About this trial
In this project, based on the information of advanced gastric/gastroesophageal junction cancer in evolution under immunotherapy combined with chemotherapy treatment, we will integrate multi-omics dynamic data to identify essential features that correlate to therapeutic effects of immunotherapy therapy, screen potential molecular markers/dominant microbiota for predicting the efficacy of immunotherapy and establish a multimodal predictive model for patients that benefit from immunotherapy. Our project could provide evidence to predict response to immunotherapy for patients with advanced gastric/gastroesophageal junction cancer and potentially optimize the clinical decision-making about therapy for advanced gastric/gastroesophageal junction cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with gastric or gastroesophageal junction adenocarcinoma confirmed by pathology and with advanced or metastatic disease that cannot be resected
HER2 negative
Not received any anti-tumor treatment before.
After evaluation, the treatment plan is chemotherapy combined with immunotherapy.
Disqualifiers
Patients with malignant tumors other than gastric cancer or those with tumors metastasized to the stomach from other sites.
Patients who have previously received anti-tumor treatments such as surgery, radiotherapy and chemotherapy, targeted therapy or immunotherapy.
Patients with severe infections.
Those with a history of mental illness cannot cooperate with the research.
Trial population
Patients with advanced or metastatic gastric or gastroesophageal junction adenocarcinoma
Trial design
Cohort
Retrospective
Treatments tested in this trial
Peripheral blood, tougue coating, saliva, and feces
Other interventionPeripheral blood, coating, saliva, and feces on the tongue and clinical data of patients with advanced gastric cancer patients who received chemotherapy combined with immunotherapy will be collected.
Treatment groups
Trial outcomes
Primary outcomes
Objective Best Tumor Response
Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.
Overall Survival
Overall survival is the duration from diagnosis to death. For patients who are alive, overall survival is censored at the last contact.
Secondary outcomes
Progression-free Survival
The period from diagnosis until disease progression or death on study, whichever occurred first.
Other outcomes
Survival rate of 12 month
The proportion of people who are still alive within 12 month from the diagnosis
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Xiangdong Cheng
Lead sponsor
Zhejiang Cancer Hospital
Sponsor institution