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The Immune Assessment of PD-1 Antibody Therapy in Tumor

Q

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

Trial contacts and locations

1

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Central trial contact

Xiaomin Fu; Xiaomin Fu

Data sourced from clinicaltrials.gov

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