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

Xiangdong Cheng

Status

Enrolling

Conditions

Advanced Gastroesophageal Junction Adenocarcinoma

Advanced Gastric Carcinoma

Treatments

Other: Peripheral blood, tougue coating, saliva, and feces

Study type

Observational

Funder types

Other

Identifiers

NCT06642857

IRB-2024-175

Details and patient eligibility

About

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.

Full 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

Enrollment

150 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.