Efficacy, TeamNCT06693440
The Immune Assessment of PD-1 Antibody Therapy in Tumor
An observational study of Efficacy, Team and Adverse Event, run by Quanli Gao at 1 site in China.
Trial summary
This retrospective study will leverage previous immune function monitoring results in conjunction with clinical case data at this medical center. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Efficacy, Team, Adverse Event
- What is being tested?
- PD-1 Inhibitors
- Type of treatment
- Injection or infusion
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2021to 13 Nov 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with cancer
Who may be able to join
- Age ≥18 years.
- Pathologically confirmed malignant tumors.
- Complete medical records.
- Assessable immune function test data.
Who cannot join
- Age <18 years.
- No confirmed tumor pathology.
- Untraceable medical records.
- Non-assessable immune function tests.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
Zhengzhou, Henan, 450008
Quanli Gao, Ph.D, +86-371-65587795, gaoquanli2015@126.com
Xiaomin Fu, Ph.D, +86-371-65587483, fuxiaomin0880@126.com
About this study
Official title: The Immune Assessment of PD-1 Antibody Therapy in Tumor - A Case-Control Study
This retrospective study will leverage previous immune function monitoring results in conjunction with clinical case data at this medical center.
Read the 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.
- Conditions
- Efficacy, Team, Adverse Event
- Being tested
- PD-1 Inhibitors
- Keywords
- PD(L)-1 inhibitor, efficacy, adverse event
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-1 InhibitorsDrug
Also called Nivolumab, Pembrolizumab
Patients received PD-1 inhibitors mono- or combined therapy in real-world clinical practice
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | PD-1 inhibitor combined therapy, 200mg, iv, q3w, 1 year for adjuvant therapy or 2 years for advanced therapy Receives: Drug: PD-1 Inhibitors | |
| Control group | PD-1 inhibitor mono-therapy, 200mg, iv, q3w, 1 year for adjuvant therapy or 2 years for advanced therapy Receives: Drug: PD-1 Inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
The objective response rate at 6 months
Measured: 6 months
Adverse events
Number of participants who experienced immune-related adverse events at 1 year according to CTCAE 5.0
Measured: 1 year
Secondary outcomes (1)
Overall survival
The overall survival rate at 1 year
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start1 Jul 2021
- Primary completion13 Nov 2027 (estimated)
- Study completion13 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Efficacy, TeamStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Quanli Gao
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Quanli Gao, Henan Cancer Hospital
- Investigators
- Quanli Gao, Study director, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06693440
- Sponsor's protocol ID
- HenanCH OS001
- Status last verified
- Nov 2024
- First submitted
- 11 Nov 2024
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Immune Assessment of PD-1 Antibody Therapy in Tumor - A Case-Control Study
- ClinicalTrials.gov ID
- NCT06693440
- Acronym / sponsor ID
- HenanCH OS001
- Conditions
- Efficacy, Team, Adverse Event
- Keywords
- PD(L)-1 inhibitor, efficacy, adverse event
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Quanli GaoOther government
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 13 Nov 2027 (estimated)
- Study completion
- 13 Nov 2030 (estimated)
- First posted
- 18 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | – | Drug: PD-1 InhibitorsPD-1 inhibitor combined therapy, 200mg, iv, q3w, 1 year for adjuvant therapy or 2 years for advanced therapy |
| Control group | – | Drug: PD-1 InhibitorsPD-1 inhibitor mono-therapy, 200mg, iv, q3w, 1 year for adjuvant therapy or 2 years for advanced therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with cancer
Key inclusion criteria (4 listed)
- Age ≥18 years.
- Pathologically confirmed malignant tumors.
- Complete medical records.
- Assessable immune function test data.
Key exclusion criteria (4 listed)
- Age <18 years.
- No confirmed tumor pathology.
- Untraceable medical records.
- Non-assessable immune function tests.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PD-1 InhibitorsAlso: Nivolumab, PembrolizumabPatients received PD-1 inhibitors mono- or combined therapy in real-world clinical practice | Drug | Control group, Experimental group |
Primary outcome
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
1 secondary outcome
Overall survival
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Quanli Gao study director
Henan Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Efficacy, Team and Adverse Event, run by Quanli Gao at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaomin Fu (+86037165587483, fuxiaomin0880@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2024.