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Conversion Therapy of Hyperthermic Intraperitoneal Chemotherapy Plus Chemotherapy and Chemotherapy in Stage IV Gastric Cancer

Primary Purpose

Gastric Cancer

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Comparing Hyperthermic Intraperitoneal Chemotherapy

Paclitaxel

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring conversion therapy, HIPEC, peritoneal metastasis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosed as gastric adenocarcinoma by pathology and had not received any other anti-tumor treatment such as radiotherapy and chemotherapy;
≥ 18 and ≤ 70 years of age; Eastern Cooperative Oncology Group Performance Status (ECOG): 0-1;
Intraoperative pathological diagnosis was peritoneal metastasis (stage ≤ P1b), with or without ascites (ascites volume exceeding pelvic cavity but not reaching full abdominal ascites)
Patients have adequate baseline organ and marrow function :hemoglobin≥9g/dL; absolute neutrophil count (ANC) ≥1,500/mm3; PLT(platelets)≥1000,000/mm3; total bilirubin ≤1.5×upper normal limit(ULN); AST ≤2.5 ×ULN, ALT ≤2.5 ×ULN; prothrombin time-international normalized ratio≤1.5, and APTT(activated partial thromboplastin time) was within normal range; creatine ≤ 1.5 x ULN;
Written informed consent provided;

Exclusion Criteria:

Diagnosed as Her-2(+++)/FISH(+) by pathology;
With other distant metastasis(ovarian metastasis was excluded)
Patients with Serious liver disease (such as cirrhosis, etc.), kidney disease, respiratory disease or uncontrolled diabetes, hypertension and other chronic systemic diseases, heart disease with Clinical symptoms, such as congestive heart failure, coronary heart disease symptoms, drug is difficult to control arrhythmia, hypertension, or six months had a myocardial infarction attack, or cardiac insufficiency;
Organ transplantation patients need immunosuppressive therapy;
Severe recurrent infections were not controlled or with other serious concomitant diseases;
Patients got other primary malignant tumors (except curable skin basal cell carcinoma and cervical cancer in situ) except gastric cancer within 5 years; Psychiatric disease which require treatment;
Within 6 months before study starts and in the process of this study, patients participate in other clinical researches;
Patients with peripheral nervous system disorder or apparent mental disorders or had the history of central nervous system disorders;
Pregnant or lactating women, women of child-bearing potential, unwilling to use adequate contraceptive protection during the process of the study;
Patients without legal capacity,or medical/ethical reasons may influence the study to continue.

Sites / Locations

Department of Gastrointestinal Medical Oncology, Tianjin Medical University Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

HIPEC plus Paclitaxel IP/IV, S-1

Paclitaxel IP/IV, S-1

Arm Description

After laparoscopic exploration, HIPEC was started immediately, at least 4 HIPEC was completed.Three to six weeks after HIPEC was completed, chemotherapy was started.The curative effect was evaluated every 2-4 cycles. If the operation standard of R0 was met, the second laparoscopic staging was performed: if the peritoneal metastasis reached P 0 or P1a, the operator judged that R0 could be removed. Open radical gastrectomy (D2 / D2 +) was performed. For P1b / c cases, the original treatment was continued until the disease progressed.

Within one week after laparoscopic exploration, chemotherapy was started. The curative effect was evaluated every 2-4 cycles. If the operation standard of R0 was met, the second laparoscopic staging was performed: if the peritoneal metastasis reached P 0 or P1a, the operator judged that R0 could be removed. Open radical gastrectomy (D2 / D2 +) was performed. For P1b / c cases, the original treatment was continued until the disease progressed.

Outcomes

Primary Outcome Measures

R0 resection rate

Secondary Outcome Measures

1 year overall survival

Full Information

NCT ID

NCT05228743

First Posted

November 30, 2020

Last Updated

January 26, 2022

Sponsor

Tianjin Medical University Cancer Institute and Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05228743

Brief Title

Conversion Therapy of Hyperthermic Intraperitoneal Chemotherapy Plus Chemotherapy and Chemotherapy in Stage IV Gastric Cancer

Official Title

A Randomized, Multicenter, Controlled Study to Compare Hyperthermic Intraperitoneal Chemotherapy Plus Paclitaxel IP/IV, S-1 and Paclitaxel IP/IV，S-1 as Conversion Therapy for Gastric Cancer Patients With Peritoneal Metastasis

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Recruiting

Study Start Date

September 1, 2020 (Actual)

Primary Completion Date

August 31, 2023 (Anticipated)

Study Completion Date

October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tianjin Medical University Cancer Institute and Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The main purpose of this study is to compare Hyperthermic Intraperitoneal Chemotherapy combined with Chemotherapy and Chemotherapy as a conversion therapy for gastric Cancer Patients with peritoneal metastasis in Safety and Effectiveness.

Detailed Description

Follow-up results from the PHOENIX study failed to show statistical superiority of intraperitoneal paclitaxel plus systemic chemotherapy. However, in the subgroup analysis, it can be seen that after correcting for the bias effect of ascites, the difference between the two groups was statistically significant, further proving the significance of ascites control on the prognosis of patients with gastric cancer peritoneal metastasis. Based on the existing data, for patients with moderate amount of ascites, the IP regimen is recommended to control ascites and relieve ascites. Symptoms, purpose of improving quality of life and prolonging survival. HIPEC is traditionally used to treat peritoneal cancer. Patients who diagnosed with gastric cancer with peritoneal metastasis were divided into two groups based on whether they underwent HIPEC. The primary endpoint is the R0 resection rate and the secondary endpoints are 1-year overall survival, and Safety.

