The Immune Assessment of PD-1 Antibody Therapy in Tumor
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PD-1 Inhibitors.
- Who it may be relevant to
- Registry conditions: Efficacy, Team, Adverse Event. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Immune Assessment of PD-1 Antibody Therapy in Tumor - A Case-Control Study
Overview
This retrospective study will leverage previous immune function monitoring results in conjunction with clinical case data at this medical center.
Detailed description
The primary aim of this study is to evaluate the efficacy and safety of PD(L)-1 antibody therapy for malignant tumors in real-world settings. Treatment outcomes will be assessed according to RECIST V1.1 and iRECIST criteria, with safety graded according to CTCAE V5.0 standards. The study aims to enroll 3000 adult cancer patients treated at this center and analyze their prognosis outcomes based on previous treatment.
Interventions
- Drug PD-1 Inhibitors
Patients received PD-1 inhibitors mono- or combined therapy in real-world clinical practice
Primary outcome measures
- Objective response rate [Time frame: 6 months]
- Adverse events [Time frame: 1 year]
Secondary outcome measures (1)
- Overall survival [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- Age ≥18 years.
- Pathologically confirmed malignant tumors.
- Complete medical records.
- Assessable immune function test data.
Exclusion criteria
- Age <18 years.
- No confirmed tumor pathology.
- Untraceable medical records.
- Non-assessable immune function tests.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
China · 1 center
- Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital — Zhengzhou
Identifiers
NCT: NCT06693440 · HenanCH OS001