The Immune Assessment of PD-1 Antibody Therapy in Tumor
- Conditions
- Efficacy, TeamAdverse Event
- Interventions
- Drug: PD-1 Inhibitors
- Registration Number
- NCT06693440
- Lead Sponsor
- Quanli Gao
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 3000
- Age ≥18 years.
- Pathologically confirmed malignant tumors.
- Complete medical records.
- Assessable immune function test data.
- Age <18 years.
- No confirmed tumor pathology.
- Untraceable medical records.
- Non-assessable immune function tests.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Experimental group PD-1 Inhibitors PD-1 inhibitor combined therapy, 200mg, iv, q3w, 1 year for adjuvant therapy or 2 years for advanced therapy Control group PD-1 Inhibitors PD-1 inhibitor mono-therapy, 200mg, iv, q3w, 1 year for adjuvant therapy or 2 years for advanced therapy
- Primary Outcome Measures
Name Time Method Objective response rate 6 months The objective response rate at 6 months
Adverse events 1 year Number of participants who experienced immune-related adverse events at 1 year according to CTCAE 5.0
- Secondary Outcome Measures
Name Time Method Overall survival 1 year The overall survival rate at 1 year
Trial Locations
- Locations (1)
Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China