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Capecitabine

Paclitaxel

Albumin-Bound Paclitaxel

Oxaliplatin

Postoperative hyperthermic intraperitoneal chemotherapy (HIPEC) is performed after radical surgery, followed by 6-8 cycles of systemic chemotherapy. The first HIPEC is conducted within 48 h after surgery: Paclitaxel 75 mg/m\^2, 43°C, 60min. The second HIPEC is performed after 24 hours of the first HIPEC. The regimens are Paclitaxel 100 mg/m\^2, 43°C, 60min.

Systemic chemotherapy (XELOX or SOX regimens):

XELOX regimen: Oxaliplatin: 130 mg/m\^2, IV, d1; Capecitabine: 1 g/m\^2 bid, days 1-14, every 3 weeks for a total of 6-8 cycles.

If XELOX regimen is not conducted in some collaborators, SOX regimen is also permitted. The regimen is Oxaliplatin: 130 mg/m\^2, IV, d1; S-1, 40-60 mg/m\^2 bid, po, day 1-14, every 3 weeks for a total of 6-8 cycles.

6-8 cycles of systemic chemotherapy (XELOX or SOX regimens) were performed after radical gastrectomy with D2 lymphadenectomy.

XELOX regimen is Oxaliplatin: 130 mg/m\^2, IV, d1; Capecitabine: 1 g/m\^2 bid, days 1-14, every 3 weeks for a total of 6-8 cycles.

If XELOX regimen is not conducted in some collaborators, SOX regimen as comment systemic chemotherapy in Asia is also permitted to treat the patients. The treatment bundles are listed as follows: Oxaliplatin: 130 mg/m\^2, IV, d1; S-1, 40-60 mg/m\^2 bid (S-1: BSA \<1.25m\^2, 40mg bid, 1.25m\^2≤ BSA ≤1.5m\^2, 50mg bid, BSA\>1.5m\^2, 60 mg bid), po, day 1-14, every 3 weeks for a total of 6-8 cycles.

D2 lymphadenectomy

The first HIPEC is conducted within 48 h after surgery: Normal saline 3000 -4000ml, Paclitaxel 75mg/m\^2, 43°C, 60min. The second HIPEC is performed after 24 hours of the first HIPEC. The regimens are Paclitaxel 100 mg/m\^2, 43°C, 60min.

Hyperthermic Intraperitoneal Chemotherapy

XELOX regimen: Oxaliplatin: 130 mg/m\^2, IV, d1; Capecitabine: 1 g/m\^2 bid, days 1-14, every 3 weeks for a total of 6-8 cycles.

SOX regimen: Oxaliplatin: 130 mg/m\^2, IV, d1; S-1, 40 mg/m\^2 bid, po, day 1-14 (S-1: BSA \<1.25m\^2, 40mg bid, 1.25m\^2≤ BSA ≤1.5m\^2, 50mg bid, BSA\>1.5m\^2, 60 mg bid) bid, d1-14, po, every 3 weeks for a total of 6-8 cycles.

Systemic chemotherapy (XELOX or SOX regimens)

shuzhong cui, M.D

Xian-Zi Yang, M.M

Zheng Peng, M.D

Zhi-Wei Zhou, M.D

Xiao-Xi Zhu, M.B

Yong Li, M.D

Ze-Jian Lv, M.M

Zhen Tang, M.M

Jin Wang, M.D

Wen-Jun Xiong, M.M

Guo-Xin Li, M.D

Hao Liu, M.D

Bao-Jun Zhou, M.M

Shao-Wei Ma, M.M

Qing-Wei Liu, M.M

Kuan Wang, M.D

Guan-Yu Zhu, M.D

Guang-Sen Han

Wei Yang, M.M

Kai-Xiong Tao, M.D

Ke Wu, M.D

Hong-Liang Yao, M.D

San-Lin Lei, M.D

Han Liang, M.M

Xue-Jun Wang, M.D

Xin-Bao Wang, M.D

Chao Hu, M.D

HIPEC-01 is a prospective, open, randomized multicenter phase III clinical study conducted in China. To determine the efficacy of hyperthermic intraperitoneal chemotherapy (HIPEC) in the treatment of locally advanced gastric cancer, patients are randomized into HIPEC group and control group. In HIPEC group, the patients undergo radical gastrectomy with D2 lymphadenectomy and HIPEC with paclitaxel and postoperative chemotherapy. Patients in the control group just undergo radical gastrectomy with D2 lymphadenectomy followed by postoperative chemotherapy. Patients in both groups receive 6-8 cycles of postoperative systemic chemotherapy (XELOX or SOX regimens) and are followed up for 5 years or until death.

Gastric cancer (GC) is the fourth most common cancer, and the second leading cause of cancer-related death worldwide. Advances in diagnostic and therapeutic approaches have achieved long-term survival for early GC. However, receiving perioperative/postoperative systemic chemotherapy and gastrectomy with D1-D2 lymph node dissection, 5-year survival rates of advanced gastric cancer remain under 30%. 40-60% of recurrences are peritoneal and/or locoregional. hyperthermic intraperitoneal chemotherapy (HIPEC) technique is increasingly used in the curative treatment of primary and digestive peritoneal carcinomatosis, in association with cytoreductive surgery. Theoretically, HIPEC eliminates free cancer cells that can be released into peritoneal cavity during the gastrectomy and prevents peritoneal carcinomatosis recurrences. The benefit of using HIPEC as an adjuvant treatment for advanced gastric cancer has been reported in several randomized studies and a meta-analysis. Surgical resection combined with HIPEC significantly reduces the peritoneal recurrences and improves the overall survival of GC patients. But there is not a prospective and randomized phase III clinical study of HIPEC in the treatment of locally advanced gastric cancer after radical surgery in China so far.

