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

January 22, 2025 updated by: Xinxin Wang, Chinese PLA General Hospital

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Beijing, China, 100853
        • Recruiting
        • Chinese PLA General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Advanced gastric cancer patients who received preoperative PD-1 inhibitor combined with chemotherapy and gastrectomy

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group A
The group A contains participants who received ≤4 cycles of neoadjuvant PD-1 inhibitor combined with chemotherapy and then received gastrectomy.
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
Procedure: Gastrectomy
Any type of surgical procedure for gastric adenocarcinoma patients in which part or all of the stomach is removed
Group B
The group B contains participants who received ≥5 cycles of neoadjuvant PD-1 inhibitor combined with chemotherapy and then received gastrectomy.
Procedure: Gastrectomy
Any type of surgical procedure for gastric adenocarcinoma patients in which part or all of the stomach is removed
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Approximately 1 week after surgery (when the pathology examination report available)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: From the start of neoadjuvant chemotherapy to 7 days after surgery
Adverse events during neoadjuvant therapy and postoperative complications
From the start of neoadjuvant chemotherapy to 7 days after surgery
R0 resection
Time Frame: 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
Approximately 1 week after surgery (when the pathology examination report available)
Operative time
Time Frame: 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
On the day of the surgery (can be obtained immediately after the completion of the surgery)
Time to first flatus
Time Frame: 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
From date of surgery until the date of first flatus, assessed up to 10 days post-surgery
Nutritional Risk Screening 2002 (NRS 2002)
Time Frame: 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.
Approximately 1 week after completing all neoadjuvant therapy
YpTNM staging
Time Frame: 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.
Approximately 1 week after surgery (when the pathology examination report available)
Dissected lymph node number
Time Frame: Approximately 1 week after surgery (when the pathology examination report available)
The total number of lymph nodes surgically removed and examined
Approximately 1 week after surgery (when the pathology examination report available)
Positive lymph node number
Time Frame: Approximately 1 week after surgery (when the pathology examination report available)
The number of lymph nodes found to contain cancer cells upon pathological examination
Approximately 1 week after surgery (when the pathology examination report available)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese PLA General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 16, 2025

Primary Completion (Estimated)

January 31, 2025

Study Completion (Estimated)

January 31, 2025

Study Registration Dates

First Submitted

January 16, 2025

First Submitted That Met QC Criteria

January 22, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 22, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S2024-823

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The datasets used and/or analyzed during the current study containing data related to the outcomes observed in the study, without any personal information or other data of the patients will be shared.

IPD Sharing Time Frame

Within 3 years after the publication of the study results

IPD Sharing Access Criteria

The datasets used and/or analyzed during the current study containing data related to the outcomes observed in the study, without any personal information or other data of the patients will be shared. Qualified medical professionals can access the datasets by submitting a written request and obtaining approval from the principal investigator and other researchers involved in the study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gastric Adenocarcinoma

Clinical Trials on ≤4 cycles of neoadjuvant PD-1 Inhibitors combined with chemotherapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kuwait

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe