ESCCNCT07388095
Adebrelimab Neoadjuvant Treatment for Resectable ESCC
A study testing Adebrelimab (PD-L1 inhibitor) in people with ESCC, run by Tianjin Medical University Cancer Institute and Hospital.
Trial summary
This is a prospective, phase II, exploratory clinical trial. The study aims to evaluate the efficacy and safety of in combination adebrelimab with nimotuzumab and chemotherapy as neoadjuvant therapy in patients with resectable esophageal squamous cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- ESCC
- What is being tested?
- Adebrelimab (PD-L1 inhibitor)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2026to 28 Feb 2028
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent to voluntarily participate in this study;
- Pathologically confirmed resectable esophageal squamous cell carcinoma (excluding mixed adenocarcinoma-squamous cell carcinoma types);
- Thoracic esophageal cancer confirmed by CT/MRI/EUS assessment with clinical stage IIA-IIIB (according to AJCC 8th edition);
- Age 18-75 years, male or female;
- ECOG PS 0-1;
- No prior anticancer treatment for esophageal cancer, including radiotherapy, chemotherapy, or surgery;
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- Planned surgical treatment following completion of neoadjuvant therapy;
- No surgical contraindications;
- Normal major organ function, including: (1) Complete blood count (no use of blood components, cell growth factors, leukocyte-stimulating agents, platelet-stimulating agents, or anemia-correcting agents within 14 days prior to first study drug administration): White blood cell count ≥ 4.0 × 10^9/L Neutrophil count ≥ 1.5 × 10^9/L Platelet count ≥ 90 × 10^9/L Hemoglobin ≥ 90 g/L (2) Blood Biochemistry Tests: Total Bilirubin ≤ 1.5×ULN, LT ≤ 2.5×ULN, AST ≤ 2.5×ULN, Serum Creatinine ≤ 1.5×ULN, or Creatinine Clearance ≥ 50 mL/min (Cockcroft-Gault formula) c) Coagulation Function: International Normalized Ratio (INR) ≤ 1.5×ULN Activated Partial Thromboplastin Time (APTT) ≤ 1.5×ULN
- Female subjects of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to initiation of study drug administration and must use effective contraception (e.g., intrauterine device, oral contraceptives, or condoms) during the trial and for at least 3 months after the last dose. Male subjects with female partners of childbearing potential must use effective contraception during the trial and for 3 months after the last dose;
- Subjects must demonstrate good compliance and willingness to participate in follow-up.
Who cannot join
- Tumor has significantly invaded adjacent organs (major arteries or trachea) near the esophageal lesion;
- Presence of supraclavicular lymph node metastasis;
- Presence of uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage;
- Malnutrition with BMI < 18.5 kg/m²; if corrected by symptomatic nutritional support prior to enrollment and approved by the principal investigator, enrollment may still be considered;
- History of allergy to monoclonal antibodies, any component of adebrelimab, any component of Nimotuzumab, albumin-bound paclitaxel, cisplatin, or other platinum-based drugs;
- Prior or current treatment with any of the following: (1) Any radiation therapy, chemotherapy, or other anti-neoplastic agents directed at the tumor; (2) Use of immunosuppressive agents or systemic corticosteroids for immunosuppression (dose >10 mg/day prednisone or equivalent) within 2 weeks prior to first study drug administration; Inhaled or topical steroids and corticosteroid replacement therapy at a dose >10 mg/day of prednisone or equivalent are permitted in the absence of active autoimmune disease; (3) Received a live attenuated vaccine within 4 weeks prior to the first dose of study drug; (4) Undergone major surgery or sustained severe trauma within 4 weeks prior to the first dose of study drug;
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- Presence of any active autoimmune disease or history of autoimmune disease, including but not limited to: interstitial pneumonia, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (may be considered for inclusion after hormone replacement therapy); Individuals with psoriasis or childhood asthma/allergies that have achieved complete remission and require no intervention in adulthood may be considered for inclusion; however, patients requiring medical intervention with bronchodilators are excluded;
- History of immunodeficiency, including HIV-positive status, or other acquired or congenital immunodeficiency disorders, or history of organ transplantation or allogeneic bone marrow transplantation;
- Uncontrolled cardiac clinical symptoms or disease, including but not limited to: (1) NYHA Class II or higher heart failure, (2) unstable angina, (3) myocardial infarction within the past year, (4) clinically significant supraventricular or ventricular arrhythmias uncontrolled despite clinical intervention or with poor control after intervention;
- Severe infection (CTCAE ≥ Grade 2) within 4 weeks prior to first study drug administration, such as severe pneumonia requiring hospitalization, bacteremia, or infection-related complications; exclusion if baseline chest imaging indicates active pulmonary inflammation, or if symptoms/signs of infection or need for oral/IV antibiotics exist within 14 days prior to first study drug administration (excluding prophylactic antibiotic use);
- Active pulmonary tuberculosis infection identified through medical history or CT examination; history of active pulmonary tuberculosis infection within 1 year prior to enrollment; or history of active pulmonary tuberculosis infection more than 1 year prior without formal treatment;
- Active hepatitis B (HBV DNA ≥ 2000 IU/mL or 10^4 copies/mL) or hepatitis C (HCV antibody positive with HCV RNA above the lower limit of detection of the assay method);
- Imaging demonstrating tumor invasion into the perivascular space of a major vessel, or patients judged by the investigator to be at high risk of fatal hemorrhage due to tumor invasion into a major vessel during the study period;
- Patients diagnosed with other malignancies within 5 years prior to first administration of the study drug, unless the malignancy carries a low risk of metastasis or mortality (5-year survival rate > 90%), such as adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or cervical carcinoma in situ, which may be considered for inclusion;
- Patients with uncontrolled hypertension despite antihypertensive therapy (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg); or patients requiring two or more antihypertensive agents to control blood pressure; patients with a history of hypertensive crisis or hypertensive encephalopathy;
- Pregnant or lactating women;
- Other factors deemed by the investigator to potentially necessitate premature study discontinuation, such as concomitant treatment for other serious illnesses (including psychiatric disorders), alcohol abuse, substance misuse, or familial/social factors that may compromise subject safety or compliance.
