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Sequential HIPEC of Oxaliplatin and Paclitaxel for Gastric Cancer Patients With Peritoneum Metastasis (SHOP-G01)

P

Peking University

Status and phase

Unknown
Phase 2

Conditions

Gastric Cancer
Metastases to Perineum

Treatments

Drug: Oxaliplatin
Drug: Paclitaxel

Study type

Interventional

Funder types

Other

Identifiers

NCT01471132
HIPEC-GCOT

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

HIPEC
Experimental group
Treatment:
Drug: Paclitaxel
Drug: Oxaliplatin

Trial contacts and locations

1

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Central trial contact

Xiaojiang Wu

Data sourced from clinicaltrials.gov

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