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NCT Number: NCT04821843

Neoadjuvant Treatment Modalities in Esophageal Cancer

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.

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Key information

Conditions

Esophageal Cancer Chemoradiation Chemotherapy Effect Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Esophagogastric Juction Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Immunotherapy Neoplasms Neoplasms by Site Surgery Targeted Therapy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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, 100021, China

Location status: Recruiting

Location contact

Xin Wang, MD

CONTACT

[email protected]

+861013311583220

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Platinum based chemotherapy

Drug

q1-3W according to physician's preference

Paclitaxel based chemotherapy

Drug

q1-3W according to physician's preference

Radiotherpay

Radiation

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

Surgery

Procedure

Radical esophagectomy

Immunotherapy

Drug

Anti-PD-1/PD-L1 Antibody

5-FU Analog based chemotherpay

Drug

W1-5 qW or d1-14, q3W according to physician's preference

Nimotuzumab

Drug

200-400mg, d1,qW

Primary outcomes

  1. Overall survival

    Time frame: 5 year

Secondary outcomes

  1. Progression free survival

    Time frame: 1 year, 2 year, 3 year, 5 year

  2. Number of participants with Acute and late toxicities of radiotherapy,chemotherapy and immunotherapy

    Time frame: 3 months

    Acute and late toxicities are evaluated by NCI-CTC version 5.0

  3. Pathological response rate

    Time frame: 3 months

    Pathological response were classified into three grades.Grade I signifies that there is little shrinkage in the tumor; only mild regression in the tumor cells is observed under themicroscope. Grade II shows gross reduction in size of the tumor and marked regression in the cancer cells microscopically, yet viable nests of cancer tissue are still visible. Grade III implies complete or almost total resolution of the tumor on exploration, and disappearance of the tumor tissue microscopically; only remnants of degenerated cancer cells can be seen (so-called ghost cancer cells).

  4. R0 resection rate

    Time frame: 3 months

  5. Locoregional recurrence free survival

    Time frame: 1 year, 2 year, 3 year, 5 year

  6. Distant metastasis free survival

    Time frame: 1 year, 2 year, 3 year, 5 year

Other outcomes

  1. Analysis of the correlation between radiation dose and the number of participants with treatment-related adverse events as assessed by CTCAE v4.0.

    Time frame: 1 year, 2 year, 3 year, 5 year

  2. Radiomics analysis

    Time frame: 1 year, 2 year, 3 year, 5 year

    The value of Radiomics of MRI and CT in predicting pathological complete response (pCR) or no response (NR) and the correlation between radiomics of MRI and CT and overall survival (OS), which is defined as the time from the beginning of neoadjuvant chemotherapy to the death with any causes.

  3. Target dealineation of organs at risk and their impact on the prognosis and adverse effects of radiotherapy

    Time frame: 1 year, 2 year, 3 year, 5 year

  4. Target dealineation of clinical target volumn and their impact on the prognosis

    Time frame: 1 year, 2 year, 3 year, 5 year

Study contacts

Contact information is provided by the study sponsor or research team.

Xin Wang, MD

CONTACT

[email protected]

+861013311583220

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Registry information

Official study title

Cohort Study of Neoadjuvant Treatment Modalities for Esophageal Cancer

Important dates

Study start
2002
Primary completion
2030
Study completion
2030
First posted
Mar 30, 2021
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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