Study Evaluating Neoadjuvant Immunotherapy Increasing CD8+ Cell Infiltration in Advance Gastric Adenocarcinoma
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFujian Medical University
About this trial
Focusing on the clinical question of whether patients with advanced gastric cancer can benefit from immunotherapy, this project intends to detect the degree of CD8+ tumor-infiltrating lymphocyte infiltration in patients with advanced gastric cancer before and after receiving neoadjuvant combined immunotherapy and neoadjuvant therapy alone. To explore the evolving nature of tumor immune response before and after neoadjuvant therapy for gastric cancer, and quantitatively present it through chemical immunohistochemical techniques to achieve a more accurate diagnosis and treatment and improve the long-term efficacy of patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age from 18 to 75 years
Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically ；
CT/MRI, PET-CT, or laparoscopic exploration should be performed before surgery to confirm the diagnosis of stage ≥cT2 or N+；
Patients who have not received other treatments such as surgery, radiotherapy, chemotherapy, targeted therapy or immunotherapy；
Disqualifiers
History of other malignant disease within past five years；
History of immunodeficiency, including HIV positive, or other acquired congenital immunodeficiency disease, or a history of organ transplantation and allogeneic bone marrow transplantation；
Contraindications to surgery and chemotherapy, or whose physical condition and organ function do not allow for major abdominal surgery
Distant metastases；
Trial design
Design model
Parallel
Treatments tested in this trial
radical surgery after neoadjuvant immunotherapy
Combination productA total or distal gastrectomy with D2 lymph node dissection was done depending on the tumor location after neoadjuvant immunotherapy.
radical surgery after neoadjuvant chemotherapy
Combination productA total or distal gastrectomy with D2 lymph node dissection was done depending on the tumor location after neoadjuvant immunotherapy.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: radical surgery after neoadjuvant immunotherapy (albumin Paclitaxel + Seggio + PD-1 inhibitor)Experimental treatment 1 intervention
Group B: radical surgery after neoadjuvant chemotherapy (albumin Paclitaxel + Seggio)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
The number of CD8+ tumor-infiltrating lymphocytes in tumor tissue and adjacent tissue before and after treatment
Changes in the number of CD8+ tumor-infiltrating lymphocytes in the tumor and adjacent tissues of the experimental group before and after the surgery compared with the control group.
Time frame
6 monthsSecondary outcomes
1
Objective response rate (ORR)
Complete response (CR) + partial response (PR)
Time frame
6 months2
Disease-free survival (DFS)
Time from study entry to disease recurrence or patient death due to disease progression
Time frame
2 years3
Overall survival (OS)
Time from study entry to death from any cause.
Time frame
2 years4
Therapeutic drug safety
Adverse events (AEs), serious adverse events (SAEs), drug-related AEs, SAEs, and class-specific AEs (eg, hypertension, proteinuria, and hand-foot syndrome)
Time frame
6 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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