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

ConditionsStomach NeoplasmsPeritoneal Metastases
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • HIPEC

    Procedure/Surgery

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

  • Paclitaxel-albumin

    Drug

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

  • Tegafur-gimeracil-oteracil potassium

    Drug

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

  • Surgery+HIPEC

    Procedure/Surgery

    gastrectomy with D2 lymphadenectomy+HIPEC procedure

Treatment groups

157 Participants
are divided into 3 treatment groups
Group A: Group AExperimental treatment 4 interventions
Group B: Group BExperimental treatment 4 interventions
Group C: Group CExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

3-year Overall Survival, OS

The time from the date of enrollment of the patient to the date of death or the date of the last follow-up

Time frame
3 years

Secondary outcomes

1

3-year Progression Free Survival, PFS

The time from the date of enrollment of the patient to the first occurrence of disease progression or death from any cause.

Time frame
3 years
2

NCI CTC Adverse Events Version 4.0

Safety of HIPEC-AS plan

Time frame
1 year

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xuefei.Wang

Lead sponsor

Shanghai Zhongshan Hospital

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: