Esophageal Squamous Cell Carcinoma (ESCC)Phase 2/3NCT06861777
Total Neoadjuvant Therapy Combined With Adebrelimab in Locally Advanced Resectable ESCC
A Phase 2/3 study testing Adebrelimab + paclitaxel/nab-paclitaxel + cisplatin followed by chemoradiotherapy, chemoradiotherapy followed by adebrelimab + paclitaxel/nab-paclitaxel + cisplatin and TNT treatment [TNT group one (phase 2) or TNT group two (phase 2)] in people with Esophageal Squamous Cell Carcinoma (ESCC), run by YIN LI at 1 site in China.
Trial summary
Esophageal cancer is a malignant tumor with high incidence rate and mortality in China. According to the data of the World Health Organization, 324000 new cases and 301000 deaths of esophageal cancer will occur in China in 2020, accounting for 53.70% and 55.35% of the global incidence and death of esophageal cancer… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma (ESCC)
- What is being tested?
- Adebrelimab + paclitaxel/nab-paclitaxel + cisplatin followed by chemoradiotherapy, chemoradiotherapy followed by adebrelimab + paclitaxel/nab-paclitaxel + cisplatin and TNT treatment [TNT group one (phase 2) or TNT group two (phase 2)]
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 474 participants
- Where
- 1 siteChina
- Study dates
- Mar 2025to May 2031
- Phase
- Phase 2/3
- 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
- Sign a informed consent form and voluntarily join this study;
- Esophageal squamous cell carcinoma diagnosed by histopathology or cytology;
- Diagnosed as thoracic esophageal cancer by CT/MRI/EUS and clinically staged as T1b-3N1-2M0 or T3N0M0 (according to AJCC 8th edition);
- Expected to achieve R0 resection;
- Age ≥ 18 years old, regardless of gender;
- ECOG PS 0-1;
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- Have not received any anti-tumor treatment for esophageal cancer in the past;
- Plan to undergo surgical treatment after completion of neoadjuvant therapy;
- No surgical contraindications;
- The main organ functions are normal, including:
- Blood routine examination:
- neutrocyte count ≥ 1.5 × 109/L Platelet count ≥ 100 × 109/L Hemoglobin ≥ 90 g/L
- Blood biochemistry test:
- Total bilirubin ≤ 1.5 × ULN ALT ≤ 2.5×ULN，AST ≤ 2.5×ULN， Serum creatinine ≤ 1.5 × ULN, or creatinine clearance rate ≥ 50 mL/min (Cocheroft Gault formula, see Appendix 2)
- Coagulation function:
- INR ≤ 1.5 × ULN APTT ≤ 1.5 × ULN
- Women who have the ability to conceive or men whose spouses have the ability to conceive should use effective contraceptive measures during the study period;
- The subjects showed good compliance and cooperated with follow-up visits;
Who cannot join
- Tumors or lymph nodes significantly invade adjacent organs of esophageal lesions;
- Patients with supraclavicular lymph node metastasis;
- Individuals at risk of perforation, fistula, etc;
- There are uncontrollable pleural effusion, pericardial effusion, or ascites that require repeated drainage;
- Poor nutritional status, BMI < 18.5 Kg/m2；
- Have a history of allergies to monoclonal antibodies, any components of Adebrelimab, paclitaxel, cisplatin, or other platinum based drugs in the past;
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- Have received or are currently receiving any of the following treatments:
- Any radiotherapy, chemotherapy, or other anti-tumor drugs targeting tumors;
- Within 2 weeks prior to the first use of the investigational drug, immunosuppressive or systemic hormone therapy was being used to achieve immunosuppressive effects;
- Received attenuated live vaccine within 4 weeks prior to the first use of the investigational drug;
- Having undergone major surgery or suffered severe trauma within 4 weeks prior to the first use of the investigational drug;
- Suffering from any active autoimmune disease or history of autoimmune disease;
- History of immunodeficiency, including HIV testing positive, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation or allogeneic bone marrow transplantation;
- There are clinical symptoms or diseases of the heart that have not been well controlled;
- Severe infection (CTCAE>grade 2) occurred within 4 weeks prior to the first use of the investigational drug;
- Discovery of active pulmonary tuberculosis infection through medical history or CT examination;
- Active hepatitis B and hepatitis C exist;
- Diagnosed with other malignant tumors within 5 years prior to the first use of the investigational drug;
- Pregnant or lactating women;
- According to the researchers' assessment, there are other factors that may lead to the forced termination of the study midway.
