A Randomized Controlled, Multicenter Clinical Study of Benmelstobart Combined With Radiochemotherapy Versus Radiochemotherapy as Neoadjuvant Treatment for Esophageal Squamous Cell Carcinoma

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This study will explore the efficacy and safety of benmelstobart combined with radiochemotherapy compared to radiochemotherapy alone as neoadjuvant treatment for esophageal squamous cell carcinoma. It will also compare the effectiveness and safety of low-dose radiotherapy versus standard-dose radiotherapy in neoadjuvant regimens that include benmelstobart with concurrent radiochemotherapy. This research may provide more treatment options for patients with esophageal squamous cell carcinoma.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• Patients voluntarily participate in this study and sign informed consent forms, with good compliance.

• Aged 18 years and older, regardless of gender.

• ECOG performance status: 0-1.

• Patients with histologically confirmed clinical stages T1-3N+M0 or T3NanyM0 of resectable esophageal squamous cell carcinoma.

• No prior antitumor treatment for esophageal cancer, including chemotherapy, hormone therapy, radiotherapy, or immunotherapy.

• Laboratory tests must meet the following criteria (within 7 days prior to baseline enrollment):

‣ Complete blood count: a. Hemoglobin (Hb) ≥ 90 g/L (no blood transfusion in the last 14 days); b. Neutrophil count (NEUT) ≥ 1.5 × 10\^9/L; c. Platelet count (PLT) ≥ 100 × 10\^9/L; d. White blood cell count (WBC) ≥ 3 × 10\^9/L;

⁃ Biochemical tests: a. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; b. Total bilirubin (TBIL) ≤ 1.5 × ULN; c. Serum creatinine (Cr) ≤ 1.5 × ULN (or creatinine clearance (CCr) ≥ 60 mL/min);

⁃ Coagulation function: activated partial thromboplastin time (APTT), International normalized ratio (INR), prothrombin time (PT) ≤ 1.5 × ULN;

⁃ Thyroid function: Thyroid-stimulating hormone (TSH) ≤ ULN (if abnormal, FT3 and FT4 levels should also be assessed; if FT3 and FT4 levels are normal, the patient can be enrolled);

⁃ Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ 50%;

• Female participants must agree to use contraception (e.g., intrauterine device \[IUD\], contraceptive pills, or condoms) during the study and for 6 months after the study ends; a negative serum pregnancy test must be obtained within 7 days prior to enrollment, and participants must not be breastfeeding. Male participants must also agree to use contraception during the study and for 6 months after the study ends.

Locations
Other Locations
China
Zhejiang Cancer Hospital
RECRUITING
Hangzhou
Zhongshan Hospital Fudan University
RECRUITING
Shanghai
Cancer Hospital of Shantou University Medical College
RECRUITING
Shantou
Liaoning Cancer Hospital and Institute
RECRUITING
Shenyang
Tianjin Medical University Cancer Institute and Hospital
RECRUITING
Tianjin
Contact Information
Primary
Lijie Tan, Professor
tan.lijie@zs-hospital.sh.cn
+8613681972151
Time Frame
Start Date: 2024-10-24
Estimated Completion Date: 2027-04
Participants
Target number of participants: 100
Treatments
Experimental: Benmelstobart combined with radiochemotherapy
Benmelstobart + Paclitaxel + Carboplatin + Radiotherapy
Active_comparator: radiochemotherapy
Paclitaxel + Carboplatin + Radiotherapy
Related Therapeutic Areas
Sponsors
Leads: Shanghai Zhongshan Hospital

This content was sourced from clinicaltrials.gov

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