HIPEC-AS in Patients With Peritoneal Metastasis of the Stomach or Esophagogastric Junction
NCT ID: NCT05095467
Last Updated: 2021-10-27
Study Results
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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NOT_YET_RECRUITING
PHASE2
157 participants
INTERVENTIONAL
2021-10-31
2026-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A
patients with locally resectable GC (cT4aNxM0, P0)
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)
HIPEC
The abdominal cavity will be filled with paclitaxel 120mg/m2 heated at 43℃ for 1 hour with a hyperthermic circulation machine.
Paclitaxel-albumin
albumin paclitaxel D1, D8; S-1: D1-D14
Tegafur-gimeracil-oteracil potassium
40mg bid(BSA\<1.5 m2) ，60mg bid(BSA\>=1.5 m2); D1-D14, po, bid.
Surgery+HIPEC
gastrectomy with D2 lymphadenectomy+HIPEC procedure
Group B
patients with peritoneal metastasis stage P1a or P1b (cTxNxM1, P1a or P1b)
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)
HIPEC
The abdominal cavity will be filled with paclitaxel 120mg/m2 heated at 43℃ for 1 hour with a hyperthermic circulation machine.
Paclitaxel-albumin
albumin paclitaxel D1, D8; S-1: D1-D14
Tegafur-gimeracil-oteracil potassium
40mg bid(BSA\<1.5 m2) ，60mg bid(BSA\>=1.5 m2); D1-D14, po, bid.
Surgery+HIPEC
gastrectomy with D2 lymphadenectomy+HIPEC procedure
Group C
group C is patients with peritoneal metastasis stage P1c (cTxNxM1, P1c)
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)
HIPEC
The abdominal cavity will be filled with paclitaxel 120mg/m2 heated at 43℃ for 1 hour with a hyperthermic circulation machine.
Paclitaxel-albumin
albumin paclitaxel D1, D8; S-1: D1-D14
Tegafur-gimeracil-oteracil potassium
40mg bid(BSA\<1.5 m2) ，60mg bid(BSA\>=1.5 m2); D1-D14, po, bid.
Interventions
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HIPEC
The abdominal cavity will be filled with paclitaxel 120mg/m2 heated at 43℃ for 1 hour with a hyperthermic circulation machine.
Paclitaxel-albumin
albumin paclitaxel D1, D8; S-1: D1-D14
Tegafur-gimeracil-oteracil potassium
40mg bid(BSA\<1.5 m2) ，60mg bid(BSA\>=1.5 m2); D1-D14, po, bid.
Surgery+HIPEC
gastrectomy with D2 lymphadenectomy+HIPEC procedure
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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);
18 Years
75 Years
ALL
No
Sponsors
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Xuefei.Wang
OTHER
Responsible Party
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Xuefei.Wang
Professor
Principal Investigators
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Xuefei Wang, MD
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Central Contacts
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Other Identifiers
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B2021-574
Identifier Type: -
Identifier Source: org_study_id