Clinical trial Recruiting at 1 site Observational Ages 70 and up

Immunotherapy plus chemoradiotherapy for older adults with esophageal squamous cell carcinoma

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

Run by Three Gorges Hospital of Chongqing University · NCT07080437 · Data updated 2026-11-12

This project will test if adding immunotherapy to chemoradiotherapy helps people aged 70 and older with esophageal squamous cell carcinoma.

Quick facts

Study typeObservational
Ages70 Years and up
SexAll
Enrollment40 (estimated)
SponsorThree Gorges Hospital of Chongqing University
Academic / other
Drugs / interventionschemotherapy, Immunotherapy
Locations1 site (Chongqing, Chongqing Municipality)
StatusRecruiting
StartedMarch 1, 2021
Main results expectedAugust 1, 2026
Study endsNovember 1, 2026
Registry record updatedJuly 23, 2025
Trial IDNCT07080437 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 70 or older with histologically confirmed ESCC who are inoperable or refuse surgery, have ECOG 0–2, adequate organ function, no distant organ metastases (except supraclavicular nodes), and no prior PD-1 inhibitor or thoracic radiotherapy.

Probably not a fit

Patients with distant organ metastases, active autoimmune disease, prior PD-1 inhibitor exposure, previous thoracic radiotherapy, severe organ dysfunction, or prior esophageal fistula/perforation are unlikely to benefit or be eligible.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center, open-label, retrospective review will analyze medical records of patients aged 70 or older with histologically confirmed esophageal squamous cell carcinoma who received concurrent chemoradiotherapy plus immunotherapy at a Chongqing hospital. Investigators will record tumor responses (ORR, DCR), survival outcomes (OS, PFS), duration of response, R0 resection rates, and treatment-related adverse events. Available tissue or blood samples will be examined for potential predictive biomarkers. The aim is to characterize safety and real-world effectiveness of the combination in an elderly population.

Why it matters

Potential benefit: If successful, adding immunotherapy could improve tumor response and survival for patients aged 70 and older while providing important safety information for this age group.

How similar studies have gone: Similar combinations of immunotherapy with chemoradiotherapy or systemic therapy have shown promise in esophageal cancer in other trials, but robust evidence specifically in elderly patients treated with concurrent chemoradiotherapy is limited.

Who can join: the full rules

Show full inclusion / exclusion 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:

* 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).

Where it's running

  • Affiliated Shangxia Hospital of Chongqing University
    Chongqing, Chongqing Municipality, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.