New combo therapy aims to extend life for elderly esophageal cancer patients
NCT ID NCT07196345
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a chemotherapy drug (TAS-102) combined with radiation in people aged 65-85 with advanced esophageal cancer. The goal is to find the safest dose and see if the combination helps control the cancer and improves survival. About 45 participants will take part across multiple hospitals.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 45 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2025
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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65 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients must have newly confirmed histologically or cytologically diagnosed esophageal squamous cell carcinoma. * Age between 65 and 85 years. * Esophageal cancer staged as IIB to IVB according to the 8th edition AJCC staging system (including IVB with supraclavicular or celiac lymph node metastasis, but excluding IVB with other distant metastases). * ECOG performance status of 0 or 1. * No history of esophageal perforation, active esophageal bleeding, or significant invasion of the trachea or major thoracic blood vessels. * No prior anticancer therapy such as radiotherapy or chemotherapy. Adequate bone marrow function: hemoglobin ≥9 g/dL, white blood cells ≥3.0×10⁹/L, neutrophils ≥1.5×10⁹/L, platelets ≥100×10⁹/L. * Adequate liver and kidney function: serum creatinine (Scr) ≤1.5×ULN, total bilirubin ≤1.5×ULN, ALT and AST ≤2.5×ULN. * No history of interstitial lung disease. * Forced expiratory volume (FEV1) ≥0.8 liters. * Signed informed consent form before study initiation. Exclusion Criteria: * Patients with hematogenous metastasis or distant lymph node metastasis (except supraclavicular or celiac lymph node metastasis), multiple esophageal cancer lesions, or malignant pleural/pericardial effusion. * History of radiotherapy, chemotherapy, or surgery targeting the primary tumor or lymph nodes. * Tracheoesophageal fistula, invasion of the trachea or main bronchi by the primary tumor, deep esophageal ulcer, or hematemesis. * Severe comorbidities such as active infection, cardiovascular disease, or pulmonary disease. * History of other malignancies except adequately treated non-melanoma skin cancer. * Participation in another clinical trial within the past 30 days. * Any other condition deemed by the investigator to preclude participation in the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, 250000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Node-Sparing Short-Course radiotherapy (25 Gy/5 fractions) combined with chemoimmunotherapy as neoadjuvant treatment for locally advanced esophageal squamous cell Carcinoma:A prospective Single-Arm, phase II study
- Can a Butter-Derived supplement protect the gut during cancer radiation?
- Can repeated MRI scans reveal how tumors respond to radiation?
- Can radiation before or after breast reconstruction improve outcomes?
- A sharper MRI could reveal radiation sensitivity of brain tumors
- Can a pair of PET scans reveal who will beat esophageal cancer?