Benmelstobart Combined With Radiochemotherapy as Neoadjuvant Treatment Iin ESCC

NCT06637163 | Recruiting Phase 2

• 1 other identifier: B2024-236R
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Pathological complete response (pCR)

  The ratio of patients with no residual cancer cells found in the pathological examination after treatment.

  4 months

Secondary Outcomes (9)

• Major pathologic response (MPR)

  4 months

• Overall response rate (ORR)

  4 months

• Diseases control rate (DCR)

  4 months

• R0 resection rate

  4 months

• Disease free survival (DFS), 1y-DFS

  15 months

Study Arms (2)

Benmelstobart combined with radiochemotherapy

EXPERIMENTAL

Benmelstobart + Paclitaxel + Carboplatin + Radiotherapy

Drug: Benmelstobart+ Paclitaxel + Carboplatin+ Radiotherapy

radiochemotherapy

ACTIVE COMPARATOR

Paclitaxel + Carboplatin + Radiotherapy

Drug: Paclitaxel + Carboplatin + Radiotherapy

Interventions

Benmelstobart+ Paclitaxel + Carboplatin+ Radiotherapy DRUG

Benmelstobart: 1200 mg, i.v.gtt , d1, 22; Paclitaxel 50mg/m2, i.v.gtt , d1, 8, 15, 22, 29; Carboplatin AUC 2 mg/mL per minute, i.v.gtt , d1, 8, 15, 22, 29; Radiotherapy 41.4 Gy in 23 fractions, 5 days per week(If the number of patients achieving pCR in this group is ≥ 18 with the first 30 patients enrolled, the subsequent 20 patients will receive a reduced dose of 36 Gy in 20 fractions, 5 days per week.)

Benmelstobart combined with radiochemotherapy

Paclitaxel + Carboplatin + Radiotherapy DRUG

Paclitaxel 50mg/m2, i.v.gtt , d1, 8, 15, 22, 29; Carboplatin AUC 2 mg/mL per minute, i.v.gtt , d1, 8, 15, 22, 29; Radiotherapy 41.4 Gy in 23 fractions, 5 days per week

radiochemotherapy

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• Participants with any of the following criteria will be excluded from the study:
• Presence of other malignant tumors (except for previously cured basal cell carcinoma of the skin).
• Diagnosis of cervical esophageal cancer.
• Severe hypersensitivity reactions following the administration of other monoclonal antibodies.
• Any active autoimmune disease or history of autoimmune disease (such as, but not limited to: autoimmune hepatitis, interstitial pneumonia, enteritis, vasculitis, nephritis; asthma requiring bronchodilator intervention). However, patients with the following conditions may be included: vitiligo, psoriasis, alopecia that do not require systemic treatment, well-controlled type 1 diabetes, and hypothyroidism with normal thyroid function under replacement therapy.
• Use of immunosuppressants, systemic, or absorbable local hormone therapy to achieve immunosuppressive effects (doses \> 10 mg/day of prednisone or equivalent), and continuing use within 2 weeks of the first dose.
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
• Uncontrollable neurological symptoms from brain metastases, spinal cord compression, or carcinomatous meningitis occurring within 4 weeks prior to the first dose, or evidence of brain or leptomeningeal disease found on CT or MRI screening.
• Presence of any severe and/or uncontrolled disease, including:
• Acute or persistent myocardial ischemia or myocardial infarction, poorly controlled clinically significant arrhythmias, and NYHA class II or higher heart failure; LVEF \< 50%.
• Active or uncontrolled severe infections (≥ CTCAE grade 2 infections).
• Vaccination with preventive or attenuated vaccines within 4 weeks prior to the first dose.
• Any factors, as judged by the investigator, that could lead to premature termination of the study, such as other serious illnesses (including mental illness) requiring concurrent treatment, significant laboratory abnormalities, or family or social factors that could affect participant safety.
• For participants who are 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 must continue to receive effective anti-HBV treatment during the study, or must have initiated treatment with entecavir or tenofovir prior to the study drug.
• For participants who are HCV antibody positive, HCV-RNA testing is required; those with HCV-RNA \> 10\^3 copies/mL will be excluded.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (5)

Cancer Hospital of Shantou University Medical College

Shantou, Guangdong, 515041, China

RECRUITING

Liaoning Cancer Hospital and Institute

Shenyang, Liaoning, 110041, China

RECRUITING

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300202, China

RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Paclitaxel; Carboplatin; Radiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes; Therapeutics

Study Officials

• Lijie Tan, Professor

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lijie Tan, Professor

CONTACT

+8613681972151; tan.lijie@zs-hospital.sh.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: October 9, 2024
• First Posted: October 15, 2024
• Study Start: October 24, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 17, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)