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

NCT06798376 | Recruiting

• 1 other identifier: S2024-823
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Adenocarcinoma

Keywords

Advanced Gastric Adenocarcinoma; Neoadjuvant; Immunotherapy; Chemotherapy; Cycles

Outcome Measures

Primary Outcomes (1)

• Tumor Regression Grading (TRG)

  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 Outcomes (8)

• Safety

  From the start of neoadjuvant chemotherapy to 7 days after surgery

• R0 resection

  Approximately 1 week after surgery (when the pathology examination report available)

• Operative time

  On the day of the surgery (can be obtained immediately after the completion of the surgery)

• Time to first flatus

  From date of surgery until the date of first flatus, assessed up to 10 days post-surgery

• Nutritional Risk Screening 2002 (NRS 2002)

  Approximately 1 week after completing all neoadjuvant therapy

Study Arms (2)

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; Procedure: Gastrectomy

Group B

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

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

Interventions

≤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

Group A

≥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

Group B

Gastrectomy PROCEDURE

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

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, 100853, China

RECRUITING

Related Publications (16)

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MeSH Terms

Interventions

Drug Therapy; Gastrectomy

Intervention Hierarchy (Ancestors)

Therapeutics; Digestive System Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Xinxin Wang

CONTACT

+86-15022709006; wangxx301@outlook.com

Shuo Li

CONTACT

+86-16602664949; lsxyfz112@yeah.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: January 29, 2025
• Study Start: January 16, 2025
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: Within 3 years after the publication of the study results
• 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.

Locations

CN (1)