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A Real-World Study of Toripalimab in Chinese Patients With Lung Cancer(THUNDER Study)

NCT ID: NCT05652712

Last Updated: 2022-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2023-06-01

Brief Summary

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Our project is going to clarify the efficacy and safety of Toripalimab in lung cancer in the real world, and to evaluate the incidence of adverse events (AEs) of special interest during Toripalimab immunotherapy.

Detailed Description

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Tumor immunotherapy, as another important treatment after surgical treatment, chemoradiotherapy and targeted therapy, has achieved great success and gradually become one of the standard treatment methods for tumors. Toripalimab is the first Chinese PD-1 inhibitor approved for the treatment of nasopharyngeal carcinoma, malignant melanoma, urothelial carcinoma, esophageal squamous cell carcinoma and non-small cell lung cancer. It has been widely used in clinical practice. Several clinical studies have confirmed that it is safe and effective. In recent years, several clinical studies have reported that Toripalimab alone or in combination can improve the response rate of cancer treatment and improve survival. The results of Toripalimab research are mainly derived from rigorously designed randomized controlled trials (RCTs), and the efficacy and safety in the real world still need to be further explored. Real world studies, based on a large sample size, non-randomly select treatment measures according to the actual condition and wishes of patients, and pay attention to meaningful outcome treatment, which is closer to real clinical practice, without extrapolation difficulties, and has more clinical practical value. Therefore, it is of great significance to carry out a real-world study to investigate the differences in the efficacy and adverse reactions of Toripalimab immunotherapy in Chinese lung cancer patients in order to better guide clinical practice, which also provides research direction and data support for further prospective studies.

Conditions

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Lung Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Immunotherapy Regimen

Patients receiving different treatment regimens of Toripalimab in each center were consecutively enrolled from January 1, 2019 to December 31, 2022

Toripalimab

Intervention Type DRUG

Toripalimab injection, recommended dose is 3 mg/kg, intravenous infusion every 2 weeks or 240 mg fixed dose, intravenous infusion every 3 weeks.

Other treatment options are individualized according to the diagnosis and treatment experience of doctors in each center, diagnosis and treatment specifications and individual conditions of patients.

Interventions

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Toripalimab

Toripalimab injection, recommended dose is 3 mg/kg, intravenous infusion every 2 weeks or 240 mg fixed dose, intravenous infusion every 3 weeks.

Other treatment options are individualized according to the diagnosis and treatment experience of doctors in each center, diagnosis and treatment specifications and individual conditions of patients.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years.
* Cytologically or histologically confirmed lung cancer.
* Complete clinical data.
* Indications for immunotherapy with Toripalimab.

Exclusion Criteria

* Lack of patient key data.
* Refusal or uncooperation with the study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qianfoshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jiandong Zhang

Qianfoshan Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The First Affiliated Hospital of Shandong First Medical University

Jinan, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jiandong ZHANG

Role: CONTACT

Phone: (+86531)89269208

Email: [email protected]

Facility Contacts

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Jiandong ZHANG

Role: primary

Other Identifiers

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YXLL-KY-2022(80)

Identifier Type: -

Identifier Source: org_study_id