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Comparing Induced Chemoimmunotherapy Followed By Concurrent Chemoradiotherapy And Concurrent Chemoradiotherapy Followed By Immunotherapy In Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma: A Multicenter, Randomized, Phase II Trial

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Radiation, Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Beijing Cancer Hospital
RECRUITING
Beijing
National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences
RECRUITING
Beijing
Sichuan Cancer Hospital
RECRUITING
Chengdu
Liaoning Cancer Hospital
RECRUITING
Shenyang
Shanxi Cancer Hospital
RECRUITING
Taiyuan
Tianjin Medical University Cancer Institute and Hospital
RECRUITING
Tianjin
Henan Cancer Hospital
RECRUITING
Zhengzhou
Contact Information
Primary
Wencheng Zhang, MD
wczhang@tmu.edu.cn
02223340123
Time Frame
Start Date: 2026-07-31
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 120
Treatments
Experimental: Arm A
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.
Experimental: Arm B
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.
Related Therapeutic Areas
Sponsors
Leads: Tianjin Medical University Cancer Institute and Hospital

This content was sourced from clinicaltrials.gov

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