HIPEC Combined Gastrectomy in Patients With Advanced Gastric Cancer Received Neoadjuvant Chemotherapy

Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZhixin Cao

About this trial

Patients with stage cT3-4N+M0 gastric cancer were recommended to receive neoadjuvant chemotherapy before radical surgery in terms of the eradication of micrometastasis in addition to local control, higher compliance with intensive chemotherapy, and avoidance of futile surgery by detection of initially invisible distant metastasis after rapid disease progression. However, in some studies, gastrectomy followed by neoadjuvant chemotherapy failed to demonstrate survival benefits for these patients. And peritoneal recurrence was the most common and devastating reason. Hyperthermic intraperitoneal chemotherapy (HIPEC) was introduced for peritoneal cancer last century. A few studies suggested HIPEC could improve prognosis in patients with limited peritoneal metastasis from various cancer. In summary, we conducted this study to confirm the efficacy and safety of HIPEC after gastrectomy in patients with advanced gastric cancer received neoadjuvant chemotherapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

histologically proven adenocarcinoma of stomach

stage cT3-4N+M0

no involvement of esophagus > 3 cm

ECOG (Eastern Cooperative Oncology Group) : 0~1

Disqualifiers

Serious diseases that are difficult to control

Severe hepatic and renal dysfunction

Abnormal coagulation

The presence of other serious physical or mental illness or laboratory abnormalities may increase the risk of participating in the study, or interfere with the results of the study, as well as the patients who the investigator believes are not suitable for participating in the study

Trial design

Design model

Parallel

Treatments tested in this trial

  • HIPEC

    Combination product

    HIPEC after gastrectomy with D2 local lymph node dissection.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: ControlNo intervention 0 interventions
Group B: HIPECExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Peritoneal recurrence

Time frame
3 years
2

OS

overall survival

Time frame
3 years

Secondary outcomes

1

DFS

disease free survival

Time frame
3 years
2

Adverse Events

Number and degree of Adverse Events

Time frame
3 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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Zhixin Cao

Lead sponsor

Tongji Hospital

Sponsor institution

This trial is not recruiting at the moment. You can still explore other options: