Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06798376

Different Cycles of Neoadjuvant PD-1 Blockades + Chemotherapy for 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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Gastric Adenocarcinoma

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

Any PD-1 inhibitors combined with any chemotherapy regimen given before surgery for no more than 4 cycles

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

Drug

Any PD-1 inhibitors combined with any chemotherapy regimen given before surgery for no less than 5 cycles

gastrectomy

Procedure

Any type of surgical procedure for gastric adenocarcinoma patients in which part or all of the stomach is removed

Primary outcomes

  1. 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

  1. Safety

    Time frame: From the start of neoadjuvant chemotherapy to 7 days after surgery

    Adverse events during neoadjuvant therapy and postoperative complications

  2. 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

  3. 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

  4. 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

  5. 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.

  6. 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.

  7. 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

  8. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Shuo Li

CONTACT

[email protected]

+86-16602664949

Xinxin Wang

CONTACT

[email protected]

+86-15022709006

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 29, 2025
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.