NCT07196345Not yet recruitingPhase 1/2
TAS-102 Plus Radiotherapy in Elderly ESCC
Efficacy and Safety of Trifluridine/Tipiracil Combined With Radiotherapy in Elderly Patients With Locally Advanced Esophageal Cancer
Source: ClinicalTrials.gov · Last updated 29 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This study is a single-arm, multicenter clinical trial evaluating the efficacy and safety of radiotherapy combined with TAS-102 monotherapy in elderly patients with locally advanced esophageal cancer. Treatment Phase: The treatment phase is divided into a Phase I stage and a Phase II stage. The Phase I stage aims to explore the maximum tolerated dose (MTD) of TAS-102 in elderly esophageal cancer patients. A total of 9 subjects were enrolled, and the dose was escalated from 30 mg/m² in 5 mg/m² increments up to 40 mg/m². The MTD was defined as the highest drug dose at which no dose-limiting toxicity (DLT) was observed in more than 40% of treated patients during the first two weeks of combined radiotherapy and TAS-102 administration. The Phase II stage aims to investigate the efficacy of radiotherapy combined with TAS-102 at the MTD in elderly esophageal cancer patients, with 36 subjects enrolled. Consolidation Phase: Following the treatment phase, subjects had a 3-4 week rest period. This was followed by consolidation therapy with TAS-102 monotherapy at a dose of 35 mg/m², administered twice daily on days 1-5 of a 28-day cycle for two cycles. Subsequently, patients entered the efficacy and safety follow-up phase until the study endpoints were reached or after a full 2-year follow-up period.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 45 (estimated)
- First submitted
- 21 Sept 2025
- Start date
- 25 Sept 2025
- Primary completion date
- 25 Sept 2027
- Lead sponsor
- Qianfoshan Hospital
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT07196345
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 45
- From 25 Sept 2025 to the primary completion date, 25 Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
- Any other condition deemed by the investigator to preclude participation in the study.
Other
- Participation in another clinical trial within the past 30 days.
Who the study is looking for
- 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.
Age in the registry: 65 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Shandong First Medical University Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.