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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorAnhui Provincial Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18-85 years old;

Eastern Cooperative Oncology Group (ECOG) 0-2;

Esophageal squamous cell carcinoma;

cT2-4aN0-3M0 (AJCC 8th) confirmed by radiological examination;

Disqualifiers

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;

Trial 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.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Whole-course Immunonutrition Combined With Chemoradiotherapy±ICIs

    Dietary supplement

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

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Experimental1 intervention
Group B: Comparator1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.