TAS-102 Plus Radiotherapy in Elderly ESCC
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age65-85
SponsorQianfoshan Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
TAS-102
DrugAdministered orally at 35 mg/m²/dose twice daily (morning and evening), in a bi-weekly regimen on Days 1-5.
Radiotherapy
RadiationTotal dose of 50-60 Gy, delivered in 25-28 fractions, administered Monday through Friday (daily) until the full prescribed dose is achieved.
Treatment groups
45 Participants
are divided into 1 treatment groupGroup A: TAS-102 + RadiotherapyExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Approximately 24 months after the last subject participating inSecondary outcomes
1
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.
Time frame
Approximately 4 months after the last subject participating in2
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).
Time frame
Approximately 12 months after the last subject participating in3
Adverse Event (AE)
Type, incidence, grading (based on NCI-CTCAE v5.0 criteria), and duration of adverse event.
Time frame
Up to approximately 2 yearsSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: