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

NCT05095467 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 157

Last updated 2021-10-27

No results posted yet for this study

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.

Conditions

  • Stomach Neoplasms
  • Peritoneal Metastases

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

Sponsors & Collaborators

  • Xuefei.Wang

    lead OTHER

Principal Investigators

  • Xuefei Wang, MD · Fudan University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-31
Primary Completion
2023-10-31
Completion
2026-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05095467 on ClinicalTrials.gov