NCT04821843

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for phase_3

Timeline
57mo left

Started Jan 2002

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Jan 2002Dec 2030

Study Start

First participant enrolled

January 1, 2002

Completed
19.2 years until next milestone

First Submitted

Initial submission to the registry

March 15, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 30, 2021

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

29 years

First QC Date

March 15, 2021

Last Update Submit

January 18, 2026

Conditions

Esophageal CancerChemotherapy EffectSurgeryChemoradiationTargeted TherapyImmunotherapyEsophagogastric Juction Cancer

Outcome Measures

Primary Outcomes (1)

  • 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

  • +1 more secondary outcomes

Other Outcomes (4)

  • Analysis of the correlation between radiation dose 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

  • +1 more other outcomes

Study Arms (2)

(Neoadjuvant chemotherapy) nCT

EXPERIMENTAL

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

Drug: Platinum based chemotherapyDrug: Paclitaxel based chemotherapyRadiation: RadiotherpayProcedure: SurgeryDrug: ImmunotherapyDrug: 5-FU Analog based chemotherpayDrug: Nimotuzumab

(Neoadjuvant Chemoradiation) nCRT

PLACEBO COMPARATOR

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

Drug: Platinum based chemotherapyDrug: Paclitaxel based chemotherapyProcedure: SurgeryDrug: ImmunotherapyDrug: 5-FU Analog based chemotherpayDrug: Nimotuzumab

Interventions

Paclitaxel based chemotherapyDRUG

q1-3W according to physician's preference

(Neoadjuvant Chemoradiation) nCRT(Neoadjuvant chemotherapy) nCT
RadiotherpayRADIATION

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

(Neoadjuvant chemotherapy) nCT
Platinum based chemotherapyDRUG

q1-3W according to physician's preference

(Neoadjuvant Chemoradiation) nCRT(Neoadjuvant chemotherapy) nCT
SurgeryPROCEDURE

Radical esophagectomy

(Neoadjuvant Chemoradiation) nCRT(Neoadjuvant chemotherapy) nCT
ImmunotherapyDRUG

Anti-PD-1/PD-L1 Antibody

(Neoadjuvant Chemoradiation) nCRT(Neoadjuvant chemotherapy) nCT
5-FU Analog based chemotherpayDRUG

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

(Neoadjuvant Chemoradiation) nCRT(Neoadjuvant chemotherapy) nCT
NimotuzumabDRUG

200-400mg, d1,qW

(Neoadjuvant Chemoradiation) nCRT(Neoadjuvant chemotherapy) nCT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Platinum CompoundsSurgical Procedures, OperativeImmunotherapynimotuzumab

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Inorganic ChemicalsImmunomodulationBiological TherapyTherapeutics

Central Study Contacts

Xin Wang, MD

CONTACT

+861013311583220beryl_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(1)