ESCCPhase 2NAT-ESCC-01NCT07584031
Adebrelimab Plus Full-course Neoadjuvant Therapy for Resectable Locally Advanced ESCC (Phase 2)
A Phase 2 study testing Combination therapy with chemotherapy and immunotherapy and Surgery in people with ESCC, run by Tianjin Medical University Cancer Institute and Hospital.
Trial summary
This is a prospective, single-center, randomized phase 2 study of adebrelimab plus full-course neoadjuvant therapy in resectable locally advanced 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?
- Combination therapy with chemotherapy and immunotherapy and Surgery
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 31 Dec 2028
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients voluntarily participate in this study, sign an informed consent form, and demonstrate good compliance;
- At least 18 years of age; gender is not restricted;
- ECOG performance status: 0-1;
- Patients with histologically confirmed resectable esophageal squamous cell carcinoma clinically staged as (T1N+M0 or T2-4aNanyM0);
- No prior anticancer therapy for esophageal cancer, including chemotherapy, hormone therapy, radiation therapy, or immunotherapy;
- Laboratory tests must meet the following criteria (within 7 days prior to baseline enrollment):
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- Complete blood count (CBC):
- Hemoglobin (Hb) ≥ 90 g/L (no blood transfusion within the past 14 days);
- Neutrophil count (NEUT) ≥ 1.5 × 10⁹/L;
- Platelet count (PLT) ≥ 100 × 10⁹/L;
- White blood cell count (WBC) ≥ 3 × 10⁹/L;
- Biochemical Tests:
- Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5×ULN;
- Serum total bilirubin (TBIL) ≤ 1.5×ULN;
- Serum creatinine (Cr) ≤ 1.5×ULN; (or creatinine clearance (CCr) ≥ 60 mL/min);
- Coagulation function: Activated partial thromboplastin time (APTT), International Normalized Ratio (INR), and prothrombin time (PT) ≤ 1.5×ULN;
- Thyroid function: Thyroid-stimulating hormone (TSH) ≤ ULN (if abnormal, FT3 and FT4 levels should also be evaluated; if FT3 and FT4 levels are normal, the patient may be enrolled);
- Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) ≥50%;
- Female participants must agree to use contraceptive measures, such as an intrauterine device (IUD), oral contraceptives, or condoms, during the study and for 6 months after study completion; they must have a negative serum pregnancy test within 7 days prior to study enrollment and must not be breastfeeding; male participants must agree to use contraceptive measures during the study and for 6 months after study completion.
Who cannot join
- Concurrent malignant neoplasms (except for cured basal cell carcinoma of the skin);
- Diagnosis of cervical esophageal cancer;
- History of severe hypersensitivity reactions following administration of other monoclonal antibodies;
- Presence of any active autoimmune disease or history of autoimmune disease (such as, but not limited to: autoimmune hepatitis, interstitial pneumonia, enteritis, vasculitis, or nephritis; asthma requiring bronchodilators for medical intervention); however, the following patients are eligible for enrollment: vitiligo, psoriasis, or alopecia not requiring systemic treatment; well-controlled type 1 diabetes; hypothyroidism with normal thyroid function following replacement therapy;
- Requiring immunosuppressants, or systemic or absorbable topical corticosteroids for immunosuppressive purposes (dose > 10 mg/day of prednisone or other corticosteroids of equivalent potency), and still using them within 2 weeks of the first dose;
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage;
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- Uncontrolled symptoms of brain metastases, spinal cord compression, or carcinomatous meningitis occurring within 4 weeks prior to the first dose, or patients with brain or meningeal disease identified by CT or MRI at screening;
- Patients with any severe and/or uncontrolled medical conditions, including:
- Acute or recurrent myocardial ischemia or myocardial infarction; poorly controlled and clinically significant arrhythmias; and heart failure of Class II or higher (New York Heart Association [NYHA] functional class); LVEF (left ventricular ejection fraction) < 50%;
- Active or uncontrolled severe infection (≥ Grade 2 CTC AE infection);
- Receipt of a prophylactic or attenuated vaccine within 4 weeks prior to the first dose;
- Other factors, as determined by the investigator, that may lead to forced discontinuation of the study, such as other serious illnesses (including psychiatric disorders) requiring concomitant treatment, severe laboratory abnormalities, or family or social factors that could compromise the subject's safety.
- If HBsAg (+) and/or HBcAb (+), HBV DNA must be < 500 IU/mL (if the local center's lower limit of detection is higher than 500 IU/mL, the investigator may decide on enrollment based on specific circumstances) and the subject must continue to receive effective anti-HBV therapy during the study, or must have already started treatment with entecavir or tenofovir prior to study drug administration;
- If HCV antibodies are positive, HCV-RNA testing must be performed; subjects with HCV-RNA > 10³ copies/mL must be excluded;
- HIV-positive.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective, Single-Center, Phase II Clinical Trial of Adebrelimab Combined With Full-Course Neoadjuvant Therapy for Watchful Waiting or Surgery in Patients With Resectable Locally Advanced Esophageal Squamous Cell Carcinoma
This is a prospective, single-center, randomized phase 2 study of adebrelimab plus full-course neoadjuvant therapy in resectable locally advanced esophageal squamous cell carcinoma. Patients achieving clinical complete response (cCR) after neoadjuvant treatment will be randomized 1:1 to watchful waiting with 2 cycles consolidation chemo-Immunotherapy or standard surgery. Primary endpoint is 2-year DFS. Secondary endpoints include OS, pCR/MPR, R0 resection rate, safety, and quality of life.
- Conditions
- ESCC
- Being tested
- Combination therapy with chemotherapy and immunotherapy, Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination therapy with chemotherapy and immunotherapyDrug
Adebrelimab Injection，intravenous infusion, Day 1, every 3 weeks for 2 cycles. Albumin-bound paclitaxel 260 mg/m², carboplatin AUC = 5, intravenous infusion, Day 1, every 3 weeks for 2 cycles.
Two cycles of chemotherapy combined with immunotherapy.
SurgeryOther
surgery
| Study group | Role | What they receive |
|---|---|---|
| Combination therapy with chemotherapy and immunotherapy | Experimental | Not described Receives: Drug: Combination therapy with chemotherapy and immunotherapy |
| Surgery | Active comparator | Not described Receives: Other: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year Disease-Free Survival (DFS) rate in the watchful waiting arm
Measured: Assessed from randomization to disease recurrence, progression, or death, up to 2 years
Secondary outcomes (10)
2-year Overall Survival (OS) in the watchful waiting arm
Measured: From randomization to death, up to 2 years
2-year OS in the surgery arm
Measured: From randomization to death, up to 2 years
R0 resection rate
Measured: Assessed at surgery
Pathological Complete Response (pCR) rate
Measured: Assessed at surgery
Major Pathological Response (MPR) rate
Measured: Assessed at surgery
Event-Free Survival (EFS)
Measured: From enrollment to progression/recurrence/death, up to 2 years
Clinical Complete Response (cCR) rate
Assessed after completion of neoadjuvant therapy, prior to surgical resection.
Measured: Within 1-2 weeks prior to surgery, after completion of neoadjuvant therapy.
EORTC QLQ-C30 Quality of Life Score
Assessed using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30). The scale ranges from 0 to 100, with higher scores indicating better quality of life for functional scales and worse symptoms for symptom scales.
Measured: Baseline, 6 months, 12 months, 24 months
Treatment Completion Rate
The proportion of patients who complete the planned neoadjuvant therapy regimen as defined in the protocol.
Measured: From first study treatment to end of neoadjuvant therapy,Evaluation period: up to 12 months.
Adverse Event (AE) and Serious Adverse Event (SAE) Incidence (CTCAE v6.0)
Incidence of all adverse events (AEs) and serious adverse events (SAEs) graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 6.0.
Measured: From first study treatment to 30 days after last study treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients first received two cycles of neoadjuvant immunotherapy combined with chemotherapy followed by concurrent chemoradiotherapy. Patients who achieved complete remission (CCR) were randomly assigned to either the watchful waiting group or the surgical group.
- Masking
- None (open label)
- Enrolment
- 200 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
- NCT07584031
- Sponsor's protocol ID
- NAT-ESCC-01
- Acronym
- NAT-ESCC-01
- Status last verified
- Mar 2026
- First submitted
- 9 Apr 2026
- Last updated
- 13 May 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 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Center, Phase II Clinical Trial of Adebrelimab Combined With Full-Course Neoadjuvant Therapy for Watchful Waiting or Surgery in Patients With Resectable Locally Advanced Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07584031
- Acronym / sponsor ID
- NAT-ESCC-01 / NAT-ESCC-01
- Conditions
- ESCC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 13 May 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, single-center, randomized phase 2 study of adebrelimab plus full-course neoadjuvant therapy in resectable locally advanced esophageal squamous cell carcinoma. Patients achieving clinical complete response (cCR) after neoadjuvant treatment will be randomized 1:1 to watchful waiting with 2 cycles consolidation chemo-Immunotherapy or standard surgery. Primary endpoint is 2-year DFS. Secondary endpoints include OS, pCR/MPR, R0 resection rate, safety, and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients first received two cycles of neoadjuvant immunotherapy combined with chemotherapy followed by concurrent chemoradiotherapy. Patients who achieved complete remission (CCR) were randomly assigned to either the watchful waiting group or the surgical group.
| Arm | Type | Receives |
|---|---|---|
| Combination therapy with chemotherapy and immunotherapy | Experimental | Drug: Combination therapy with chemotherapy and immunotherapy |
| Surgery | Active comparator | Other: Surgery |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Patients voluntarily participate in this study, sign an informed consent form, and demonstrate good compliance;
- At least 18 years of age; gender is not restricted;
- ECOG performance status: 0-1;
- Patients with histologically confirmed resectable esophageal squamous cell carcinoma clinically staged as (T1N+M0 or T2-4aNanyM0);
- No prior anticancer therapy for esophageal cancer, including chemotherapy, hormone therapy, radiation therapy, or immunotherapy;
Key exclusion criteria (15 listed)
- Concurrent malignant neoplasms (except for cured basal cell carcinoma of the skin);
- Diagnosis of cervical esophageal cancer;
- History of severe hypersensitivity reactions following administration of other monoclonal antibodies;
- Presence of any active autoimmune disease or history of autoimmune disease (such as, but not limited to: autoimmune hepatitis, interstitial pneumonia, enteritis, vasculitis, or nephritis; asthma requiring bronchodilators for medical intervention); however, the following patients are eligible for enrollment: vitiligo, psoriasis, or alopecia not requiring systemic treatment; well-controlled type 1 diabetes; hypothyroidism with normal thyroid function following replacement therapy;
- Requiring immunosuppressants, or systemic or absorbable topical corticosteroids for immunosuppressive purposes (dose > 10 mg/day of prednisone or other corticosteroids of equivalent potency), and still using them within 2 weeks of the first dose;
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 |
|---|---|---|
| Combination therapy with chemotherapy and immunotherapyAdebrelimab Injection，intravenous infusion, Day 1, every 3 weeks for 2 cycles. Albumin-bound paclitaxel 260 mg/m², carboplatin AUC = 5, intravenous infusion, Day 1, every 3 weeks for 2 cycles. Two cycles of chemotherapy combined with immunotherapy. | Drug | Combination therapy with chemotherapy and immunotherapy |
| Surgerysurgery | Other | Surgery |
Primary outcome
2-year Disease-Free Survival (DFS) rate in the watchful waiting arm
Time frame: Assessed from randomization to disease recurrence, progression, or death, up to 2 years
10 secondary outcomes
2-year Overall Survival (OS) in the watchful waiting arm
Time frame: From randomization to death, up to 2 years
2-year OS in the surgery arm
Time frame: From randomization to death, up to 2 years
R0 resection rate
Time frame: Assessed at surgery
Pathological Complete Response (pCR) rate
Time frame: Assessed at surgery
Major Pathological Response (MPR) rate
Time frame: Assessed at surgery
Event-Free Survival (EFS)
Time frame: From enrollment to progression/recurrence/death, up to 2 years
Clinical Complete Response (cCR) rate
Time frame: Within 1-2 weeks prior to surgery, after completion of neoadjuvant therapy.
EORTC QLQ-C30 Quality of Life Score
Time frame: Baseline, 6 months, 12 months, 24 months
Treatment Completion Rate
Time frame: From first study treatment to end of neoadjuvant therapy,Evaluation period: up to 12 months.
Adverse Event (AE) and Serious Adverse Event (SAE) Incidence (CTCAE v6.0)
Time frame: From first study treatment to 30 days after last study treatment.
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 13 May 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Combination therapy with chemotherapy and immunotherapy and Surgery 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 19 inclusion and 15 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 13 May 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.
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 Peng Tang Peng Tang (+8618622228653, 18526812877@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year Disease-Free Survival (DFS) rate in the watchful waiting arm (time frame: Assessed from randomization to disease recurrence, progression, or death, up to 2 years). 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 13 May 2026; AzTrials last refreshed its copy on 31 Oct 2026.