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Clinical Trials in China / NCT04821843
Recruiting Phase 3

Neoadjuvant Treatment Modalities in Esophageal Cancer

NCT04821843 · tracked via the Priya Life Science China tracker
Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Phase
Phase 3
Started
2002-01-01
Last updated
2026-01-21

Condition(s) studied

Esophageal CancerChemotherapy EffectChemoradiationSurgeryTargeted TherapyImmunotherapyEsophagogastric Juction Cancer

Investigational drug(s) / intervention(s)

Platinum based chemotherapyPaclitaxel based chemotherapyRadiotherpaySurgeryImmunotherapy5-FU Analog based chemotherpayNimotuzumab

Platinum based chemotherapy: q1-3W according to physician's preference

Paclitaxel based chemotherapy: q1-3W according to physician's preference

Radiotherpay: 40-50Gy/1.8-2.2Gy/20-25f

Surgery: Radical esophagectomy

Immunotherapy: Anti-PD-1/PD-L1 Antibody

5-FU Analog based chemotherpay: W1-5 qW or d1-14, q3W according to physician's preference

Nimotuzumab: 200-400mg, d1,qW

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC) Beijing China Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04821843 on ClinicalTrials.gov ↗ ← All trials in China