The Immune Assessment of PD-1 Antibody Therapy in Tumor

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

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

Study Overview

• Status: Recruiting
• Conditions: Adverse Event; Efficacy, Team
• Intervention / Treatment: Drug: PD-1 Inhibitors

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

• Study Contact: Name: Xiaomin Fu; Phone Number: +86037165587483; Email: fuxiaomin0880@126.com
• Study Contact Backup: Name: Xiaomin Fu; Phone Number: +86037165587483; Email: zlyygql0855@zzu.edu.cn

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450008
      • Recruiting
      • Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
      • Contact: Quanli Gao, Ph.D; Phone Number: +86-371-65587795; Email: gaoquanli2015@126.com
      • Contact: Xiaomin Fu, Ph.D; Phone Number: +86-371-65587483; Email: fuxiaomin0880@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adult patients with cancer

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Experimental group; PD-1 inhibitor combined therapy, 200mg, iv, q3w, 1 year for adjuvant therapy or 2 years for advanced therapy	Drug: PD-1 Inhibitors; Patients received PD-1 inhibitors mono- or combined therapy in real-world clinical practice; Other Names: Pembrolizumab; Nivolumab
Control group; PD-1 inhibitor mono-therapy, 200mg, iv, q3w, 1 year for adjuvant therapy or 2 years for advanced therapy	Drug: PD-1 Inhibitors; Patients received PD-1 inhibitors mono- or combined therapy in real-world clinical practice; Other Names: Pembrolizumab; Nivolumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate	The objective response rate at 6 months	6 months
Adverse events	Number of participants who experienced immune-related adverse events at 1 year according to CTCAE 5.0	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	The overall survival rate at 1 year	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of response	The duration of response at 2-year	2 years

Collaborators and Investigators

• Sponsor: Quanli Gao
• Investigators: Study Director: Quanli Gao, Henan Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Estimated): November 13, 2027
• Study Completion (Estimated): November 13, 2030

Study Registration Dates

• First Submitted: November 11, 2024
• First Submitted That Met QC Criteria: November 14, 2024
• First Posted (Estimated): November 18, 2024

Study Record Updates

• Last Update Posted (Estimated): November 18, 2024
• Last Update Submitted That Met QC Criteria: November 14, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: efficacy; adverse event; PD(L)-1 inhibitor
• Additional Relevant MeSH Terms: Antineoplastic Agents, Immunological; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Nivolumab; Immune Checkpoint Inhibitors; Pembrolizumab
• Other Study ID Numbers: HenanCH OS001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No