gastric cancer
Conditions
Interventions
the experimental group:After the surgical field was exposed, 2.0-3.0ml mitoxantrone hydrochloride injection for tracing was taken with a syringe and injected at 2-3 points on each side of the greater
the control group:After the surgical field was exposed, 1ml (50mg) of carbon nanoparticle suspension injection was taken and injected into the subserous membrane at 4 ~ 6 points around the tumor with
Sponsors
The Fourth Hospital of Hebei Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Volunteer to participate in clinical research; Fully understand and be informed of this study, and sign an informed consent form; Willing to follow and capable of completing all testing procedures 2. No gender limit; Age between 18 and 75 when signing ICF 3. Patients with gastric adenocarcinoma confirmed by histopathology or cytology with clear diagnosis 4. Local advanced gastric adenocarcinoma subjects who meet the criteria of cT2-T4a, N0 or cN+, M0 (according to the TNM staging of gastric cancer AJCC/UICC 8th edition) and plan to undergo gastric cancer radical surgery 5. No severe liver or kidney dysfunction 6. No obvious surgical Contraindication before routine operation
Exclusion criteria
Exclusion criteria: 1. Subjects who have previously received chemotherapy (including neoadjuvant therapy) or radiation therapy 2 subjects who have undergone radical gastrectomy for recurrent gastric cancer 3. Subjects who have experienced peritoneal, liver, and other organ metastasis 4. Those who have undergone major surgeries within one month before participating in clinical trials 5. Subjects with other malignant tumors and currently in the advanced stage; Note: Subjects who have received potentially curative treatment for basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast cancer, carcinoma in situ of the cervix) are admitted 6. Alanine aminotransferase (ALT), aspartate aminotransferase AST > 3 times the upper limit of normal; Serum creatinine (Cr) > 3 times the upper limit of normal 7. Patients with severe allergy to experimental drugs or known foods and drugs (CTCAE5.0 related criteria =3, CTCAE5.0 immune system disease allergic reaction) 8. People with a known psychiatric or neurological disorder that would affect the participant's ability to cooperate with the study, or with a history of psychotropic substance abuse, drug use, or alcohol dependence 9. Those who are currently undergoing other clinical trials or have participated in any drug (excluding vitamins and minerals) clinical trials within the first 28 days of randomization (excluding those who have failed to participate in clinical trial screening) 10. Pregnant or lactating women 11. Subjects have a pregnancy plan during the trial or within 6 months after the trial 12. Other subjects who the investigator believes may interfere with the test results, affect the subject's disease history, treatment history or laboratory Outlier during the whole study, or the investigator believes that participating in the study is not in the best interests of the subject
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference of lymph node staining rate between experimental group and control group was compared; | — |
Secondary
| Measure | Time frame |
|---|---|
| The total number of lymph nodes detected in experimental group and control group was compared;The staining rates of lymph nodes at station 1 (N1) and at station 2 (N2) were compared between the experimental group and the control group;The short diameter of detected lymph nodes was classified into grades, and the difference analysis between groups was carried out: the detection rates of lymph nodes with short diameter =1mm and short diameter =2mm in the experimental group and the control group were statistically analyzed; | — |
Countries
China
Contacts
Public ContactLi Yong / Zhang Zhidong
The Fourth Hospital of Hebei Medical University
Outcome results
None listed