Esophageal cancer
Conditions
Interventions
Test group:Iparomlimab and Tuvonralimab Combined with albumin paclitaxel and nedaplatin
Sponsors
Harbin Medical University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.The subjects voluntarily joined this study and signed the informed consent form; 2.Aged 18 or above and under 75 years old, with no gender restrictions; 3.Patients with thoracic esophageal squamous cell carcinoma, confirmed by histopathology or cytology, with clinical stages of IIa-IIIb, and whose lesions are assessed by the researcher as resectable; 4.Have not received any anti-tumor treatment for esophageal cancer in the past, including but not limited to radiotherapy, chemotherapy, surgery, clinical research drugs, etc; 5.Patients who agreed to accept radical surgery and were judged by the investigator to have no contraindications to surgery; 6.The Eastern Cooperative Oncology Group (ECoG) physical status score was 0 or 1; 7.The expected survival time was > 6 months; 8. It has sufficient organ function and meets the following criteria (no blood component or cell growth factor correction treatment drugs are allowed within 14 days before medication):(1) The absolute neutrophil count (ANC) >= 1.5 × 10^9 / L, platelet (PLT) >= 100 × 10^9 / L, hemoglobin >= 90g / L; (2) Total bilirubin (TBIL) = 60ml/min; (4) Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) <= 1.5 × ULN; 5) The muscle enzyme spectrum is within the normal range (for example, simple laboratory abnormalities that are not clinically significant according to the comprehensive judgment of the investigator are also allowed to be enrolled); 9.Female subjects of childbearing age should receive a urine or serum pregnancy test with negative results within 3 days before receiving the first study drug administration (day 1 of cycle 1), or non lactation. If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Women of non reproductive age were defined as having been postmenopausal for at least 1 year, or having undergone surgical sterilization or hysterectomy. 10.For fertile subjects (male and female), they must agree to use reliable methods of contraception from signing the informed consent form until at least 90 days after the last administration of the study drug.
Exclusion criteria
Exclusion criteria: 1.Other malignancies were diagnosed within 5 years before the first administration. Cured localized tumors, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate cancer in situ, cervical cancer in situ, breast cancer in situ, etc., can be enrolled; 2.Those with a history of gastrointestinal hemorrhage within 6 months before the first administration, or those with high bleeding tendency accompanied by abnormal coagulation function and receiving thrombolytic or anticoagulant treatment, or those with esophageal or gastric varices at the time of enrollment; 3.There is uncontrollable effusion in the third space requiring puncture and drainage, such as pleural effusion, pericardial effusion, pelvic effusion or ascites, etc; 4.Have received systemic treatment with Chinese patent drugs with anti-tumor indications or drugs with immunomodulatory effects (including thymosin, interferon, interleukin, except for local use to control pleural effusion) within 14 days before the first administration; 5.Have not fully recovered from the toxicity and / or complications caused by any intervention before starting treatment (i.e., = grade 1 or reaching baseline, excluding fatigue or alopecia); 6.Pregnant or lactating women; 7.There were severe unhealed wounds, active ulcers, and untreated fractures at the time of enrollment, or major organ surgery or significant trauma within 28 days before the first dose; 8.Clinically obvious cardiovascular and cerebrovascular diseases, including but not limited to severe acute myocardial infarction, unstable or severe angina, coronary artery bypass surgery, congestive heart failure, ventricular arrhythmia requiring medical intervention, and left ventricular ejection fraction < 50% within 6 months before the first administration; 9.Active tuberculosis is known?Subjects suspected of active pulmonary tuberculosis should be excluded by chest imaging, sputum and clinical symptoms and signs; 10.Subjects with active hepatitis B or active hepatitis C; 11.Known history of immunodeficiency or HIV test positive; 12.It is known that there is interstitial lung disease or non infectious pneumonia, the disease is currently symptomatic or previously required systemic glucocorticoid treatment, and the investigator's judgment may affect the toxicity assessment or management related to the study treatment; 13.Active infections, including infections requiring intravenous antibiotics and antifungal treatment 2 weeks before the first administration, and fever of unknown cause during the screening period (nci-ctcae v5.0 = 1, except those caused by tumor as judged by the investigator); 14.Had received or expected to receive systemic glucocorticoid therapy (excluding nasal spray, inhalation or other local glucocorticoids) or any other form of immunosuppressive therapy within 14 days before the first dose of Glucocorticoid (= 10 mg/ day of prednisone or equivalent)); 15.Previously received immune checkpoint inhibitors (such as anti-PD-1 antibody, anti-PD-L1 antibody, anti-CTLA-4 antibody, etc.), immune checkpoint agonists (such as antibodies against ICOS, CD40, CD137, GITR, OX40 targets, etc.), immune cell therapy (such as car-t), and other treatments targeting tumor immune mechanism; 16.Active autoimmune diseases requiring systemic treatment within 2 years before the first administration, or autoimmune diseases that may recur or are planned to be treated according to the judgment of t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete Response (pCR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease-Free Survival;Safty;Objective response rate;Overall survival;R0 resection rate;Quality of Life Score;Major Pathological response; | — |
Countries
China
Contacts
Public ContactJianqun Ma
Harbin Medical University Cancer Hospital
Outcome results
None listed