Squamous Cell Carcinoma of Esophagus
Conditions
Keywords
Neoadjuvant chemotherapy, Nimotuzumab, Nab-Paclitaxel, Carcinoma of Esophagus
Brief summary
Nimotuzumab, a humanized monoclonal antibody against epidermal growth factor receptor (EGFR),has been shown to be effective and safe in some studies with head-neck cancers.Nab-paclitaxel regimen in advanced NSCLC has a better tumor response rate and safety than solvent-based paclitaxel.However,the safety and efficacy of Nimotuzumab plus nab-paclitaxel regimen is uncertain in neoadjuvant therapy in esophageal cancer.The investigators then initiated a phase II clinical trial with Nimotuzumab plus Nab-paclitaxel/cisplatin as the neoadjuvant chemotherapy in patients with locally advanced esophageal squamous cell carcinoma to observe the efficacy and safety of the combination.
Detailed description
In the past decade, clinical trials have evaluated the role of neoadjuvant chemotherapy, radiation, or both, for patients with surgically resectable esophageal carcinoma, but have all failed to demonstrate a consistent survival benefit. In Eastern countries, preoperative chemotherapy followed by radical surgery became one of the treatment strategies for resectable, clinical stage II or III esophageal cancer. In an effort to improve the efficacy of systemic chemotherapy, we conducted a prospective study to evaluate the regimen of Nimotuzumab plus Nab-paclitaxel/cisplatin as perioperative therapy for patients with resectable esophageal squamous cell carcinoma.
Interventions
DRUGNimotuzumab
Nimotuzumab: 200mg,IV once a week for 6 weeks during chemotherapy (days 1,8,15,22,29,36).
Sponsors
Zhejiang University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed squamous cell carcinoma of the thoracic esophagus, including the gastroesophageal junction (Siewert type I) * Locally advanced disease that is technically operable with curative intent (R0) * T3, N0 OR T1-3, N+ OR T4, Nx * No T1-2, N0 * No inoperable T4 (unequivocal organ involvement) * No distant metastasis, including M1a lymph node status * Lymph nodes suspicious of M1a status by CT scan, PET scan, or ultrasound must be verified by fine-needle aspiration cytology * No carcinoma of the cervical esophagus * Obstructive tumors allowed
Exclusion criteria
* Not suitable to surgery * cervical Esophageal Carcinoma(distance of incisor tooth\<19cm) * early Esophageal Carcinoma(Stage I) * complete esophageal obstruction，Esophageal perforation or hematemesis * other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ * pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives * Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior * History of serious allergic or castor oil allergy * Patients who are not suitable to participate in the trial according to researchers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| response rate | From date of treatment until the date of progression, assessed up to 2 months | pathological response rate and clinical response rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | Overall survival was measured from the date of treatment to the date of death, or last follow-up,assessed up to 48 months | — |
| Progression-free survival | Progression-free survival was measured from the date of treatment to the date of first evidence of relapse or death due to any cause,assessed up to 36 months | — |
| Adverse events | During the chemotherapy,an expected average of 3 weeks | Adverse events were classified according to U.S. National Cancer Institute common toxicity criteria, version 4.0 |
Countries
China
Outcome results
None listed