- Other circumstances deemed unsuitable for inclusion by the investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Xiangming liu Tianjin Medical University Cancer Institute and Hospital contact
About this study
Official title: Neoadjuvant Treatment With Adebrelimab in Combination With Nimotuzumab and Chemotherapy for Resectable Esophageal Squamous Cell Carcinoma: A Single-arm, Exploratory Phase II Clinical Study
This is a prospective, phase II, exploratory clinical trial.
The study aims to evaluate the efficacy and safety of in combination adebrelimab with nimotuzumab and chemotherapy as neoadjuvant therapy in patients with resectable esophageal squamous cell carcinoma.
Read more
The primary endpoint is pCR ( pathological complete response), evaluating the efficacy of adebrelimab in combination with nimotuzumab and neoadjuvant chemotherapy in patients with resectable esophageal squamous cell carcinoma. After the primary objective is achieved, EFS (event free survival ), R0 resection rate, MPR (major pathological response), OS (overall survival), and safety will be assessed as key secondary objectives. The study plans to enroll 22 patients with resectable esophageal squamous cell carcinoma.
The study is divided into a screening period, a treatment period, and a follow-up period. Subjects will enter the screening period after signing informed consent. Subjects who pass the screening assessment will be enrolled in the study. Eligible subjects will receive two cycles of neoadjuvant therapy with adebrelimab, nimotuzumab, nab-paclitaxel, and cisplatin. Esophagectomy will be performed after two cycles of neoadjuvant therapy (4-6 weeks after the last dose). Researchers will determine subsequent treatment based on postoperative pathology. After treatment (surgery), safety and efficacy follow-ups will commence. When a subject first experiences disease progression as assessed by the investigator according to RECIST v1.1, confirmation is required after 4-6 weeks (except for rapid or significant clinical progression). Subjects whose disease progression is not confirmed by imaging after 4-6 weeks may continue treatment if their clinical symptoms remain stable, as determined by the investigator, until imaging-confirmed disease progression occurs, or other termination criteria as specified in the protocol are met, whichever occurs first.
- Conditions
- ESCC
- Being tested
- Adebrelimab (PD-L1 inhibitor)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adebrelimab (PD-L1 inhibitor)Drug
Adebrelimab: 1200mg, iv, d1, Q3W, 2cycles Nimotuzumab:400 mg, d1,d8, Q3W, 2cycles Cisplatin: 75mg/m2，d1, Q3W, 2cycles Albumin-bound paclitaxel: 260 mg/m2, d1, Q3W, 2cycles
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Adebrelimab+Nimotuzumab+chemotherapy Receives: Drug: Adebrelimab (PD-L1 inhibitor) |
What is being measured
The primary outcome is the main question the study is designed to answer.
pCR, Pathological Complete Response
Measured: From patient enrollment to the end of surgery, assessed up to 12 months
Secondary outcomes (5)
MPR，Main Pathological Response Rate
Measured: From patient enrollment to the end of surgery, assessed up to 12 months
Margin-free (R0) resection rate
Measured: From patient enrollment to the end of surgery, assessed up to 12 months
EFS, Event free survival
Measured: The time from the start of treatment to the first occurrence of any of the following events: disease progression beyond surgical intervention, local or distant recurrence, death from any cause, etc. assessed up to 36 months
OS, Overall Survival
Measured: From the start of treatment to death from any cause，assessed up to 60 months
Adverse events rate (CTCAE 5.0)
All treatment-related adverse events, immune-related adverse events, and adverse events of grade 3 or higher, as defined by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: From the start of enrollment to the completion of the study，assessed up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start15 Feb 2026 (estimated)
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ESCCStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07388095
- Sponsor's protocol ID
- neoESCC-001
- Status last verified
- Jan 2026
- First submitted
- 23 Jan 2026
- Last updated
- 4 Feb 2026
- 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 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Treatment With Adebrelimab in Combination With Nimotuzumab and Chemotherapy for Resectable Esophageal Squamous Cell Carcinoma: A Single-arm, Exploratory Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT07388095
- Acronym / sponsor ID
- neoESCC-001
- Conditions
- ESCC
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 15 Feb 2026 (estimated)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 4 Feb 2026 (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 is a prospective, phase II, exploratory clinical trial.
The study aims to evaluate the efficacy and safety of in combination adebrelimab with nimotuzumab and chemotherapy as neoadjuvant therapy in patients with resectable esophageal squamous cell carcinoma.
The primary endpoint is pCR ( pathological complete response), evaluating the efficacy of adebrelimab in combination with nimotuzumab and neoadjuvant chemotherapy in patients with resectable esophageal squamous cell carcinoma. After the primary objective is achieved, EFS (event free survival ), R0 resection rate, MPR (major pathological response), OS (overall survival), and safety will be assessed as key secondary objectives. The study plans to enroll 22 patients with resectable esophageal squamous cell carcinoma.
The study is divided into a screening period, a treatment period, and a follow-up period. Subjects will enter the screening period after signing informed consent. Subjects who pass the screening assessment will be enrolled in the study. Eligible subjects will receive two cycles of neoadjuvant therapy with adebrelimab, nimotuzumab, nab-paclitaxel, and cisplatin. Esophagectomy will be performed after two cycles of neoadjuvant therapy (4-6 weeks after the last dose). Researchers will determine subsequent treatment based on postoperative pathology. After treatment (surgery), safety and efficacy follow-ups will commence. When a subject first experiences disease progression as assessed by the investigator according to RECIST v1.1, confirmation is required after 4-6 weeks (except for rapid or significant clinical progression). Subjects whose disease progression is not confirmed by imaging after 4-6 weeks may continue treatment if their clinical symptoms remain stable, as determined by the investigator, until imaging-confirmed disease progression occurs, or other termination criteria as specified in the protocol are met, whichever occurs first.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Adebrelimab (PD-L1 inhibitor)Adebrelimab+Nimotuzumab+chemotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Signed written informed consent to voluntarily participate in this study;
- Pathologically confirmed resectable esophageal squamous cell carcinoma (excluding mixed adenocarcinoma-squamous cell carcinoma types);
- Thoracic esophageal cancer confirmed by CT/MRI/EUS assessment with clinical stage IIA-IIIB (according to AJCC 8th edition);
- Age 18-75 years, male or female;
- ECOG PS 0-1;
Key exclusion criteria (18 listed)
- Tumor has significantly invaded adjacent organs (major arteries or trachea) near the esophageal lesion;
- Presence of supraclavicular lymph node metastasis;
- Presence of uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage;
- Malnutrition with BMI < 18.5 kg/m²; if corrected by symptomatic nutritional support prior to enrollment and approved by the principal investigator, enrollment may still be considered;
- History of allergy to monoclonal antibodies, any component of adebrelimab, any component of Nimotuzumab, albumin-bound paclitaxel, cisplatin, or other platinum-based drugs;
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 (PD-L1 inhibitor)Adebrelimab: 1200mg, iv, d1, Q3W, 2cycles Nimotuzumab:400 mg, d1,d8, Q3W, 2cycles Cisplatin: 75mg/m2，d1, Q3W, 2cycles Albumin-bound paclitaxel: 260 mg/m2, d1, Q3W, 2cycles | Drug | Arm 1 |
Primary outcome
pCR, Pathological Complete Response
Time frame: From patient enrollment to the end of surgery, assessed up to 12 months
5 secondary outcomes
MPR，Main Pathological Response Rate
Time frame: From patient enrollment to the end of surgery, assessed up to 12 months
Margin-free (R0) resection rate
Time frame: From patient enrollment to the end of surgery, assessed up to 12 months
EFS, Event free survival
Time frame: The time from the start of treatment to the first occurrence of any of the following events: disease progression beyond surgical intervention, local or distant recurrence, death from any cause, etc. assessed up to 36 months
OS, Overall Survival
Time frame: From the start of treatment to death from any cause，assessed up to 60 months
Adverse events rate (CTCAE 5.0)
Time frame: From the start of enrollment to the completion of the study，assessed up to 60 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 4 Feb 2026.
- 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.
Xiangming liu Tianjin Medical University Cancer Institute and Hospital contact
Questions about this trial
What is this clinical trial studying?
A study testing Adebrelimab (PD-L1 inhibitor) in people with ESCC, run by Tianjin Medical University Cancer Institute and Hospital.
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 11 inclusion and 18 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 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Xiangming liu Tianjin Medical University Cancer Institute and Hospital (18622221070, juyongzhi2010@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pCR, Pathological Complete Response (time frame: From patient enrollment to the end of surgery, assessed up to 12 months). 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 4 Feb 2026.