NCT06642857 Multi-omics Based Prediction of Treatment Response to Immunotherapy Combined with Chemotherapy in Advanced Gastric/Gastroesophageal Junction Cancer.
| NCT ID | NCT06642857 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Xiangdong Cheng |
| Condition | Advanced Gastric Carcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2024-03-25 |
| Primary Completion | 2026-02-01 |
Trial Parameters
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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.
Eligibility 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.