Clinical trial: NCT04808466
Section: Alternatives
Subsections: Other Therapeutic Intervention Methods:

In addition to participating in this research, you have the following options 1. Routine surgical treatment; 2.Routine adjuvant chemotherapy regimens: SOX, XELOX, mFOLFOX6, etc.; 3. According to the results of the examination, assist with chemotherapy and targeted drug therapy.
Clinical trial: NCT04808466
Section: Confidentiality
Subsections: Private Issues:

If you decide to participate in this study, your participation in the study and your personal information in the study are confidential. For you, all information will be kept confidential. Information that can identify you will not be disclosed to members other than the research
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team unless we have your permission. All research members and research sponsors are  
  
 required to keep your identity confidential. Your files will be stored uniformly and are only available to researchers. In order to protect your privacy, the personal name will be hidden in the data, saved in the form of initials and research code, and stored in the clinical research special file cabinet, only for researchers to view; your specimen will be marked with the research number instead of the name. To ensure that the research is conducted in accordance with the regulations, when necessary, members of the government management department or the ethics review committee can consult your personal data in the research unit as required.  
When the results of this research are published, your information will be kept confidential.
Clinical trial: NCT04808466
Section: Participant's Rights
Subsections: Subject Statement

I have read this informed consent form carefully. I have the opportunity to ask questions and all questions have been answered. I understand that participation in this research is voluntary. I can choose not to participate in this research, or I can withdraw after notifying the researcher at any time without being discriminated against or retaliated. Any of my medical treatment and rights will not be affected by this. If I need other diagnosis/treatment, or I did not follow the research plan, or have other reasonable reasons, the researcher can terminate my continued participation in this clinical research. I voluntarily agree to participate in the clinical study, and I will receive a signed copy of the "Informed Consent". Subject's signature: Date: Year Month Day
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If the subject is unable to sign the informed consent due to incapacity or other reasons, or the subject is a minor, it shall be signed by the guardian.  
Guardian's Signature: Date: Year Month Day Relationship with subjects:
Reasons why the subject cannot sign the informed consent form:
Clinical trial: NCT04808466
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Possible Risks And Discomforts:

Although the clinical trials are rigorous and safe, it cannot be ruled out that there may be some serious and even life-threatening side effects. Of course, this probability is very low. This study may have risks associated with radical GC surgery, including the risk of anastomotic leakage, delayed exhaust, intestinal adhesions, intestinal obstruction, tumor recurrence or metastasis. The risk is minimized by strictly following the protocol, performing the operation in the correct and standardized hospital environment, limiting the surgical operator, and closely monitoring the condition of the subject during and after the operation. This study also has the risks associated with intraperitoneal hyperthermic perfusion chemotherapy. HIPEC must use special thermal perfusion tubing components, and there are adverse reactions such as heat injury, local infection, unexpected termination of the treatment process, environmental pollution, abdominal pain and bloating. The risk is minimized by strictly following the protocol, operating in the correct and standardized hospital environment, restricting the operator, and closely monitoring the conditions of the subjects after the operation, etc., and actively adjusting the treatment plan according to the patient's condition, and assisting with sedation and analgesics. Stop the treatment when necessary. This study involves surgery and chemotherapy drugs lobaplatin, paclitaxel, the main adverse reactions include: gastrointestinal tract, blood system and liver function. The most common
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adverse reactions in the gastrointestinal tract are mainly nausea, vomiting, diarrhea, and loss  
  
  
  
 of appetite; the hematopoietic system is mainly white blood cells, neutrophils, thrombocytopenia and anemia; the liver function is mainly affected by the reversible increase of ALT and AST. Adverse reactions mainly include: 1. Neurotoxicity is mainly manifested as hypoesthesia, paresthesia, and aggravated by cold, occasionally reversible acute throat paresthesia; 2. Gastrointestinal reactions are mainly mild and moderate nausea, vomiting and diarrhea, mucosal Inflammation; 3. Anemia of the blood system, leukopenia, and neutropenia. Diarrhea, nausea, vomiting and mucositis; the main hematological side effects of this type of chemotherapy drugs in the blood system are: anemia, leukopenia, neutropenia and thrombocytopenia. During the implementation of this study, the general conditions of the patients were fully monitored and evaluated in each treatment cycle. If there are corresponding adverse reactions during the process, the corresponding complications will be actively handled in accordance with clinical strategies. In addition, the treatment of clinical trials may be ineffective and lead to disease progression, severe complications in the process require further treatment, increase treatment costs, and even lead to patient death. The Ethics Committee of Union Hospital of Huazhong University of Science and Technology will supervise the entire research process of this clinical project.
Clinical trial: NCT04808466
Section: Procedures
Subsections: Research Methods And Content:

1. Patient screening and evaluation Strictly select patients according to the above-mentioned inclusion and exclusion criteria of this research program. Complete the following projects within 1 week after admission: (1) Improve medical history and physical examination
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(2) Blood routine, biochemical, immunological indicators, CRP/PCT and tumor markers  
  
 (3) B-ultrasound, electrocardiogram, chest radiograph and stomach CT/MRI (4) Gastroscopy 2.D2 surgical resection of GC Operation method: open surgery or laparoscopic surgery The steps are as follows: anesthesia → blood collection → abdominal cavity exploration and evaluation → intraoperative drawing in accordance with the admission criteria →
preoperative abdominal lavage → standard D2 surgical resection → removal of cancer, adjacent and normal tissue specimens → surgery area requires photo for evidence (Proved to be D2 surgery) → Postoperative abdominal lavage. During the abdominal cavity exploration,
"assessment of lesion area", "assessment of tumor size" and "intraoperative staging" should be carried out, and according to whether the patient has peritoneal cancer or not, the experimental group and control group can be determined. (1) Surgical resection range: the distance between the gastric resection margin of the localized GC and the tumor should be more than 3-4cm, and the distance between invasive GC should be more than 5cm. For esophageal gastric junction cancer, the resection margin of the esophagus should be more than 3cm from the tumor. Frozen pathological biopsy should be performed when necessary. For tumors that invade the pyloric duct, the distance between the duodenal resection margin and the tumor should be more than 3 cm. Remove enough lymph nodes according to the staging method of GC. (2) The principle of tumor-free operation: first ligate veins and arteries at the root of the blood vessel, and at the same time sweep the lymph nodes, then separate and resect the specimen. The operation should be gentle, more sharp separation and less blunt separation. The tumor could not be directly touched to avoid the damage to the lymph nodes which can cause cancer cells to spread and local implantation. The serosal layer can be protected by covering method or applying various glues
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(3)protect the incision when removing the specimen to prevent the incision from planting  
  
  
  
tumor cells.
Clinical trial: NCT04808466
Section: Purpose of Research
Subsections: Research Purpose:

Primary purpose: To compare the OS rate and the survival rate without peritoneal metastasis of paclitaxel and lobaplatin using for GCs with D2+HIPEC+ SOX/XELOX regimen. Observation period is 3 years Secondary purpose: the incidence of postoperative adverse reactions (refer to CTCAE5.0
(including blood routine, liver and kidney function, patient's reaction to HIPEC, adverse events)
Clinical trial: NCT04808466
Section: Voluntary Participation
Subsections: Voluntary Participation And Withdrawal Of Research:

As a subject, you can learn about the information and research progress related to this research at any time, and voluntarily decide (continue) to participate or not (continue) to participate. After participating, you can choose to notify the investigator to withdraw from the study at any time, regardless of whether the injury has occurred or whether it is serious. Your data will not be included in the study results, and any of your medical treatment and rights will not be affected.  
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