Esophageal Squamous Cell CarcinomaNCT05833594
Whole-course Immunonutrition Combined With Chemoradiotherapy±ICIs for Local Advanced Patients With Inoperable Esophageal Squamous Cell Carcinoma
An observational study of Esophageal Squamous Cell Carcinoma and Chemoradiotherapy, run by Anhui Provincial Hospital at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma, Chemoradiotherapy, Immunonutrition
- What is being tested?
- Whole-course Immunonutrition Combined With Chemoradiotherapy±ICIs
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Anhui provincial hospital
Hefei
dong qian, M.D., +86-19156007756, qiankeyu1983@163.com
Yuan He, M.D., +86-18926243766, heyuan3766@126.com
About this study
Official title: Anhui Provincial Hospita
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.
- Being tested
- Whole-course Immunonutrition Combined With Chemoradiotherapy±ICIs
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole-course Immunonutrition Combined With Chemoradiotherapy±ICIsDietary supplement
The Experimental group received a combination of omega-3 fatty acids, and glutamine, whereas the control group received standard formula.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Whole-course Immunonutrition Combined With Chemoradiotherapy±ICIs Receives: Dietary Supplement: Whole-course Immunonutrition Combined With Chemoradiotherapy±ICIs | |
| Comparator | Whole-course nutrition Combined With Chemoradiotherapy±ICIs Receives: Dietary Supplement: Whole-course Immunonutrition Combined With Chemoradiotherapy±ICIs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of adverse events
Rate of adverse events (CTCAE V4.0)
Measured: 1 month post treatment
Disease Control Rate
Disease Control Rate
Measured: 1 month post treatment
Secondary outcomes (1)
1-, 2-, 3-year Progression-free survival rate (PFS).
1-, 2-, 3-year Progression-free survival rate (PFS).
Measured: 1 to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start1 Jul 2023
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Anhui Provincial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05833594
- Sponsor's protocol ID
- 2023WCIN001
- Status last verified
- Dec 2023
- First submitted
- 16 Apr 2023
- Last updated
- 26 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anhui Provincial Hospita
- ClinicalTrials.gov ID
- NCT05833594
- Acronym / sponsor ID
- 2023WCIN001
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 27 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | – | Dietary Supplement: Whole-course Immunonutrition Combined With Chemoradiotherapy±ICIsWhole-course Immunonutrition Combined With Chemoradiotherapy±ICIs |
| Comparator | – | Dietary Supplement: Whole-course Immunonutrition Combined With Chemoradiotherapy±ICIsWhole-course nutrition Combined With Chemoradiotherapy±ICIs |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * 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.
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole-course Immunonutrition Combined With Chemoradiotherapy±ICIsThe Experimental group received a combination of omega-3 fatty acids, and glutamine, whereas the control group received standard formula. | Dietary supplement | Comparator, Experimental |
Primary outcome
Rate of adverse events
Time frame: 1 month post treatment
Rate of adverse events (CTCAE V4.0)
Disease Control Rate
Time frame: 1 month post treatment
Disease Control Rate
1 secondary outcome
1-, 2-, 3-year Progression-free survival rate (PFS).
Time frame: 1 to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Squamous Cell Carcinoma and Chemoradiotherapy, run by Anhui Provincial Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact dong qian, M.D. (+86-19156007756, qiankeyu1983@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of adverse events (time frame: 1 month post treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2023.