Immunotherapy plus chemoradiotherapy for older adults with esophageal squamous cell carcinoma
An Observational Study on the Safety and Efficacy of Immunotherapy Combined With Concurrent Chemoradiotherapy in Elderly Patients With Esophageal Squamous Cell Carcinoma
This project will test if adding immunotherapy to chemoradiotherapy helps people aged 70 and older with esophageal squamous cell carcinoma.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 70 Years and up |
| Sex | All |
| Sponsor | Three Gorges Hospital of Chongqing University Academic / other |
| Drugs / interventions | chemotherapy, Immunotherapy |
| Locations | 1 site (Chongqing, Chongqing Municipality) |
| Trial ID | NCT07080437 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Chongqing, Chongqing Municipality
- Affiliated Shangxia Hospital of Chongqing University — Chongqing, Chongqing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Han Zhang
- Email: 4081548@qq.com
- Phone: 86-15023366912
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.