The Comparison of Different Cycles of PD-1 Blockades Combined with Chemotherapy As Neoadjuvant Therapy for Patients with Advanced Gastric Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Tumor Regression Grading (TRG)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Group A
The group A contains participants who received ≤4 cycles of neoadjuvant PD-1 inhibitor combined with chemotherapy and then received gastrectomy.
Intervention: Gastrectomy (Procedure)
Group B
The group B contains participants who received ≥5 cycles of neoadjuvant PD-1 inhibitor combined with chemotherapy and then received gastrectomy.
Intervention: ≥5 cycles of neoadjuvant PD-1 Inhibitors combined with chemotherapy (Drug)
Group A
The group A contains participants who received ≤4 cycles of neoadjuvant PD-1 inhibitor combined with chemotherapy and then received gastrectomy.
Intervention: ≤4 cycles of neoadjuvant PD-1 Inhibitors combined with chemotherapy (Drug)
Group B
The group B contains participants who received ≥5 cycles of neoadjuvant PD-1 inhibitor combined with chemotherapy and then received gastrectomy.
Intervention: Gastrectomy (Procedure)
Outcomes
Primary Outcomes
Tumor Regression Grading (TRG)
Time Frame: 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 Outcomes
- Safety(From the start of neoadjuvant chemotherapy to 7 days after surgery)
- R0 resection(Approximately 1 week after surgery (when the pathology examination report available))
- Operative time(On the day of the surgery (can be obtained immediately after the completion of the surgery))
- Time to first flatus(From date of surgery until the date of first flatus, assessed up to 10 days post-surgery)
- Nutritional Risk Screening 2002 (NRS 2002)(Approximately 1 week after completing all neoadjuvant therapy)
- YpTNM staging(Approximately 1 week after surgery (when the pathology examination report available))
- Dissected lymph node number(Approximately 1 week after surgery (when the pathology examination report available))
- Positive lymph node number(Approximately 1 week after surgery (when the pathology examination report available))
Investigators
Xinxin Wang
Prof.
Chinese PLA General Hospital