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Status unknownNCT03966456Updated May 29, 2019

Real World Study of Four PD-1 Agents in China

An observational study in Thoracic Cancer, Gynecologic Cancer and Abdomen Tumors, sponsored by The Affiliated Hospital of Qingdao University. Status unknown at 1 site in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2019-05-29.

Sponsored by The Affiliated Hospital of Qingdao University · Observational

The sponsor has not verified this record recently (last verified May 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
500
Ages
18 Years to 90 Years
Sex
All
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Study 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 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)

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Conditions studied

  • Thoracic Cancer
  • Gynecologic Cancer
  • Abdomen Tumors
  • Malignant Melanoma

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03

In context

Melanoma

3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.

This study's planned enrollment of 500 is above the median of 182 across 438 observational studies indexed under Melanoma.

Browse Melanoma studies →

Lead sponsor

The Affiliated Hospital of Qingdao University is the lead sponsor of 142 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Consecutive patients treated with PD-1 agents (nivolumab, pebrolizumab, toripalimab, sintilimab)

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

Exclusion Criteria:

  • patients treated with PD-1 agents less than 2 terms
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Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
500 participants (estimated)
Patient registry
No

Groups and cohorts

  • nivolumab

    Consecutive patients treated with nivolumab single or combined chemotherapy/targeting therapy.

    Drug: Chemotherapy

  • pembrolizumab

    Consecutive patients treated with pembrolizumab single or combined chemotherapy/targeting therapy.

    Drug: Chemotherapy

  • toripalimab

    Consecutive patients treated with toripalimab single or combined chemotherapy/targeting therapy.

    Drug: Chemotherapy

  • sintilimab

    Consecutive patients treated with sintilimab single or combined chemotherapy/targeting therapy.

    Drug: Chemotherapy

Interventions

  • DrugChemotherapy

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

    Also known as: targeting therapy

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: 1 year

Other outcomes

  1. PFS

    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.

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
  • The Affiliated Hospital of Qingdao University
    Qingdao, Shandong 266000, China
    • Xiaochun Zhang, Dr · Contact · jasmanouc@163.com · +86-532-82915333
    • Man Jiang, Dr · Sub investigator
    Recruiting
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References and documents

Individual participant data

Plan to share: No — IPD only shared in the study group

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 29, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03966456
Lead sponsor
The Affiliated Hospital of Qingdao University
Responsible party
zhangxiaochun (Director of Cancer Precision Medical Center, The Affiliated Hospital of Qingdao University) — Principal investigator
First posted
May 29, 2019
Start date
Jun 1, 2018
Primary completion
Jun 1, 2021 (estimated)
Completion
Jun 1, 2023 (estimated)
Last update
May 29, 2019

Study contacts

Xiaochun Zhang, Dr
Contact
jasmanouc@163.com
+86-532-82915333
Man Jiang, Dr
Contact
jm_ouc@163.com
+86-532-82915333
Xiaochun Zhang, Dr
principal investigator · The Affiliated Hospital of Qingdao University

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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