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
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing
Jianjun Qin, Chief physician, 86-13838008630, qinjianjun@cicams.ac.cn
Yin Li, chief physician
About this study
Official title: Clinical Trial of Total Neoadjuvant Therapy Combined With Adebrelimab in Locally Advanced Resectable Esophageal Squamous Cell Carcinoma
Esophageal cancer is a malignant tumor with high incidence rate and mortality in China. According to the data of the World Health Organization, 324000 new cases and 301000 deaths of esophageal cancer will occur in China in 2020, accounting for 53.70% and 55.35% of the global incidence and death of esophageal cancer respectively.
Surgery is the main method for locally advanced resectable esophageal cancer, combined with chemoradiotherapy(CRT), in order to achieve curative resection. However, after neoadjuvant chemoradiotherapy and surgery, 36-50% of patients still experience recurrence or metastasis, and the prognosis for early recurrence is worse. Adjuvant chemotherapy plays a particularly beneficial role in terms of disease-free survival(DFS) in patients who did not receive neoadjuvant therapy and patients with pathologic lymph-node-positive disease. however, less than 50% of eligible patients receive their scheduled adjuvant chemotherapy due to delays, treatment compliance, and postoperative complications. Among patients with resected esophageal cancer who had received neoadjuvant CRT, DFS was significantly longer among those who received nivolumab adjuvant therapy than among those who received placebo.
Read more
Total neoadjuvant therapy (TNT), attempts to deliver both systemic chemotherapy and neoadjuvant CRT prior to surgery, which may become a new treatment direction for patients with locally advanced resectable esophageal cancer. Ongoing progress in all treatment modalities involved in TNT holds the promise to enhance further the outcomes of patients with esophageal cancer. Immunotherapy, as a breakthrough therapy in the systemic treatment of advanced esophageal cancer, has become an indispensable component of the exploration of TNT model. Currently, several prospective exploratory studies suggest that immunotherapy combined with TNT can improve the pCR rate of esophageal cancer patients, achieving good short-term efficacy and tolerable safety.
However, further exploration is needed for the combination of immunotherapy and TNT. This study first explores the efficacy and safety of two types of total neoadjuvant therapy in phase II: the combination of adebrelimab and chemotherapy followed by chemoradiotherapy, or the combination of adebrelimab and chemotherapy after chemoradiotherapy. A more promising treatment plan will be selected for a phase III randomized controlled trial and confirm the superiority of adebrelimab combined with TNT over neoadjuvant CRT in terms of pathological complete response overall survival in patients with locally advanced resectable esophageal cancer.
- Being tested
- Adebrelimab + paclitaxel/nab-paclitaxel + cisplatin followed by chemoradiotherapy, chemoradiotherapy followed by adebrelimab + paclitaxel/nab-paclitaxel + cisplatin, TNT treatment [TNT group one (phase 2) or TNT group two (phase 2)], Chemoradiotherapy
- Keywords
- locally advanced resectable ESCC, adebrelimab, total neoadjuvant therapy
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adebrelimab + paclitaxel/nab-paclitaxel + cisplatin followed by chemoradiotherapyOther
Neoadjuvant treatment:
adebrelimab 1200 mg/m2 d1+ paclitaxel d1/nab-paclitaxel d1,8, + cisplatin d1, Q2W×2 followed by chemoradiotherapy (paclitaxel /nab-paclitaxel + cisplatin + 41.4Gy/23f), surgical resection 4-8 weeks later neoadjuvant treatment.
chemoradiotherapy followed by adebrelimab + paclitaxel/nab-paclitaxel + cisplatinOther
Neoadjuvant treatment:
chemoradiotherapy (paclitaxel /nab-paclitaxel + cisplatin + 41.4Gy/23f), followed by adebrelimab 1200 mg/m2 d1+ paclitaxel d1/nab-paclitaxel d1,8, + cisplatin d1, Q2W×2 surgical resection 4-8 weeks later neoadjuvant treatment.
TNT treatment [TNT group one (phase 2) or TNT group two (phase 2)]Other
Neoadjuvant treatment:
TNT treatment [TNT group one (phase 2) or TNT group two (phase 2)] followed by surgical resection 4-8 weeks later adjuvant treatment: adebrelimab 1200 mg/m2 d1, W3Q, adjuvant treatment for one year
ChemoradiotherapyOther
Neoadjuvant treatment:
chemoradiotherapy (paclitaxel 50 mg/m2/nab-paclitaxel 60 mg/m2 d1, 8, 15, 22,29 + cisplatin 25 mg/m2 d1, 8, 15, 22,29 + 41.4Gy/23f), followed by surgical resection 4-8 weeks later. adjuvant treatment: non-pCR: adebrelimab 1200 mg/m2 d1, W3Q, adjuvant treatment for one year pCR: observation
| Study group | Role | What they receive |
|---|---|---|
| TNT group one (phase 2) | Experimental | Neoadjuvant adebrelimab combined with paclitaxel/nab-paclitaxel and cisplatin for 2 cycles, followed by chemoradiotherapy (paclitaxel/nab-paclitaxel and cisplatin+41.4Gy/23f), and then surgical resection 4-8 weeks later. Receives: Other: Adebrelimab + paclitaxel/nab-paclitaxel + cisplatin followed by chemoradiotherapy |
| TNT group two (phase 2) | Experimental | Neoadjuvant chemoradiotherapy (paclitaxel/nab-paclitaxel and cisplatin+41.4Gy/23f), followed by adebrelimab combined with paclitaxel/nab-paclitaxel and cisplatin for 2 cycles, and then surgical resection 4-8 weeks later. Receives: Other: chemoradiotherapy followed by adebrelimab + paclitaxel/nab-paclitaxel + cisplatin |
| TNT treatment group (phase 3) | Experimental | The patients received neoadjuvant TNT treatment, followed by surgical resection 4-8 weeks later, and then adjuvant adebrelimab for one year. Receives: Other: TNT treatment [TNT group one (phase 2) or TNT group two (phase 2)] |
| CRT treatment group (phase 3) | Active comparator | Neoadjuvant chemoradiotherapy (paclitaxel/nab-paclitaxel and cisplatin+41.4 Gy/23f), followed by surgical resection 4-8 weeks later. Non-pCR subjects received adjuvant treatment with adebrelimab for one year. Receives: Other: Chemoradiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
pCR (phase 2 and phase 3)
The rate of patients with primary tumor and lymph nodes both achieved pathological complete response
Measured: one month after esophageal cancer surgery
EFS (phase 3)
The time from randomization to the occurrence of events as defined by the study protocol.
Measured: Approximately 5 years
Secondary outcomes (7)
R0 resection rate (phase 2 and phase 3)
The proportion of patients with negative surgical margins among those who underwent radical surgery for esophageal cancer.
Measured: one month after esophageal cancer surgery
MPR (phase 2 and phase 3)
The percentage of subjects with less than 10% tumor residue in the primary tumor site.
Measured: one month after esophageal cancer surgery
Tumor regression (phase 2 and phase 3)
The research center performed tumor regression grade (TRG) assessments using the Mandard 5-point classification system.
Measured: one month after esophageal cancer surgery
ypTNM (phase 2 and phase 3)
According to AJCC 8th Edition criteria, the rate of patients who have reached ypI-IVA stages respectively.
Measured: one month after esophageal cancer surgery
OS (phase 2 and phase 3)
The time from randomization to death due to any cause.
Measured: Approximately 6 years
EFS (phase 2)
The time from randomization to the occurrence of events as defined by the study protocol.
Measured: Approximately 5 years
DFS (phase 3)
For postoperative subjects free of esophageal cancer disease, the time from the first day without disease (i.e., the date of surgery) to either local recurrence or distant metastasis, or death from any cause, whichever occurs first.
Measured: Approximately 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study startMar 2025 (estimated)
- Primary completionMay 2031 (estimated)
- Study completionMay 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell Carcinoma (ESCC)Studies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 474 participants (estimated)
Sponsor and investigators
- Lead sponsor
- YIN LI
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, YIN LI, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06861777
- Sponsor's protocol ID
- NCC5115
- Status last verified
- Mar 2025
- First submitted
- 3 Mar 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the conclusion of the study, Individual Participant Data (IPD) will be shared through the publication of articles.
