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Phase II Study of S-1 in Combination With Radiotherapy in Esophageal Squamous Cell Carcinoma

Phase 2
18 Years
Open (Enrolling)
Esophageal Squamous Cell Carcinoma

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Trial Information

Phase II Study of S-1 in Combination With Radiotherapy in Esophageal Squamous Cell Carcinoma

Inclusion Criteria:

- Joined the study voluntarily and signed informed consent form;

- Age >75 or age 18-75 who are intolerant of or reject intravenous chemotherapy

- Both genders

- Esophageal squamous cell carcinoma confirmed by pathology

- Local advanced esophageal squamous cell carcinoma (T2-4N0-1M0-1a,TxN1M0-1a,TxNxM1a,
AJCC 6th)

- No radiotherapy, chemotherapy or other treatments prior to enrollment

- PS ECOG 0-2

- Life expectancy of more than 3 months

- Hemoglobin(Hb)≥9 g/dL

- WBC≥3x109/L, Neutrophils (ANC )≥1.5x109/L

- platelet count (Pt) ≥100x 109/L

- Hepatic function: ALAT and ASAT < 2.5 x ULN, TBIL<1.5 x ULN

- Renal function: creatinine < 1.5 x ULN

- No immuno-deficiency

- Use of an effective contraceptive for adults to prevent pregnancy.

Exclusion Criteria:

- Complete esophageal obstruction

- Deep esophageal ulcer

- Esophageal perforation

- Haematemesis

- After surgery, exploratory thoracotomy, radiotherapy, chemotherapy, or targeting

- Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma
in situ, who survived with no evidence disease for over 3 years

- Participation in other interventional clinical trials within 30 days

- Pregnant or breast-feeding women or people during the birth-period who refused to
take contraceptives

- Drug addiction

- Alcoholism or AIDS

- Uncontrolled seizures or psychiatric diseases, loss of control over their own

- Patient who has metastasis such as lung, liver metastasis

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of participants with adverse events

Outcome Time Frame:

1 years

Safety Issue:


Principal Investigator

Kuaile Zhao, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fudan University


China: Ethics Committee

Study ID:




Start Date:

March 2013

Completion Date:

March 2018

Related Keywords:

  • Esophageal Squamous Cell Carcinoma
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Esophageal Diseases
  • Esophageal Neoplasms