RecruitingNCT06798376

Different Cycles of Neoadjuvant PD-1 Blockades + Chemotherapy for Advanced Gastric Cancer

The Comparison of Different Cycles of PD-1 Blockades Combined with Chemotherapy As Neoadjuvant Therapy for Patients with Advanced Gastric Cancer

Sponsor

Chinese PLA General Hospital

Enrollment

300 participants

Start Date

Jan 16, 2025

Study Type

OBSERVATIONAL

Conditions

Gastric Adenocarcinoma

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

Min Age: 18 YearsMax Age: 90 Years

Inclusion Criteria8

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 Criteria4

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.

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

Locations(1)

Chinese PLA General Hospital

Beijing, China

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NCT06798376

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