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NCT Number: NCT06693440

The Immune Assessment of PD-1 Antibody Therapy in Tumor

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

Recruiting

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Key information

Conditions

Efficacy, Team Adverse Event

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

The primary aim of this study is to evaluate the efficacy and safety of PD(L)-1 antibody therapy for malignant tumors in real-world settings. Treatment outcomes will be assessed according to RECIST V1.1 and iRECIST criteria, with safety graded according to CTCAE V5.0 standards. The study aims to enroll 3000 adult cancer patients treated at this center and analyze their prognosis outcomes based on previous treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years.
  • Pathologically confirmed malignant tumors.
  • Complete medical records.
  • Assessable immune function test data.

Exclusion criteria

  • Age <18 years.
  • No confirmed tumor pathology.
  • Untraceable medical records.
  • Non-assessable immune function tests.

Treatment and study plan

PD-1 Inhibitors

Drug

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

Other names: Nivolumab, Pembrolizumab

Primary outcomes

  1. Objective response rate

    Time frame: 6 months

    The objective response rate at 6 months

  2. Adverse events

    Time frame: 1 year

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

Secondary outcomes

  1. Overall survival

    Time frame: 1 year

    The overall survival rate at 1 year

Other outcomes

  1. Duration of response

    Time frame: 2 years

    The duration of response at 2-year

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaomin Fu

CONTACT

[email protected]

+86037165587483

Xiaomin Fu

CONTACT

[email protected]

+86037165587483

Sponsors and collaborators

Lead sponsor

Quanli Gao

Other Gov

Registry information

Official study title

The Immune Assessment of PD-1 Antibody Therapy in Tumor - A Case-Control Study

Important dates

Study start
2021
Primary completion
2027
Study completion
2030
First posted
Nov 18, 2024
Registry last updated
Nov 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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