Biomarker Analysis of Tislelizumab Combined With Chemotherapy for Perioperative Treatment of G/GEJ Adenocarcinoma

NCT ID: NCT05508399

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 28 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-18
• Study Completion Date: 2025-10-10

Brief Summary

G/GEJ adenocarcinoma is one of the most common malignant tumors in China, ranking the fifth highest incidence and third highest mortality worldwide. Currently, surgical resection is the preferred treatment for G/GEJ adenocarcinoma, while the 5-year survival rate of patients is lower than 25%. Compared with surgical resection, immunotherapy is proved to be able to effectively prolong the survival time of patients. On one hand, with the continuous promotion of immunotherapy drugs, the exploration of neoadjuvant application of immunotherapy in G/GEJ adenocarcinoma has become a hotspot in recent years. It's also on their way that clinical trials of programmed death receptor-1 (PD-1), programmed death ligand-1 (PD-L1) and other immune checkpoints are carried out. On the other hand, the research found that although the curative effect of immune therapy seems better, the present G/GEJ adenocarcinoma immunotherapy marker researches mainly focused on the late stage of the cancer, with few studies of immune markers of neoadjuvant therapy for G/GEJ adenocarcinoma. Additionally, it's not quite feasible for single biomarkers to predict the immune treatment effect precisely. Therefore, combined with clinicopathology and therapeutic effects, this study is aimed to construct the efficacy prediction model of anti-PD-1 antibody together with chemotherapy for G/GEJ adenocarcinoma, by detecting RNA expression. Furthermore, this study will perform drug sensitivity test and bio-molecular test on patient derived organoid model to validate the biomarkers found from biological specimens.

Conditions

Locally Advanced Gastric Adenocarcinoma; PD-1

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

PD-1 group

Patients who are qualified for receiving anti-PD-1 antibody combined with chemotherapy neoadjuvant therapy

DNA panel and RNA Sequencing

Intervention Type: OTHER

Interventions include collecting samples, DNA panel test and full transcriptome sequencing.

Before collecting samples, obtaining written informed consent from patient in advance.

1. Blood cell samples;

2. Paraffin sample of residual tumor tissue of biopsy;

3. Paraffin sample of residual tumor tissue and paracancer tissue after gastrectomy.

Interventions

DNA panel and RNA Sequencing

Interventions include collecting samples, DNA panel test and full transcriptome sequencing.

Before collecting samples, obtaining written informed consent from patient in advance.

1. Blood cell samples;

2. Paraffin sample of residual tumor tissue of biopsy;

3. Paraffin sample of residual tumor tissue and paracancer tissue after gastrectomy.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Aged 18-80 (including 18 and 80);

2. G/GEJ adenocarcinoma confirmed by basic ultrasound gastroscopy, enhanced CT (PET/CT), MRI or diagnostic laparoscopy;

3. Biopsy histologically confirmed adenocarcinoma

4. As assessed by the investigator, patients who are qualified for receiving PD-1 mab combined with chemotherapy neoadjuvant therapy;

5. Patients who volunteer to participate in this study and sign the informed consent, with good compliance and cooperation in the acquisition of biological specimens.

Exclusion Criteria

1. Patients whose biological specimens do not meet the detection standards;

2. In the judgment of the investigator, the patients with factors that might have caused the study to be terminated.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xijing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, China

Countries

China

Other Identifiers

Gang Ji -2

Identifier Type: -

Identifier Source: org_study_id