Tislelizumab Combined With Neoadjuvant Chemotherapy Used in the Perioperative Treatment.
ConditionGastric Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorXiangdong Cheng
About this trial
To evaluate the efficacy of Tislelizumab in combination with chemotherapy versus chemotherapy in neoadjuvant treatment of patients with MHC-II positive (IHC≥2+) and locally advanced gastric/gastroesophageal junction adenocarcinoma by evaluating the main pathologic response rate (MPR).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The patient voluntarily joined this study and signed an informed consent form;
Age ≥ 18 years old, ≤ 75 years old
Pathological diagnosis of gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction
Patients must be able to provide fresh slices of tumor tissue (FFPE tissue blocks or approximately 15 slides), unstained FFPE slides, and if clinically feasible, fresh biopsy samples will be preferred. If archived samples cannot be obtained, fresh tumor biopsy specimens must be collected during the baseline period, with the same requirements for glass slides as archived tumor tissue
Disqualifiers
There are non resectable factors, including tumor reasons that cannot be resected or surgical contraindications that cannot be resected or those who refuse surgery
Previously or currently suffering from other malignant tumors
Suffering from any chronic or major illness that is considered intolerable to treatment (such as severe heart disease, uncontrolled hypertension, certain degrees of liver and kidney dysfunction, etc.)
Those who have experienced gastrointestinal perforation, abdominal abscess in the past, or recent (within 3 months) intestinal obstruction or imaging and clinical symptoms indicating accompanying intestinal obstruction
Trial design
Design model
Parallel
Treatments tested in this trial
Tislelizumab
DrugPreoperative treatment with Tislelizumab
SOX/XELOX
DrugPreoperative treatment with SOX/XELOX
Treatment groups
134 Participants
are divided into 4 treatment groupsGroup A: A (MHC-II positive with Tislelizumab and SOX/XELOX)Experimental treatment 2 interventions
Group B: B (MHC-II positive with SOX/XELOX)Active comparator 1 intervention
Group C: C (MHC-II negative with Tislelizumab and SOX/XELOX)Experimental treatment 2 interventions
Group D: D (MHC-II negative with SOX/XELOX)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
MRP (Main pathological response)
The percentage of subjects who showed no residual tumor cells (including lymph nodes, stage ypT0N0M0) and only residual single or small focal cancer cells under the light microscope
Time frame
After operation about 2 weeks until postoperative pathology report come out.Secondary outcomes
1
pCR (pathologic complete response)
The percentage of subjects with a TRG grade of 0 who do not have live tumor cell residues in the primary tumor lesion
Time frame
After operation about 2 weeks until postoperative pathology report come out.2
DFS (Disease free survival)
Refers to the time between the time of baseline imaging evaluation and disease recurrence or death (whichever occurs first) in disease-free subjects after surgery.
Time frame
From date of randomization until the date of first documented progression， assessed up to 100 months3
OS (Overall survival)
The time between the date of enrollment and death from any cause
Time frame
From date of randomization until the date of death, assessed up to 120 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Xiangdong Cheng
Lead sponsor
Zhejiang Cancer Hospital
Sponsor institution
Liaoning Cancer Hospital & Institute
Collaborator
Shanxi Province Cancer Hospital
Collaborator
Sichuan Cancer Hospital and Research Institute
Collaborator
The Second Affiliated Hospital of Harbin Medical University
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: