Chemoradiotherapy in Esophageal or Esophagogastric Junction Cancer

NCT04821778 | Recruiting Phase 3

• 1 other identifier: NCC2722
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 5

Brief Summary

Definitive chemoradiotherapy is the standard of care in unresectable esophageal or esophagogastric cancer. A multidisciplinary approach, including chemotherapy and radiotherapy, is important for these patients. Morerover, molecular targeting agents does not show clear efficacy in EC up to now. Nowadays, the pace of development of cancer immunotherapies is accelerating. Clinical evidence of the efficacy of immune checkpoint inhibitors and adoptive immunotherapies herald the onset of a new era in cancer immunotherapy. There have also been recent developments to provide a promising frontier in extending the use of immunotherpay or targeting agents to radiotherapy. The purpose of this study was to explore the optimal treatment modalities including PD-1/PD-L1 antibody or targeted drug for patients with unresectable esophageal or esophagogastric junction cancer.

Conditions

Targeted Therapy; Immunotherapy; Chemotherapy Effect; Esophagus Cancer; Esophagogastric Junction Cancer; Chemoradiation

Outcome Measures

Primary Outcomes (4)

• Overall survival

  1year

• Overall survival

  2 year

• Overall survival

  3 year

• Overall survival

  5 year

Secondary Outcomes (6)

• Progression free survival

  1 year, 2 year, 3 year, 5 year

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

  3 months

• Pathological response rate

  3 months

• R0 resection rate

  3 months

• Locoregional recurrence free survival

  1 year, 2 year, 3 year, 5 year

Other Outcomes (4)

• Analysis of correlation between radiomics signature extracted by LASSO and the number of participants with treatment-related adverse events as assessed by CTCAE v4.0.

  1 year, 2 year, 3 year, 5 year

• Radiomics analysis

  1 year, 2 year, 3 year, 5 year

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

  1 year, 2 year, 3 year, 5 year

Study Arms (2)

Definitive Chemoradiation

PLACEBO COMPARATOR

This arm received chemoradiation without immunotherapy/targeting agents as definitive treatment.

Radiation: Radiotherapy; Drug: Platinum based chemotherapy; Drug: Paclitaxel based chemotherapy; Drug: 5-FU Analog based chemotherapy

Chemoradiation Combined With Immunotherapy/targeting agents

EXPERIMENTAL

This arm received chemoradiation with immunotherapy/targeting agents as definitive treatment.

Radiation: Radiotherapy; Drug: Platinum based chemotherapy; Drug: Paclitaxel based chemotherapy; Drug: Immunotherapy; Drug: 5-FU Analog based chemotherapy; Drug: Nimotuzumab

Interventions

Radiotherapy RADIATION

50-66Gy/1.8-2.2Gy/25-30f

Chemoradiation Combined With Immunotherapy/targeting agents; Definitive Chemoradiation

Platinum based chemotherapy DRUG

q1-3W according to physician's preference

Chemoradiation Combined With Immunotherapy/targeting agents; Definitive Chemoradiation

Paclitaxel based chemotherapy DRUG

q1-3W according to physician's preference

Chemoradiation Combined With Immunotherapy/targeting agents; Definitive Chemoradiation

Immunotherapy DRUG

Anti-PD-1/PD-L1 Antibody

Chemoradiation Combined With Immunotherapy/targeting agents

5-FU Analog based chemotherapy DRUG

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

Chemoradiation Combined With Immunotherapy/targeting agents; Definitive Chemoradiation

Nimotuzumab DRUG

200-400mg, d1,qW

Chemoradiation Combined With Immunotherapy/targeting agents

Eligibility Criteria

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

You may qualify if:

• ≥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；

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (5)

Department 4th of Radiation Oncology, Anyang Cancer Hospital

Anyang, Henan, 455001, China

RECRUITING

Hunan Cancer Hospital, the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University

Changsha, Hunan, 410031, China

RECRUITING

Department of Radiation oncology, Jiangsu Cancer Hospital/Jiangsu Institute of Cancer Research/The affiliated Cancer Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210009, China

RECRUITING

Department of Radiation oncology, Jiangsu Province Hospital/The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 210029, China

RECRUITING

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

RECRUITING

Related Publications (1)

• Yang X, Wang X, Xiao Q, Ge X, Yu N, Li J, Feng G, Zheng Z, Jiang Y, Lu L, Xia X, Deng L, Zhang T, Wang W, Liu W, Wang J, Xiao Z, Zhou Z, Bi N, Wang H, Chen C, Wang X. Definitive chemoradiotherapy combined with anti-PD-1 immunotherapy for inoperable esophageal squamous cell carcinoma: a multicenter real-world study. Cancer Biol Ther. 2025 Dec;26(1):2504726. doi: 10.1080/15384047.2025.2504726. Epub 2025 May 14.

  PMID: 40367097 DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Radiotherapy; Platinum Compounds; Immunotherapy; nimotuzumab

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Inorganic Chemicals; Immunomodulation; Biological Therapy

Central Study Contacts

Xin Wang, MD

CONTACT

+861013311583220; beryl_wx2000@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 15, 2021
• First Posted: March 30, 2021
• Study Start: January 1, 2002
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

CN (5)