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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorXiangdong Cheng

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Patients with advanced or metastatic gastric or gastroesophageal junction adenocarcinoma

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Peripheral blood, tougue coating, saliva, and feces

    Other intervention

    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.

Treatment groups

150 Participants
are divided into 1 treatment group
Group A: Patients with advanced gastric cancer1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

1

Progression-free Survival

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

Time frame
36 months

Other outcomes

1

Survival rate of 12 month

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

Time frame
12 month from the diagnosis

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xiangdong Cheng

Lead sponsor

Zhejiang Cancer Hospital

Sponsor institution