Combination of Toripalimab and Neoadjuvant Chemoradiotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma

Launched by WEI REN · Nov 24, 2020

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ClinConnect Summary

This study was designed as an open-lable, single-arm, single-center,exploratory clinical study. Toripalimab combination of chemoradiotherapy as neoadjuvant therapy. Participants will receive carboplatin (AUC=2) and paclitaxel liposome (50mg/m²) on day 3,10,17,24,31. And radiotherapy Intensity-modulated radiation therapy（IMRT）will start from day 1 to 31 of chemotherapy. A total of 41.4 Gy, 23 fractions of 1.8 Gy. Participants will also receive Toripalimab (240mg) on days 3, 24and 45. After the neoadjuvant treatment is over, the short-term efficacy evaluation will be performed first, and then...

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Eligibility criteria

• Inclusion Criteria:
• • 1. Aged 18 to 70 years old of either gender
• • 2. A histopathological diagnosis of resectable thoracic esophageal squamous cell carcinoma(The midpoint of the upper and lower margins of the primary tumor is ≥25cm from the incisor)
• • 3. There is no distant metastasis and the esophageal tumor can be resected or potentially resectable after the expert consultation of thoracic surgery. The clinical stage is cT3-4aN0-2M0, patients with stage Ⅱ, Ⅲ, and IVA (AJCC 8th edition cTNM staging);
• • 4. ECOG PS score of 0-1;
• • 5. Patients who are anti-tumor treatment-naive;
• • 6. Estimated life expectancy \>6 months
• • 7. Baseline the function of important organs meets the following requirements: a. white blood cell count (WBC) ≥ 3×109/L, absolute neutrophil count (ANC) ≥ 1.5×109/L，;Baseline organ function meets: ①WBC≥3×109/L, ANC≥1.5×109/L, PLT≥100×109/L, Hb≥90g/L; ②Liver function: TBIL≤2ULN, Aspartate aminotransferase（AST） ≤2.5ULN, ALT≤2.5ULN ③renal function: cCr≥60 ml/min, Cr≤1.5 ULN; ④heart function: no heart disease or coronary heart disease, the patient's heart function is 1-2 grade;
• • 8. The blood pressure of hypertensive patients should be controlled within the normal range with antihypertensive drugs;
• • 9. The fasting blood-glucose of diabetic patients should be controlled at ≤8mmol/L through hypoglycemic drugs;
• • 10. No other serious diseases that conflict with this plan (such as autoimmune diseases, immunodeficiency, organ transplantation, or other diseases that require continuous hormone therapy);
• • 11. No history of other malignant tumors;
• • 12. The patient agrees to participate in this clinical study and signs the "Informed Consent". Ability to understand the study and sign informed consent.
• Exclusion Criteria:
• • 1. Patients who have been treated previously with anti-tumor therapy (including chemotherapy, radiotherapy, surgery, immunotherapy, etc.);
• • 2. Patients with other malignant tumors (non-malignant black skin tumors, cervical cancer in situ, except for cured prostate cancer);
• • 3. Patients who have been or expected to have a significant risk of esophageal perforation, fistula, and major bleeding;
• • 4. Patients who have active autoimmune diseases or patients who are undergoing treatment of autoimmune diseases (Prior therapy with immunosuppressant, the dose of immunosuppressant used ≥10mg/day, oral prednisone for more than 2 weeks);.
• • 5. Uncontrolled clinically significant cardiovascular and cerebrovascular diseases , including but not limited to severe acute myocardial infarction, unstable or severe angina pectoris, coronary artery bypass surgery, congestive heart failure, ventricular arrhythmia requiring medical intervention within 6 months before enrollment 、Left ventricular ejection fraction \<50%, or other patients who are not expected to tolerate chemotherapy and radiotherapy;Cardiac clinical symptoms or diseases that are not well controlled, such as: a. Heart Failure（New York Heart Association）\> Class Ⅱ, b. unstable angina, c. myocardial infarction within 1 year; d. Clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention.
• • 6. Patients who were severe allergic constitution;;
• • 7. Patients who were pregnant or lactating women;
• • 8. Patients who have severe mental disorders;
• • 9. Patients who have peripheral nerve disease with common terminology criteria (CTC）grade ≥3;
• • 10. Abnormal blood coagulation function including PT\>16s, activated partial thromboplastin time（APTT）\>53s, Thrombin time（TT）\>21s, Fib\<1.5g/L, bleeding tendency or receiving thrombolytic or anticoagulant therapy;
• • 11. Patients who hsve severe pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, severely impaired lung function, etc past or present., or active tuberculosis within 1 year;
• • 12. Patients who have active hepatitis B or C;
• • 13. Patients who did not meet the enrollment conditions xia researchers evaluated.