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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2022-08-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Gastric Cancer Peritoneal Carcinomatosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Experimental group

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

Group Type EXPERIMENTAL

HIPEC with neoadjuvant chemotherapy

Intervention Type PROCEDURE

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

Control group

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

Group Type ACTIVE_COMPARATOR

Systemic chemotherapy

Intervention Type PROCEDURE

NACT 3 cycles +CRS +ACT 4-6 cycles

Interventions

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HIPEC with neoadjuvant chemotherapy

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

Intervention Type PROCEDURE

Systemic chemotherapy

NACT 3 cycles +CRS +ACT 4-6 cycles

Intervention Type PROCEDURE

Other Intervention Names

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CRS with HIPEC and adjuvant cheomtherapy CRS with systemic chemotherpay

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No