The Immune Assessment of PD-1 Antibody Therapy in Tumor

NCT ID: NCT06693440

Last Updated: 2024-11-18

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

RECRUITING

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-01

Study Completion Date

2030-11-13

Brief Summary

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

Detailed Description

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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.

Conditions

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Efficacy, Team Adverse Event

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Experimental group

PD-1 inhibitor combined therapy, 200mg, iv, q3w, 1 year for adjuvant therapy or 2 years for advanced therapy

PD-1 Inhibitors

Intervention Type DRUG

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

Control group

PD-1 inhibitor mono-therapy, 200mg, iv, q3w, 1 year for adjuvant therapy or 2 years for advanced therapy

PD-1 Inhibitors

Intervention Type DRUG

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

Interventions

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PD-1 Inhibitors

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

Intervention Type DRUG

Other Intervention Names

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Nivolumab Pembrolizumab

Eligibility Criteria

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Inclusion Criteria

1. Age ≥18 years.
2. Pathologically confirmed malignant tumors.
3. Complete medical records.
4. Assessable immune function test data.

Exclusion Criteria

1. Age \<18 years.
2. No confirmed tumor pathology.
3. Untraceable medical records.
4. Non-assessable immune function tests.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Quanli Gao

OTHER_GOV

Sponsor Role lead

Responsible Party

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Quanli Gao

Chief of Immunotherapy department

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Quanli Gao

Role: STUDY_DIRECTOR

Henan Cancer Hospital

Locations

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Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital

Zhengzhou, Henan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaomin Fu

Role: CONTACT

+86037165587483

Xiaomin Fu

Role: CONTACT

+86037165587483

Facility Contacts

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Quanli Gao, Ph.D

Role: primary

+86-371-65587795

Xiaomin Fu, Ph.D

Role: backup

+86-371-65587483

Other Identifiers

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HenanCH OS001

Identifier Type: -

Identifier Source: org_study_id

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