6. Conditions and Keywords

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

Gastric Cancer

Keywords

conversion therapy, HIPEC, peritoneal metastasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

HIPEC plus Paclitaxel IP/IV, S-1

Arm Type

Experimental

Arm Description

Arm Title

Paclitaxel IP/IV, S-1

Arm Type

No Intervention

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Comparing Hyperthermic Intraperitoneal Chemotherapy

Other Intervention Name(s)

HIPEC

Intervention Description

After laparoscopic exploration, HIPEC was started immediately: the temperature was 43 ℃ and the duration was 60 min. paclitaxel (PTX) was used with a dose of 50mg / m2. The second HIPEC was completed 24-48 hrs after the first HIPEC, and at least 4 HIPEC was completed.

Intervention Type

Drug

Intervention Name(s)

Paclitaxel

Other Intervention Name(s)

PTX

Intervention Description

A natural anticancer drug that has been widely used in the treatment of breast, ovarian and some head and neck and lung cancers.Three to six weeks after HIPEC was completed, chemotherapy was started:: PTX: 50mg / m2 IV, D1, D8; PTX: 20mg / m2 IP, D1, D8; q3w; S-1: 60mg / m2, bid, d1-14, repeated every 3 weeks.

Intervention Type

Drug

Intervention Name(s)

Intervention Description

S-1 is an oral fluoropyrimidine consisting of tegafur (a prodrug that is converted to fluorouracil, mainly in liver microsomes but also in tumour tissue), gimeracil (an inhibitor of dihydropyrimidine dehydrogenase, which degrades 5-FU), and oteracil (which inhibits the phosphorylation of 5-FU in the gastrointestinal tract, thereby reducing the toxic effects of 5-FU in the intestinum).Three to six weeks after HIPEC was completed, chemotherapy was started:: PTX: 50mg / m2 IV, D1, D8; PTX: 20mg / m2 IP, D1, D8; q3w; S-1: 60mg / m2, bid, d1-14, repeated every 3 weeks.

Primary Outcome Measure Information:

Title

R0 resection rate

Time Frame

1 year

Secondary Outcome Measure Information:

Title

1 year overall survival

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosed as gastric adenocarcinoma by pathology and had not received any other anti-tumor treatment such as radiotherapy and chemotherapy; ≥ 18 and ≤ 70 years of age; Eastern Cooperative Oncology Group Performance Status (ECOG): 0-1; Intraoperative pathological diagnosis was peritoneal metastasis (stage ≤ P1b), with or without ascites (ascites volume exceeding pelvic cavity but not reaching full abdominal ascites) Patients have adequate baseline organ and marrow function :hemoglobin≥9g/dL; absolute neutrophil count (ANC) ≥1,500/mm3; PLT(platelets)≥1000,000/mm3; total bilirubin ≤1.5×upper normal limit(ULN); AST ≤2.5 ×ULN, ALT ≤2.5 ×ULN; prothrombin time-international normalized ratio≤1.5, and APTT(activated partial thromboplastin time) was within normal range; creatine ≤ 1.5 x ULN; Written informed consent provided; Exclusion Criteria: Diagnosed as Her-2(+++)/FISH(+) by pathology; With other distant metastasis(ovarian metastasis was excluded) Patients with Serious liver disease (such as cirrhosis, etc.), kidney disease, respiratory disease or uncontrolled diabetes, hypertension and other chronic systemic diseases, heart disease with Clinical symptoms, such as congestive heart failure, coronary heart disease symptoms, drug is difficult to control arrhythmia, hypertension, or six months had a myocardial infarction attack, or cardiac insufficiency; Organ transplantation patients need immunosuppressive therapy; Severe recurrent infections were not controlled or with other serious concomitant diseases; Patients got other primary malignant tumors (except curable skin basal cell carcinoma and cervical cancer in situ) except gastric cancer within 5 years; Psychiatric disease which require treatment; Within 6 months before study starts and in the process of this study, patients participate in other clinical researches; Patients with peripheral nervous system disorder or apparent mental disorders or had the history of central nervous system disorders; Pregnant or lactating women, women of child-bearing potential, unwilling to use adequate contraceptive protection during the process of the study; Patients without legal capacity,or medical/ethical reasons may influence the study to continue.

Central Contact Person:

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

Liang Han, Master

Phone

+8602223340123

Ext

1061

tjlianghan@126.com

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

Cai Mingzhi, Master

Phone

+8602223340123

Ext

1061

tsaimingzhi@163.com

Facility Information:

Facility Name

Department of Gastrointestinal Medical Oncology, Tianjin Medical University Cancer Hospital

City

Tianjin

State/Province

Tianjin

ZIP/Postal Code

300060

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Liang Han

Phone

086-022-23340123

Ext

1061

tjlianghan@126.com

12. IPD Sharing Statement

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Conversion Therapy of Hyperthermic Intraperitoneal Chemotherapy Plus Chemotherapy and Chemotherapy in Stage IV Gastric Cancer

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