The Immune Assessment of PD-1 Antibody Therapy in Tumor

NCT06693440 | Recruiting

• 1 other identifier: HenanCH OS001
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Efficacy, Team; Adverse Event

Keywords

PD(L)-1 inhibitor; efficacy; adverse event

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Overall survival

  1 year

Other Outcomes (1)

• Duration of response

  2 years

Study Arms (2)

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

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

Interventions

PD-1 Inhibitors DRUG

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

Also known as: Nivolumab, Pembrolizumab

Control group; Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients with cancer

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Quanli Gao: lead

Study Sites (1)

Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

RECRUITING

MeSH Terms

Interventions

Immune Checkpoint Inhibitors; Nivolumab; pembrolizumab

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Quanli Gao

  Henan Cancer Hospital

  STUDY DIRECTOR

Central Study Contacts

Xiaomin Fu

CONTACT

+86037165587483; fuxiaomin0880@126.com

Xiaomin Fu

CONTACT

+86037165587483; zlyygql0855@zzu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief of Immunotherapy department

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: November 18, 2024
• Study Start: July 1, 2021
• Primary Completion (Estimated): November 13, 2027
• Study Completion (Estimated): November 13, 2030
• Last Updated: November 18, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)