Evaluating the effectiveness of PD-1 antibody therapy in cancer treatment
The Immune Assessment of PD-1 Antibody Therapy in Tumor - A Case-Control Study
This study is testing how well PD-1 antibody therapy works and how safe it is for adults with cancer by looking at real-world treatment results.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Henan Cancer Hospital Government |
| Locations | 1 site (Zhengzhou, Henan) |
| Trial ID | NCT06693440 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the efficacy and safety of PD(L)-1 antibody therapy for malignant tumors using real-world data. It will analyze treatment outcomes based on RECIST V1.1 and iRECIST criteria, while safety will be evaluated according to CTCAE V5.0 standards. The study plans to enroll 3000 adult cancer patients treated at the Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital, utilizing previous immune function monitoring results alongside clinical case data.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with pathologically confirmed malignant tumors and complete medical records.
Not a fit: Patients under 18 years old, those without confirmed tumor pathology, or individuals with untraceable medical records will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the real-world effectiveness and safety of PD-1 inhibitors for cancer patients.
How similar studies have performed: Other studies have shown promising results with PD-1 inhibitors, indicating that this approach is supported by prior research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥18 years. 2. Pathologically confirmed malignant tumors. 3. Complete medical records. 4. Assessable immune function test data. Exclusion Criteria: 1. Age \<18 years. 2. No confirmed tumor pathology. 3. Untraceable medical records. 4. Non-assessable immune function tests.
Where this trial is running
Zhengzhou, Henan
- Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital — Zhengzhou, Henan, China (Recruiting)
Study contacts
- Study coordinator: Xiaomin Fu
- Email: fuxiaomin0880@126.com
- Phone: +86037165587483
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.