Comparing ICI Followed By CCRT And CCRT Followed By Immunotherapy In Unresectable LA-ESCC

NCT07733830 | Recruiting Phase 2

• 1 other identifier: E20260838
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 7

Brief Summary

A total of 120 patients with unresectable, locally advanced esophageal squamous cell carcinoma patients will be enrolled in this study and randomly divided into two groups. Arm A: After 2 cycles of induction adebrelimab plus chemotherapy, patients will be treated with concurrent chemoradiotherapy (50.4Gy/1.8Gy/28f), and adebrelimab will maintain to PD or for a maximum of 15 cycles. Arm B: Patients will be treated with concurrent chemoradiotherapy (50.4Gy/1.8Gy/28f) and adebrelimab will maintain to PD or for a maximum of 17 cycles. This study will compare the efficacy of immunotherapy in the induction and maintenance phases of radiotherapy, optimize more precise treatment plans, and potentially further increase the survival of ESCC patients.

Conditions

Esophageal Cancer

Keywords

Induction Immunochemotherapy; Adebrelimab; Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  Two-year follow-up from the date of randomization to the date of disease progression or last follow-up.

  From date of randomization until the date of death from any cause or the date of first documented disease progression whichever came first, assessed up to 24 months.

Secondary Outcomes (6)

• Overall survival

  From date of randomization until the date of death from any cause or the date of last follow-up, whichever came first, assessed up to 24 months.

• Overall response rate

  Up to 24 months

• Duration of Response

  From date of first CR/PR to the date of first PD according to RECIST criteria and Japanese classification of esophageal cancer (12th edition), assessed up to 24 months.

• Treatment-related adverse events

  From date of randomization until the date of last follow-up, assessed up to 12 months.

• Severe adverse events

  From date of randomization until the date of last follow-up, assessed up to 12 months.

Other Outcomes (1)

• PD-L1 expression

  From date of randomization until the date of last follow-up, assessed up to 24 months.

Study Arms (2)

Arm A

EXPERIMENTAL

Induction Immunochemotherapy + CRT 1. Induction immunochemotherapy: Nab-paclitaxel：220mg/m2，IV，d1，d22; Carboplatin：AUC=5，IV，d1，d22; Adebrelimab：1200mg, IV，d1, d22. 2. Concurrent chemoradiotherapy: Nab-paclitaxel：175mg/m2，IV，d1，d22; Carboplatin：AUC=5，IV，d1，d22; Radiotherapy：50.4Gy/1.8Gy/28f. 3. Immunotherapy maintenance: Adebrelimab：1200mg, IV，q3w, until PD or for a maximum of 15 cycles.

Drug: Adebrelimab; Drug: Nab paclitaxel; Drug: Carboplatin; Radiation: radiation

Arm B

EXPERIMENTAL

CRT + Immunotherapy 1. Concurrent chemoradiotherapy: Nab-paclitaxel：175mg/m2，IV，d1，d22; Carboplatin：AUC=5，IV，d1，d22; Radiotherapy：50.4Gy/1.8Gy/28f. 2. Immunotherapy maintenance: Adebrelimab：1200mg, IV，q3w, until PD or for a maximum of 17 cycles.

Drug: Adebrelimab; Drug: Nab paclitaxel; Drug: Carboplatin; Radiation: radiation

Interventions

Adebrelimab DRUG

anti-PD-L1 immunotherapy

Arm A; Arm B

Nab paclitaxel DRUG

chemotherapy

Arm A; Arm B

Carboplatin DRUG

chemotherapy

Arm A; Arm B

radiation RADIATION

radiation

Arm A; Arm B

Eligibility Criteria

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

You may qualify if:

• Volunteered to participate, cooperated with follow-up visits, documented informed consent;
• Aged 18 -75 years, both male and female;
• Histologically confirmed cT1N2-3M0 or cT2-4bN0-3M0 or cT1-4bN0-3M1( supraclavicular lymph node metastasis) locally advanced ESCC (8th AJCC); clinically staged as II-IVb inoperable locally advanced ESCC (including non-resectable, or with contraindications to or refusal of surgery);
• Measurable and/or unmeasurable lesions as defined by the criteria for evaluating the efficacy of solid tumors (RECIST1.1) and the Japanese Classification of Esophageal Cancer (12th Edition: Part II);
• Haven't received any previous systemic anti-tumor therapy (including but not limited to systemic chemotherapy, radiotherapy, molecularly targeted drug therapy, immunotherapy, biologic therapy, topical therapy and other investigational therapeutic agents);
• ECOG performance status 0 or 1;
• Provide fresh or archived tumour tissue samples within 6 months (fresh samples preferred) for biomarker analysis (e.g.PD-L1). Sample types are formalin-fixed, paraffin-embedded \[FFPE\] tumour tissue blocks or at least 5 unstained, 3-5 μm thick FFPE tumour tissue sections;
• Expected survival ≥ 3 months;
• Adequate hematologic function, defined as ANC ≥1500/μl, platelet count ≥100,000/μl and hemoglobin count ≥9.0 g/dl or ≥5.6 mmol/l; Adequate renal function, defined as creatinine ≤1.5× ULN or measured or calculated creatinine clearance ≥60 mL/min for those with creatinine levels \>1.5× ULN (Calculated from the Cockcroft-Gault formula); Adequate hepatic function, defined as total bilirubin ≤1.5× ULN and ALT/AST/AKP levels ≤2.5× ULN and albumin ≥2.8 g/dl; Adequate coagulation function, defined as INR ≤1.5× ULN and APTT≤1.5× ULN unless the patient is receiving anticoagulant therapy as long as INR is within the therapeutic range;
• Women of childbearing potential with a negative urine pregnancy test within 3 days before the first administration of the investigational drugs.

You may not qualify if:

• Surgery for esophageal cancer;
• Esophageal fistulae due to infiltration of the primary tumour;
• Risk of gastrointestinal bleeding, oesophageal fistula or oesophageal perforation
• Poor nutritional status, weight loss of ≥10% in the previous 2 months, with no significant improvement after nutritional intervention;
• Major surgery or severe trauma within 4 weeks prior to first use of study drug;
• Uncontrollable pleural effusion, pericardial effusion, or ascites that requires repeated drainage;
• Received or receiving any of the following treatments in the past:
• Anti-PD-1 or anti-PD-L1 antibody therapy, chemotherapy, radiotherapy or targeted therapy;
• Participation in a study of an investigational agent or device within 4 weeks before the first dose of study treatment;
• Systemic treatment with corticosteroids (\>10 mg prednisone equivalent dose per day) or other immunosuppressive agents is required for 2 weeks before the first dose of study treatment(except for the use of corticosteroids for local inflammation of the oesophagus and for the prevention of allergy and nausea and vomiting). Other special circumstances need to be communicated to the sponsor.Inhaled or topical steroids and adrenocorticotropic hormone replacement at doses \>10mg/day prednisone efficacy dose are permitted if the patient does not have active autoimmune disease;
• Received an anti-tumour vaccine or received a live vaccine within 4 weeks before the first dose of study treatment;
• Any active autoimmune disease or history of autoimmune disease (e.g., interstitial pneumonitis, uveitis, enteritis, hepatitis, pituitary gland inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism);Except for patients with vitiligo or those who had asthma or allergies in childhood but did not need any intervention as adults; patients with autoimmune-mediated hypothyroidism treated with stable doses of thyroid replacement hormone and type I diabetes mellitus treated with stable doses of insulin may be included;
• Diagnosis of immunodeficiency, including positive HIV test,other acquired/congenital immunodeficiency diseases, organ transplantation and allogeneic bone marrow transplantation;
• Diagnosis of uncontrolled cardiac clinical symptoms or disease such as a.NYHA II or above heart failure b.unstable angina c.myocardial infarction within 1 year d.clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention;
• Severe infections (CTCAE \> Grade 2), such as severe pneumonia requiring hospitalisation, bacteraemia, infectious co-morbidities, etc., within 4 weeks before the first use of study treatment; Baseline chest imaging suggestive of active lung inflammation, signs and symptoms of infection requiring oral or intravenous antibiotic treatment within 2 weeks before the first use of study treatment, except for prophylactic antibiotic use;

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (7)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

RECRUITING

National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, Hanan, China

RECRUITING

Liaoning Cancer Hospital

Shenyang, Liaoning, China

RECRUITING

Shanxi Cancer Hospital

Taiyuan, Shanxi, China

RECRUITING

Sichuan Cancer Hospital

Chengdu, Sichuan, China

RECRUITING

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms; Esophageal Squamous Cell Carcinoma

Interventions

Taxes; Carboplatin; Radiation

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Economics; Health Care Economics and Organizations; Coordination Complexes; Organic Chemicals; Physical Phenomena

Study Officials

• Wencheng Zhang, MD

  Tianjin Medical University Cancer Institute and Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wencheng Zhang, MD

CONTACT

02223340123; wczhang@tmu.edu.cn

Study Design

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

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 29, 2026
• Study Start: July 31, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2029
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (7)