Combination of nab-paclitaxel and cisplatin before surgery for esophageal cancer
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
This study is testing if a combination of nab-paclitaxel and cisplatin before surgery can help people with advanced esophageal cancer have better outcomes compared to just having surgery alone.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 202 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Hebei Medical University Fourth Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Shijiazhuang, Hebei) |
| Trial ID | NCT03964753 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness and safety of using nab-paclitaxel combined with cisplatin as neoadjuvant therapy for patients with locally advanced esophageal squamous cell carcinoma. The study is designed as a prospective, randomized, controlled, multicenter phase II trial, comparing outcomes of patients receiving this combination therapy followed by surgery against those undergoing surgery alone. The aim is to determine if the addition of nab-paclitaxel improves surgical outcomes and overall patient prognosis.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with resectable locally advanced esophageal squamous cell carcinoma and no prior systemic antitumor therapy.
Not a fit: Patients with distant metastasis or those who have previously received systemic antitumor therapy for esophageal cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance treatment outcomes and survival rates for patients with locally advanced esophageal squamous cell carcinoma.
How similar studies have performed: Other studies have shown promising results with similar neoadjuvant therapies, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Shijiazhuang, Hebei
- Jun Feng Liu — Shijiazhuang, Hebei, China (Recruiting)
Study contacts
- Study coordinator: Junfeng Liu, PhD
- Email: liujf@hbmu.edu
- Phone: 13931152296
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.