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The Study of [68Ga]Ga-PD-L1 and [68Ga]Ga-CD8 PET/CT in Guiding Adaptive Radioimmunotherapy for Locally Advanced Unresectable Non-Small Cell Lung Cancer

The Study of [68Ga]Ga-PD-L1 and [68Ga]Ga-CD8 PET/CT in Guiding Adaptive Radioimmunotherapy for Locally Advanced Unresectable Non-Small Cell Lung Cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500113309
Enrollment
Unknown
Registered
2025-11-27
Start date
2025-11-30
Completion date
Unknown
Last updated
2025-12-01

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

Conditions

Patients with histologically confirmed driver gene wild-type non-small cell lung cancer (NSCLC)

Interventions

Observation Group of adaptive radiotherapy for non-small cell lung cancer:None

Sponsors

Affiliated Cancer Hospital of Shandong First Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Age >=18 years old and <= 75 years old. 2.For patients with histologically confirmed driver gene wild-type NSCLC, there is sufficient biopsy tissue for biological testing. 3. The researchers confirmed the presence of at least one measurable lesion in accordance with the RECIST 1.1 criteria. 4. Patients with locally advanced unresectable NSCLC who are scheduled to receive immunoconsolidation therapy after concurrent chemoradiotherapy. 5. Good liver function (aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels <=2.0 times ULN). 6. Good renal function (serum creatinine (BUN) and serum urea nitrogen (Cr) <= 2.0 times ULN). 7. Life expectancy exceeds three months. 8. The performance status score of the Eastern Oncology Collaboration (ECOG) is either 0 or 1. 9. Before enrollment, the subjects (or their legal representatives) were fully informed and signed the informed consent form, with the date of signature. 10. Patients who completed [18F]FDG PET/CT examination one month before enrollment and have not yet received anti-tumor treatment are given priority (baseline [18F]FDG PET/CT examination can be used for subsequent study analysis).

Exclusion criteria

Exclusion criteria: 1.More than 1 month between biopsy immunohistochemistry (IHC) and the study procedure. 2.Patients scheduled to receive neoadjuvant therapy and surgical treatment. 3.Pregnant or lactating women. 4.Patients with impaired hepatic function (AST and ALT levels >2× ULN) and renal dysfunction (BUN and Cr >2× ULN). 5.No measurable lesions confirmed by the investigator according to RECIST 1.1 criteria. 6.Patients with implanted cardiac pacemakers. 7.Patients deemed by the investigator to be unsuitable for participation in this clinical study based on professional judgment. 8.Patients with active autoimmune diseases or a history of immunodeficiency, as well as those with active infections requiring long-term antibiotic, antiviral, or immunosuppressive therapy.

Design outcomes

Primary

MeasureTime frame
SUVmax;The maximum diameter of the target lesion;

Countries

China

Contacts

Public ContactLigang Xing

Affiliated Cancer Hospital of Shandong First Medical University

xinglg@medmail.com.cn+86 531 67616819

Outcome results

None listed

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