Low-Dose Involved-Field Radiotherapy Plus Immunochemotherapy for ESCC

NCT06603402 | Recruiting Phase 2 DMC

• 1 other identifier: HX-LION Study
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this clinical trial is to evaluate whether low-dose involved-field radiotherapy combined with immunochemotherapy can reduce treatment-related adverse effects, enhance progression-free survival (PFS), and improve overall survival (OS) in patients with locally advanced, unresectable esophageal squamous cell carcinoma. The key questions this study seeks to address are:

• Can low-dose involved-field radiotherapy combined with immunochemotherapy reduce treatment-related adverse effects?
• Does this combined approach improve PFS and OS in these patients? Participants in the study will:
• Undergo an endoscopy at West China Hospital to confirm their diagnosis.
• Receive a treatment regimen that includes low-dose radiotherapy at 45.0 Gy in 1.8 Gy per fraction over 25 fractions, alongside immunochemotherapy, with three cycles of chemotherapy administered every 3 weeks.
• After completing the full treatment regimen, participants will undergo regular follow-up visits and monitoring by healthcare professionals.

Conditions

Esophageal Squamous Cell Carcinoma (ESCC); Immunotherapy

Keywords

Esophageal Squamous Cell Carcinoma; Radiotherapy; immunotherapy

Outcome Measures

Primary Outcomes (1)

• The safety of low-dose involved-field radiotherapy combined with immunochemotherapy

  This study will collected any adverse medical events that occurred during the study drug treatment, and the treatment-related adverse events as assessed by\" CTCAE v5.0\".

  12months

Secondary Outcomes (3)

• The efficacy of low-dose involved-field radiotherapy combined with immunochemotherapy

  12months

• The efficacy of low-dose involved-field radiotherapy combined with immunochemotherapy

  12months

• The efficacy of low-dose involved-field radiotherapy combined with immunochemotherapy

  24months

Study Arms (1)

low-dose involved-field radiotherapy combined with immunochemotherapy

EXPERIMENTAL

low-dose involved-field radiotherapy combined with immunochemotherapy

Radiation: low-dose involved-field radiotherapy combined with immunochemotherapy

Interventions

low-dose involved-field radiotherapy combined with immunochemotherapy RADIATION

low-dose involved-field radiotherapy combined with immunochemotherapy

low-dose involved-field radiotherapy combined with immunochemotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 years
• Patients with locally advanced, unresectable ESCC who have received radical treatment (radical chemoradiotherapy or radical radiochemotherapy), including:
• Cervical esophagus involvement, T4 stage, supraclavicular lymph node metastasis, or inability to tolerate or refusal of surgery due to personal reasons; Failure of neoadjuvant or conversion therapy;Unresectable local recurrence after surgery (with measurable target lesions)
• No evidence of tumor recurrence or metastasis on follow-up examination 2-3 weeks after radical treatment
• Ability to provide fresh tumor tissue specimens (baseline)
• Normal function of major organs
• Performance Status (PS) score ≤ 1
• Patients of childbearing potential must agree to use contraception.
• Voluntary participation with signed informed consent

You may not qualify if:

• History of fistula formation due to primary tumor invasion
• High risk of gastrointestinal bleeding, esophageal fistula, or esophageal perforation.
• Poor nutritional status
• Previous immune-related adverse events during prior radical treatment, including grade ≥3 immune-related pneumonitis, myocarditis, etc
• Presence of symptoms or signs of interstitial disease
• Patients with any severe and/or uncontrolled medical condition
• Presence of concurrent malignancies
• Presence of other autoimmune diseases or long-term use of immunosuppressants or corticosteroids.
• Patients who are difficult to communicate with or are unlikely to comply with long-term follow-up.
• Any other conditions that the investigator deems unsuitable for participation.

Sponsors & Collaborators

• Sichuan University: lead

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• zhenyu ding, MD

  West China Hospital, Sichuan University, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

zhenyu ding, MD

CONTACT

+86 028-854-22562; dingzhenyu@scu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: September 13, 2024
• First Posted: September 19, 2024
• Study Start: August 24, 2023
• Primary Completion: March 1, 2025
• Study Completion: September 1, 2025
• Last Updated: December 3, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)