A clinical study for raltitrexed and cisplatin with concurrent intensity-modulated radiotherapy for locally advanced esophageal cancer

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1900021082

Enrollment

Unknown

Registered

2019-01-27

Start date

2019-03-01

Completion date

Unknown

Last updated

2019-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

esophageal cancer

Interventions

Group 2:Tegafur + cisplatin with concurrent intensity-modulated radiotherapy

Group 1:raltitrexed and cisplatin with concurrent intensity-modulated radiotherapy

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Histopathologically confirmed esophageal squamous cell carcinoma (including high grade squamous intraepithelial neoplasia), clinical stage II to IVa; 2. Aged 18-65 years old, male or female; 3. There are measurable lesions (RECIST version 1.1); 4. ECOG physical status is 0-1, and the expected survival time is = 6 months; 5. At least fluid diet; 6. Laboratory inspections meet the following requirements: WBC = 4.0×10^9/L, neutrophil count = 2.0×10^9/L, PLT = 100×10^9/L, HB = 100g/L (without blood transfusion); total bilirubin, ALT, AST = 1.5 times the upper limit of normal; serum creatinine = upper limit of normal value (creatinine clearance = 65mL/min); normal ECG; 7. Voluntarily sign a treatment consent form.

Exclusion criteria

Exclusion criteria: 1. Cannot complete the designated pretreatment assessor; 2. The biopsy results are nonsquamous or no biopsy results; 3. Chemotherapy and chest radiotherapy before the start of the trial; 4. The primary disease becomes multifocal esophageal cancer; 5. Fiberoptic bronchoscopy or upper gastrointestinal angiography confirmed that there were tracheoesophageal fistulas and esophageal perforation, and active esophageal hemorrhage; 6. known to have an allergic reaction to any treatment 7. Pregnancy (confirmed by urine/blood examination), breast-feeding women or women who have fertility but have not used contraceptive measures; 8. History of malignancy in other sites; 9. With uncontrolled diabetes, high blood pressure, and severe cardiovascular or pulmonary disease; 10. Attending or participating in other clinical trials within the first four weeks of enrollment; 11. The researchers judged other conditions that could affect clinical research and the results of the study.

Design outcomes

Primary

Measure	Time frame
Objective response rate;disease control rate;progression-free survival;Overall survival;	—

Secondary

Measure	Time frame
drug safety;Liver and kidney function;blood routine examination;	—

Countries

China

Contacts

Public ContactHongbing Ma

The Second Affiliated Hospital of Xi'an Jiaotong University

mhbxian@126.com+86 13991845066

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026