Clinical trial NCT06642857: Multi-omics Based Prediction of Treatment Response to Immunotherapy Combined with Chemotherapy in Advanced Gastric/Gastroesophageal Junction Cancer.
Official title: Predicting Treatment Response to Immunotherapy Combined with Chemotherapy in Advanced Gastric/gastroesophageal Junction Cancer Based on the Multi-omics Information During Tumor Evolution.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Advanced Gastric Carcinoma
Advanced Gastroesophageal Junction Adenocarcinoma
Keywords: Advanced Gastric Carcinoma
Advanced Gastroesophageal Junction Adenocarcinoma
Chemotherapy combined with immunotherapy
efficacy prediction
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with advanced or metastatic gastric or gastroesophageal junction adenocarcinoma

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

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.

Primary outcomes:
measure: Objective Best Tumor Response
timeFrame: 12 months
measure: Overall Survival
timeFrame: 60 months
Secondary outcomes:
measure: Progression-free Survival
timeFrame: 36 months
Other outcomes:
measure: Survival rate of 12 month
timeFrame: 12 month from the diagnosis
Locations:
city: Hangzhou
country: China
facility: Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)
state: Zhejiang
Study officials:
References:
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citation: Siegel RL, Miller KD, Wagle NS, Jemal A. Cancer statistics, 2023. CA Cancer J Clin. 2023 Jan;73(1):17-48. doi: 10.3322/caac.21763.