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The single-arm, open clinical trial of neoadjuvant chemotherapy with docetaxel, cisplatin, and S-1 for stage IB-IIIA esophageal squamous cell carcinoma

The single-arm, open clinical trial of neoadjuvant chemotherapy with docetaxel, cisplatin, and S-1 for stage IB-IIIA esophageal squamous cell carcinoma

Status
Active, not recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800014659
Enrollment
Unknown
Registered
2018-01-27
Start date
2018-03-01
Completion date
Unknown
Last updated
2018-01-29

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

Conditions

Esophageal Carcinoma

Interventions

Case series:Docetaxel + Cisplatin + S-1 Neoadjuvant chemotherapy

Sponsors

Affilliated Tumor Hospital of ZhengZhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. The initial clinical stage was IB-IIIA phase of thoracic esophageal squamous cell carcinoma (7th UICC-TNM staging); 2. No antitumor treatment performed before neoadjuvant chemotherapy; 3. Aged 18 to 75 years; 4. All pre-treament organ function tests can tolerate neoadjuvant chemotherapy and operation; 5. Absolute white blood cells count =4.0×10^9/L, neutrophil =1.5×10^9/L, platelets =100.0×10^9/L, hemoglobin =90g/L, and normal functions of liver and kidney, total bilirubin(TBIL)=1.5N, aspartate aminotransferase (AST)=2.5N, alanine aminotransferase(ALT)=2.5N, prothrombin time(PT)=1.5N, and activated partial thromboplastin time(APTT) is in normal range, endogenous creatinine clearance rate(CRE)=1.5N; 6. No medical history of chemotherapy, radiotherapy, or hormone therapy for malignant tumors, hormone therapy for prostate cancer and patients with DFS for more than 5 years was not included; 7. Be able to achieve R0 resection; 8. ECOG score 0 ~ 2; 9. The subjects must understand and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Multiple primary cancer; 2. Patients with psychosis; 3. Patients with severe emphysema and pulmonary fibrosis; 4. Active infection requiring drug treatment; 5. Patients with bleeding tendency; 6. Other inoperable and inoperable patients; 7. Previous operation resulted in no use of the stomach to replace the esophagus for reconstruct; 8. Female patients in pregnancy or lactation; 9. Hypersensitivity of the chemotherapy drug docetaxel, cisplatin or S-1.

Design outcomes

Primary

MeasureTime frame
Response rate;

Countries

China

Contacts

Public ContactQin Jian-jun

Affilliated Tumor Hospital of ZhengZhou University

qinjianjun73@aliyun.com+86 0371-65588265

Outcome results

None listed

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