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出境医 / 临床实验 / Real World Study of Four PD-1 Agents in China
Real World Study of Four PD-1 Agents in China
Study Description
Brief 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.
| Condition or disease | Intervention/treatment |
|---|---|
| Thoracic Cancer Gynecologic Cancer Abdomen Tumors Malignant Melanoma | Drug: Chemotherapy |
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
| Study Type : | Observational |
| Estimated Enrollment : | 500 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Retrospective |
| Official Title: | Real World Study of Immunotherapy-Comparison of Four PD-1 Agents in China |
| Actual Study Start Date : | June 1, 2018 |
| Estimated Primary Completion Date : | June 1, 2021 |
| Estimated Study Completion Date : | June 1, 2023 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
|
nivolumab
Consecutive patients treated with nivolumab single or combined chemotherapy/targeting therapy.
|
Drug: Chemotherapy
compare the effecy and safety of 4 PD-1 agents single and combined with chemotherapy in chinese people.
Other Name: targeting therapy
|
|
pembrolizumab
Consecutive patients treated with pembrolizumab single or combined chemotherapy/targeting therapy.
|
Drug: Chemotherapy
compare the effecy and safety of 4 PD-1 agents single and combined with chemotherapy in chinese people.
Other Name: targeting therapy
|
|
toripalimab
Consecutive patients treated with toripalimab single or combined chemotherapy/targeting therapy.
|
Drug: Chemotherapy
compare the effecy and safety of 4 PD-1 agents single and combined with chemotherapy in chinese people.
Other Name: targeting therapy
|
|
sintilimab
Consecutive patients treated with sintilimab single or combined chemotherapy/targeting therapy.
|
Drug: Chemotherapy
compare the effecy and safety of 4 PD-1 agents single and combined with chemotherapy in chinese people.
Other Name: targeting therapy
|
Outcome Measures
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- Number of Participants Experiencing Adverse Events (AEs) [ Time Frame: 1 year ]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.
Other Outcome Measures:
- PFS [ Time Frame: 2 years ]PFS was defined as the time from the first day of study treatment to the first documented disease progression per irRC or death due to any cause, whichever occurred first.
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Consecutive patients treated with PD-1 agents (nivolumab, pebrolizumab, toripalimab, sintilimab)
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- patients treated with PD-1 agents less than 2 terms
Contacts and Locations
Contacts
| Contact: Xiaochun Zhang, Dr | +86-532-82915333 | jasmanouc@163.com | |
| Contact: Man Jiang, Dr | +86-532-82915333 | jm_ouc@163.com |
Locations
| China, Shandong | |
| The Affiliated Hospital of Qingdao University | Recruiting |
| Qingdao, Shandong, China, 266000 | |
| Contact: Xiaochun Zhang, Dr +86-532-82915333 jasmanouc@163.com | |
| Sub-Investigator: Man Jiang, Dr | |
Sponsors and Collaborators
The Affiliated Hospital of Qingdao University
Investigators
| Principal Investigator: | Xiaochun Zhang, Dr | The Affiliated Hospital of Qingdao University |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | May 22, 2019 | ||||||||
| First Posted Date | May 29, 2019 | ||||||||
| Last Update Posted Date | May 29, 2019 | ||||||||
| Actual Study Start Date | June 1, 2018 | ||||||||
| Estimated Primary Completion Date | June 1, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
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.
|
||||||||
| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures |
Number of Participants Experiencing Adverse Events (AEs) [ Time Frame: 1 year ] 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.
|
||||||||
| Original Secondary Outcome Measures | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures |
PFS [ Time Frame: 2 years ] PFS was defined as the time from the first day of study treatment to the first documented disease progression per irRC or death due to any cause, whichever occurred first.
|
||||||||
| Original Other Pre-specified Outcome Measures | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Real World Study of Four PD-1 Agents in China | ||||||||
| Official Title | Real World Study of Immunotherapy-Comparison of Four PD-1 Agents in China | ||||||||
| Brief 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. | ||||||||
| 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 Type | Observational | ||||||||
| Study Design | Observational Model: Case-Control Time Perspective: Retrospective |
||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Probability Sample | ||||||||
| Study Population | Consecutive patients treated with PD-1 agents (nivolumab, pebrolizumab, toripalimab, sintilimab) | ||||||||
| Condition |
|
||||||||
| Intervention | Drug: Chemotherapy
compare the effecy and safety of 4 PD-1 agents single and combined with chemotherapy in chinese people.
Other Name: targeting therapy
|
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| Study Groups/Cohorts |
|
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| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
500 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | June 1, 2023 | ||||||||
| Estimated Primary Completion Date | June 1, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender |
|
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| Ages | 18 Years to 90 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| Listed Location Countries | China | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT03966456 | ||||||||
| Other Study ID Numbers | Ic-01 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | zhangxiaochun, The Affiliated Hospital of Qingdao University | ||||||||
| Study Sponsor | The Affiliated Hospital of Qingdao University | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators |
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| PRS Account | The Affiliated Hospital of Qingdao University | ||||||||
| Verification Date | May 2019 | ||||||||
