NCT06840704 Immunonutrition Reduces Acute Esophagitis After Thoracic Radiotherapy in Lung Cancer
| NCT ID | NCT06840704 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Hunan Cancer Hospital |
| Condition | Non Small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 121 participants |
| Start Date | 2025-02-25 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 121 participants in total. It began in 2025-02-25 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study aims to evaluate the efficacy of immunonutrition in reducing acute esophagitis after thoracic radiotherapy in lung cancer.
Eligibility Criteria
Inclusion Criteria: 1. The subject voluntarily participates in this clinical study, understands the study procedures, and is able to provide written informed consent. 2. Age ≥ 18 years. 3. Pathologically confirmed diagnosis of lung cancer, including non-small cell lung cancer and small cell lung cancer. 4. Indication for thoracic radiotherapy, with the esophagus within 1 cm of the PTV. 5. Prescription dose for the PTV: 60-70 Gy once daily (2 Gy/Fx), 45 Gy twice daily (1.5 Gy/Fx, with intervals exceeding 6 hours), or 45 Gy once daily (3 Gy/Fx). 6. Ability to orally intake food normally. 7. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1. 8. The volume of both lungs receiving more than 20 Gy (V20) should not exceed 30% of the total lung volume. 9. Expected survival of more than 3 months. 10. Laboratory test results during the screening period: Complete blood count: ANC ≥ 1.5 × 10\^9/L; PLT ≥ 80 × 10\^9/L; Hb ≥ 90 g/L. Blood biochemistry: TBIL ≤ 1.5 × ULN; ALT and AST ≤ 2 × ULN; BUN and Cr ≤ 1.5 × ULN, with creatinine clearance ≥ 50 mL/min (calculated using the Cockcroft-Gault formula). 11. Female subjects of childbearing potential, male subjects, and partners of male subjects agree to use reliable contraceptive methods during the study period (such as abstinence, sterilization, oral contraceptives, or other contraceptive measures). Exclusion Criteria: 1. Previous history of thoracic radiotherapy. 2. Suspected or confirmed tumor invasion of the esophagus. 3. Patients with other primary tumors. 4. History of esophageal cancer, gastric cancer, or prior esophageal surgery. 5. Concurrent active reflux esophagitis. 6. Current regular use of immunonutrition (e.g., Oral Impact®). 7. Patients with severe cardiovascular or cerebrovascular diseases, or comorbidities such as liver or kidney diseases. 8. Female subjects who are pregnant, breastfeeding, or planning to become pregnant during the study period. 9. Concurrent active autoimmune diseases requiring treatment. 10. Known history of human immunodeficiency virus (HIV) positivity or acquired immunodeficiency syndrome (AIDS). 11. Any medical (e.g., pulmonary, metabolic, endocrine, or neurological diseases, congenital disorders, etc.), psychiatric, or social condition that, in the investigator's judgment, may interfere with the subject's rights, safety, health, or ability to provide informed consent, cooperate and participate in the study, or interfere with the evaluation of the study drug, interpretation of patient safety, or study results.
Contact & Investigator
Huai Liu, M.D.
PRINCIPAL INVESTIGATOR
Hunan Cancer Hospital
Frequently Asked Questions
Who can join the NCT06840704 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Non Small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06840704 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 121 participants.
Is NCT06840704 currently recruiting?
Yes, NCT06840704 is actively recruiting participants. Contact the research team at liuhuai@hnca.org.cn for enrollment information.
Where is the NCT06840704 trial being conducted?
This trial is being conducted at Changsha, China, Changsha, China, Changsha, China, Chenzhou, China and 2 additional locations.
Who is sponsoring the NCT06840704 clinical trial?
NCT06840704 is sponsored by Hunan Cancer Hospital. The principal investigator is Huai Liu, M.D. at Hunan Cancer Hospital. The trial plans to enroll 121 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.