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NCT Number: NCT06642857

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

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.

Recruiting

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Key information

Conditions

Advanced Gastric Carcinoma Advanced Gastroesophageal Junction Adenocarcinoma

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Peripheral blood, tougue coating, saliva, and feces

Other

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.

Primary outcomes

  1. Objective Best Tumor Response

    Time frame: 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.

  2. Overall Survival

    Time frame: 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 outcomes

  1. Progression-free Survival

    Time frame: 36 months

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

Other outcomes

  1. Survival rate of 12 month

    Time frame: 12 month from the diagnosis

    The proportion of people who are still alive within 12 month from the diagnosis

Study contacts

Contact information is provided by the study sponsor or research team.

Xiangdong Cheng Cheng, PhD

CONTACT

[email protected]

+0086-0571-88128041

Sponsors and collaborators

Lead sponsor

Xiangdong Cheng

Other

Registry information

Official study title

Predicting Treatment Response to Immunotherapy Combined with Chemotherapy in Advanced Gastric/gastroesophageal Junction Cancer Based on the Multi-omics Information During Tumor Evolution.

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 15, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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