The Immune Assessment of PD-1 Antibody Therapy in Tumor

Quanli Gao

Status: Enrolling

Conditions: Adverse Event; Efficacy, Team

Treatments: Drug: PD-1 Inhibitors

Study type: Observational

Funder types: Other

Identifiers

NCT06693440

HenanCH OS001

Details and patient eligibility

About

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

Full 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.

Enrollment: 3,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

3,000 participants in 2 patient groups

Experimental group

Description:

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

Treatment:

Drug: PD-1 Inhibitors

Control group

Description:

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

Treatment:

Drug: PD-1 Inhibitors