Sequential HIPEC of Oxaliplatin and Paclitaxel for Gastric Cancer Patients With Peritoneum Metastasis

Phase 2 Study of Sequential Hyperthermic Intraperitoneal Chemotherapy of Oxaliplatin and Paclitaxel for Gastric Cancer Patients With Peritoneum Metastasis or Positive Free Cancer Cells in Abdomen

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01471132

Acronym

SHOP-G01

Enrollment

Registered

2011-11-11

Start date

2011-09-30

Completion date

2015-09-30

Last updated

2012-12-07

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

Conditions

Gastric Cancer, Metastases to Perineum

Brief summary

The recurrence and metastasis of peritoneum is always the lethal consequence for gastric cancer patients, and there is no effective therapy until now. It has been reported by Dr.Fujimoto that intraperitoneal chemotherapy plus hyperthermic therapy, which called hyperthermic intraperitoneal chemotherapy (HIPEC), can eliminate and suppress the free cancer cells and tiny metastasis in abdomen. Refer to the experience of systematic chemotherapy, HIPEC with combination regimen would have a brighter prospect. In this study, the investigators would use Oxaliplatin and paclitaxel sequent as HIPEC regimen. The safety and overall survival would be observed and evaluated.

Interventions

DRUGOxaliplatin

Oxaliplatin 345mg/m2,43℃，30mins

DRUGPaclitaxel

Paclitaxel 260mg/m2,43℃，30mins

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Histologically proved gastric adenocarcinoma. * Peritoneum metastasis is observed or suspected by laparoscopy or radiologic examination,or free cancer cells are detected in peritoneal lavage liquid. * Potentially resectable gastric cancer. * ALT, AST \< 80U/L; Total Bilirubin \< 30μmol/L; WBC \> 4x10\^9/L; PLT \> 100x10\^9/L; Cr \< 1.5 fold normal value. * ECOG 0-2 points. * Expected survival time longer than 3 months. * Informed consent.

Exclusion criteria

* Recurrent gastric cancer. * Pregnant or lactating women. * Allergic to oxaliplatin or paclitaxel. * Abnormal liver/kidney function. * Serious heart/metabolic disease.

Design outcomes

Primary

Measure	Time frame
Overall Survival	every 3 month postoperation up to 24 months

Secondary

Measure	Time frame	Description
Safety	every 3 month postoperation up to 24 months	Number of Participants with Adverse Events(III or IV grades according to NCI-CTC)

Countries

China

Contacts

Primary ContactXiaojiang Wu

wu.xiaojiang@hotmail.com8601088196598

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026