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NOT YET RECRUITING
NCT05095467
PHASE2

HIPEC-AS in Patients With Peritoneal Metastasis of the Stomach or Esophagogastric Junction

Sponsor: Xuefei.Wang

View on ClinicalTrials.gov

Summary

HIPEC-AS01 is an open, prospective, single-center phase II clinical study, which will include "cT4aNxM0, P0 or cTxNxM1, P1" patients with gastric or esophagogastric junction adenocarcinoma, to evaluate the efficacy and safety of systemic chemotherapy with HIPEC combined with AS in the perioperative period. Patients enrolled will be divided into three groups. Among them, group A is the patients with locally resectable GC; group B is patients with peritoneal metastasis stage P1a or P1b, group C is patients with peritoneal metastasis stage P1c. The primary purpose is to evaluate the 3-year overall survival rate.

Official title: Prospective Study With HIPEC-AS in Patients With Locally Advanced, Limited or Extensive Peritoneal Metastatic Adenocarcinoma of the Stomach or Esophagogastric Junction

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

157

Start Date

2021-10

Completion Date

2026-10

Last Updated

2021-10-27

Healthy Volunteers

No

Interventions

PROCEDURE

HIPEC

The abdominal cavity will be filled with paclitaxel 120mg/m2 heated at 43℃ for 1 hour with a hyperthermic circulation machine.

DRUG

Paclitaxel-albumin

albumin paclitaxel D1, D8; S-1: D1-D14

DRUG

Tegafur-gimeracil-oteracil potassium

40mg bid(BSA\<1.5 m2) ,60mg bid(BSA\>=1.5 m2); D1-D14, po, bid.

PROCEDURE

Surgery+HIPEC

gastrectomy with D2 lymphadenectomy+HIPEC procedure