONE ◽  
2019 ◽  
Vol 14 (5) ◽  
pp. e0215970 ◽  
Author(s):  
Patricia Martin-Romano ◽  
Belén P. Solans ◽  
David Cano ◽  
Jose Carlos Subtil ◽  
Ana Chopitea ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Neoadjuvant Therapy ◽  
Advanced Gastric Cancer ◽  
Cancer Patients ◽  
Locally Advanced ◽  
Pharmacodynamic Modeling ◽  
Locally Advanced Gastric Cancer ◽  
Gastric Cancer Patients

scholarly journals Phase II trial of prophylactic hyperthermic intraperitoneal chemotherapy in patients with locally advanced gastric cancer after curative surgery

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Biao Fan ◽  
Zhaode Bu ◽  
Ji Zhang ◽  
Xianglong Zong ◽  
Xin Ji ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Postoperative Complications ◽  
Advanced Gastric Cancer ◽  
Phase Ii Trial ◽  
Locally Advanced ◽  
Control Group ◽  
Radical Gastrectomy ◽  
Curative Surgery ◽  
Locally Advanced Gastric Cancer ◽  
Experimental Group

Abstract Background HIPEC is an emerging procedure to treat peritoneal metastasis of gastric cancer. Data about HIPEC in locally advanced gastric cancer is scarce. The purpose of this trial is to evaluate the safety and toxicity of prophylactic HIPEC with cisplatin for patients with locally advanced gastric cancer. Methods From March 2015 to November 2016, a prospective, randomized phase II trial was conducted. After radical gastrectomy, patients in the experimental group underwent HIPEC with cisplatin followed by adjuvant chemotherapy with SOX regime. Patients in the other group were treated with SOX regime alone. Postoperative complications and patient survival were compared. Results In total, 50 patients were eligible for analyses. No significant difference was found in the incidence of postoperative complications including anastomotic/intestinal leakage, liver dysfunction, bone marrow suppression, wound infection and ileus (P > 0.05). Mean duration of hospitalization after radical gastrectomy was 11.7 days. 12.2 days in experimental group and 10.8 days in control group respectively (P = 0.255). The percentage of patients with elevated tumor markers was 12.1% in experimental group, which was significantly lower than 41.2% in control group (P = 0.02). 3-year RFS of patients who treated with or without prophylactic HIPEC were 84.8 and 88.2% respectively (P = 0.986). In the multivariate analysis, pathological T stage was the only independent risk factor for the RFS of patients (P = 0.012, HR =15.071). Conclusion Additional intraoperative HIPEC with cisplatin did not increase postoperative complications for locally advanced gastric cancer after curative surgery. Prophylactic HIPEC with cisplatin was safe and tolerable, while it did not reduce the risk of peritoneal recurrence in this trial, supporting further studies to validate the efficacy of it. Trial registration Chinese Clinical Trial Registry, ChiCTR2000038331. Registered 18 September 2020 - Retrospectively registered, http://www.chictr.org.cn/showproj.aspx?proj=59692.

scholarly journals High expressions of CD10, FAP and GPR77 in CAFs are associated with chemoresistance and worse prognosis in gastric cancer

2021 ◽  
Author(s):  
Yilin Tong ◽  
Zehua Zhao ◽  
Jianjun Zhang ◽  
Wentao Wang ◽  
Yanmei Zhu
Keyword(s):  
Gastric Cancer ◽  
Overall Survival ◽  
Regression Model ◽  
Cancer Patients ◽  
Tumor Regression ◽  
Locally Advanced ◽  
Multivariable Analysis ◽  
Predictive Values ◽  
Locally Advanced Gastric Cancer ◽  
Gastric Cancer Patients

Abstract Background As neoadjuvant chemotherapy (NCT) has been successfully introduced in gastric cancer (GC), more biomarkers are needed to evaluate the efficacy. Cancer-associated fibroblasts (CAFs) is associated with chemoresistance and prognosis. Three biomarkers, CD10, fibroblast activation protein-α (FAP) and G-protein-coupled receptor 77 (GPR77), have been proved to express in CAFs. However, their predictive values for efficacy of NCT and prognosis in gastric cancer is unknown. Methods Totally, specimens of 171 locally advanced gastric cancer patients who underwent NCT and D2 radical gastrectomy and matched preoperative biopsy specimens were retrospectively analyzed. Tumor regression grade (TRG) is reevaluated according to Mandard TRG. Expressions of CD10, FAP and GPR77 in CAFs before NCT (pre-) and after NCT (post-) were evaluated by immunohistochemistry. Survival curves on overall survival (OS) were obtained by Kaplan-Meier method, and differences were analyzed by log-rank test. Associations between categorical variables were explored by chi-square test or Fisher's exact method. Univariable and multivariate analyses were performed by logistic regression model and Cox proportional hazard regression model. Results High expressions of post-CD10, post-FAP, post-GPR77 and pre-CD10 were related to worse TRG (all p<0.05). In multivariable analysis, post- and pre-FAP were independent predictive factors to TRG (p<0.010). Post-CD10 (p=0.032) and post-FAP (p=0.013) were related to OS in univariable analysis, but none of biomarkers were independent prognostic factors in multivariable analysis. Conclusions Expressions of CD10, FAP and GPR77 in CAFs were related to chemoresistance and overall survival, and these biomarkers have predictive values for tumor regression and prognosis in locally advanced gastric cancer patients.

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