Advanced Gastric Carcinoma, Advanced Gastroesophageal Junction Adenocarcinoma
Conditions
Keywords
Advanced Gastric Carcinoma, Advanced Gastroesophageal Junction Adenocarcinoma, Chemotherapy combined with immunotherapy, efficacy prediction
Brief summary
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.
Detailed description
Main objective: to extract and identify multi omics information tags related to the efficacy of immunotherapy for advanced gastric / gastroesophageal junction cancer Secondary objective: to construct and validate the efficacy prediction model of chemotherapy combined with immunotherapy for gastric cancer, in order to optimize the scheme decision of advanced gastric cancer treatment Exploratory purpose: to screen potential molecular markers / dominant flora for predicting the efficacy of immunotherapy in patients with advanced gastric / gastroesophageal junction cancer
Interventions
OTHERPeripheral blood, tougue coating, saliva, and feces
Peripheral 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.
Sponsors
Xiangdong Cheng
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
： * 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. * Aged 18 to 75 years old, gender is not limited. * Expected survival time is greater than or equal to 3 months.
Exclusion criteria
： * 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. * Patients with severe heart, liver, kidney and other diseases. * Pregnant or lactating patients. * HER2 positive.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Best Tumor Response | 12 months | 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 | 60 months | Overall survival is the duration from diagnosis to death. For patients who are alive, overall survival is censored at the last contact. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival | 36 months | The period from diagnosis until disease progression or death on study, whichever occurred first. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Survival rate of 12 month | 12 month from the diagnosis | The proportion of people who are still alive within 12 month from the diagnosis |
Countries
China
Contacts
Primary ContactXiangdong Cheng Cheng, PhD
Outcome results
None listed