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

Primary Purpose

Stomach Neoplasms, Peritoneal Metastases

Status

Not yet recruiting

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

HIPEC

Paclitaxel-albumin

Tegafur-gimeracil-oteracil potassium

Surgery+HIPEC

About this trial

This is an interventional treatment trial for Stomach Neoplasms focused on measuring Stomach Neoplasms, Peritoneal Metastases, Hyperthermic Intraperitoneal Chemotherapy, paclitaxel

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

18 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.

Exclusion Criteria:

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);

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Group A

Group B

Group C

Arm Description

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)

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)

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)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

3-year Progression Free Survival, PFS

The time from the date of enrollment of the patient to the first occurrence of disease progression or death from any cause.

NCI CTC Adverse Events Version 4.0

Safety of HIPEC-AS plan

Full Information

NCT ID

NCT05095467

First Posted

October 25, 2021

Last Updated

October 26, 2021

Sponsor

Xuefei.Wang

1. Study Identification

Unique Protocol Identification Number

NCT05095467

Brief Title

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

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Not yet recruiting

Study Start Date

October 2021 (Anticipated)

Primary Completion Date

October 2023 (Anticipated)

Study Completion Date

October 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Xuefei.Wang

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stomach Neoplasms, Peritoneal Metastases

Keywords

Stomach Neoplasms, Peritoneal Metastases, Hyperthermic Intraperitoneal Chemotherapy, paclitaxel

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

157 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Experimental

Arm Description

Arm Title

Group B

Arm Type

Experimental

Arm Description

Arm Title

Group C

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

HIPEC

Other Intervention Name(s)

Paclitaxel injection

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Paclitaxel-albumin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Tegafur-gimeracil-oteracil potassium

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Surgery+HIPEC

Intervention Description

gastrectomy with D2 lymphadenectomy+HIPEC procedure

Primary Outcome Measure Information:

Title

3-year Overall Survival, OS

Description

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

Time Frame

3 years

Secondary Outcome Measure Information:

Title

3-year Progression Free Survival, PFS

Description

The time from the date of enrollment of the patient to the first occurrence of disease progression or death from any cause.

Time Frame

3 years

Title

NCI CTC Adverse Events Version 4.0

Description

Safety of HIPEC-AS plan

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18 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. Exclusion Criteria: 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);

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xuefei Wang, MD

Phone

+86 13917270428

wang.xuefei@zs-hospital.sh.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xuefei Wang, MD

Organizational Affiliation

Fudan University

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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