Esophageal squamous cell carcinoma
Conditions
Interventions
Iparomlimab and Tuvorralimab Combined with Neoadjuvant Chemotherapy Group:Eligible study participants were treated with Otto combination antibody (5mg/kg, d1) in combination with nab-paclitaxel (260mg
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Study participants must meet all of the following criteria to be enrolled in this trial: Study participants voluntarily join this study, sign an informed consent form, and cooperate with follow-up; Histological/cytologically confirmed esophageal squamous cell carcinoma; Thoracic esophageal cancer as assessed by CT/MRI/EUS and clinically staged cT1b-3N1-3M0 or cT3N0M0 (according to AJCC version 8, see Annex I); Have not received anti-tumor therapy in the past, including radiotherapy, chemotherapy, surgery, etc.; Age 18-75 years old, male or female; Planned surgical treatment after completion of neoadjuvant therapy; There were no contraindications to surgery in various organ function examinations before surgery; ECOG PS: 0~1 point (see Annex 2); Vital organ function meets the following requirements (no blood components and cell growth factors are allowed 2 weeks prior to starting study treatment): Routine blood tests should be done in: Absolute neutrophil count (ANC) >=1.5×10^9/L; Hemoglobin (HB) >=9g/dL; Platelets (PLT) >=100×10^9/L; Serum albumin (ALB) >=2.8 g/dL. Biochemical tests must be carried out in: total bilirubin (TBIL) =50ml/min (Cockcroft-Gault formula); The thyroid gland is functioning normally. Coagulation must be consistent with: International normalized ratio (INR) =3 months; The investigator judged that the patient could be treated with aitol combination antibody combined with chemotherapy; Female subjects of childbearing potential should have a urine or serum pregnancy test within 72 hours prior to receiving the first dose of study drug and be proven negative, and willing to use an effective method of contraception during the trial period until 3 months after the last administration of the Otto combination antibody; For male subjects whose partner is a woman of childbearing age, an effective method of contraception should be used during the trial and for 3 months after the last dose of the aitol combination antibody; Study participants had good compliance and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following will be excluded from this trial: 1. The tumor obviously invades the organs adjacent to the esophageal lesion (large artery or trachea); 2. Those with supraclavicular lymph node metastasis; 3. Presence of uncontrollable pleural effusion, pericardial effusion or ascites that requires repeated drainage; 4. Poor nutritional status, BMI 10mg/day prednisone or equivalent); In the absence of active autoimmune disease, inhaled or topical steroids and adrenocorticosteroid replacement at a dose of > 10mg/day prednisone or equivalent are permitted; c) Receipt of a live attenuated vaccine within 4 weeks prior to the first use of study drug; d) Major surgery or severe trauma within 4 weeks prior to the first use of study drug; 7. Have any active autoimmune disease or history of autoimmune disease, including but not limited to: interstitial pneumonia, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (may be considered for inclusion after hormone replacement therapy); Patients with psoriasis or childhood asthma/allergies that have been completely resolved and do not require any intervention in adulthood may be considered, but patients requiring medical intervention with bronchodilators may not be included; 8. Have a history of immunodeficiency, including a positive HIV test, or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation or allogeneic bone marrow transplantation; 9. Presence of unwell controlled cardiac clinical symptoms or diseases, including but not limited to: such as: (1) NYHA grade II or above heart failure, (2) unstable angina, (3) myocardial infarction within 1 year, (4) clinically significant supraventricular or ventricular arrhythmia without clinical intervention or poor control after clinical intervention; 10. Severe infection (CTCAE > grade 2) within 4 weeks before the first use of the study drug, such as severe pneumonia, bacteremia, infection complications, etc., requiring hospitalization; Those with active lung inflammation on baseline chest imaging, symptoms and signs of infection within 14 days prior to the first dose of study drug, or the need for oral or intravenous antibiotic therapy, except for prophylactic antibiotics; 11. Those who have active pulmonary tuberculosis infection through medical history or CT examination, or those who have a history of active pulmonary tuberculosis infection within 1 year before enrollment, or those who have a history of active pulmonary tuberculosis infection more than 1 year ago but have not been formally treated; 12. Presence of active hepatitis B (HBV DNA >= 2000 IU/mL or 104 copies/mL), hepatitis C (positive for hepatitis C antibody, and HCV RNA above the lower limit of detection by the analytical method); 13. Diagnosis of other malignancies within 5 years prior to the first use of the study drug, unless malignancies with low risk of metastasis or death (5-year survival
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete remission rate (pCR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Major Pathological Response (MPR);R0 resection;Objective Response Rate (ORR);Disease Control Rate (DCR);Event-Free Survival (EFS);Overall Survival(OS); | — |
Countries
China
Contacts
Public ContactYong Yuan
West China Hospital, Sichuan University
Outcome results
None listed