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Clinical Trial NCT07196345 for ESCC, TAS 102, Radiotherapy is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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TAS-102 Plus Radiotherapy in Elderly ESCC Phase 1, Phase 2 45 Senior-Focused

Not yet recruiting
Clinical Trial NCT07196345 is designed to study Treatment for ESCC, TAS 102, Radiotherapy. This Phase 1 Phase 2 interventional study is not yet recruiting. Enrollment is planned to begin on September 25, 2025 until the study accrues 45 participants. Led by Qianfoshan Hospital, this study is expected to complete by December 31, 2028. The latest data from ClinicalTrials.gov was last updated on September 29, 2025.
Brief Summary
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...

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Official Title

Efficacy and Safety of Trifluridine/Tipiracil Combined With Radiotherapy in Elderly Patients With Locally Advanced Esophageal Cancer

Conditions
ESCCTAS 102Radiotherapy
Other Study IDs
  • YXLL-KY-2025(055)
NCT ID Number
NCT07196345
Start Date (Actual)
2025-09-25
Last Update Posted
2025-09-29
Completion Date (Estimated)
2028-12-31
Enrollment (Estimated)
45
Study Type
Interventional
PHASE
Phase 1
Phase 2
Status
Not yet recruiting
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalTAS-102 + Radiotherapy
TAS-102
Administered orally at 35 mg/m²/dose twice daily (morning and evening), in a bi-weekly regimen on Days 1-5.
Radiotherapy
Total dose of 50-60 Gy, delivered in 25-28 fractions, administered Monday through Friday (daily) until the full prescribed dose is achieved.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
2-years OS rate
The percentage of study participants who are still alive at 2 years after the starting date of the study drug, calculated from the starting date of the study drug to the date of death from any cause.
Approximately 24 months after the last subject participating in
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
ORR
The time from the date for first documented response of complete response (CR) or partial response (PR) to the date of first documented of disease progression or death, whichever occurs first.
Approximately 4 months after the last subject participating in
PFS
The time from the starting date of study drug to the date of first documentation of disease progression or death, whichever occurs first (per RECIST 1.1).
Approximately 12 months after the last subject participating in
Adverse Event (AE)
Type, incidence, grading (based on NCI-CTCAE v5.0 criteria), and duration of adverse event.
Up to approximately 2 years
Participation Assistant
Eligibility Criteria

Eligible Ages
Older Adult
Minimum Age
65 Years
Eligible Sexes
All
  • 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.

  • 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.
Qianfoshan Hospital logoQianfoshan Hospital
Study Responsible Party
Jiandong Zhang, Principal Investigator, Director of Department of Radiotherapy, Qianfoshan Hospital
Study Central Contact
Contact: Jiandong Zhang, Director of Department of Radiotherapy., +86 0531-89268118, [email protected]
1 Study Locations in 1 Countries

Shandong

The First Affiliated Hospital of Shandong First Medical University, Jinan, Shandong, 250000, China
Jiandong Zhang, Director of Department of Radiotherapy, Contact, +86 0531-89268118, [email protected]