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Total Neoadjuvant Therapy Combined With Adebrelimab in Locally Advanced Resectable Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT06861777
- Acronym / sponsor ID
- NCC5115
- Keywords
- locally advanced resectable ESCC, adebrelimab, total neoadjuvant therapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 474 participants (estimated)
- Lead sponsor
- YIN LIUniversity, hospital or other
- Study start
- Mar 2025 (estimated)
- Primary completion
- May 2031 (estimated)
- Study completion
- May 2031 (estimated)
- First posted
- 6 Mar 2025 (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 a malignant tumor with high incidence rate and mortality in China. According to the data of the World Health Organization, 324000 new cases and 301000 deaths of esophageal cancer will occur in China in 2020, accounting for 53.70% and 55.35% of the global incidence and death of esophageal cancer respectively.
Surgery is the main method for locally advanced resectable esophageal cancer, combined with chemoradiotherapy(CRT), in order to achieve curative resection. However, after neoadjuvant chemoradiotherapy and surgery, 36-50% of patients still experience recurrence or metastasis, and the prognosis for early recurrence is worse. Adjuvant chemotherapy plays a particularly beneficial role in terms of disease-free survival(DFS) in patients who did not receive neoadjuvant therapy and patients with pathologic lymph-node-positive disease. however, less than 50% of eligible patients receive their scheduled adjuvant chemotherapy due to delays, treatment compliance, and postoperative complications. Among patients with resected esophageal cancer who had received neoadjuvant CRT, DFS was significantly longer among those who received nivolumab adjuvant therapy than among those who received placebo.
Total neoadjuvant therapy (TNT), attempts to deliver both systemic chemotherapy and neoadjuvant CRT prior to surgery, which may become a new treatment direction for patients with locally advanced resectable esophageal cancer. Ongoing progress in all treatment modalities involved in TNT holds the promise to enhance further the outcomes of patients with esophageal cancer. Immunotherapy, as a breakthrough therapy in the systemic treatment of advanced esophageal cancer, has become an indispensable component of the exploration of TNT model. Currently, several prospective exploratory studies suggest that immunotherapy combined with TNT can improve the pCR rate of esophageal cancer patients, achieving good short-term efficacy and tolerable safety.
However, further exploration is needed for the combination of immunotherapy and TNT. This study first explores the efficacy and safety of two types of total neoadjuvant therapy in phase II: the combination of adebrelimab and chemotherapy followed by chemoradiotherapy, or the combination of adebrelimab and chemotherapy after chemoradiotherapy. A more promising treatment plan will be selected for a phase III randomized controlled trial and confirm the superiority of adebrelimab combined with TNT over neoadjuvant CRT in terms of pathological complete response overall survival in patients with locally advanced resectable esophageal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TNT group one (phase 2) | Experimental | Other: Adebrelimab + paclitaxel/nab-paclitaxel + cisplatin followed by chemoradiotherapyNeoadjuvant adebrelimab combined with paclitaxel/nab-paclitaxel and cisplatin for 2 cycles, followed by chemoradiotherapy (paclitaxel/nab-paclitaxel and cisplatin+41.4Gy/23f), and then surgical resection 4-8 weeks later. |
| TNT group two (phase 2) | Experimental | Other: chemoradiotherapy followed by adebrelimab + paclitaxel/nab-paclitaxel + cisplatinNeoadjuvant chemoradiotherapy (paclitaxel/nab-paclitaxel and cisplatin+41.4Gy/23f), followed by adebrelimab combined with paclitaxel/nab-paclitaxel and cisplatin for 2 cycles, and then surgical resection 4-8 weeks later. |
| TNT treatment group (phase 3) | Experimental | Other: TNT treatment [TNT group one (phase 2) or TNT group two (phase 2)]The patients received neoadjuvant TNT treatment, followed by surgical resection 4-8 weeks later, and then adjuvant adebrelimab for one year. |
| CRT treatment group (phase 3) | Active comparator | Other: ChemoradiotherapyNeoadjuvant chemoradiotherapy (paclitaxel/nab-paclitaxel and cisplatin+41.4 Gy/23f), followed by surgical resection 4-8 weeks later. Non-pCR subjects received adjuvant treatment with adebrelimab for one year. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Sign a informed consent form and voluntarily join this study;
- Esophageal squamous cell carcinoma diagnosed by histopathology or cytology;
- Diagnosed as thoracic esophageal cancer by CT/MRI/EUS and clinically staged as T1b-3N1-2M0 or T3N0M0 (according to AJCC 8th edition);
- Expected to achieve R0 resection;
- Age ≥ 18 years old, regardless of gender;
Key exclusion criteria (20 listed)
- Tumors or lymph nodes significantly invade adjacent organs of esophageal lesions;
- Patients with supraclavicular lymph node metastasis;
- Individuals at risk of perforation, fistula, etc;
- There are uncontrollable pleural effusion, pericardial effusion, or ascites that require repeated drainage;
- Poor nutritional status, BMI < 18.5 Kg/m2；
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 |
|---|---|---|
| Adebrelimab + paclitaxel/nab-paclitaxel + cisplatin followed by chemoradiotherapyNeoadjuvant treatment: adebrelimab 1200 mg/m2 d1+ paclitaxel d1/nab-paclitaxel d1,8, + cisplatin d1, Q2W×2 followed by chemoradiotherapy (paclitaxel /nab-paclitaxel + cisplatin + 41.4Gy/23f), surgical resection 4-8 weeks later neoadjuvant treatment. | Other | TNT group one (phase 2) |
| chemoradiotherapy followed by adebrelimab + paclitaxel/nab-paclitaxel + cisplatinNeoadjuvant treatment: chemoradiotherapy (paclitaxel /nab-paclitaxel + cisplatin + 41.4Gy/23f), followed by adebrelimab 1200 mg/m2 d1+ paclitaxel d1/nab-paclitaxel d1,8, + cisplatin d1, Q2W×2 surgical resection 4-8 weeks later neoadjuvant treatment. | Other | TNT group two (phase 2) |
| TNT treatment [TNT group one (phase 2) or TNT group two (phase 2)]Neoadjuvant treatment: TNT treatment [TNT group one (phase 2) or TNT group two (phase 2)] followed by surgical resection 4-8 weeks later adjuvant treatment: adebrelimab 1200 mg/m2 d1, W3Q, adjuvant treatment for one year | Other | TNT treatment group (phase 3) |
| ChemoradiotherapyNeoadjuvant treatment: chemoradiotherapy (paclitaxel 50 mg/m2/nab-paclitaxel 60 mg/m2 d1, 8, 15, 22,29 + cisplatin 25 mg/m2 d1, 8, 15, 22,29 + 41.4Gy/23f), followed by surgical resection 4-8 weeks later. adjuvant treatment: non-pCR: adebrelimab 1200 mg/m2 d1, W3Q, adjuvant treatment for one year pCR: observation | Other | CRT treatment group (phase 3) |
Primary outcome
pCR (phase 2 and phase 3)
Time frame: one month after esophageal cancer surgery
The rate of patients with primary tumor and lymph nodes both achieved pathological complete response
EFS (phase 3)
Time frame: Approximately 5 years
The time from randomization to the occurrence of events as defined by the study protocol.
7 secondary outcomes
R0 resection rate (phase 2 and phase 3)
Time frame: one month after esophageal cancer surgery
MPR (phase 2 and phase 3)
Time frame: one month after esophageal cancer surgery
Tumor regression (phase 2 and phase 3)
Time frame: one month after esophageal cancer surgery
ypTNM (phase 2 and phase 3)
Time frame: one month after esophageal cancer surgery
OS (phase 2 and phase 3)
Time frame: Approximately 6 years
EFS (phase 2)
Time frame: Approximately 5 years
DFS (phase 3)
Time frame: Approximately 5 years
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 11 Mar 2025.
- Individual participant dataSharing planned: Yes. After the conclusion of the study, Individual Participant Data (IPD) will be shared through the publication of articles.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Adebrelimab + paclitaxel/nab-paclitaxel + cisplatin followed by chemoradiotherapy, chemoradiotherapy followed by adebrelimab + paclitaxel/nab-paclitaxel + cisplatin and TNT treatment [TNT group one (phase 2) or TNT group two (phase 2)] in people with Esophageal Squamous Cell Carcinoma (ESCC), run by YIN LI 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 18 inclusion and 20 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: opening soon, as of the sponsor's last update on 11 Mar 2025. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Jianjun Qin, chief physician (86-13838008630, qinjianjun@cicams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pCR (phase 2 and phase 3) (time frame: one month after esophageal cancer surgery). The study lists 2 primary outcomes in all. 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 11 Mar 2025; AzTrials last refreshed its copy on 6 Nov 2026.