Clinical trial NCT05095467: HIPEC-AS in Patients With Peritoneal Metastasis of the Stomach or Esophagogastric Junction
Official title: Prospective Study With HIPEC-AS in Patients With Locally Advanced, Limited or Extensive Peritoneal Metastatic Adenocarcinoma of the Stomach or Esophagogastric Junction
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Stomach Neoplasms
Peritoneal Metastases
Keywords: Stomach Neoplasms
Peritoneal Metastases
Hyperthermic Intraperitoneal Chemotherapy
paclitaxel
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2021-10-27
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: HIPEC-AS01 is an open, prospective, single-center phase II clinical study, which will include "cT4aNxM0, P0 or cTxNxM1, P1" patients with gastric or esophagogastric junction adenocarcinoma, to evaluate the efficacy and safety of systemic chemotherapy with HIPEC combined with AS in the perioperative period. Patients enrolled will be divided into three groups. Among them, group A is the patients with locally resectable GC; group B is patients with peritoneal metastasis stage P1a or P1b, group C is patients with peritoneal metastasis stage P1c. The primary purpose is to evaluate the 3-year overall survival rate.

Detailed description: HIPEC-AS01 is an open, prospective, single-center phase II clinical study, which will include Patients With cT4aNxM0, P0, or cTxNxM1\*, P1 Adenocarcinoma of the Stomach or Esophagogastric Junction, to evaluate the efficacy and safety of systemic chemotherapy with HIPEC combined with AS in the perioperative period.

Patients enrolled will be divided into three groups. Among them, group A is the patients with locally resectable GC; group B is patients with peritoneal metastasis stage P1a or P1b, group C is patients with peritoneal metastasis stage P1c.

Intervention:

Group A: 1 cycle HIPEC+S-1 chemotherapy, sequential 3 cycles of chemotherapy (AS plan, Q21d × 3), surgery+HIPEC, sequential 3 cycles of chemotherapy ( AS plan, Q21d × 3).

Group B: 1 cycle HIPEC+S-1 chemotherapy, sequential 3 cycles of chemotherapy (AS plan, Q21d × 3), surgery+HIPEC, sequential 3 cycles of chemotherapy ( AS plan, Q21d × 3).

Group C: 1 cycle HIPEC+S-1 chemotherapy, sequential 3 cycles of chemotherapy (AS plan, Q21d × 3), HIPEC+S-1 chemotherapy, sequential 3 cycles of chemotherapy ( AS plan, Q21d × 3).

In this study, the patient's overall survival was the main evaluation index. It is estimated that the case recruitment will be completed in 2 years, and the follow-up time will be 3 years. The total sample size is approximately 157 cases.

Eligibility criteria: Inclusion Criteria:

1. 18 years old ≤ age ≤ 75 years old;
2. The primary gastric lesion was diagnosed as gastric or esophagogastric junction adenocarcinoma (papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, signet ring cell carcinoma, and poorly differentiated adenocarcinoma. )
3. The tumor is located in the stomach or esophagogastric junction (Siewert type II/III)
4. The preoperative clinical staging is cT4aNxM0, P0 or cTxNxM1\*, P1 (\*no other distant metastases except peritoneal metastasis)
5. Good bone marrow reserve function: HB≥90g/L; ANC ≥1.5×10\*9/L; PLT ≥80×10\*9/L
6. Good liver and kidney function reserve: BIL ≤ 1.5 times the upper limit of normal (ULN); ALT and AST ≤ 2.5×ULN; Crea≤1×ULN;
7. Good coagulation function: International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN, activated partial thromboplastin time (APTT) ≤ 1.5 times ULN
8. ECOG (Eastern Cooperative Oncology Group) physical status score 0-2;
9. No prior treatment of chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc;
10. Written informed consent.

Exclusion Criteria:

1. There are distant metastases other than peritoneal metastases;
2. Complications of gastric cancer require emergency treatment, such as bleeding, perforation, obstruction, etc.;
3. Suffer from other malignant tumors within five years;
4. Body temperature ≥38℃ or complicated with infectious diseases requiring systemic treatment;
5. If there is a history of uncontrolled epilepsy, central nervous system disease, or mental disorder, the investigator will determine whether the clinical severity hinders the signing of informed consent or affects the patient's compliance with oral medications;
6. Clinically serious (ie active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) grade II or more severe congestive heart failure, or severe arrhythmia requiring drug intervention, or recent history of myocardial infarction within 12 months;
7. Severe respiratory diseases;
8. Severe liver and kidney dysfunction;
9. Upper gastrointestinal obstruction or abnormal physiological function or malabsorption syndrome, which may affect the absorption of oral drugs;
10. Diseases such as severe diabetes, hyperthyroidism and hypothyroidism have not been clinically controlled.
11. Those who continue to use glucocorticoid therapy within 1 month (except for local application) or who require immunosuppressive therapy for organ transplantation;
12. Pregnant or lactating women;
13. The patient has participated or is participating in other clinical studies (within 6 months);

Primary outcomes:
measure: 3-year Overall Survival, OS
timeFrame: 3 years
Secondary outcomes:
measure: 3-year Progression Free Survival, PFS
timeFrame: 3 years
measure: NCI CTC Adverse Events Version 4.0
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Fudan University
name: Xuefei Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: