Induction Immunochemotherapy Followed by Concurrent Chemoradiotherapy in Patients With ESCC.

NCT06452602 | Recruiting Phase 2

• 1 other identifier: E20240610
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is conducted in patients with unresectable locally advanced esophageal squamous cell carcinoma. The investigators plan to enroll 60 patients with unresectable locally advanced esophageal cancer in Tianjin cancer hospital. After 2 cycles of induction immunochemotherapy, 60 patients with ESCC will be divided into 2 groups (CR+PR group and SD+PD group) according to the efficacy of induction therapy. Patients in the CR+PR group will be treated with the same immunochemotherapy regimen plus concurrent radiotherapy (50.4Gy/1.8Gy/28f) . And immunotherapy will maintain for a maximum of 1 year. Patients in the SD+PD group will be treated with concurrent chemoradiotherapy (Radiotherapy: PTV/PGTV:50.4Gy/59.92Gy/28f and another chemotherapy regimen). Immunotherapy will not used during chemoradiotherapy because of immunotherapy resistance. The trial can effectively stratify patients by induction immunochemotherapy, and a more appropriate treatment regimen for patients has the potential to further improve PFS and prolong OS in all patients.

Conditions

Esophageal Cancer

Keywords

Induction Immunochemotherapy; Adebrelimab; Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• PFS

  progression-free survival

  up to 2 years

Secondary Outcomes (4)

• OS

  up to 2 years

• ORR

  up to 2 years

• DoR

  up to 2 years

• AE

  up to 3 years

Study Arms (1)

Induction Immunochemotherapy

EXPERIMENTAL

Drug: Induction immunochemotherapy followed by Adebrelimab plus concurrent chemoradiotherapy; Drug: Induction immunochemotherapy followed by concurrent chemoradiotherapy

Interventions

Induction immunochemotherapy followed by concurrent chemoradiotherapy DRUG

Induction immunochemotherapy: Nab-paclitaxel：220mg/m2，IV，d1，d22; Carboplatin：AUC=5，IV，d1，d22; Adebrelimab：1200mg, IV，d1, d22. Evaluation of the Curative Effect：SD+PD Concurrent chemoradiotherapy: Oxaliplatin：85 mg/m2，IV，d1，d15，d29; Leucovorin：400mg/m2，IV，d1，d15，d29; 5-FU：400mg/m2，IV，d1，d15，d29; 5-FU：1600mg/m2，CIV48h，d1，d15，d29; Radiotherapy：PTV/PGTV:50.4Gy/59.92Gy/28f.

Also known as: Concurrent chemoradiotherapy, SD+PD group

Induction Immunochemotherapy

Induction immunochemotherapy followed by Adebrelimab plus concurrent chemoradiotherapy DRUG

Induction immunochemotherapy: Nab-paclitaxel：220mg/m2，IV，d1，d22; Carboplatin：AUC=5，IV，d1，d22; Adebrelimab：1200mg, IV，d1, d22. Evaluation of the Curative Effect：CR+PR Adebrelimab plus concurrent chemoradiotherapy: Adebrelimab：1200mg, IV，q3w, until PD; Nab-paclitaxel：175mg/m2，IV，d1，d22; Carboplatin：AUC=5，IV，d1，d22; Radiotherapy：50.4Gy/1.8Gy/28f.

Also known as: Adebrelimab plus concurrent chemoradiotherapy, CR+PR group

Induction Immunochemotherapy

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;
• Aged 18 years or older, 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);
• ECOG performance status 0 or 1;
• Presence of measurable and/or non-measurable lesions as defined by RECIST 1.1;
• 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);
• 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.
• Documented informed consent.

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 (1)

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms; Esophageal Squamous Cell Carcinoma

Interventions

Chemoradiotherapy

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)

Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Study Officials

• Wencheng zhang, M.D.

  Tianjin Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wencheng zhang, M.D.

CONTACT

02223340123; zhangwencheng@tjmuch.com

Study Design

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

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 11, 2024
• Study Start: June 19, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: February 27, 2026

Record last verified: 2025-06

Locations

CN (1)