A Real-world Study of the Efficacy and Safety of ICIs as First-line Therapy for Advanced Malignancies

Xinqiao Hospital of Chongqing120 enrolled

Overview

In this study, we collected the data of immunohistochemistry, gene detection, image, OS, PFS, Orr, and so on. Secondly, the database of immunotherapy for malignant tumor was established, and the predictive model was constructed to verify and establish the rationality and validity of the biomarkers and predictive system of immunotherapy

Study Type

OBSERVATIONAL

Enrollment

120

Conditions

Malignant Tumor Immunotherapy Artificial Intelligence

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Informed consent has been signed and, in the judgment of the investigator, the patient is able to comply with the study protocol and sign a written informed consent. 2. the advanced malignant tumors (solid tumors of the non-small-cell lung carcinoma, stomach, breast, urinary system, etc.) were diagnosed by histopathology. 3. the stage IV according to the eighth edition of IASLC. 4. PS 0-2, the expected survival \> 3 months. 5. the age of 18-75 years. 6. no contraindication to treatment with immune checkpoint inhibitors. Exclusion Criteria: 1. the patients' compliance was poor, which violated the rules of the trial; 2. the patients with severe dysfunction of vital organs (heart, liver and kidney) ; 3. the patients with other malignant tumors; 4. the researchers considered that the patients should not participate in other conditions of the trial.

Locations (1)

the second affiliated hospital of Army medical university

Chongqing, Chongqing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Progression-free survival

The time between randomization and the first occurrence of disease progression or death from any cause

Time frame: six months

Secondary Outcomes

Overall survival

Time from randomization to death from any cause

Time frame: two years

Objective response rate

Proportion of patients whose tumors have shrunk to pre-defined volumes and who are able to maintain minimum time requirements

Time frame: one years

Immune-Related Adverse Events

In clinical trials of antineoplastic drugs/therapies, all levels of adverse drug reactions that are judged to be related to immune mechanisms,

Time frame: two years

Data from ClinicalTrials.gov

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