Clinical trial NCT02549911: HIPEC, Intravenous Chemotherapy and Surgery for the Treatment of Advanced GC With Peritoneal Metastasis
Official title: Hyperthermic Intraperitoneal Chemotherapy, Intravenous Chemotherapy Combined With Surgery for the Treatment of Advanced Gastric Cancer With Peritoneal Metastasis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Gastric Cancer
Keywords: chemotherapy
surgery
Surgically-Created Resection Cavity
Adverse Reaction to Drug
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2015-09-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Explore the hyperthermic intraperitoneal chemotherapy (HIPEC) and intravenous chemotherapy for Creating the Operation Chance in advanced gastric cancer with peritoneal metastasis.

Detailed description: To assess the effectiveness and safety of Hyperthermic intraperitoneal chemotherapy, intravenous chemotherapy combined with surgery for the treatment of advanced gastric cancer with peritoneal metastasis,so as to further find out the optimal protocol for the Conversion therapy in the patients with advanced gastric cancer.

Eligibility criteria: Inclusion Criteria:

gastric cancer confirmed by endoscopic biopsy , and enhanced CT suspected to have peritoneal metastasis, including ascites, ovarian metastasis, omentum or peritoneal metastasis.

* Definitely diagnosed as above stage of stomach cancer before the operation via CT or MRI, ultrasonic endoscopy and blood tumor antigen test, or through the laparoscopy if necessary
* Untreated (e.g. radiotherapy, chemotherapy, target therapy and immunotherapy)
* ECOG (Eastern Cooperative Oncology Group) : 0\~2
* Age: 18\~75 years old
* Normal hemodynamic indices before the recruitment (including blood cell count and liver/kidney function). For example: WBC\>4.0×109/L, NEU \>1.5×109/L, PLT\>100×109/L, BIL\<1.5 times of upper limit of normal reference value, ALT and AST\<2.5 times of upper limit of normal reference value, and CRE\<1.2mg/dl
* Good cardiac function before the recruitment, no seizure of myocardial infarction in past half year, and controllable hypertension and other coronary heart diseases
* Not concomitant with other uncontrollable benign diseases before the recruitment (e.g. the infection in the lung, kidney and liver)
* Not participating in other study projects before and during the treatment
* Signed the Informed Consent Form

Exclusion Criteria:

* Not conforming to above inclusion criteria
* Distal metastasis to lung, liver, or para aortic lymph node metastasis
* Ever operation on the stomach
* Operation intolerance due to other systemic basic diseases
* Ever administered other drugs (including TCM drugs) before the recruitment, or no guarantee of progress according to the study requirement after the recruitment
* Allergy to the drugs in this protocol
* Pregnant or lactating women
* Women at childbearing age and of pregnancy desire during the study

Primary outcomes:
measure: R0 resection
timeFrame: 3 months
Secondary outcomes:
measure: Adverse Events
timeFrame: 6 months
measure: Overall survival time
timeFrame: 3 years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Zhejiang Cancer Hospital
name: Yian Du, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wu X, Li Z, Li Z, Jia Y, Shan F, Ji X, Bu Z, Zhang L, Wu A, Ji J. Hyperthermic intraperitoneal chemotherapy plus simultaneous versus staged cytoreductive surgery for gastric cancer with occult peritoneal metastasis. J Surg Oncol. 2015 Jun;111(7):840-7. doi: 10.1002/jso.23889. Epub 2015 Apr 10.
citation: Xia W, Hu Y, Mou T, Chen T, Yu J, Li G. [Safety and efficacy of intraperitoneal hyperthermic perfusion chemotherapy following laparoscopic palliative resection for gastric cancer patients with peritoneal metastasis]. Zhonghua Wei Chang Wai Ke Za Zhi. 2014 Nov;17(11):1087-91. Chinese.
citation: Di Vita M, Cappellani A, Piccolo G, Zanghi A, Cavallaro A, Bertola G, Bolognese A, Facchini G, D'Aniello C, Di Francia R, Cardi F, Berretta M. The role of HIPEC in the treatment of peritoneal carcinomatosis from gastric cancer: between lights and shadows. Anticancer Drugs. 2015 Feb;26(2):123-38. doi: 10.1097/CAD.0000000000000179.
citation: Yu P, Ye Z, Dai G, Zhang Y, Huang L, Du Y, Cheng X. Neoadjuvant systemic and hyperthermic intraperitoneal chemotherapy combined with cytoreductive surgery for gastric cancer patients with limited peritoneal metastasis: a prospective cohort study. BMC Cancer. 2020 Nov 16;20(1):1108. doi: 10.1186/s12885-020-07601-x.