Risk Factors and Long-term Impact of ICIs | NCT05754983

Studies
Risk Factors and Long-term Impact of ICIs

NCT05754983

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Status

Active, not recruiting

Last Update Posted

Feb 7, 2025Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Malignant Neoplasm

Interventions

Solid tumor patients receiving immunotherapy for the first time were included in the study

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 24, 2022Actual

Primary Completion Date

Dec 30, 2024Actual

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Jan 10, 2023

First Submission Date that Met QC Criteria

Feb 22, 2023

First Posted Date

Mar 6, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 5, 2025

Last Update Posted Date

Feb 7, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study plans to conduct a multicenter, observable and controlled cohort study to solid-tumor patients with receiving immunotherapy and to collect information about their treatment related efficacy, adverse events and health status to build a disease cohort database based on patient reports, and then analyze the risk factors affecting the efficacy, prognosis and adverse events of immunotherapy and the impact of immunotherapy on health status. It is expected to provide high-level evidence-based medical evidence for the selection of immunotherapy schemes for these patients, the precise prevention and health management of adverse events after immunotherapy, and the further improvement of survival prognosis of patients

Detailed Description

This study is intended to conduct a multicenter, observable and controlled cohort study in multiple clinical centers including the First Affiliated Hospital of Xi'an Jiaotong University to solid-tumor patients who received immunotherapy for the first time. The baseline information before treatment was collected (mainly including three collection methods, namely, patients' self filling information, physician assisted filling information, and medical record system import information. The information collected was mainly in the following aspects: demographic characteristics, tumor and anti-tumor information, gene testing information, blood sample collection information, and questionnaire evaluation information) and follow-up information after treatment (The collection method and content are the same as the baseline information.) Collect the relevant factors that may affect the treatment efficacy and prognosis of patients, build a prospective disease cohort database based on patient reports, and then analyze the risk factors that affect the efficacy, prognosis and adverse events of immunotherapy and the impact of immunotherapy on health status. We also retrospectively collected some data from medicine records for validation. The outcome indicators are mainly disease free progression survival (PFS), The secondary indicators were the total survival period (OS), objective response rate (ORR), immune-related adverse events (irAEs) and the scoring results of various questionnaires (PHQ-9, etc). It is expected to provide high-level evidence-based medical evidence for the selection of immunotherapy schemes for these patients, the precise prevention and health management of adverse events after immunotherapy, and the further improvement of survival prognosis of patients.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Solid tumor patients receiving immunotherapy for the first time were included in the study	Drug	Solid tumor patients receiving immunotherapy were included in the study. Baseline information before treatment (including demographic characteristics, basic diseases and their medication history, tumor and anti-tumor history, quality of life scores, etc.) and follow-up information after treatment (PFS, OS, etc.) were collected to summarize factors that may affect the efficacy and prognosis of patients receiving immunotherapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression-Free-Survival (PFS)	It refers to the time from randomization to disease progression	Two years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age range of subjects: the age of subjects is no less than 18 years old;
Receiving any ICIs treatment or ICIs combined with other treatments;
Soild malignant tumor proved by pathology (histology or cytology);
First treatment with ICIs {including ICIs (first) combined with other treatments)};
Any stage and treatment line (new auxiliary, auxiliary and advanced treatment)
Willing to treat, and can come to the hospital regularly in the later period

Exclusion Criteria:

Previous medical history of other malignant tumors;
No pathology (histology or cytology) certificate;
Having received ICIs or other immunotherapy in the past;
Participated in clinical research in the past and may have applied ICIs or other immunotherapy;
Weak treatment intention or long-term treatment in other hospitals/departments

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

The included population is malignant solid tumor patients receiving immunotherapy for the first time

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
First Affiliated Hospitap of Xian Jiaotong University		Xi’an	Shanxi	710061	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41922087	Derived	Li Y, Jia X, Liu M, Zhu Z, Qiao H, Jiang J, Li M, Xia W, Xu L, Zhang E, Wang W, Liu J, Xu R, Qi Y, Jing G, Bai Y, Jiao M, Hu S, Liu Z, Guo H, Jiang L. Impact of NSAID type, initiation timing, duration and dose on clinical outcomes of immunotherapy in NSCLC: a multicenter two-cohort study. J Immunother Cancer. 2026 Apr 1;14(4):e014360. doi: 10.1136/jitc-2025-014360.