In order to evaluate the survival benefit and safety of radical surgery and HIPEC followed by postoperative chemotherapy in local advanced gastric cancer, patients who fulfill the inclusion and exclusion criteria will be recruited in this study and randomized to two treatment groups (HIPEC group and control group). In HIPEC group, the patients undergo radical gastrectomy with D2 lymphadenectomy and HIPEC with paclitaxel and postoperative chemotherapy. Patients in the control group just undergo radical gastrectomy with D2 lymphadenectomy followed by postoperative chemotherapy. Patients in both groups receive 6-8 cycles of postoperative systemic chemotherapy (XELOX or SOX regimens) . Patients are followed up for 5 years and the survival outcome will be analyzed.

Efficacy of HIPEC in the Treatment of Locally Advanced Gastric Cancer After radIcal Gastrectomy With D2

A Phase III Study of Hyperthermic Intraperitoneal Chemotherapy in the Treatment of Locally Advanced Gastric Cancer After radIcal Gastrectomy With D2

Quantitative RT-PCR is used to analyze CEA mRNA expression of peritoneal lavage fluid before and after D2 lymphadenectomy between two arms

assess overall survival during 5 years in both study arms

assess progression-free survival rate during 5 years in both study arms

calculate the percent of liver metastatic in both two arms during 5 years

calculate the percent of local recurrence in both two arms during 5 years

determine percent of adverse events or side effects according to NCI criteria, Common Terminology Criteria for AE (CTCAE 4.0).

Tianjin Medical University Cancer Institute and Hospital

Nanfang Hospital, Southern Medical University

Zhejiang Cancer Hospital

The Second Hospital of Hebei Medical University

Chinese PLA General Hospital

Henan Cancer Hospital

Harbin Medical University

Central South University

Guangdong Provincial People's Hospital

Wuhan Union Hospital, China

Sun Yat-sen University

Hebei Medical University Fourth Hospital

Guangdong Provincial Hospital of Traditional Chinese Medicine

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Patients are managed by radical gastrectomy with D1 lymphadenectomy

Patients are managed by radical gastrectomy with D2 lymphadenectomy

Radical gastrectomy with D1 lymphadenectomy

Radical gastrectomy with D2 lymphadenectomy

Mohamed Elmessiry, MD

Surgery is the mainstay treatment of operable gastric carcinoma but the optimal extent of lymph node (LN) dissection is controversial. The aim of this observational study is to assess the outcomes after curative D2 compared to D1 gastrectomy of operable gastric carcinoma regarding operative and long term oncological outcomes.

This observational study included 80 consecutive patients presented by operable gastric cancer treated by D2 gastrectomy at Alexandria University hospital between January 2010 and January 2016, (Group I). Another 68 consecutive patients presented by operable gastric cancer treated by D1 gastrectomy earlier during the same period were included as a control (Group II). All patients had undergone preoperative gastroscopy and biopsy, chest and abdomen computed tomography (CT). All surgeries were performed by surgeons experienced in both D1 and D2 dissection and a standardized protocol for D1 and D2 gastrectomy was followed in all patients. The type of gastrectomy (distal or total) was done according to the site of the tumor; distal gastrectomy was done if there is a free safety margin of 4 cm beyond the proximal resection line otherwise total gastrectomy was done. Resection of the spleen and/or pancreatic tail were done if directly invaded by the primary tumor or metastatic LN. Patients with p T2 or greater, or with positive LN received adjuvant chemotherapy. Follow up was done as outpatient visits for average 5 years. Both groups were compared regarding postoperative morbidity and mortality, disease recurrence and survival rates.

D2 Versus D1 Gastrectomy of Operable Gastric Cancer

Operative and Long Term Oncological Outcomes After D2 Versus D1 Gastrectomy of Operable Gastric Cancer

Frequency of early postoperative complications

Frequency of early postoperative mortality

Frequency of tumor recurrence within 5 years after curative surgery

Frequency of Cancer specific mortality within 5 years after curative surgery

Percentage of patients survived for 5 years after surgery without tumor recurrence

Percentage of patients survived for 5 years after surgery with/without tumor recurrence

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Efficacy of HIPEC in the Treatment of Locally Advanced Gastric Cancer After radIcal Gastrectomy With D2	NCT02356276	Gastric Cancer	D2 lymphadenect... Hyperthermic In... Systemic chemot...	18 Years - 70 Years	Affiliated Cancer Hospital & Institute of Guangzhou Medical University
D2 Versus D1 Gastrectomy of Operable Gastric Cancer	NCT04429841	Gastric Cancer	Radical gastrec... Radical gastrec...	20 Years - 80 Years	Alexandria University

Spots Global Cancer Trial Database for radical gastrectomy with d2 lymphadenectomy