An Observational Study on the Safety and Efficacy of Immunotherapy Combined With Concurrent Chemoradiotherapy in Elderly Patients With Esophageal Squamous Cell Carcinoma

NCT07080437 | Recruiting

• 1 other identifier: TGHEC001
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Title: Observational Study on the Safety and Efficacy of Immunotherapy Combined with Concurrent Chemoradiotherapy in Elderly Patients with Esophageal Squamous Cell Carcinoma Study Purpose: This single-center, open-label, retrospective study aims to evaluate the safety and efficacy of immunotherapy combined with concurrent chemoradiotherapy (CCRT) in elderly patients with esophageal squamous cell carcinoma (ESCC). The primary objectives include assessing the objective response rate (ORR), overall survival (OS), progression-free survival (PFS), disease control rate (DCR), duration of response (DoR), R0 resection rate, adverse events (AEs), and potential predictive biomarkers in elderly patients receiving this treatment regimen. Condition Studied: Esophageal Squamous Cell Carcinoma (ESCC) in elderly patients (≥70 years). Intervention: Participants will receive concurrent chemoradiotherapy (CCRT) combined with immunotherapy. The study will retrospectively analyze the outcomes of patients treated between January 2022 and March 2025. Study Design: This is a retrospective, single-arm study. Patients aged 70 years or older with histologically confirmed ESCC (stages IB to IVB according to the 6th edition of the American Joint Committee on Cancer) will be included. Patients will undergo radiotherapy with concurrent chemotherapy and immunotherapy. Follow-up evaluations will be conducted every 3 months until disease progression or up to 2 years. Eligibility Criteria: Inclusion Criteria: Voluntary participation with written informed consent. Age ≥70 years, regardless of gender. Histologically or cytologically confirmed ESCC. Inoperable or refusal of surgery, with tolerance for anti-tumor treatment. ECOG performance status 0-2. Expected survival ≥6 months. No severe abnormalities in hematologic, cardiac, pulmonary, hepatic, or renal function, and no immunodeficiencies. Exclusion Criteria: Distant organ metastasis (excluding supraclavicular lymph nodes). Previous esophageal fistula, perforation, or pre-treatment for malignancy. Prior thoracic radiotherapy. Active autoimmune diseases or history of autoimmune diseases. Previous or ongoing PD-1 inhibitor treatment or participation in other interventional clinical studies. Allergy to large protein formulations or components of S-1 capsules. Uncontrolled cardiac conditions. Immunodeficiencies (e.g., HIV infection), active hepatitis B or C, or active tuberculosis. Active infection or unexplained fever \>38.5°C within 2 weeks before screening. History of other malignancies within 5 years (except cured basal cell carcinoma of the skin or cervical carcinoma in situ). Scientific and Social Value: This study aims to explore effective treatment options for elderly ESCC patients and enhance the influence of the discipline in this field. Recruitment and Informed Consent: Participants will be recruited through physician referrals. Informed consent will be obtained from all participants, ensuring their privacy and confidentiality. Outcome Measures: Primary outcomes: ORR, OS, PFS, DCR, DoR, R0 resection rate, and AEs. Secondary outcomes: Identification of potential predictive biomarkers. Study Duration: The study will cover a period from January 2022 to March 2025, with follow-up evaluations conducted every 3 months until disease progression or up to 2 years. Publication Plan: The results of this study will be published in high-quality scientific journals.

Conditions

Esophageal Squamous Cell Carcinoma (ESCC)

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  Imaging assessments every 3 months after treatment initiation until disease progression or up to 2 years.

  3 months

Interventions

Immunotherapy Therapy DRUG

Patients will receive concurrent chemoradiotherapy (CCRT) combined with immunotherapy. The treatment includes: Radiotherapy: Individualized radiotherapy targeting the tumor. Concurrent Chemotherapy: Platinum-based doublet chemotherapy (e.g., cisplatin + fluorouracil or S-1) administered during radiotherapy. Immunotherapy: PD-1 inhibitor (e.g., tislelizumab) used to enhance the immune response against cancer cells. The treatment will be tailored to each patient's condition, with regular follow-up assessments every 3 months for up to 2 years to monitor efficacy and safety.

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of elderly patients (≥70 years) with histologically confirmed ESCC who are not suitable for surgery or refuse surgery but are able to tolerate anti-tumor treatment. The inclusion and exclusion criteria are designed to ensure the safety and efficacy of the study while maintaining a representative patient population for the research objectives.

You may qualify if:

• Voluntary participation with written informed consent. Age ≥70 years, regardless of gender. Histologically or cytologically confirmed ESCC. Inoperable or refusal of surgery, with tolerance for anti-tumor treatment. ECOG performance status 0-2. Expected survival ≥6 months. No severe abnormalities in hematologic, cardiac, pulmonary, hepatic, or renal function, and no immunodeficiencies.

You may not qualify if:

• No severe abnormalities in hematologic, cardiac, pulmonary, hepatic, or renal function, and no immunodeficiencies.
• Distant organ metastasis (excluding supraclavicular lymph nodes). Previous esophageal fistula, perforation, or pre-treatment for malignancy. Prior thoracic radiotherapy. Active autoimmune diseases or history of autoimmune diseases. Previous or ongoing PD-1 inhibitor treatment or participation in other interventional clinical studies.
• Allergy to large protein formulations or components of S-1 capsules. Uncontrolled cardiac conditions. Immunodeficiencies (e.g., HIV infection), active hepatitis B or C, or active tuberculosis.
• Active infection or unexplained fever \>38.5°C within 2 weeks before screening. History of other malignancies within 5 years (except cured basal cell carcinoma of the skin or cervical carcinoma in situ).

Sponsors & Collaborators

• Three Gorges Hospital of Chongqing University: lead

Study Sites (1)

Affiliated Shangxia Hospital of Chongqing University

Chongqing, Chongqing Municipality, 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

Central Study Contacts

Han Zhang

CONTACT

86-15023366912; 4081548@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: July 23, 2025
• Study Start: March 1, 2021
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: July 23, 2025

Record last verified: 2025-07

Locations

CN (1)