Gastric Adenocarcinoma
Conditions
Keywords
Advanced Gastric Adenocarcinoma, Neoadjuvant, Immunotherapy, Chemotherapy, Cycles
Brief summary
The goal of this observational study is to analyze the impact of different durations of neoadjuvant PD-1 inhibitor combined with chemotherapy on tumor regression and safety in patients with advanced gastric cancer. The main questions it aims to answer are: * Does the duration of neoadjuvant treatment influence tumor regression grading (TRG)? * How does treatment duration affect perioperative safety and clinical outcomes? Participants who have previously undergone neoadjuvant PD-1 inhibitor combined with chemotherapy followed by surgery as part of their routine medical care will have their clinical data retrospectively reviewed and analyzed.
Interventions
DRUG≤4 cycles of neoadjuvant PD-1 Inhibitors combined with chemotherapy
Any PD-1 inhibitors combined with any chemotherapy regimen given before surgery for no more than 4 cycles
DRUG≥5 cycles of neoadjuvant PD-1 Inhibitors combined with chemotherapy
Any PD-1 inhibitors combined with any chemotherapy regimen given before surgery for no less than 5 cycles
PROCEDUREGastrectomy
Any type of surgical procedure for gastric adenocarcinoma patients in which part or all of the stomach is removed
Sponsors
Chinese PLA General Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Non-bedridden patients aged 18-90 years; * Histologically confirmed gastric or gastroesophageal junction adenocarcinoma by biopsy; * Evaluated as resectable advanced gastric cancer via CT, MRI, or laparoscopic exploration; * No prior anti-tumor treatments such as chemotherapy, radiotherapy, or immunotherapy; * No history of other malignancies within the past 5 years; * Received at least one cycle of PD-1 inhibitor combined with chemotherapy preoperatively, with no restrictions on the specific PD-1 inhibitor or chemotherapeutic agents; * Underwent radical gastrectomy after neoadjuvant therapy; * No severe underlying diseases.
Exclusion criteria
* Incomplete or inaccessible clinical and pathological data; * Postoperative pathology confirming non-gastric or non-gastroesophageal junction adenocarcinoma; * Distant metastases present prior to treatment; * Concurrent diagnosis of other malignancies.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor Regression Grading (TRG) | Approximately 1 week after surgery (when the pathology examination report available) | Tumor Regression Grading (TRG) based on the Chinese Society of Clinical Oncology (CSCO) guidelines ranging from 0 (no residual tumor) to 3 (extensive residual tumor cells with no or minimal tumor cell necrosis), with higher scores indicating worse outcomes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| R0 resection | Approximately 1 week after surgery (when the pathology examination report available) | Complete removal of a tumor with no residual cancer cells at the surgical margins, confirmed by pathological examination |
| Operative time | On the day of the surgery (can be obtained immediately after the completion of the surgery) | The total duration of a surgical procedure, measured from the first incision to the completion of wound closure |
| Time to first flatus | From date of surgery until the date of first flatus, assessed up to 10 days post-surgery | The duration from the completion of surgery to the first passing of gas (flatus) by the patient |
| Safety | From the start of neoadjuvant chemotherapy to 7 days after surgery | Adverse events during neoadjuvant therapy and postoperative complications |
| YpTNM staging | Approximately 1 week after surgery (when the pathology examination report available) | Pathological classification used to assess cancer characteristics after neoadjuvant therapy, based on the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition. |
| Dissected lymph node number | Approximately 1 week after surgery (when the pathology examination report available) | The total number of lymph nodes surgically removed and examined |
| Positive lymph node number | Approximately 1 week after surgery (when the pathology examination report available) | The number of lymph nodes found to contain cancer cells upon pathological examination |
| Nutritional Risk Screening 2002 (NRS 2002) | Approximately 1 week after completing all neoadjuvant therapy | The Nutritional Risk Screening 2002 (NRS 2002) is a scale used to assess the nutritional risk of hospitalized patients. The score ranges from 0 to 7, with higher scores indicating a higher risk of malnutrition. A score of 0 signifies no nutritional risk, while a score of 3 or higher indicates a significant nutritional risk that may require intervention. |
Countries
China
Contacts
Primary ContactXinxin Wang
Backup ContactShuo Li
Outcome results
None listed