Efficacy and Safety of TPFinduction Chemotherapy Boundary Resectable Local Advanced Esophageal Squamous Cell Carcinoma

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Paclitaxel In combination with DDP and 5-FU(TPF) as neoadjuvant chemotherapy in treating boundary resectable locally advanced esophageal squamous cell carcinoma: A phase II clinical trial.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yuhong Li
• Treatments: Albumin-Bound Paclitaxel; Cisplatin; Fluorouracil; Paclitaxel

Criteria

Inclusion Criteria:

1. Patients should be voluntary to the trial and provide with signed informed consent.

2. Male or female patients, age:18-70 years old

3. Confirmed by histology of thoracic esophageal squamous cell carcinoma without metastasis and diagnosed as boundary resectable by Multidisciplinary consultation, including cT4 and lymph node metastasis that may invade nearby organs(such as great vessels,trachea,etc.)

4. Lesions can be measured according the RECIST 1.1 criteria.

5. No previous chemotherapy or radiotherapy.

6. Life expectancy ≥ 3 months.

7. ECOG PS 0-1.

8. Blood routine within 7 days：Hb ≥9g/L，NE ≥1.5×109/L，PLT ≥100×109/L；

9. Hepatic and renal function：TB £ 1.5 UNL， Cr £ 1.5× UNL， AST / ALT £ 2.5 ´ UNL， ALP £ 5.0 ´ UNL。

10. No severe complications such as active digestive tract hemorrhage, perforation, jaundice, gastrointestinal obstruction, non-cancerous fever > 38 ℃

11. Fertile patients should take effective contraceptive measures.

12. Patients should have good compliance and cooperate with the evaluation of efficacy and adverse events and follow-ups according to the research plan.

Exclusion Criteria:

1. Cervical esophageal carcinoma.

2. Known severe hypersensitivity to drugs in the regimen.

3. Patient has a concurrent malignancy or has a malignancy within 5 years of study enrollment(with the exception of nonmelanoma skin cancer or cervical carcinoma in situ).

4. Evidence of serious heart disease, including recorded history of congestive heart-failure, uncontrolled serious arrhythmia, angina that needs treatment of drugs, clinical diagnosed cardiac valve disease, history of serious myocardial infarction and intractable hypertension.

5. Evidence of chronic diarrhea(≥4 times/day) or renal dysfunction.

6. Evidence of active infection or active epidemic disease.

7. Psychiatric illness that would prevent the patient from giving informed consent

8. Pregnant or lactating women.