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RecruitingNCT05833594Updated Dec 26, 2023

Whole-course Immunonutrition Combined With Chemoradiotherapy±ICIs for Local Advanced Patients With Inoperable Esophageal Squamous Cell Carcinoma

An observational study in Esophageal Squamous Cell Carcinoma, Chemoradiotherapy and Immunonutrition, sponsored by Anhui Provincial Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-12-26.

Sponsored by Anhui Provincial Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Jan 2026, 9 months ago, but the record still lists the study as recruiting.
  • Started Jul 2023; still recruiting 3 years 3 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
70
Ages
18 Years to 85 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Esophageal Squamous Cell Carcinoma
  • Chemoradiotherapy
  • Immunonutrition
  • Inoperable
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's planned enrollment of 70 is below the median of 149 across 1,175 observational studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Anhui Provincial Hospital is the lead sponsor of 129 studies on the registry; 95 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

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

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.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
70 participants (estimated)
Patient registry
No

Groups and cohorts

  • Experimental

    Whole-course Immunonutrition Combined With Chemoradiotherapy±ICIs

    Dietary Supplement: Whole-course Immunonutrition Combined With Chemoradiotherapy±ICIs

  • Comparator

    Whole-course nutrition Combined With Chemoradiotherapy±ICIs

    Dietary Supplement: Whole-course Immunonutrition Combined With Chemoradiotherapy±ICIs

Interventions

  • Dietary supplementWhole-course Immunonutrition Combined With Chemoradiotherapy±ICIs

    The Experimental group received a combination of omega-3 fatty acids, and glutamine, whereas the control group received standard formula.

06

What researchers measure

Primary outcomes

  1. Rate of adverse events

    Rate of adverse events (CTCAE V4.0)

    Time frame: 1 month post treatment

  2. Disease Control Rate

    Disease Control Rate

    Time frame: 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).

    Time frame: 1 to 3 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 26, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05833594
Lead sponsor
Anhui Provincial Hospital
Responsible party
Sponsor
First posted
Apr 27, 2023
Start date
Jul 1, 2023
Primary completion
Jan 1, 2026 (estimated)
Completion
Dec 1, 2026 (estimated)
Last update
Dec 26, 2023

Study contacts

dong qian, M.D.
Contact
qiankeyu1983@163.com
+86-19156007756

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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