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ATP-tumor chemosensitivity assay (ATP-TCA) directed neoadjuvant therapy versus conventional neoadjuvant therapy for patients with adenocarcinoma or squamous cell carcinoma of the esophagus

ATP-tumor chemosensitivity assay (ATP-TCA) directed neoadjuvant therapy versus conventional neoadjuvant therapy for patients with adenocarcinoma or squamous cell carcinoma of the esophagus

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900024882
Enrollment
Unknown
Registered
2019-08-01
Start date
2019-08-01
Completion date
Unknown
Last updated
2019-08-27

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

Conditions

Esophageal cancer

Interventions

Experimental group:The biopsies of patients in ATP-TCA directed neoadjuvant therapy arm will be used to measure the sensitivity of the five given chemotherapeutic drugs and the four combination regime
Control group:Patients in Conventional neoadjuvant therapy arm will take the common chemotherapy regimen: DDP+5-Fu.

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. The tumor is histologically proven squamous cell carcinoma or adenocarcinoma of the esophagus; 2. Thoracic esophagus tumor; 3.The preoperative staging according to the 8th AJCC TNM staging is T3-4aN0-2M0 and tumor is recognized as resectable esophageal carcinoma; 4. Aged 18 to 75 years old; 5. An acceptable general condition: ECOG performance status 0, 1, 2; weight loss 50%; 7. Abundant pulmonary function: FEV1 >=1.2 L; 8. Patients must have adequate hematological, renal and hepatic functions defined as: granulocytes >=1.5*10^9/L, platelets >=100*10^9/L, total bilirubin <=28 mol, creatinine <=120 mol/L; 9. Patients who will sign the informed consent voluntarily.

Exclusion criteria

Exclusion criteria: 1. Other types of esophageal carcinoma; 2. The tumor extend more than 2 cm into the gastric cardia, or the longitudinal tumor length exceed 8 cm or the radial size exceed 5 cm; 3. The tumor locates <20cm from incisors; 4. The cT1-2, cT4b, and cN3 tumors are not eligible; 5.The patients are accompanied with other malignant tumors; 6. Malnutrition patients; 7. Patients with poor compliance.

Design outcomes

Primary

MeasureTime frame
Overall survival;Pathological responses;

Secondary

MeasureTime frame
Disease free survival;The number of R0 resections;Treatment toxicity;Cost;

Countries

China

Contacts

Public ContactChen Long-Qi

West China Hospital, Sichuan University

drchenlq@scu.edu.cn+86 18980601850

Outcome results

None listed

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