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

A Phase III Study of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Combined With Systemic Chemotherapy And Cytoreductive Surgery (CRS) in the Treatment of Peritoneal Carcinomatosis From Gastric Cancer

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03179579

Enrollment

Registered

2017-06-07

Start date

2017-08-01

Completion date

2022-08-01

Last updated

2017-06-07

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

Conditions

Gastric Cancer, Peritoneal Carcinomatosis

Keywords

Gastric Cancer, Peritoneal Carcinomatosis, Hyperthermic Intraperitoneal Chemotherapy, Systemic Chemotherapy, Cytoreductive Surgery

Brief summary

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.

Detailed 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.

Interventions

PROCEDUREHIPEC with neoadjuvant chemotherapy

HIPEC 3 times +NACT 2 cycles +CRS +HIPEC 3 times+ ACT 4-6 cycles

PROCEDURESystemic chemotherapy

NACT 3 cycles +CRS +ACT 4-6 cycles

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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 10\. 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

Design outcomes

Primary

Measure	Time frame	Description
Median overall survival	3 years	assess median overall survival rate during 3 years in both study arms

Secondary

Measure	Time frame	Description
Risk factors for morbidity and mortality	Through study completion, an average of 1 year.	determine percent of patients wtih Grade I-IV adverse events according to NCI criteria, Common Terminology Criteria for AE (CTCAE 4.0).

Countries

China

Contacts

Primary ContactXian-Zi Yang, M.D

7097359@qq.com8602066673666

Backup ContactZhen Tang, M.M

tangzhentangmin@163.com8602066673666

Outcome results

None listed

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