Neoadjuvant Treatment Modalities in Esophageal Cancer

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Enrolling; Phase 3

Conditions: Esophagogastric Juction Cancer; Chemotherapy Effect; Targeted Therapy; Esophageal Cancer; Immunotherapy; Surgery; Chemoradiation

Treatments: Drug: Platinum based chemotherapy; Radiation: Radiotherpay; Drug: 5-FU Analog based chemotherpay; Drug: Paclitaxel based chemotherapy; Drug: Immunotherapy; Drug: Nimotuzumab; Procedure: Surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT04821843

NCC2721

Details and patient eligibility

About

Esophageal cancer is the most prevalent cancer globally with poor survival outcome. The prognosis with surgery alone is poor, accounting for 30-40% of overall survival at 5 year. Either neoadjuvant chemotherapy (nCT) or chemoradiotherapy (nCRT) has been shown as efficatious therapy to improve patients outcomes in esophageal or esophagogastric junction cancer as compared with surgery alone. The purpose of this study was to explore the optimal neoadjuvant treatment modalities including PD-1/PD-L1 antibody or targeted drug for patients with esophageal or esophagogastric junction cancer.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≥18 years；
• Esophageal or Esophagogastric cancer；
• Histologically proven squamous cell carcinoma or adenocarcinoma in patients staged as I-IVa (AJCC 8th)；
• Primary treatment performed in Cancer Hospital, Chinese Academy of Medical Sciences；
• ECOG PS score: 0~1；
• Estimated survival time ≥3 months；
• Normal organ and marrow function as defined below:Hemoglobin: greater than or equal to 100g/L ;Leukocytes: greater than or equal to 4,000 G/L; Neutrophil: greater than or equal to 2,000 G/L; Platelets: greater than or equal to 100,000/mm3 ; Creatinine: less than or equal to 1.5 times the upper limit or CCR greater than or equal to 60 ml/min; AST/ALT: less than or equal to 2.5 times the upper limit; Total bilirubin: less than or equal to 1.5 times the upper limit; INR: less than or equal to 1.5 times the upper limit; APTT: less than or equal to 1.5 times the upper limit; PT: less than or equal to 1.5 times the upper limit；
• Informed consent；

Exclusion criteria

• With any distant metastasis out of regional lymphatic drainage or in liver, lung, bone, CNS, etc；
• Patients with other cancer history in 5 years except cervical carcinoma in situ and non-malignant melanoma skin cancer；
• Existing active infection such as active tuberculosis and hepatitis；
• History of myocardial infarction within the past 6 months or history of ventricular arrhythmia；
• Uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness History of allergic reactions attributed to paclitaxel, albumin or cisplatin；
• Participation in other clinical trials currently or within 4 weeks of selection；
• Pregnant or lactating females；
• Absence of medical records.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,000 participants in 2 patient groups, including a placebo group

(Neoadjuvant chemotherapy) nCT

Experimental group

Description:

This arm received chemotherapy with or without immunotherapy/targeting agents as neoadjuvant treatment.

Treatment:

Procedure: Surgery

Drug: Nimotuzumab

Drug: Immunotherapy

Drug: Paclitaxel based chemotherapy

Drug: 5-FU Analog based chemotherpay

Radiation: Radiotherpay

Drug: Platinum based chemotherapy

(Neoadjuvant Chemoradiation) nCRT

Placebo Comparator group

Description:

This arm received chemoradiotherapy with or without immunotherapy/targeting agents as neoadjuvant treatment.

Treatment:

Procedure: Surgery

Drug: Nimotuzumab

Drug: Immunotherapy

Drug: Paclitaxel based chemotherapy

Drug: 5-FU Analog based chemotherpay

Drug: Platinum based chemotherapy