RecruitingPhase 2NCT03964753

Neoadjuvant Therapy With Nab-paclitaxel and Cisplatin for Locally Advanced Esophageal Squamous Cell Carcinoma

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

Sponsor

Hebei Medical University Fourth Hospital

Enrollment

202 participants

Start Date

Apr 24, 2019

Study Type

INTERVENTIONAL

Conditions

Esophageal Squamous Cell Carcinoma

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria13

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.

Exclusion Criteria15

Histological confirmation of esophageal adenocarcinoma
with distant metastasis, without radical resection (stage IV)
Ever administrated with other drugs(including TCM drugs) before the recruitment, or no guarantee of progress according to the study requirement after recruitment
Grade 2 or above peripheral neuropathy or hemorrhage according to NCI CTCAE 4.03
Combined with severe cardiovascular disease, including hypertension that cannot be controlled by medical treatment(BP≥160/95mmHg), unstable angina, a history of myocardial infarction in the past 6 months,Congestive heart failure\>NYHA grade II, severe arrhythmia, pericardial effusion, etc.
Combined with severe ADH abnormal secretion syndrome, poorly controlled diabetes: more than 40 units of insulin per day need to be continuously administered; or 40 units of insulin per day for continuous use or not used, but fasting blood glucose is still above 14mmol / L, HbA1c above 9.0
Long-term use of anticoagulants or vitamin K antagonists such as warfarin, heparin or its analogues for more than 6 months,small doses of warfarin (≤1mg / day) or aspirin (≤100mg / day) for prevention purposes are not included
Major surgery within 4 weeks prior to enrollment, or surgical wounds have not fully healed
Operation can not use the stomach instead of esophageal cancer to reconstruct the digestive tract due to previous operation
Severe infection within 1 week prior to the start of study, requiring intravenous antibiotics, antifungal or antiviral therapy
Known to be allergic, highly sensitive or intolerable to research-related drugs or excipient
In the past 5 years, there were other malignant tumors, melanoma skin cancer or ervical carcinoma in situ were excepted
Any indicator shows chemotherapy and surgery contraindications
Women who are pregnant or lactating
The investigator determined that unable to complete the study due to medical, social, or psychological reasons or were unable to sign valid informed consent