Multi-omics Based Prediction of Treatment Response to Immunotherapy Combined with Chemotherapy in Advanced Gastric/Gastroesophageal Junction Cancer.

Xiangdong Cheng150 enrolled

Overview

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.

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

Study Type

OBSERVATIONAL

Enrollment

150

Conditions

Advanced Gastric Carcinoma Advanced Gastroesophageal Junction Adenocarcinoma

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

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.

Time frame: 12 months

Overall Survival

Overall survival is the duration from diagnosis to death. For patients who are alive, overall survival is censored at the last contact.

Time frame: 60 months

Secondary Outcomes

Progression-free Survival

The period from diagnosis until disease progression or death on study, whichever occurred first.

Time frame: 36 months