Evaluating the effectiveness of PD-1 antibody therapy in cancer treatment
Official title: The Immune Assessment of PD-1 Antibody Therapy in Tumor - A Case-Control Study
Run by Henan Cancer Hospital · NCT06693440 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 3000 (estimated) |
| Sponsor | Henan Cancer Hospital Government |
| Locations | 1 site (Zhengzhou, Henan) |
| Status | Recruiting |
| Started | July 1, 2021 |
| Main results expected | November 13, 2027 |
| Study ends | November 13, 2030 |
| Registry record updated | November 18, 2024 |
| Trial ID | NCT06693440 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 and older with pathologically confirmed malignant tumors and complete medical records.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies have shown promising results with PD-1 inhibitors, indicating that this approach is supported by prior research.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Mycophenolate mofetil with prednisone for immune-related hepatitis from cancer therapy
This study tests whether starting mycophenolate mofetil plus prednisone can help liver inflammation caused by immune checkpoint inhibitors in adults with moderate to severe immune-related hepatitis.
-
Thymosin Alpha-1 plus PD-1 therapy in older adults with advanced melanoma
This trial tests whether adding Thymosin Alpha-1 to a PD-1 antibody helps people age 60 and up with advanced melanoma.
-
Inhaled budesonide to prevent recurrent checkpoint inhibitor–related pneumonitis
This study tests whether adding inhaled budesonide to usual care can prevent recurrence of pneumonitis in adults who developed grade 2 or higher lung inflammation from checkpoint inhibitor immunotherapy.
-
Investigating serum ferritin as a biomarker for immune-related adverse events
This study is testing if a blood marker called serum ferritin can help doctors identify and predict immune-related side effects in patients with cancer receiving different types of treatment.
-
Exploring PD-1 therapy duration for rectal cancer treatment
This study is testing how long PD-1 therapy should be given to people with stage II-III rectal cancer to see if it helps them have the best chance of a complete response before surgery.
-
Vedolizumab to prevent ICI-related diarrhea or colitis in cancer patients
This study tests whether vedolizumab can prevent immune checkpoint inhibitor–related diarrhea or colitis in adults with unresectable or metastatic melanoma, lung, or kidney cancer starting immunotherapy.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.