HIPEC-AS in Patients With Peritoneal Metastasis of the Stomach or Esophagogastric Junction
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorXuefei.Wang
About this trial
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.
Eligibility criteria
Qualifiers
18 years old ≤ age ≤ 75 years old;
The primary gastric lesion was diagnosed as gastric or esophagogastric junction adenocarcinoma (papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, signet ring cell carcinoma, and poorly differentiated adenocarcinoma. )
The tumor is located in the stomach or esophagogastric junction (Siewert type II/III)
The preoperative clinical staging is cT4aNxM0, P0 or cTxNxM1*, P1 (*no other distant metastases except peritoneal metastasis)
Disqualifiers
There are distant metastases other than peritoneal metastases;
Complications of gastric cancer require emergency treatment, such as bleeding, perforation, obstruction, etc.;
Suffer from other malignant tumors within five years;
Body temperature ≥38℃ or complicated with infectious diseases requiring systemic treatment;
Trial design
Treatments tested in this trial
- HIPEC
- Paclitaxel-albumin
- Tegafur-gimeracil-oteracil potassium
- Surgery+HIPEC
Treatment groups
157 Participants
are divided into 3 treatment groupsLocations
Sponsors and collaborators
Xuefei.Wang
Lead sponsor
Shanghai Zhongshan Hospital
Sponsor institution
Source ClinicalTrials.gov