A randomized controlled clinical study of postoperative intraperitoneal chemotherapy as a prophylactic treatment to resectable advanced gastric cancer on preventing peritoneal metastasis

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-IIR-17013434

Enrollment

Unknown

Registered

2017-11-18

Start date

2018-01-01

Completion date

Unknown

Last updated

2017-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Gastric Cancer

Interventions

treatment group(surgery+IP+adjuvant chemotherapy):surgery plus IP and adjuvant chemotherapy

control group( surgery+IP+adjuvant chemotherapy:surgery alone plus adjuvant chemotherapy

Eligibility

Sex/Gender

All

Age

20 Years to 70 Years

Inclusion criteria

Inclusion criteria: Patients with histologically confirmed locally advanced adenocarcinoma of the stomach or EGJ; no prior antineoplastic therapy; TNM stage T3/T4N+( confirmed by CT or EUS);examining before surgery indicated that local lymph node metastasis or serosa-Involved; Borrman III/IV by EUS; pathology by EUS: Lauren diffuse type; Eastern Cooperative Oncology Group(ECOG) performance status of zero to two; Aged ranges from 20 to 70 years; adequate bone marrow function(leukocyte count 3000–12 000/mm3, hemoglobin =8.0 g/dl and platelet count =100000/mm3); adequate liver function (total serum bilirubin =2.0 mg/dl and serum transaminases=100/UI); adequate renal function (serum creatinine within the upper limit of normal);Inclusion criteria: Patients with histologically confirmed locally advanced adenocarcinoma of the stomach or EGJ; no prior antineoplastic therapy; TNM stage T3/T4N+( confirmed by CT or EUS);examining before surgery indicated that local lymph node metastasis or serosa-Involved; Borrman III/IV by EUS; pathology by EUS: Lauren diffuse type; Eastern Cooperative Oncology Group(ECOG) performance status of zero to two; Aged ranges from 20 to 70 years; adequate bone marrow function(leukocyte count 3000–12 000/mm3, hemoglobin =8.0 g/dl and platelet count =100000/mm3); adequate liver function (total serum bilirubin =2.0 mg/dl and serum transaminases=100/UI); adequate renal function (serum creatinine within the upper limit of normal)

Exclusion criteria

Exclusion criteria: Distant metastasis or other current and previous malignancy;pregnant or breast feeding; serious or no uncontrolled medical diseases and infection; neoadjuvant radotherapy or chemotherapy; serious or no uncontrolled physological or mental diseases; non-compliant patient; disease progression during therapy;known hypersensitivity to therapy-related drugs;Exclusion criteria: Distant metastasis or other current and previous malignancy;pregnant or breast feeding; serious or no uncontrolled medical diseases and infection; neoadjuvant radotherapy or chemotherapy; serious or no uncontrolled physological or mental diseases; non-compliant patient; disease progression during therapy;known hypersensitivity to therapy-related drugs

Design outcomes

Primary

Measure	Time frame
IP-related safty;morbidity;;IP-related safty;morbidity;	—

Secondary

Measure	Time frame
Overall Survival;Progression-free survival;expression of SYT8 and CA125;recurrence rate;metastasis rate;mortality rate;;Overall Survival;Progression-free survival;expression of SYT8 and CA125;recurrence rate;metastasis rate;mortality rate;	—

Countries

China

Contacts

Public ContactZheng Zhichao;Zheng Zhichao ;

Liaoning Cancer Hospital and Institute ;Liaoning Cancer Hospital and Institute

drzhengzhichao@126.com;drzhengzhichao@126.com+86 18900918181;+86 18900918181

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026