Efficacy of HIPEC Combined With Systemic Chemotherapy and CRS on Peritoneal Metastases From Gastric Cancer

Shu-Zhong Cui

Status and phase: Unknown; Phase 3

Conditions: Gastric Cancer; Peritoneal Carcinomatosis

Treatments: Procedure: HIPEC with neoadjuvant chemotherapy; Procedure: Systemic chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03179579

HIPEC-02

Details and patient eligibility

About

This project is a multi-center, prospective, randomized controlled clinical observation the safety and efficacy that stage IV limited peritoneal metastasis of gastric cancer patients accept hyperthermic intraperitoneal chemotherapy plus neoadjuvant chemotherapy with CRS and systemic chemotherapy. With advanced-stage gastric patients of confined to the peritoneal as the research object, with median progression-free survival and overall survival, adverse events as the end points.

Full description

Peritoneal metastases in gastric cancer are considered as terminal disease with poor prognosis, the median survival time of this kind of patients is less than 1 year and even worse in China. Recently, cytoreductive surgery (CRS) combined with hyperthermic intraperitoneal chemotherapy (HIPEC) has been suggested to improve survival in patients with peritoneal metastases from gastric cancer. Even though the REGATTA trial demonstrated that the removal of the primary tumor is not necessarily beneficial, the role of operation aiming at R0 resection combined with new regimens like HIPEC and new chemotherapeutic agents is still confusing. Neoadjuvant chemotherapy prolonged OS of patients received macroscopically radical (CC0) surgery. Compared to systemic chemotherapy, HIPEC promotes chemotherapy to penetrate deeper into the cancer tissue, which needed multicenter randomized clinical trials (RCTs) to comfirm. Therefore, we has conducting prospective phase III trial of HIPEC combined with systemic chemotherapy and CRS for gastric cancer with peritoneal metastasis.

Enrollment: 88 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Gastic adenocarcinoma is diagnosed by histological and cytological examination.

2. Peritoneal carcinomastosis of gastric cancer is diagnosed by laparotomy or laparoscopic exploration.

3. According to Sugarbaker's peritoneal cancer index (PCI), PCI score of participant is no more than 20.

4. 18 < Age < 70 year old

5. Expected survival > 3 months

6. Performance status: ECOG 0-1

7. Adequate bone marrow function Hb ≥9 g/dl (After correction in case of iron deficient anemia) WBC ≥ 3,500/mm3, Platelet ≥ 100,000/mm3

8. Adequate renal function Creatinine ≤ 1.5 mg/dl, and adequate hepatic function Bilirubin ≤ 1.5 mg/dl and AST and ALT ≤ 2.5×ULN

9. Voluntary participation after getting written informed consent.

Exclusion criteria

1. Except for peritoneal carcinomatosis, gastric cancer concurrently metastasized to liver, lung, para-aortic lymph node and other distant organs.
2. Extensive adhesion in peritoneal cavity
3. Previous History of other malignancies
4. Poorly controlled disease e.g. atrial fibrillation, stenocardia, cardiac insufficiency, persistent hypertension despite medicinal treatment, ejection fraction<50%
5. Receiving other chemotherapy, radiotherapy or immunotherapy
6. Patients who are unsuitable candidates by doctor's decision
7. Without given written informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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88 participants in 2 patient groups

Experimental group

Experimental group

Description:

1. HIPEC with paclitaxel 135 mg/m\^2+HIPEC with cisplatin 75 mg/m\^2±HIPEC with Raltitrexed 3 mg/m\^2 intraperitoneally in succession 2. 2 cycles of neoadjuvant chemotherapy: S-1 40-60 mg/m\^2, d1-d14, Bid p.o.+ oxaliplatin 130 mg/m\^2, d1, IV, every 3 weeks 3. Cytoreductive surgery 4. HIPEC with paclitaxel 135 mg/m\^2+HIPEC with cisplatin 75 mg/m\^2±HIPEC with Raltitrexed 3 mg/m\^2 intraperitoneally in succession 5. 4-6 cycles of adjuvant chemotherapy: S-1 40-60 mg/m\^2, d1-d14, Bid p.o.+ oxaliplatin 130 mg/m\^2, d1, IV, every 3 weeks

Treatment:

Procedure: HIPEC with neoadjuvant chemotherapy

Control group

Active Comparator group

Description:

1. 3 cycles of neoadjuvant chemotherapy: S-1 40-60 mg/m\^2, d1-d14, Bid p.o.+ oxaliplatin 130 mg/m\^2, d1, IV, every 3 weeks 2. Cytoreductive surgery 3. 4-6 cycles of adjuvant chemotherapy: S-1 40-60 mg/m\^2, d1-d14, Bid p.o.+ oxaliplatin 130 mg/m\^2, d1, IV, every 3 weeks

Treatment:

Procedure: Systemic chemotherapy