Conversion Therapy of Hyperthermic Intraperitoneal Chemotherapy Plus Chemotherapy and Chemotherapy in Stage IV Gastric Cancer
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ClinicalTrials.gov Identifier: NCT05228743 |
Recruitment Status :
Recruiting
First Posted : February 8, 2022
Last Update Posted : February 8, 2022
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Condition or disease | Intervention/treatment | Phase |
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Gastric Cancer | Procedure: Comparing Hyperthermic Intraperitoneal Chemotherapy Drug: Paclitaxel Drug: S1 | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 180 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | September 1, 2020 |
Estimated Primary Completion Date : | August 31, 2023 |
Estimated Study Completion Date : | October 31, 2023 |

Arm | Intervention/treatment |
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Experimental: 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.
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Procedure: 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.
Other Name: HIPEC Drug: 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.
Other Name: PTX 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. |
No Intervention: 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.
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- R0 resection rate [ Time Frame: 1 year ]
- 1 year overall survival [ Time Frame: 1 year ]

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05228743
Contact: Liang Han, Master | +8602223340123 ext 1061 | tjlianghan@126.com | |
Contact: Cai Mingzhi, Master | +8602223340123 ext 1061 | tsaimingzhi@163.com |
China, Tianjin | |
Department of Gastrointestinal Medical Oncology, Tianjin Medical University Cancer Hospital | Recruiting |
Tianjin, Tianjin, China, 300060 | |
Contact: Liang Han 086-022-23340123 ext 1061 tjlianghan@126.com |
Responsible Party: | Tianjin Medical University Cancer Institute and Hospital |
ClinicalTrials.gov Identifier: | NCT05228743 |
Other Study ID Numbers: |
E20201130 |
First Posted: | February 8, 2022 Key Record Dates |
Last Update Posted: | February 8, 2022 |
Last Verified: | September 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
conversion therapy HIPEC peritoneal metastasis |
Stomach Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Stomach Diseases |
Paclitaxel Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |