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

NCT ID: NCT05228743

Last Updated: 2022-02-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2023-10-31

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.

Conditions

Gastric Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HIPEC plus Paclitaxel IP/IV, S-1

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.

Group Type: EXPERIMENTAL

Comparing Hyperthermic Intraperitoneal Chemotherapy

Intervention Type: PROCEDURE

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.

Paclitaxel

Intervention Type: DRUG

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.

S1

Intervention Type: DRUG

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.

Paclitaxel IP/IV, S-1

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Comparing Hyperthermic Intraperitoneal Chemotherapy

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: PROCEDURE

Paclitaxel

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

S1

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.

Intervention Type: DRUG

Other Intervention Names

HIPEC; PTX

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Gastrointestinal Medical Oncology, Tianjin Medical University Cancer Hospital

Tianjin, Tianjin Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Liang Han, Master

Role: CONTACT

tjlianghan@126.com

+8602223340123 ext. 1061

Cai Mingzhi, Master

Role: CONTACT

tsaimingzhi@163.com

+8602223340123 ext. 1061

Facility Contacts

Liang Han

Role: primary

tjlianghan@126.com

086-022-23340123 ext. 1061

Other Identifiers

E20201130

Identifier Type: -

Identifier Source: org_study_id