Esophageal Squamous Cell CarcinomaPhase 2NCT07266493
Efficacy and Safety of Neoadjuvant Envafolimab Combined With Albumin-bound Paclitaxel and Carboplatin for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma
A Phase 2 study testing Chemotherapy （Albumin bound paclitaxel and Carboplatin） in people with Esophageal Squamous Cell Carcinoma and Neoadjuvant Therapy, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
This single center, prospective, single arm clinical study aims to evaluate the clinical efficacy and safety of Envafolimab combined with albumin bound paclitaxel and carboplatin as neoadjuvant therapy for locally advanced esophageal squamous cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma, Neoadjuvant Therapy
- What is being tested?
- Chemotherapy （Albumin bound paclitaxel and Carboplatin）
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2023to 1 Dec 2026
- Phase
- Phase 2
- 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
- The subjects voluntarily joined this study, were able to sign the informed consent form, and had good compliance;
- Age ≥ 18 years old (when signing the informed consent form);
- ECOG score 0-1 points;
- Diagnosed with operable esophageal squamous cell carcinoma through pathological diagnosis (pathological tissue/cytology) and imaging;
- The clinical TNM staging is T2-4aNxM0
- Patients assessed to require routine neoadjuvant therapy;
- Have not received immunotherapy, chemotherapy, targeted therapy, or radiotherapy in the past;
- Expected survival ≥ 12 weeks
Who cannot join
- The subjects have any active autoimmune diseases or a history of autoimmune diseases (such as but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, pituitary inflammation, vasculitis, nephritis, thyroid dysfunction (hyperthyroidism/hypothyroidism), and the use of drugs cannot maintain thyroid function within the normal range, or patients who have undergone thyroid surgery and require long-term replacement therapy with thyroid hormone and other drugs after surgery); Subjects with vitiligo or complete remission of childhood asthma who do not require any intervention in adulthood may be included; Asthma in which subjects require bronchodilators for medical intervention cannot be included
- The subject has previous or concurrent malignant tumors;
- Patients who have received systemic anti-tumor therapy in the past;
- Individuals who have undergone significant surgical treatment, open biopsy, or significant traumatic injury within 28 days prior to the start of treatment; Or there may be wounds or fractures that have not been cured for a long time;
- There is a risk of bleeding, coagulation dysfunction, or currently undergoing thrombolytic therapy; Or have experienced esophageal or gastric variceal rupture bleeding in the past 6 months;
- It is known that the subject has a history of allergies to large molecule protein preparations or drug ingredients used;
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- Subjects with any severe and/or uncontrolled illnesses
- Ascites or pleural effusion with clinical symptoms cannot be controlled with medication and require therapeutic puncture or drainage;
- The subject is known to have a history of substance abuse, alcoholism, or drug use;
- The researchers believe that participants should be excluded from this study, for example, if the researchers determine that there are other factors that may cause the study to be terminated 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, 1 recruiting
- Recruiting
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
Di Ge, MD, 86-18202188606, gedi@zs-hospital.sh.cn
About this study
Official title: A Single-arm, Open-label, Single-center Prospective Study of Neoadjuvant Envafolimab Combined With Albumin-bound Paclitaxel and Carboplatin for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma
This single center, prospective, single arm clinical study aims to evaluate the clinical efficacy and safety of Envafolimab combined with albumin bound paclitaxel and carboplatin as neoadjuvant therapy for locally advanced esophageal squamous cell carcinoma.
- Being tested
- Chemotherapy （Albumin bound paclitaxel and Carboplatin）
- Keywords
- Esophageal Squamous Cell Carcinoma, Neoadjuvant therapy, Chemotherapy, Immunotherapy
- 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.
Chemotherapy （Albumin bound paclitaxel and Carboplatin）Drug
Also called Albumin bound paclitaxel and Carboplatin
Albumin bound paclitaxel: administered on days 1, 8, and 15, 100 mg/m2, IV , treated for 3 weeks, followed by a 1-week rest period; Carboplatin: administered on days 1, AUC 5, treated for 3 weeks, followed by a 1-week rest period.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Envafolimab+Chemotherapy Group（EC Group） | Experimental | Envafolimab: 150mg, subcutaneous injection, administered on days 1, 8, and 15, treated for 3 weeks, followed by a 1-week rest period; Albumin bound paclitaxel: administered on days 1, 8, and 15, 100 mg/m2, IV , treated for 3 weeks, followed by a 1-week rest period; Carboplatin: administered on days 1, AUC 5, treated for 3 weeks, followed by a 1-week rest period. All patients will receive treatment with Envafolimab combined with albumin bound paclitaxel and carboplatin for three weeks, followed by one week of rest and a 28 day treatment cycle, for a total of two cycles. Then, the tumor condition of the patients will be evaluated to determine whether surgical treatment is feasible. Receives: Drug: Chemotherapy （Albumin bound paclitaxel and Carboplatin） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response (pCR) rate
Measured: From enrollment to the end of treatment at 8 weeks
Secondary outcomes (5)
R0 resection rate
Measured: From enrollment to the end of treatment at 10 weeks
Major pathological response rate
Measured: From enrollment to the end of treatment at 8 weeks
ORR
Objective response rate
Measured: From enrollment to the end of Cycle 2 (each cycle is 28 days)
3y-RFS rate
3-year recurrence free survival rate
Measured: From enrollment until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 36 months
3y-OS rate
3-year Overall survival rate
Measured: From enrollment until the date of death from any cause, assessed up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start1 Dec 2023
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Dec 2026 (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 CarcinomaStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Ge Di, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07266493
- Sponsor's protocol ID
- B2023-222R
- Status last verified
- Nov 2025
- First submitted
- 25 Nov 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Open-label, Single-center Prospective Study of Neoadjuvant Envafolimab Combined With Albumin-bound Paclitaxel and Carboplatin for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07266493
- Acronym / sponsor ID
- B2023-222R
- Keywords
- Esophageal Squamous Cell Carcinoma, Neoadjuvant therapy, Chemotherapy, Immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Collaborators
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 5 Dec 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.
This single center, prospective, single arm clinical study aims to evaluate the clinical efficacy and safety of Envafolimab combined with albumin bound paclitaxel and carboplatin as neoadjuvant therapy for locally advanced esophageal squamous cell carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Envafolimab+Chemotherapy Group（EC Group） | Experimental | Drug: Chemotherapy （Albumin bound paclitaxel and Carboplatin）Envafolimab: 150mg, subcutaneous injection, administered on days 1, 8, and 15, treated for 3 weeks, followed by a 1-week rest period; Albumin bound paclitaxel: administered on days 1, 8, and 15, 100 mg/m2, IV , treated for 3 weeks, followed by a 1-week rest period; Carboplatin: administered on days 1, AUC 5, treated for 3 weeks, followed by a 1-week rest period. All patients will receive treatment with Envafolimab combined with albumin bound paclitaxel and carboplatin for three weeks, followed by one week of rest and a 28 day treatment cycle, for a total of two cycles. Then, the tumor condition of the patients will be evaluated to determine whether surgical treatment is feasible. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The subjects voluntarily joined this study, were able to sign the informed consent form, and had good compliance;
- Age ≥ 18 years old (when signing the informed consent form);
- ECOG score 0-1 points;
- Diagnosed with operable esophageal squamous cell carcinoma through pathological diagnosis (pathological tissue/cytology) and imaging;
- The clinical TNM staging is T2-4aNxM0
Key exclusion criteria (10 listed)
- The subjects have any active autoimmune diseases or a history of autoimmune diseases (such as but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, pituitary inflammation, vasculitis, nephritis, thyroid dysfunction (hyperthyroidism/hypothyroidism), and the use of drugs cannot maintain thyroid function within the normal range, or patients who have undergone thyroid surgery and require long-term replacement therapy with thyroid hormone and other drugs after surgery); Subjects with vitiligo or complete remission of childhood asthma who do not require any intervention in adulthood may be included; Asthma in which subjects require bronchodilators for medical intervention cannot be included
- The subject has previous or concurrent malignant tumors;
- Patients who have received systemic anti-tumor therapy in the past;
- Individuals who have undergone significant surgical treatment, open biopsy, or significant traumatic injury within 28 days prior to the start of treatment; Or there may be wounds or fractures that have not been cured for a long time;
- There is a risk of bleeding, coagulation dysfunction, or currently undergoing thrombolytic therapy; Or have experienced esophageal or gastric variceal rupture bleeding in the past 6 months;
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 |
|---|---|---|
| Chemotherapy （Albumin bound paclitaxel and Carboplatin）Also: Albumin bound paclitaxel and CarboplatinAlbumin bound paclitaxel: administered on days 1, 8, and 15, 100 mg/m2, IV , treated for 3 weeks, followed by a 1-week rest period; Carboplatin: administered on days 1, AUC 5, treated for 3 weeks, followed by a 1-week rest period. | Drug | Experimental: Envafolimab+Chemotherapy Group（EC Group） |
Primary outcome
Pathological complete response (pCR) rate
Time frame: From enrollment to the end of treatment at 8 weeks
5 secondary outcomes
R0 resection rate
Time frame: From enrollment to the end of treatment at 10 weeks
Major pathological response rate
Time frame: From enrollment to the end of treatment at 8 weeks
ORR
Time frame: From enrollment to the end of Cycle 2 (each cycle is 28 days)
3y-RFS rate
Time frame: From enrollment until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 36 months
3y-OS rate
Time frame: From enrollment until the date of death from any cause, assessed up to 36 months
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 5 Dec 2025.
- Individual participant dataSharing planned: No
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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 study testing Chemotherapy （Albumin bound paclitaxel and Carboplatin） in people with Esophageal Squamous Cell Carcinoma and Neoadjuvant Therapy, run by Shanghai Zhongshan Hospital 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 10 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 5 Dec 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 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.
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 Di Ge, MD (86-18202188606, gedi@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response (pCR) rate (time frame: From enrollment to the end of treatment at 8 weeks). 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 5 Dec 2025.