NCT05833594Recruiting
Whole-course Immunonutrition Combined With Chemoradiotherapy±ICIs for Local Advanced Patients With Inoperable Esophageal Squamous Cell Carcinoma
Anhui Provincial Hospita
Source: ClinicalTrials.gov · Last updated 26 Dec 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Chemoradiotherapy has been a standard modality for inoperable locally advance esophageal carcinoma. The goal of this randomized control study is to compare the feasibility, and survival benefits of whole-course immunonutrition combined with chemoradiotherapy±ICIs for local advanced patients with inoperable esophageal squamous cell carcinoma. The main questions it aims to answer are: • If the feasibility and safety of whole-course immunonutrition combined with chemoradiotherapy±ICIs is better. • If the survival benefits (1, 2 and 3-years progression free survival) of whole-course immunonutrition combined with chemoradiotherapy±ICIs is longer. The Experimental group will receive a combination immunonutrition of omega-3 fatty acids, and glutamine, whereas the control group will receive standard formula.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 70 (estimated)
- First submitted
- 16 Apr 2023
- Start date
- 1 Jul 2023
- Primary completion date
- 1 Jan 2026
- Lead sponsor
- Anhui Provincial Hospital
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT05833594
What you commit to
- Study type: Observational
- Planned participants: 70
- From 1 Jul 2023 to the primary completion date, 1 Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous treatment of chemotherapy, radiotherapy, and other treatment;
Other illness
- Esophageal adenocarcinoma, small-cell cancer and other pathological types;
Age
- younger than 18 years old or older than 85 years old;
Other
- ECOG\>2;
- cT1anyNM0, cT4banyNM0, c anyTanyNM0 confirmed by radiological examination;
- Resectable at initial diagnosis confirmed by thoracic surgeons;
- Contraindications for chemoradiotherapy;
- No signature of inform consent.
Who the study is looking for
- 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.
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Anhui Provincial Hospital Coordinator of this site? Confirm its status | Hefei | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.