The Immune Assessment of PD-1 Antibody Therapy in Tumor - A Case-Control Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 3,000
- Locations
- 1
- Primary Endpoint
- Objective response rate
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Experimental group
PD-1 inhibitor combined therapy, 200mg, iv, q3w, 1 year for adjuvant therapy or 2 years for advanced therapy
Intervention: PD-1 Inhibitors (Drug)
Control group
PD-1 inhibitor mono-therapy, 200mg, iv, q3w, 1 year for adjuvant therapy or 2 years for advanced therapy
Intervention: PD-1 Inhibitors (Drug)
Outcomes
Primary Outcomes
Objective response rate
Time Frame: 6 months
The objective response rate at 6 months
Adverse events
Time Frame: 1 year
Number of participants who experienced immune-related adverse events at 1 year according to CTCAE 5.0
Secondary Outcomes
- Overall survival(1 year)
Investigators
Quanli Gao
Chief of Immunotherapy department
Henan Cancer Hospital