The Effectiveness and Safety of Neoadjuvant Therapy With Nab-paclitaxel and Cisplatin Followed by Surgery Versus Surgery Alone for Locally Advanced Esophageal Squamous Cell Carcinoma

Who is this study for? Patients with Esophageal Cancer
What treatments are being studied? Surgery
Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

To verify the role of nab-paclitaxel in neoadjuvant therapy for esophageal squamous cell carcinoma, the investigators designed a prospective, randomized, controlled , multicente phase II trial, to investigate the efficacy and safety of nab-paclitaxel combined with cisplatin as neoadjuvant therapy followed by surgery versus surgery alone for esophageal squamous cell carcinoma.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Age ranges from 18 to 75 years

• Radiographically, histologically or/and cytologically diagnosed resectable locally advanced middle-lower esophageal squamous cell carcinoma without distant metastasis,cT1N1M0 or T2-3N0-1M0(according to UICC esophageal cancer TNM staging system 8th edition)

• Enhanced CT showed the presence of potentially resectable lesions. Resectability features included no evidence of mediastinal infiltration, No evidence of tracheobronchial fistula or tumor entry into the airway

• Have not previously received systemic antitumor therapy for esophageal squamous cell carcinoma (Including radiotherapy, chemotherapy, targeted therapy, immunotherapy)

• ECOG performance status 0-1

• Expected survival more than 6 months

• No contraindications in the organ function tests before surgery

• The laboratory test meet the following requirements:

⁃ Bone marrow function: neutrophils ≥ 1.5×10(9)/L, platelets ≥ 100×10(9)/L, hemoglobin ≥ 90 g/L Liver function:Total bilirubin ≤ 1.5x ULN;AST and ALT) ≤ 2.5x ULN Renal function:Cr ≤ 1.5x ULN,Ccr ≥ 55 ml/min Coagulation function:INR≤1.5×ULN, PT≤1.5ULN, APTT within the normal range

• Female patients of child-bearing age agree to take effective contraceptive measures during the study period and 6 months after reseach completion;Pregnancy tests in serum or urine must be negative 7 days prior to study enrollment;Non-lactating patients;male patients agree to take effective contraceptive measures during the study period and 6 months after reseach completion

• Not concomitant with other uncontrollable benign disease before the recruitment(e.g. the infection in the kidney, lung and liver)

• Not participating in other clinical trials 4 weeks before the treatment

• The patient has good compliance with the planned treatment, understands the research process of the study and signs a written informed consent form.

Locations
Other Locations
China
Jun Feng Liu
RECRUITING
Shijiazhuang
Contact Information
Primary
Junfeng Liu, PhD
liujf@hbmu.edu
13931152296
Time Frame
Start Date: 2019-04-24
Estimated Completion Date: 2026-12-24
Participants
Target number of participants: 202
Treatments
Experimental: Neo-adjuvant chemotherapy group
cisplatin and nab-paclitaxel: Nab-paclitaxel, 125mg/m(2), d1,d8, Cisplatin, 75mg/m(2), d1, 3 week, 2 cycles.~Surgery:~4-6weeks after Neo-adjuvant chemotherapy
Active_comparator: Surgery alone
Surgery alone
Related Therapeutic Areas
Sponsors
Leads: Hebei Medical University Fourth Hospital

This content was sourced from clinicaltrials.gov

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