Low-dose Radiotherapy Combined With Conventional Fractionated Radiotherapy in Lung Cancer After Immunotherapy Resistance

Launched by QIANFOSHAN HOSPITAL · Jun 7, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment approach for patients with non-small cell lung cancer who have not responded well to immunotherapy. The researchers want to find out if combining low-dose radiation therapy with traditional radiation therapy can help overcome this resistance and improve patient outcomes. They are looking to see how effective this combination is in terms of shrinking tumors and extending the time patients can live without their cancer getting worse, as well as assessing any side effects and the overall quality of life for participants.

To be eligible for this trial, participants must be between 18 and 65 years old and have a confirmed diagnosis of non-small cell lung cancer. They should also be able to understand the study and agree to participate. Patients need to have measurable tumors and must have shown no improvement after 6-8 weeks of prior immunotherapy. Those who have had severe side effects from immunotherapy, brain metastases, or other serious health issues may not qualify. If you join this study, you can expect to undergo the new treatment and be closely monitored for its effects on your cancer and overall health.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients are able to understand the informed consent form, voluntarily participate and sign the informed consent form.
• • 2. Age range from 18 to 65 years old, regardless of gender.
• • 3. ECOG level 0-1; Expected life\>6 months.
• • 4. At least get into a liquid diet.
• • 5. No history of severe allergies.
• • 6. Hemoglobin ≥ 100 g/L, WBC ≥ 3.5 x10\~9/L, neutrophils ≥ 1.8 x10\~9/L, platelets ≥ 10 x10\~9/L; AST and ALT ≤ 2.5 × normal upper limit, AKP ≤ 2.5 × normal upper limit.
• • 7. Non small cell lung cancer (adenocarcinoma, large cell carcinoma, squamous carcinoma, adenosquamous carcinoma, sarcomatoid carcinoma) confirmed by cytology or histology.
• • 8. Complete clinical data.
• • 9. ≤ 10 primary and regional metastatic lymph nodes and distant metastatic lesions, and ≤ 5 organ metastases.
• • 10. Malignant tumor patients with immune therapy resistance (evaluated after 6-8 weeks of treatment and no improvement in clinical symptoms) without standard treatment options.
• • 11. There are measurable primary lesions, regional lymph node metastasis, and distant metastatic lesions.
• Exclusion Criteria:
• • 1. Missing key patient information (pathological diagnosis, radiation dose, imaging examination, previous treatment plans, etc.).
• • 2. Refusal or lack of cooperation in research.
• • 3. Patients who have participated in other clinical studies/trials within three months.
• • 4. Patients with brain metastases.
• • 5. The researcher determines that there are any patients who are not suitable to participate in the study.
• • 6. Accompanied by severe infections.
• • 7. Serious liver disease (such as cirrhosis), kidney disease, respiratory disease or chronic system diseases such as uncontrollable diabetes and hypertension; Patients who cannot tolerate radiation therapy.
• • 8. Previous occurrence of immune related toxic side effects (immune myocarditis, pneumonia, etc.).
• • 9. Previous history of radiation therapy.