Actively Recruiting
The Immune Assessment of PD-1 Antibody Therapy in Tumor - A Case-Control Study
Led by Quanli Gao · Updated on 2024-11-18
3000
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effectiveness and safety of PD(L)-1 antibody therapy in treating malignant tumors using real-world clinical data. The study will analyze treatment outcomes based on established criteria like RECIST V1.1 and iRECIST, while monitoring safety using CTCAE V5.0 standards. It plans to include 3000 adult cancer patients previously treated at the medical center to better understand prognosis outcomes. Participants received either PD-1 inhibitor combination therapy or PD-1 inhibitor monotherapy, administered intravenously at 200 mg every three weeks. Treatment duration is one year for adjuvant therapy or up to two years for advanced therapy. The study is retrospective, using existing data from immune function monitoring and clinical records at the center. During the study, researchers will review objective response rates at six months and record adverse events over one year. Overall survival will also be assessed after one year. Data from immune function tests and complete medical records will be analyzed to understand treatment effects. The total participation involves retrospective data collection with no active intervention or follow-up visits.
CONDITIONS
Brief Title
The Immune Assessment of PD-1 Antibody Therapy in Tumor
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Pathologically confirmed malignant tumors
- Complete medical records available
- Assessable immune function test data available
You will not qualify if you...
- Age under 18 years
- No confirmed tumor pathology
- Medical records not traceable
- Immune function tests not assessable or missing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 year for adjuvant therapy or 2 years for advanced therapy
Participants receive PD-1 inhibitor therapy either as mono-therapy or combined therapy administered intravenously every 3 weeks for 1 to 2 years depending on treatment purpose.
Regular infusions every 3 weeks
Duration - Up to 1 year after treatment
Participants are monitored for treatment outcomes and safety, including assessment of objective response and adverse events.
Visits according to clinical follow-up schedules
Trial Site Locations
Total: 1 location
1
Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
Zhengzhou, Henan, China, 450008
Actively Recruiting
Research Team
X
Xiaomin Fu
X
Xiaomin Fu
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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