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

NCT03964753 | Recruiting Phase 2

• 1 other identifier: HebeiJLiu
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• OS

  Overall survival，From date of randomization until death due to any cause

  up to 5 years

Secondary Outcomes (6)

• OS rate

  1 year,3years,5years

• DFS rate

  1 year,3years,5years

• R0 resection rate

  within 4 weeks following the operation

• Down-staging rate

  within 6 weeks following the last dose of chemotherapy

• Rate of Operative Complications

  within 4 weeks following the operation

Study Arms (2)

Neo-adjuvant chemotherapy group

EXPERIMENTAL

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

Drug: Nab-paclitaxel and Cisplatin; Procedure: surgery

Surgery alone

ACTIVE COMPARATOR

Surgery alone

Procedure: surgery

Interventions

Nab-paclitaxel and Cisplatin DRUG

Nab-paclitaxel,125mg/m(2), d1,d8, Cisplatin,75mg/m(2), d1, 3 week, 2 cycles.

Neo-adjuvant chemotherapy group

surgery PROCEDURE

surgery

Neo-adjuvant chemotherapy group; Surgery alone

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hebei Medical University Fourth Hospital: lead

Study Sites (1)

Jun Feng Liu

Shijiazhuang, Hebei, 050011, China

RECRUITING

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

130-nm albumin-bound paclitaxel; Cisplatin; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Central Study Contacts

Junfeng Liu, PhD

CONTACT

13931152296; liujf@hbmu.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of thoracic surgery

Study Record Dates

• First Submitted: May 18, 2019
• First Posted: May 28, 2019
• Study Start: April 24, 2019
• Primary Completion (Estimated): June 24, 2026
• Study Completion (Estimated): December 24, 2026
• Last Updated: October 10, 2023

Record last verified: 2023-10

Locations

CN (1)