Advanced Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma
Conditions
Interventions
Post-Surgery group:Trilaciclib prophylaxis before chemotherapy
First-Lin group:Trilaciclib prophylaxis before chemotherapy
Sponsors
Shanxi Province Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent before enrollment; 2. Age> 18 years old, male or female; 3. Pathological examination confirmed the diagnosis of gastric adenocarcinoma or gastroesophageal junction adenocarcinoma, advanced gastric cancer containing T1-4bN0-3M0, D2 and R0 resection, advanced gastric cancer is metastatic gastric cancer, chemotherapy-based treatment is required, and it is first-line treatment (including patients who need treatment after recurrence after half a year of postoperative adjuvant therapy); 4. Karl Fibre Fibre score (KPS) >=50 points, expected survival >=3 months, follow-up observation for more than 3 months; 5. There were no obvious abnormalities in blood routine, liver and kidney function, cardiac enzymes and electrocardiogram. 6. Subjects voluntarily joined this study, with good compliance, and cooperated with safety and survival follow-up.
Exclusion criteria
Exclusion criteria: 1. Diagnosis of another malignancy within 5 years prior to the first use of the investigational drug, except for effectively treated basal cell carcinoma, squamous cell carcinoma of the skin, and/or effectively resected carcinoma in situ of the cervix and/or breast. 2. Patients with a history of allergy to biologics. 3. Receipt of any cytotoxic chemotherapy or PD-1/PD-L1 inhibitor therapy (if applicable) =10^4 copies/mL), or hepatitis C (positive hepatitis C antibody with HCV-RNA above the lower limit of detection of the assay). 15. Other conditions deemed by the investigator as grounds for exclusion from the study, such as factors that may lead to premature termination of the study, including other severe diseases (including psychiatric disorders) requiring concurrent treatment, significant laboratory abnormalities, or familial or social factors that may compromise the participant's safety or the collection of data and samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Grade 3 Neutropenia;Rate of FN; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate, ORR;Quality of Life, QoL;Rate of Full-Dose Chemotherapy; | — |
Countries
China
Contacts
Public ContactWenhui Yang
Shanxi Province Cancer Hospital
Outcome results
None listed