Adebrelimab Plus Full-course Neoadjuvant Therapy for Resectable Locally Advanced ESCC (Phase 2)

NCT07584031 | Not Yet Recruiting Phase 2

• 1 other identifier: NAT-ESCC-01
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 2-year Disease-Free Survival (DFS) rate in the watchful waiting arm

  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

  From randomization to death, up to 2 years

• 2-year OS in the surgery arm

  From randomization to death, up to 2 years

• R0 resection rate

  Assessed at surgery

• Pathological Complete Response (pCR) rate

  Assessed at surgery

• Major Pathological Response (MPR) rate

  Assessed at surgery

Study Arms (2)

Combination therapy with chemotherapy and immunotherapy

EXPERIMENTAL

Drug: Combination therapy with chemotherapy and immunotherapy

Surgery

ACTIVE COMPARATOR

Other: Surgery

Interventions

Combination therapy with chemotherapy and immunotherapy DRUG

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.

Combination therapy with chemotherapy and immunotherapy

Surgery OTHER

surgery

Surgery

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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):
• 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);

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

MeSH Terms

Interventions

Combined Modality Therapy; Drug Therapy; Immunotherapy; Surgical Procedures, Operative

Intervention Hierarchy (Ancestors)

Therapeutics; Immunomodulation; Biological Therapy

Central Study Contacts

Peng Tang Peng Tang

CONTACT

+8618622228653; 18526812877@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: May 13, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share