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Real World Study of Four PD-1 Agents in China

Real World Study of Immunotherapy-Comparison of Four PD-1 Agents in China

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03966456
Enrollment
500
Registered
2019-05-29
Start date
2018-06-01
Completion date
2023-06-01
Last updated
2019-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdomen Tumors, Gynecologic Cancer, Malignant Melanoma, Thoracic Cancer

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)

Interventions

DRUGChemotherapy

compare the effecy and safety of 4 PD-1 agents single and combined with chemotherapy in chinese people.

Sponsors

The Affiliated Hospital of Qingdao University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Overall Response Rate (ORR)1 yearORR 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

MeasureTime frameDescription
Number of Participants Experiencing Adverse Events (AEs)1 yearAdverse 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

MeasureTime frameDescription
PFS2 yearsPFS 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.

Countries

China

Contacts

Primary ContactXiaochun Zhang, Dr
jasmanouc@163.com+86-532-82915333
Backup ContactMan Jiang, Dr
jm_ouc@163.com+86-532-82915333

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026