Esophageal CancerPhase 3NCT04821843
Neoadjuvant Treatment Modalities in Esophageal Cancer
A Phase 3 study testing Platinum based chemotherapy, Paclitaxel based chemotherapy and Radiotherpay in people with Esophageal Cancer and Chemotherapy Effect, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer, Chemotherapy Effect, Chemoradiation
- What is being tested?
- Platinum based chemotherapy, Paclitaxel based chemotherapy and Radiotherpay
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2002to 31 Dec 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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；
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- 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
Xin Wang, MD, +861013311583220, beryl_wx2000@163.com
About this study
Official title: Cohort Study of Neoadjuvant Treatment Modalities for 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.
- Conditions
- Esophageal Cancer, Chemotherapy Effect, Chemoradiation, Surgery, Targeted Therapy, Immunotherapy
- Being tested
- Platinum based chemotherapy, Paclitaxel based chemotherapy, Radiotherpay, Surgery, Immunotherapy
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platinum based chemotherapyDrug
q1-3W according to physician's preference
Paclitaxel based chemotherapyDrug
q1-3W according to physician's preference
RadiotherpayRadiation
40-50Gy/1.8-2.2Gy/20-25f
SurgeryProcedure or surgery
Radical esophagectomy
ImmunotherapyDrug
Anti-PD-1/PD-L1 Antibody
5-FU Analog based chemotherpayDrug
W1-5 qW or d1-14, q3W according to physician's preference
NimotuzumabDrug
200-400mg, d1,qW
| Study group | Role | What they receive |
|---|---|---|
| (Neoadjuvant chemotherapy) nCT | Experimental | This arm received chemotherapy with or without immunotherapy/targeting agents as neoadjuvant treatment. Receives: Drug: Platinum based chemotherapy; Drug: Paclitaxel based chemotherapy; Radiation: Radiotherpay; Procedure: Surgery; Drug: Immunotherapy; Drug: 5-FU Analog based chemotherpay; Drug: Nimotuzumab |
| (Neoadjuvant Chemoradiation) nCRT | Placebo comparator | This arm received chemoradiotherapy with or without immunotherapy/targeting agents as neoadjuvant treatment. Receives: Drug: Platinum based chemotherapy; Drug: Paclitaxel based chemotherapy; Procedure: Surgery; Drug: Immunotherapy; Drug: 5-FU Analog based chemotherpay; Drug: Nimotuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 5 year
Secondary outcomes (6)
Progression free survival
Measured: 1 year, 2 year, 3 year, 5 year
Number of participants with Acute and late toxicities of radiotherapy,chemotherapy and immunotherapy
Acute and late toxicities are evaluated by NCI-CTC version 5.0
Measured: 3 months
Pathological response rate
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).
Measured: 3 months
R0 resection rate
Measured: 3 months
Locoregional recurrence free survival
Measured: 1 year, 2 year, 3 year, 5 year
Distant metastasis free survival
Measured: 1 year, 2 year, 3 year, 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2021
- Study start1 Jan 2002
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, XIN WANG, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04821843
- Sponsor's protocol ID
- NCC2721
- Status last verified
- Jan 2026
- First submitted
- 15 Mar 2021
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Study of Neoadjuvant Treatment Modalities for Esophageal Cancer
- ClinicalTrials.gov ID
- NCT04821843
- Acronym / sponsor ID
- NCC2721
- Conditions
- Esophageal Cancer, Chemotherapy Effect, Chemoradiation, Surgery, Targeted Therapy, Immunotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jan 2002 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 30 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| (Neoadjuvant chemotherapy) nCT | Experimental | Drug: Platinum based chemotherapy, Drug: Paclitaxel based chemotherapy, Radiation: Radiotherpay, Procedure: Surgery, Drug: Immunotherapy, Drug: 5-FU Analog based chemotherpay, Drug: NimotuzumabThis arm received chemotherapy with or without immunotherapy/targeting agents as neoadjuvant treatment. |
| (Neoadjuvant Chemoradiation) nCRT | Placebo comparator | Drug: Platinum based chemotherapy, Drug: Paclitaxel based chemotherapy, Procedure: Surgery, Drug: Immunotherapy, Drug: 5-FU Analog based chemotherpay, Drug: NimotuzumabThis arm received chemoradiotherapy with or without immunotherapy/targeting agents as neoadjuvant treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ≥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；
Key exclusion criteria (8 listed)
- 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；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platinum based chemotherapyq1-3W according to physician's preference | Drug | (Neoadjuvant Chemoradiation) nCRT, (Neoadjuvant chemotherapy) nCT |
| Paclitaxel based chemotherapyq1-3W according to physician's preference | Drug | (Neoadjuvant Chemoradiation) nCRT, (Neoadjuvant chemotherapy) nCT |
| Radiotherpay40-50Gy/1.8-2.2Gy/20-25f | Radiation | (Neoadjuvant chemotherapy) nCT |
| SurgeryRadical esophagectomy | Procedure or surgery | (Neoadjuvant Chemoradiation) nCRT, (Neoadjuvant chemotherapy) nCT |
| ImmunotherapyAnti-PD-1/PD-L1 Antibody | Drug | (Neoadjuvant Chemoradiation) nCRT, (Neoadjuvant chemotherapy) nCT |
| 5-FU Analog based chemotherpayW1-5 qW or d1-14, q3W according to physician's preference | Drug | (Neoadjuvant Chemoradiation) nCRT, (Neoadjuvant chemotherapy) nCT |
| Nimotuzumab200-400mg, d1,qW | Drug | (Neoadjuvant Chemoradiation) nCRT, (Neoadjuvant chemotherapy) nCT |
Primary outcome
Overall survival
Time frame: 5 year
6 secondary outcomes
Progression free survival
Time frame: 1 year, 2 year, 3 year, 5 year
Number of participants with Acute and late toxicities of radiotherapy,chemotherapy and immunotherapy
Time frame: 3 months
Pathological response rate
Time frame: 3 months
R0 resection rate
Time frame: 3 months
Locoregional recurrence free survival
Time frame: 1 year, 2 year, 3 year, 5 year
Distant metastasis free survival
Time frame: 1 year, 2 year, 3 year, 5 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
Related trials for Esophageal Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Platinum based chemotherapy, Paclitaxel based chemotherapy and Radiotherpay in people with Esophageal Cancer and Chemotherapy Effect, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xin Wang, MD (+861013311583220, beryl_wx2000@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.