Clinical trial NCT06798376: Different Cycles of Neoadjuvant PD-1 Blockades + Chemotherapy for Advanced Gastric Cancer
Official title: The Comparison of Different Cycles of PD-1 Blockades Combined with Chemotherapy As Neoadjuvant Therapy for Patients with Advanced Gastric Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastric Adenocarcinoma
Keywords: Advanced Gastric Adenocarcinoma
Neoadjuvant
Immunotherapy
Chemotherapy
Cycles
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2025-01-29
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Advanced gastric cancer patients who received preoperative PD-1 inhibitor combined with chemotherapy and gastrectomy

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Tumor Regression Grading (TRG)
timeFrame: Approximately 1 week after surgery (when the pathology examination report available)
Secondary outcomes:
measure: Safety
timeFrame: From the start of neoadjuvant chemotherapy to 7 days after surgery
measure: R0 resection
timeFrame: Approximately 1 week after surgery (when the pathology examination report available)
measure: Operative time
timeFrame: On the day of the surgery (can be obtained immediately after the completion of the surgery)
measure: Time to first flatus
timeFrame: From date of surgery until the date of first flatus, assessed up to 10 days post-surgery
measure: Nutritional Risk Screening 2002 (NRS 2002)
timeFrame: Approximately 1 week after completing all neoadjuvant therapy
measure: YpTNM staging
timeFrame: Approximately 1 week after surgery (when the pathology examination report available)
measure: Dissected lymph node number
timeFrame: Approximately 1 week after surgery (when the pathology examination report available)
measure: Positive lymph node number
timeFrame: Approximately 1 week after surgery (when the pathology examination report available)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
Study officials:
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