HIPEC and Systemic Chemotherapy Combined With Apatinib in Unresectable Peritoneal Metastases From Gastric Cancer

Wuhan University

Status: Terminated

Conditions: Peritoneal Metastases From Gastric Cancer

Treatments: Procedure: HIPEC; Drug: Systemic chemotherapy; Drug: Apatinib; Procedure: exploratory laparoscopy or laparotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT03349827

WuhanU_Peritoneal Metastases

Details and patient eligibility

About

The prognosis of patients with unresectable peritoneal metastases from gastric cancer is poor. These patients may obtain survival benefit from radical gastrectomy and cytoreductive surgery (CRS). The response rates of previous conversion therapy are low. Hyperthermic intraperitoneal chemoperfusion (HIPEC) and systemic chemotherapy are effective methods of reducing peritoneal cancer index (PCI) levels. Apatinib, a novel targeted inhibitor of VEGF receptor 2 (VEGFR2), shows significant antitumor activity in the patients with gastric cancer. The purpose of this study is to investigate the efficacy and safety of HIPEC and systemic chemotherapy combined with Apatinib in the conversion therapy of peritoneal metastases from gastric cancer.

Full description

To determine the efficacy and safety of HIPEC and systemic chemotherapy combined with Apatinib in the conversion therapy of peritoneal metastases from gastric cancer, patients undergo HIPEC with Docetaxel/ Lobaplatin at the time of fist surgery and twice repeat within one week after the surgery, following 2 cycles of 3-week Oxaliplatin/S1 chemotherapy combined with Apatinib and 1 cycles of 3-week Oxaliplatin/S1 chemotherapy. The second surgery, exploratory laparoscopy or laparotomy, is carried out one week later after the series of systemic chemotherapy.

Enrollment: 20 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histological proved diagnosis of gastric cancer.
• Unresectable peritoneal metastases and primary tumor proved at surgery.
• No evidence of distant metastases.
• Have not received radiotherapy, chemotherapy or immunotherapy.
• ECOG score: 0~2.
• Written informed consent is obtained prior to commencement of trial treatment.

Exclusion criteria

• Existence of distant metastasis outside the abdomen.
• Any previous radiotherapy, chemotherapy or immunotherapy.
• Active systemic infections.
• Inadequate cardiac function, renal function, liver function or bone marrow function at the beginning of the trial.
• Female patients who are pregnant or breast feeding

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Experimental

Experimental group

Description:

HIPEC with Docetaxel/ Lobaplatin at the time of fist surgery and twice repeat within one week after the surgery, following 2 cycles of 3-week Oxaliplatin/S1 chemotherapy combined with Apatinib and 1 cycles of 3-week Oxaliplatin/S1 chemotherapy. The second surgery, exploratory laparoscopy or laparotomy, is carried out one week later after the series of systemic chemotherapy.

Treatment:

Drug: Apatinib

Procedure: exploratory laparoscopy or laparotomy

Procedure: HIPEC

Drug: Systemic chemotherapy