NCT05833594

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
7mo left

Started Jul 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress83%
Jul 2023Dec 2026

First Submitted

Initial submission to the registry

April 16, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 27, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

December 26, 2023

Status Verified

December 1, 2023

Enrollment Period

2.5 years

First QC Date

April 16, 2023

Last Update Submit

December 20, 2023

Conditions

Esophageal Squamous Cell CarcinomaChemoradiotherapyImmunonutritionInoperable

Outcome Measures

Primary Outcomes (2)

  • Rate of adverse events

    Rate of adverse events (CTCAE V4.0)

    1 month post treatment

  • Disease Control Rate

    Disease Control Rate

    1 month post treatment

Secondary Outcomes (1)

  • 1-, 2-, 3-year Progression-free survival rate (PFS).

    1 to 3 years

Study Arms (2)

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

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.

ComparatorExperimental

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anhui provincial hospital

Hefei, China

RECRUITING

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Squamous CellEsophageal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Central Study Contacts

dong qian, M.D.

CONTACT

+86-19156007756qiankeyu1983@163.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2023

First Posted

April 27, 2023

Study Start

July 1, 2023

Primary Completion

January 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

December 26, 2023

Record last verified: 2023-12

Locations

CN(1)