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
Qualifiers
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
Treatments tested in this trial
- Tislelizumab
- SOX/XELOX
Treatment groups
134 Participants
are divided into 4 treatment groupsSponsors and collaborators
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