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Trial Title:
Biomarker Analysis of Tislelizumab Combined With Chemotherapy for Perioperative Treatment of G/GEJ Adenocarcinoma
NCT ID:
NCT05508399
Condition:
Locally Advanced Gastric Adenocarcinoma
PD-1
Conditions: Official terms:
Adenocarcinoma
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
DNA panel and RNA Sequencing
Description:
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.
Arm group label:
PD-1 group
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.
Criteria for eligibility:
Study pop:
Patients with G/GEJ adenocarcinoma who are ready to receive PD-1 monoclonal antibody
combined with chemotherapy neoadjuvant treatment.
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Xijing Hospital of Digestive Diseases
Address:
City:
Xi'an
Zip:
710000
Country:
China
Status:
Recruiting
Contact:
Last name:
Gang Ji, Doctoral
Phone:
+8618153227717
Email:
xijingweichang@163.com
Start date:
July 18, 2022
Completion date:
July 18, 2026
Lead sponsor:
Agency:
Xijing Hospital
Agency class:
Other
Source:
Xijing Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05508399
