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A prospective multicenter randomized controlled clinical study of intraoperative intraperitoneal lavage chemotherapy for esophagogastric junction adenocarcinoma

A prospective multicenter randomized controlled clinical study of intraoperative intraperitoneal lavage chemotherapy for esophagogastric junction adenocarcinoma

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400082841
Enrollment
Unknown
Registered
2024-04-09
Start date
2024-04-15
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

Adenocarcinoma of esophagogastric junction

Interventions

Treatment group:The experimental group began intraperitoneal lavage chemotherapy with loplatin immediately after surgery. 500-1000ml 5% glucose water or distilled water containing loplatin (loplatin c
Control group:In the control group, the operation was performed according to the conventional procedure. After abdominal cavity irrigation was completed, the incision was closed to complete the operat

Sponsors

Cancer Hospital, Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Age 18 ~ 80 years old, gender is not limited. 2) ECOG PS score of physical strength is 0 ~ 1. 3) Patients with Siewert type II adenocarcinoma of the esophagogastric junction confirmed by histopathology will undergo radical esophagogastric junction adenocarcinoma. 4) Patients who had received neoadjuvant therapy and had clinical stage T3-4aN0 or any TN+ in preoperative imaging examination. 5) No retroperitoneal lymph node metastasis was detected by preoperative imaging examination. 6) No distant metastasis were detected by preoperative imaging examination. 7) Women of childbearing age need to take effective contraceptive measures. 8) Can understand the situation of this study and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1) History of other malignant tumors within 5 years. 2) No neoadjuvant therapy was received before surgery. 3) Any presence of M1 was found during the operation. 4) Significant organ failure or other critical disease, including clinically relevant coronary artery disease, cardiovascular disease, or myocardial infarction within 12 months prior to enrollment; A history of severe neurological or psychiatric illness; Severe infection; Active disseminated intravascular coagulation.

Design outcomes

Primary

MeasureTime frame
Incidence of postoperative abdominal metastasis (including peritoneal implantation metastasis and abdominal and pelvic lymph node metastasis);

Secondary

MeasureTime frame
Recurrence-free survival;1 -, 2 -, and 3-year survival rates;Liver metastasis rate;Safety;Postoperative complications (postoperative bleeding, anastomotic fistula, incision infection, abdominal infection, etc.) occurred in both groups;

Countries

China

Contacts

Public ContactYong Li

Cancer Hospital, Chinese Academy of Medical Sciences

liyongdoctor@126.com+86 10 8778 8053

Outcome results

None listed

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