Esophageal cancer
Conditions
Interventions
study arm:Neoadjuvant Therapy with Anlotinib Hydrochloride and Camrelizumab Combined with Chemotherapy
Sponsors
The General Hospital of the Western Theater Command of the Chinese People's Liberation Army
Eligibility
Sex/Gender
All
Age
18 Years to 76 Years
Inclusion criteria
Inclusion criteria: 1.Age at initial diagnosis between 18 and 76 years, inclusive. 2.Histologically confirmed thoracic esophageal squamous cell carcinoma, with a clinical stage of cT3-4aN0M0 or cT1b-4aN1-3M0 (AJCC 8th edition), deemed by the investigator to be suitable for curative esophagectomy and for whom neoadjuvant therapy is recommended. 3.Absence of suspicious metastatic lymph nodes in the neck. No evidence of distant metastasis on imaging studies, including contrast-enhanced CT of the neck, chest, and abdomen, contrast-enhanced MRI of the brain, and bone scan or PET-CT. 4.ECOG Performance Status score of 0 to 2. 5.Normal function of major organs, sufficient to tolerate surgical intervention. 6.Laboratory tests within the following parameters, confirming adequate bone marrow, liver, and renal function: Hemoglobin (Hb) >= 90 g/L. White Blood Cell (WBC) count >= lower limit of normal (LLN). Absolute Neutrophil Count (ANC) >= 1.5 × 10^9/L. Platelet count (PLT) >= 100 × 10^9/L.Total Bilirubin (TBIL) = 50 mL/min (calculated using the Cockcroft-Gault formula). 7.No prior antitumor therapy for esophageal cancer. 8.At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. 9.Females of childbearing potential must agree to use highly effective contraception (e.g., intrauterine device, contraceptive pills, or condoms) during the study treatment and for 60 days after the last dose, have a negative serum pregnancy test within 7 days prior to study enrollment, and must not be breastfeeding. Male subjects must agree to use effective contraception during the study treatment and for 60 days after the last dose. 10.Willing and able to understand and sign an Institutional Review Board (IRB)-approved informed consent form.
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria will be excluded from the study: 1.Previous treatment for esophageal squamous cell carcinoma, including surgery, radiotherapy, chemotherapy, targeted therapy, or immunotherapy. 2.Presence of distant organ metastasis. 3.History of active bleeding within the past 2 months; tumor suspected of invading major airways or blood vessels; or patients with a high risk of bleeding, such as those with coagulopathy at enrollment or undergoing thrombolytic or anticoagulant therapy. 4.Documented history of autoimmune disease, or long-term use of immunosuppressive agents or systemic corticosteroids. 5.History of other malignancies within the past 5 years, except for cured localized tumors such as carcinoma in situ of the cervix, basal cell carcinoma of the skin, papillary carcinoma of the thyroid, or carcinoma in situ of the prostate. Patients with prostate cancer who received hormonal therapy and have achieved disease-free survival (DFS) for over 5 years are not excluded. 6.Severe cardiovascular or cerebrovascular diseases, including any of the following: Congestive heart failure (New York Heart Association Class III or IV), unstable angina, myocardial infarction, poorly controlled arrhythmia, or cerebrovascular accident within the past 12 months. Left ventricular ejection fraction (LVEF) 480 ms (calculated using Fridericia's formula; if QTc is abnormal, the average of 3 consecutive readings taken 2 minutes apart may be used). Poorly controlled hypertension (systolic blood pressure >= 160 mmHg and/or diastolic blood pressure >= 100 mmHg) despite medication, based on the average of two or more measurements. History of hypertensive crisis or hypertensive encephalopathy. 7.Significant history of interstitial lung disease, or presence of pneumonitis at enrollment requiring treatment with steroids or immunosuppressants. 8.Active tuberculosis, or having received anti-tuberculosis treatment within 1 year prior to enrollment. 9.Presence of severe non-healing wounds, untreated fractures, or severe infectious diseases requiring systemic anti-infective therapy at the time of enrollment. 10.Systemic corticosteroid therapy (>10 mg prednisone equivalent per day) or other immunosuppressants within 2 weeks prior to enrollment. 11.History of severe allergic reactions to chemotherapeutic agents (e.g., nab-paclitaxel or carboplatin) or any monoclonal antibody. 12.Active autoimmune disease that required systemic treatment (i.e., immunomodulators, corticosteroids, or immunosuppressants) within the past 2 years. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed. Patients with type 1 diabetes mellitus controlled on a stable insulin regimen are eligible. 13.Previous history of organ transplantation. 14.For subjects who are HBsAg positive and/or HBcAb positive, HBV-DNA must be < 500 IU/mL (or below the lower limit of quantification if the local assay threshold is higher than 500 IU/mL, subject to discussion with the sponsor). These subjects must continue effective anti-HBV therapy (e.g., entecavir or tenofovir) during the study. 15.Positive HCV antibody test, unless subsequent HCV-RNA is <= 10^3 copies/mL. 16.Co-infection with HIV or other immunodeficiency diseases. 17.Inability to communicate effectively, expected poor com
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response (PCR) rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major Pathological Response Rate;Rate of R0 Resection;Objective Response Rate (ORR);Disease Control Rate (DCR);Event-Free Survival (EFS);Overall Survival; | — |
Countries
China
Contacts
Public ContactYifeng Zheng
The General Hospital of the Western Theater Command of the Chinese People's Liberation Army
Outcome results
None listed