HIPEC-AS in Patients With Peritoneal Metastasis of the Stomach or Esophagogastric Junction

NCT05095467 | Not Yet Recruiting Phase 2

• 1 other identifier: B2021-574
• Study Type: interventional
• Target: 157
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stomach Neoplasms; Peritoneal Metastases

Keywords

Stomach Neoplasms; Peritoneal Metastases; Hyperthermic Intraperitoneal Chemotherapy; paclitaxel

Outcome Measures

Primary Outcomes (1)

• 3-year Overall Survival, OS

  The time from the date of enrollment of the patient to the date of death or the date of the last follow-up

  3 years

Secondary Outcomes (2)

• 3-year Progression Free Survival, PFS

  3 years

• NCI CTC Adverse Events Version 4.0

  1 year

Study Arms (3)

Group A

EXPERIMENTAL

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)

Procedure: HIPEC; Drug: Paclitaxel-albumin; Drug: Tegafur-gimeracil-oteracil potassium; Procedure: Surgery+HIPEC

Group B

EXPERIMENTAL

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)

Procedure: HIPEC; Drug: Paclitaxel-albumin; Drug: Tegafur-gimeracil-oteracil potassium; Procedure: Surgery+HIPEC

Group C

EXPERIMENTAL

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)

Procedure: HIPEC; Drug: Paclitaxel-albumin; Drug: Tegafur-gimeracil-oteracil potassium

Interventions

HIPEC PROCEDURE

The abdominal cavity will be filled with paclitaxel 120mg/m2 heated at 43℃ for 1 hour with a hyperthermic circulation machine.

Also known as: Paclitaxel injection

Group A; Group B; Group C

Paclitaxel-albumin DRUG

albumin paclitaxel D1, D8; S-1: D1-D14

Group A; Group B; Group C

Tegafur-gimeracil-oteracil potassium DRUG

40mg bid(BSA\<1.5 m2) ，60mg bid(BSA\>=1.5 m2); D1-D14, po, bid.

Group A; Group B; Group C

Surgery+HIPEC PROCEDURE

gastrectomy with D2 lymphadenectomy+HIPEC procedure

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old ≤ age ≤ 75 years old;
• 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. )
• The tumor is located in the stomach or esophagogastric junction (Siewert type II/III)
• The preoperative clinical staging is cT4aNxM0, P0 or cTxNxM1\*, P1 (\*no other distant metastases except peritoneal metastasis)
• Good bone marrow reserve function: HB≥90g/L; ANC ≥1.5×10\*9/L; PLT ≥80×10\*9/L
• 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;
• Good coagulation function: International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN, activated partial thromboplastin time (APTT) ≤ 1.5 times ULN
• ECOG (Eastern Cooperative Oncology Group) physical status score 0-2;
• No prior treatment of chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc;
• Written informed consent.

You may not qualify if:

• There are distant metastases other than peritoneal metastases;
• Complications of gastric cancer require emergency treatment, such as bleeding, perforation, obstruction, etc.;
• Suffer from other malignant tumors within five years;
• Body temperature ≥38℃ or complicated with infectious diseases requiring systemic treatment;
• 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;
• 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;
• Severe respiratory diseases;
• Severe liver and kidney dysfunction;
• Upper gastrointestinal obstruction or abnormal physiological function or malabsorption syndrome, which may affect the absorption of oral drugs;
• Diseases such as severe diabetes, hyperthyroidism and hypothyroidism have not been clinically controlled.
• Those who continue to use glucocorticoid therapy within 1 month (except for local application) or who require immunosuppressive therapy for organ transplantation;
• Pregnant or lactating women;
• The patient has participated or is participating in other clinical studies (within 6 months);

Sponsors & Collaborators

• Xuefei.Wang: lead

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Hyperthermic Intraperitoneal Chemotherapy; Paclitaxel

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Chemotherapy, Adjuvant; Combined Modality Therapy; Therapeutics; Drug Therapy; Hyperthermia, Induced; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Xuefei Wang, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xuefei Wang, MD

CONTACT

+86 13917270428; wang.xuefei@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 25, 2021
• First Posted: October 27, 2021
• Study Start: October 1, 2021
• Primary Completion: October 1, 2023
• Study Completion (Estimated): October 1, 2026
• Last Updated: October 27, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share