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Effect of granulocyte-macrophage colony-stimulating factor concurrent with intensity-modulated radiotherapy on T-lymphocyte homeostasis in patients with metastatic solid tumors

Safety and immune efficacy of GM-CSF in combination with precision radiotherapy in the treatment of metastatic solid tumors

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200055547
Enrollment
Unknown
Registered
2022-01-11
Start date
2020-04-01
Completion date
Unknown
Last updated
2023-02-06

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

Conditions

Advanced solid tumors

Interventions

Experimental group:GM-CSF + radiotherapy

Sponsors

Affiliated Hospital of Medical College of Qingdao University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 18 to 75 years; 2. Patients with stage IV metastatic malignant solid tumors diagnosed by pathological histology; 3. Patients with ECOG score = 3 months; 4. 1.0×10^9/L = 100g/L, platelets >= 80×10^9/L, serum transaminase not higher than 2.5 times the upper limit of normal value in patients without liver metastases, serum transaminase not higher than 5 times the upper limit of normal value in patients with liver metastases, serum bilirubin level not higher than 1.5 times the upper limit of normal value; serum creatinine level is not higher than 1.5 times the upper limit of normal value; 5. At least 2 lesions measurable by CT or MRI; 6. Sign the written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients who are allergic or hypersensitive to therapeutic agents, patients with autoimmune diseases; 2. Patients with only non-measurable lesions, such as thoracic ascites, cancerous lymphangitis, diffuse liver invasion, bone metastases; those with no measurable lesions or lesions that cannot be evaluated; 3. Pregnant or lactating women, those who are fertile but refuse to use contraception; 4. Uncontrolled symptomatic brain metastases or those with psychiatric abnormalities unable to correctly express subjective symptoms; 5. Those with significant organ failure; 6. Patients with factors affecting drug administration, absorption, distribution, metabolism, excretion, patients with uncontrollable seizures, central nervous system disorders or loss of self-awareness due to psychosis, patients with physiological or pathological malnutrition, chronic diarrhea, and cachexia; 7. Patients with complete or incomplete intestinal obstruction; 8. Patients with severe heart disease or history of disease, including: documented history of congestive heart failure, high-risk uncontrolled arrhythmias, angina pectoris requiring medication, clinically definite heart valve disease, history of severe myocardial infarction, and intractable hypertension; 9. Serious uncontrollable infections; 10.Alcohol and/or drug abuse or poor compliance as judged by the investigator; 11.History of other malignancies.

Design outcomes

Primary

MeasureTime frame
Lymphocyte subsets;Adverse reactions;

Secondary

MeasureTime frame
Objective remission rate;

Countries

China

Contacts

Public ContactMa Xuezhen

Department of Oncology, the Second Affiliated Hospital of Medical College of Qingdao University

maxuezhen1968@126.com+86 18660229289

Outcome results

None listed

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