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Clinical study of radiotherapy combined with immunity in the treatment of oligometastasis of malignant tumor

Clinical study of radiotherapy combined with immunity in the treatment of oligometastasis of malignant tumor

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100041733
Enrollment
Unknown
Registered
2021-01-03
Start date
2021-01-01
Completion date
Unknown
Last updated
2021-03-22

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

Conditions

Oligometastatic tumor of lung

Interventions

experimental group:Radiotherapy combined with anti-PD-1 therapy

Sponsors

The First Affiliated Hospital of Bengbu Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age: >= 18 years old, male or female; 2. The primary tumor should be confirmed by pathology or histology, the number of oligometastatic organs in the lung is not more than 3, and the total number of metastatic lesions is not more than 5. And the diagnosis of pulmonary oligometastasis is at least confirmed by imaging evidence or pathology. And at least one measurable lesion (helical CT scan >=10mm, conform the RECIST 1.1 standard); 3. If accompanied by other site metastasis, it is necessary to meet the definition of oligodeoxynucleotide metastasis, and there are no more than 3 metastatic organs; 4. Patients without intracranial and meningeal metastases were confirmed by cranial MRI enhancement; 5. The ECOG score of the patients was 0-2, while the KPS score was 70; 6.expected survival more than three months; 7. The function of the main organs is normal, and the blood routine examination and biochemical examination meet the general requirements of radiotherapy and chemotherapy. 8. The subjects voluntarily joined the study and signed an informed consent form with good compliance and follow-up.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating; 2. Patients have previous immune-related diseases, such as rheumatoid arthritis, psoriasis, systemic lupus erythematosus, etc. 3. Those who receive hormone therapy such as AIDS, hepatitis C, hepatitis B infection; 4. Patients with meningeal metastasis or worsening brain metastasis; 5. Patients who have received allotransplantation and immunosuppressive therapy; 6. Patients with interstitial pneumonia; 7. Patients with severe hepatorenal insufficiency, cardiac insufficiency and severe hypertension and diabetes mellitus; 8. The other above are not included, but the patients who have been jointly evaluated by the researchers are not suitable for this study.

Design outcomes

Primary

MeasureTime frame
Overall survival;

Secondary

MeasureTime frame
Objective response rate;Progression Free Survival;Disease control rate;The quality of life;Observation on adverse events of radiotherapy and drug use;

Countries

China

Contacts

Public ContactHao jiang

The First Affiliated Hospital of Bengbu Medical College

jianghao1223@163.com+86 135 0056 8891

Outcome results

None listed

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