Esophagus CancerPhase 3NCT04821778
Chemoradiotherapy in Esophageal or Esophagogastric Junction Cancer
A Phase 3 study testing Radiotherapy, Platinum based chemotherapy and Paclitaxel based chemotherapy in people with Esophagus Cancer and Esophagogastric Junction Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 5 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophagus Cancer, Esophagogastric Junction Cancer, Chemoradiation
- What is being tested?
- Radiotherapy, Platinum based chemotherapy and Paclitaxel based chemotherapy
- 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
- 5 sitesChina
- 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
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Department 4th of Radiation Oncology, Anyang Cancer Hospital
Anyang, Henan, 455001
Yidian Zhao, ayydz101@163.com
Xiaomin Wang, MD, shine828@163.com
- 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
- Recruiting
Hunan Cancer Hospital, the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University
Changsha, Hunan, 410031
Qin Xiao, MD, xiaoqin_200909@163.com
- Recruiting
Department of Radiation oncology, Jiangsu Cancer Hospital/Jiangsu Institute of Cancer Research/The affiliated Cancer Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210009
Cheng Chen, MD
- Recruiting
Department of Radiation oncology, Jiangsu Province Hospital/The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 210029
Xiaolin Ge, MD, doctorgxl@163.com
Xinchen Sun
About this study
Official title: Cohort Study of Definitive Chemoradiotherapy for Esophageal or Esophagogastric Junction Cancer
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
- Esophagus Cancer, Esophagogastric Junction Cancer, Chemoradiation, Targeted Therapy, Immunotherapy, Chemotherapy Effect
- Being tested
- Radiotherapy, Platinum based chemotherapy, Paclitaxel based chemotherapy, Immunotherapy, 5-FU Analog based chemotherapy
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
50-66Gy/1.8-2.2Gy/25-30f
Platinum based chemotherapyDrug
q1-3W according to physician's preference
Paclitaxel based chemotherapyDrug
q1-3W according to physician's preference
ImmunotherapyDrug
Anti-PD-1/PD-L1 Antibody
5-FU Analog based chemotherapyDrug
W1-5 qW or d1-14, q3W according to physician's preference
NimotuzumabDrug
200-400mg, d1,qW
| Study group | Role | What they receive |
|---|---|---|
| Definitive Chemoradiation | Placebo comparator | This arm received chemoradiation without immunotherapy/targeting agents as definitive treatment. Receives: 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. Receives: Radiation: Radiotherapy; Drug: Platinum based chemotherapy; Drug: Paclitaxel based chemotherapy; Drug: Immunotherapy; Drug: 5-FU Analog based chemotherapy; Drug: Nimotuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 1year
Overall survival
Measured: 2 year
Overall survival
Measured: 3 year
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
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophagus 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
- NCT04821778
- Sponsor's protocol ID
- NCC2722
- 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
Publications
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.
PubMed 40367097
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 Definitive Chemoradiotherapy for Esophageal or Esophagogastric Junction Cancer
- ClinicalTrials.gov ID
- NCT04821778
- Acronym / sponsor ID
- NCC2722
- Conditions
- Esophagus Cancer, Esophagogastric Junction Cancer, Chemoradiation, Targeted Therapy, Immunotherapy, Chemotherapy Effect
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Definitive Chemoradiation | Placebo comparator | Radiation: Radiotherapy, Drug: Platinum based chemotherapy, Drug: Paclitaxel based chemotherapy, Drug: 5-FU Analog based chemotherapyThis arm received chemoradiation without immunotherapy/targeting agents as definitive treatment. |
| Chemoradiation Combined With Immunotherapy/targeting agents | Experimental | Radiation: Radiotherapy, Drug: Platinum based chemotherapy, Drug: Paclitaxel based chemotherapy, Drug: Immunotherapy, Drug: 5-FU Analog based chemotherapy, Drug: NimotuzumabThis arm received chemoradiation with immunotherapy/targeting agents as definitive 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 |
|---|---|---|
| Radiotherapy50-66Gy/1.8-2.2Gy/25-30f | Radiation | Chemoradiation Combined With Immunotherapy/targeting agents, Definitive Chemoradiation |
| Platinum based chemotherapyq1-3W according to physician's preference | Drug | Chemoradiation Combined With Immunotherapy/targeting agents, Definitive Chemoradiation |
| Paclitaxel based chemotherapyq1-3W according to physician's preference | Drug | Chemoradiation Combined With Immunotherapy/targeting agents, Definitive Chemoradiation |
| ImmunotherapyAnti-PD-1/PD-L1 Antibody | Drug | Chemoradiation Combined With Immunotherapy/targeting agents |
| 5-FU Analog based chemotherapyW1-5 qW or d1-14, q3W according to physician's preference | Drug | Chemoradiation Combined With Immunotherapy/targeting agents, Definitive Chemoradiation |
| Nimotuzumab200-400mg, d1,qW | Drug | Chemoradiation Combined With Immunotherapy/targeting agents |
Primary outcome
Overall survival
Time frame: 1year
Overall survival
Time frame: 2 year
Overall survival
Time frame: 3 year
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.
- Derived from this study: PubMed 40367097Yang 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.
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Radiotherapy, Platinum based chemotherapy and Paclitaxel based chemotherapy in people with Esophagus Cancer and Esophagogastric Junction Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 5 sites 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 5 sites 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: 1year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04821778, which also lists 1 linked publication.
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.