The Immune Assessment of PD-1 Antibody Therapy in Tumor

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorQuanli Gao

About this trial

This retrospective study will leverage previous immune function monitoring results in conjunction with clinical case data at this medical center.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years.

Pathologically confirmed malignant tumors.

Complete medical records.

Assessable immune function test data.

Disqualifiers

Age <18 years.

No confirmed tumor pathology.

Untraceable medical records.

Non-assessable immune function tests.

Trial population

Adult patients with cancer

Trial design

Design model

Case-control

Time perspective

Retrospective

Treatments tested in this trial

  • PD-1 Inhibitors

    Drug

    Patients received PD-1 inhibitors mono- or combined therapy in real-world clinical practice

Treatment groups

3,000 Participants
are divided into 2 treatment groups
Group A: Experimental group1 intervention
Group B: Control group1 intervention

Trial outcomes

Primary outcomes

1

Objective response rate

The objective response rate at 6 months

Time frame
6 months
2

Adverse events

Number of participants who experienced immune-related adverse events at 1 year according to CTCAE 5.0

Time frame
1 year

Secondary outcomes

1

Overall survival

The overall survival rate at 1 year

Time frame
1 year

Other outcomes

1

Duration of response

The duration of response at 2-year

Time frame
2 years

Sponsors and contacts

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Quanli Gao

Lead sponsor

Henan Cancer Hospital

Sponsor institution