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Application Research on Combined Immune Monitoring and Circulating Tumor Cells in the Efficacy Evaluation and Prognostic Assessment of Advanced Tumors.

Application Research on Combined Immune Monitoring and Circulating Tumor Cells in the Efficacy Evaluation and Prognostic Assessment of Advanced Tumors.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400091573
Enrollment
Unknown
Registered
2024-10-30
Start date
2024-11-01
Completion date
Unknown
Last updated
2024-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

advanced tumors

Interventions

Observation group:None

Sponsors

The Fifth Affiliated Hospital, Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Willing to voluntarily sign an informed consent form; 2.Age > 18 years; 3.Gender not limited; 4.ECOG performance status score = 2, with an expected life span greater than 12 weeks; 5.Inoperable advanced tumors, including all patients with M1 stage according to TNM staging, all patients with recurrence after radical treatment, or patients with locally advanced disease; 6.Intended to undergo at least 4 cycles of standard radiotherapy, chemotherapy, targeted therapy, or monotherapy or combination therapy of immunotherapy, including patients in the first or second line; 7.At least one measurable lesion based on the RECIST 1.1 criteria for solid tumor response evaluation.

Exclusion criteria

Exclusion criteria: 1.Pregnant or breastfeeding women; 2.Known human immunodeficiency virus (HIV) infection or history of organ transplantation; 3.Severe uncontrolled underlying diseases, such as severe cardiopulmonary insufficiency, uncontrolled infections, etc.; 4.Patients with active autoimmune diseases requiring systemic treatment (using corticosteroids, immunosuppressants, etc.); Replacement therapies (such as thyroid hormone, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) are not considered a form of systemic treatment; 5.Patients with severe hepatic or renal dysfunction, or cardiac insufficiency prior to treatment; 6.Patients with poor compliance to treatment, or incomplete medical records; 7.Patients deemed unsuitable for this study by the investigator.

Design outcomes

Primary

MeasureTime frame
Study the correlation between baseline NK cell activity, circulating tumor cell count, and objective response rate (ORR) after advanced cancer treatment;Analyzing the changes in NK cell activity and circulating tumor cell count in patients before treatment and upon developing resistance (progression);Monitoring the correlation between changes in NK cell activity and circulating tumor cell count during treatment and the objective response rate (ORR) after treatment;

Secondary

MeasureTime frame
Study the relationship between the dynamic changes in NK cell activity and circulating tumor cell count.;Study the relationship between the dynamic changes in NK cell activity and circulating tumor cell count and the treatment.;Study the correlation between the dynamic changes in NK cell activity, TBNK count, circulating tumor cell count, and progression-free survival (PFS), disease control rate (DCR), and duration of response (DOR).;

Countries

China

Contacts

Public Contactzeng qi

The Fifth Affiliated Hospital, Sun Yat-sen University

zengqi37@mail.sysu.edu.cn+86 756 2526862

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026