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

Chinese PLA General Hospital (301 Hospital)

Status: Enrolling

Conditions: Gastric Adenocarcinoma

Treatments: Procedure: Gastrectomy; Drug: ≥5 cycles of neoadjuvant PD-1 Inhibitors combined with chemotherapy; Drug: ≤4 cycles of neoadjuvant PD-1 Inhibitors combined with chemotherapy

Study type: Observational

Funder types: Other

Identifiers

NCT06798376

S2024-823

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

300 participants in 2 patient groups

Group A

Description:

The group A contains participants who received ≤4 cycles of neoadjuvant PD-1 inhibitor combined with chemotherapy and then received gastrectomy.

Treatment:

Drug: ≤4 cycles of neoadjuvant PD-1 Inhibitors combined with chemotherapy

Procedure: Gastrectomy

Group B

Description:

The group B contains participants who received ≥5 cycles of neoadjuvant PD-1 inhibitor combined with chemotherapy and then received gastrectomy.

Treatment:

Procedure: Gastrectomy

Drug: ≥5 cycles of neoadjuvant PD-1 Inhibitors combined with chemotherapy