Perioperative Chemotherapy Combined With HIPEC for High-risk Advanced Gastric Cancer

Sun Yat-sen University

Status and phase: Unknown; Phase 3

Conditions: Survival

Treatments: Drug: Hyperthermic intraperitoneal perfusion chemotherapy; Drug: Neoadjuvant chemotherapy; Procedure: D2 radical resection; Drug: Adjuvant chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02960061

HIPEC-006

Details and patient eligibility

About

The investigators intend to conduct a randomized controlled study to find if combining HIPEC (hyperthermic intraperitoneal perfusion chemotherapy) with post-neoadjuvant chemotherapy D2 resection could improve survival for patients with advanced gastric cancer, while comparing with the traditional approach of D2 resection after neoadjuvant chemotherapy.

Full description

Gastric cancer, as the second common malignant tumors in china, is marked by its poor prognosis and high recurrent rate. Although R0 resection could be achieved in most advanced gastric cancer(AGC) patients without metastasis, age-standardized 5-years survival rate was no more than 27.4%. Peritoneal metastasis accounts for 50% of the recurrent case and remain to be the most fatal recurrence pattern.

Hyperthermic intraperitoneal perfusion chemotherapy ( HIPEC ), has been proved as one of the most efficient approach against peritoneal carcinomatosis from gastric cancer and recommended in the guideline for gastric cancer published by the health committee of china. However, its role as prophylactic treatment after curative has never been determined. HIPEC works by delivering heat and cytotoxic drug to the cancer cell and is more effective on the tumor with small size. As present study suggest that Peritoneal metastasis is related to lymph node dissection during surgery while opening lymphatic channels and spreading viable cancer cells into the peritoneal cavity, HIPEC might be a reasonable approach to destroy the remaining cancer cells after curative surgery. Thus this research aim to explore the efficacy and safety of combining HIPEC (hyperthermic intraperitoneal perfusion chemotherapy) with post-neoadjuvant chemotherapy D2 resection.

Enrollment: 640 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. First diagnosed as gastric cancer by pathological examination;
2. No previous chemotherapy or radiotherapy;
3. T stage:3-4, N stage: 1-3, M stage: 0, assessed by CT or ultrasound endoscope;
4. Eastern Cooperative Oncology Group performance status (ECOG PS): 0-1;
5. Informed consent signed;

Exclusion criteria

1. Other malignancy within 5 years.
2. Peritoneal metastasis detected during surgery.
3. Pregnant or lactating women;
4. Patients with conditions requiring emergency surgery;
5. Tumor progress during neo-adjuvant chemotherapy
6. Severe, uncontrolled physical or metal disease.
7. Poor compliance.
8. Uncontrolled infection

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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640 participants in 2 patient groups

HIPEC

Experimental group

Description:

After receiving neoadjuvant chemotherapy and D2 radical resection, Hyperthermic intraperitoneal perfusion chemotherapy is conducted,4 catheters are placed in 4 position in the peritoneal cavity: ① under the left diaphragm ② hepatorenal recess ③ left pelvis ④ right pelvis.catheters, all four tubes are connected to the perfusion device.Perfusion prescription: cycle 1, Paclitaxel 75mg/ m2 diluted with 3000ml normal saline heated up to a fixed temperature of 43°C circulate continuously for 60min at a speed of 400-500ml/h; cycle 2 start within 24-48 hours after cycle 1, dosage of paclitaxel adjust to 100mg/ m2, the rest of the same. A total of two cycle is administered, routine adjuvant chemotherapy using SOX (oxaliplatin plus S-1 capsule)or XELOX regimens follows within 4-6 weeks.

Treatment:

Procedure: D2 radical resection

Drug: Adjuvant chemotherapy

Drug: Hyperthermic intraperitoneal perfusion chemotherapy

Drug: Neoadjuvant chemotherapy

controlled group

Sham Comparator group

Description:

After receiving neoadjuvant chemotherapy and D2 radical resection, patients receive peritoneal lavage with 3000ml distilled water.Adjuvant chemotherapy using SOX or XELOX regimens is administered as routine within 4-6 weeks.

Treatment:

Procedure: D2 radical resection

Drug: Adjuvant chemotherapy

Drug: Neoadjuvant chemotherapy