Clinical observation of elective lymph node irradiation ( ENI ) and lymph node-sparing irradiation (NSI ) combined with immune checkpoint inhibition(ICI) therapy for malignant tumors

Status

Active, not recruiting

Phases

Phase 2

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2500109753

Enrollment

Unknown

Registered

2025-09-24

Start date

2025-09-25

Completion date

Unknown

Last updated

2025-09-29

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

Conditions

locally advanced or advanced tumors

Interventions

elective lymph node irradiation ( ENI ) group:None

lymph node-sparing irradiation (NSI ) group:None

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. >=18 years of age; 2. Confirmed malignant tumor by cells or pathology; 3. Patients with locally advanced solid tumors, or who cannot tolerate surgery, fail first-line treatment, and who cannot tolerate or refuse systemic therapy; 4. Patients with oligometastatic solid tumors who are expected to be locally cured by SBRT; 5. ECOG =60 points; 5. ECOG >=60 points; 7. No serious comorbidities (bone marrow, liver and kidney function, coagulation function, heart function) Blood routine: WBC >= 3.0×10^9/L, ANC >= 1.5×10^9/L, PLT >= 90×10^9/L, HGB >= 8g/dL; 1 Liver function: TBIL =55%, QTCF interval 4 weeks; 9. Sign informed consent in writing; 10, consent to collect biological specimens of tissue or blood) for backup;

Exclusion criteria

Exclusion criteria: 1. during pregnancy or lactation; 2. Patients with diffuse central nervous system metastases (>=10 brain metastases, meninges, spinal cord) or multiple organ metastases; 3. Severe Comorbidities (severe infection, bone marrow suppression, cardiac Cerebrovascular disease, persistent or intractable epilepsy; severe cardiac dysfunction, Coagulation Disorder, active bleeding, electrolyte disorders); 4. KPS <60 points; 5. Any arterial thrombosis, embolism or ischemia occurred within the 6 months before enrollment, such as myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack; 6. a history of psychiatric illness, alcoholism, drug use, or drug abuse;

Design outcomes

Primary

Measure	Time frame
regional relapse rate;Progression-free survival,PFS;regional control rate;	—

Secondary

Measure	Time frame
peripheral blood CD4/CD8 ratio;Correlation of Lymphocyte Subsets with Immune Therapy Response;Evaluation of the correlation between physical parameters of radiotherapy planning and efficacy and toxicities and side effects;side-effect;Incidence of reduction in >=3 grade Lymphocytes;	—

Countries

China

Contacts

Public ContactYunxiu Luo

Hainan Cancer Hospital

luoyunxiu@hnszlyy.wecom.work+86 898 36379999

Outcome results

None listed

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