Combining benmelstobart with radiochemotherapy for esophageal cancer treatment
Official title: A Randomized Controlled, Multicenter Clinical Study of Benmelstobart Combined With Radiochemotherapy Versus Radiochemotherapy as Neoadjuvant Treatment for Esophageal Squamous Cell Carcinoma
Run by Shanghai Zhongshan Hospital · NCT06637163 · Data updated 2026-11-12
This study is testing if adding a new drug called benmelstobart to standard radiation and chemotherapy can help people with esophageal cancer have better treatment outcomes before surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Shanghai Zhongshan Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, prednisone |
| Locations | 5 sites (Shantou, Guangdong and 4 other locations) |
| Status | Recruiting |
| Started | October 24, 2024 |
| Main results expected | April 2026 |
| Study ends | April 2027 |
| Registry record updated | April 17, 2025 |
| Trial ID | NCT06637163 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older with resectable esophageal squamous cell carcinoma who have not received prior antitumor treatments.
✕Probably not a fit
Patients with advanced esophageal cancer or those who have previously undergone antitumor therapies may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effectiveness and safety of benmelstobart when combined with radiochemotherapy as a neoadjuvant treatment for esophageal squamous cell carcinoma. Participants will be randomly assigned to receive either the combination treatment or standard radiochemotherapy alone. The study aims to evaluate the rate of pathological complete response (pCR) following treatment, with surgery scheduled 6-8 weeks after the neoadjuvant therapy. Additionally, it will compare low-dose versus standard-dose radiotherapy in conjunction with benmelstobart. This research may expand treatment options for patients with this type of cancer.
Why it matters
Potential benefit: If successful, this approach could provide a more effective neoadjuvant treatment option for patients with esophageal squamous cell carcinoma.
How similar studies have gone: Other studies have shown promise in combining targeted therapies with radiochemotherapy, suggesting potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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): 1. 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; 2. 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); 3. Coagulation function: activated partial thromboplastin time (APTT), International normalized ratio (INR), prothrombin time (PT) ≤ 1.5 × ULN; 4. 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); 5. 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. Exclusion Criteria: 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: 1. Acute or persistent myocardial ischemia or myocardial infarction, poorly controlled clinically significant arrhythmias, and NYHA class II or higher heart failure; LVEF \< 50%. 2. 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. * Positive HIV test.
Where it's running
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Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, China Recruiting -
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, China Recruiting -
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China Recruiting -
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China Recruiting -
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China Recruiting
Study contacts
- Principal investigator: Lijie Tan, Professor — Fudan University
- Study coordinator: Lijie Tan, Professor
- Email: tan.lijie@zs-hospital.sh.cn
- Phone: +8613681972151
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Radiotherapy target-volume choices in locally advanced esophageal cancer during immunotherapy
This observational study looks at how doctors outline the radiation area for locally advanced esophageal squamous cell cancer patients treated with radiotherapy and immunotherapy to see which approaches correlate with better outcomes.
-
Sacituzumab Govitecan plus Tislelizumab for advanced esophageal cancer
This phase II study tests whether the cancer-fighting drug sacituzumab tirumotecan (SKB264) combined with tislelizumab can help adults with advanced esophageal squamous cell carcinoma that progressed after initial immunotherapy.
-
Neoadjuvant therapy with adebrelimab, famitinib, and chemotherapy for resectable ESCC
This study tests a combination of adebrelimab, famitinib, and chemotherapy before surgery in people with resectable locally advanced esophageal squamous cell carcinoma to see if it can lead to a complete tumor disappearance at the time of surgery.
-
SKB500 combinations for esophageal squamous cell carcinoma
This study tests SKB500 combined with other drugs to see if it is safe and shows early signs of activity in adults with unresectable or metastatic esophageal squamous cell carcinoma who have limited prior treatment.
-
Neoadjuvant Cardonilizumab With Chemotherapy Before Surgery for Locally Advanced Esophageal Squamous Cell Carcinoma
This study tests whether adding cardonilizumab to preoperative chemotherapy (versus chemoradiotherapy) helps patients with locally advanced ESCC have a better chance at complete tumor removal and longer survival.
-
Surgery or chemoradiotherapy after neoadjuvant immunochemotherapy for esophageal squamous cell carcinoma
In people with locally advanced ESCC who respond to neoadjuvant immunochemotherapy, this study tests whether organ preservation with treatment other than surgery can be as effective as radical esophagectomy.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.