Thoracic CancerNCT03966456
Real World Study of Four PD-1 Agents in China
An observational study of Thoracic Cancer and Gynecologic Cancer, run by The Affiliated Hospital of Qingdao University at 1 site in China.
Trial summary
Consecutive patients treated with PD-1 therapy in Qingdao City were included in our study. The effecy and safety of the four PD-1 agents according to clinical outcomes in real world will be studied. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Thoracic Cancer, Gynecologic Cancer, Abdomen Tumors
- What is being tested?
- Chemotherapy
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2018to 1 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients treated with PD-1 agents (nivolumab, pebrolizumab, toripalimab, sintilimab)
Who may be able to join
- Patients with lung cancer, liver cancer and other solid cancers
- Histologically or cytologically confirmed diagnosis cancer treated with PD-1 agents
- At least one measurable lesion
- Eastern Cooperative Oncology Group (ECOG) Performance Scale 0 or 1 Adequate organ function
Who cannot join
- patients treated with PD-1 agents less than 2 terms
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000
Xiaochun Zhang, Dr, +86-532-82915333, jasmanouc@163.com
Man Jiang, Dr
About this study
Official title: Real World Study of Immunotherapy-Comparison of Four PD-1 Agents in China
Consecutive patients treated with PD-1 therapy in Qingdao City were included in our study. The effecy and safety of the four PD-1 agents according to clinical outcomes in real world will be studied.
Read the detailed description
Consecutive patients treated with PD-1 therapy in Qingdao City were included in our study. The effecy and safety of the four PD-1 agents according to clinical outcomes in real world will be studied. ORR will be studied of the four PD-1 agents（nivolumab, pembrolizumab, toripalimab, sintilimab）
- Being tested
- Chemotherapy
- Medical subject headings
- Abdominal Neoplasms, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemotherapyDrug
Also called targeting therapy
compare the effecy and safety of 4 PD-1 agents single and combined with chemotherapy in chinese people.
| Study group | Role | What they receive |
|---|---|---|
| nivolumab | Consecutive patients treated with nivolumab single or combined chemotherapy/targeting therapy. Receives: Drug: Chemotherapy | |
| pembrolizumab | Consecutive patients treated with pembrolizumab single or combined chemotherapy/targeting therapy. Receives: Drug: Chemotherapy | |
| toripalimab | Consecutive patients treated with toripalimab single or combined chemotherapy/targeting therapy. Receives: Drug: Chemotherapy | |
| sintilimab | Consecutive patients treated with sintilimab single or combined chemotherapy/targeting therapy. Receives: Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR; disappearance of all target lesions) or Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters). The percentage of strongly PD-L1 positive participants who experienced a CR or PR is presented.
Measured: 1 year
Secondary outcomes (1)
Number of Participants Experiencing Adverse Events (AEs)
Adverse events are defined as any adverse medical events that occur in the participants taking the drugs and do not necessarily have a causal relationship with the treatment.
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 posted29 May 2019
- Study start1 Jun 2018
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic CancerStudies of the same condition, open and under way.
- More trials run by The Affiliated Hospital of Qingdao UniversityThe sponsor's other registered studies.
- 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, zhangxiaochun, The Affiliated Hospital of Qingdao University
- Investigators
- Xiaochun Zhang, Dr, Principal investigator, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03966456
- Sponsor's protocol ID
- Ic-01
- Status last verified
- May 2019
- First submitted
- 22 May 2019
- Last updated
- 29 May 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: IPD only shared in the study group
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Study of Immunotherapy-Comparison of Four PD-1 Agents in China
- ClinicalTrials.gov ID
- NCT03966456
- Acronym / sponsor ID
- Ic-01
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 29 May 2019 (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.
Consecutive patients treated with PD-1 therapy in Qingdao City were included in our study. The effecy and safety of the four PD-1 agents according to clinical outcomes in real world will be studied.
Detailed description
Consecutive patients treated with PD-1 therapy in Qingdao City were included in our study. The effecy and safety of the four PD-1 agents according to clinical outcomes in real world will be studied. ORR will be studied of the four PD-1 agents（nivolumab, pembrolizumab, toripalimab, sintilimab）
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| nivolumab | – | Drug: ChemotherapyConsecutive patients treated with nivolumab single or combined chemotherapy/targeting therapy. |
| pembrolizumab | – | Drug: ChemotherapyConsecutive patients treated with pembrolizumab single or combined chemotherapy/targeting therapy. |
| toripalimab | – | Drug: ChemotherapyConsecutive patients treated with toripalimab single or combined chemotherapy/targeting therapy. |
| sintilimab | – | Drug: ChemotherapyConsecutive patients treated with sintilimab single or combined chemotherapy/targeting therapy. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients treated with PD-1 agents (nivolumab, pebrolizumab, toripalimab, sintilimab)
Key inclusion criteria (4 listed)
- Patients with lung cancer, liver cancer and other solid cancers
- Histologically or cytologically confirmed diagnosis cancer treated with PD-1 agents
- At least one measurable lesion
- Eastern Cooperative Oncology Group (ECOG) Performance Scale 0 or 1 Adequate organ function
Key exclusion criteria (1 listed)
- patients treated with PD-1 agents less than 2 terms
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 |
|---|---|---|
| ChemotherapyAlso: targeting therapycompare the effecy and safety of 4 PD-1 agents single and combined with chemotherapy in chinese people. | Drug | nivolumab, pembrolizumab, sintilimab, toripalimab |
Primary outcome
Overall Response Rate (ORR)
Time frame: 1 year
ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR; disappearance of all target lesions) or Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters). The percentage of strongly PD-L1 positive participants who experienced a CR or PR is presented.
1 secondary outcome
Number of Participants Experiencing Adverse Events (AEs)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2019.
- Individual participant dataSharing planned: No. IPD only shared in the study group
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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. This study is not recruiting at the moment.
Xiaochun Zhang, Dr principal investigator
The Affiliated Hospital of Qingdao University
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 Thoracic Cancer and Gynecologic Cancer, run by The Affiliated Hospital of Qingdao University 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 1 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: status not confirmed, as of the sponsor's last update on 29 May 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaochun Zhang, Dr (+86-532-82915333, jasmanouc@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) (time frame: 1 year). 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 29 May 2019.