Combining immunonutrition with chemoradiotherapy for inoperable esophageal cancer
Anhui Provincial Hospita
This study is testing whether a special nutritional formula can help people with inoperable esophageal cancer live longer and feel better when combined with chemoradiotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Anhui Provincial Hospital Government |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Hefei) |
| Trial ID | NCT05833594 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility and survival benefits of whole-course immunonutrition combined with chemoradiotherapy, with or without immune checkpoint inhibitors (ICIs), for patients with inoperable esophageal squamous cell carcinoma. Participants will be randomized into two groups: one receiving a specialized immunonutrition formula containing omega-3 fatty acids and glutamine, and the other receiving a standard nutritional formula. The study aims to assess safety, feasibility, and progression-free survival rates at 1, 2, and 3 years. It targets patients who are treatment naive and have specific tumor characteristics as confirmed by radiological examination.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-85 with treatment naive, unresectable esophageal squamous cell carcinoma.
Not a fit: Patients with resectable tumors or those with other types of esophageal cancer, such as adenocarcinoma, will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve survival rates and quality of life for patients with inoperable esophageal squamous cell carcinoma.
How similar studies have performed: While the combination of immunonutrition and chemoradiotherapy is a novel approach, similar studies have shown promising results in enhancing treatment outcomes for cancer patients.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18-85 years old; * Eastern Cooperative Oncology Group (ECOG) 0-2; * Esophageal squamous cell carcinoma; * cT2-4aN0-3M0 (AJCC 8th) confirmed by radiological examination; * initial unresectable at initial diagnosis confirmed by thoracic surgeons; * Treatment naive; * No contraindications for adjuvant chemoradiotherapy; * Signature of inform consent. Exclusion Criteria: * younger than 18 years old or older than 85 years old; * ECOG\>2; * Esophageal adenocarcinoma, small-cell cancer and other pathological types; * cT1anyNM0, cT4banyNM0, c anyTanyNM0 confirmed by radiological examination; * Resectable at initial diagnosis confirmed by thoracic surgeons; * Previous treatment of chemotherapy, radiotherapy, and other treatment; * Contraindications for chemoradiotherapy; * No signature of inform consent.
Where this trial is running
Hefei
- Anhui provincial hospital — Hefei, China (Recruiting)
Study contacts
- Study coordinator: dong qian, M.D.
- Email: qiankeyu1983@163.com
- Phone: +86-19156007756
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.