Advanced esophageal squamous cell carcinoma
Conditions
Interventions
Test group:Anlotinib combined with TQB2450 (PD-L1 inhibitor)
Sponsors
Zhenjiang First People's Hospital (Affiliated People’s Hospital of Jiangsu University)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.The patients voluntarily joined this study, signed the informed consent form, had good compliance and cooperated with the follow-up. 2. Unresectable locally advanced, unresectable recurrent or metastatic ESCC (excluding adenosquamous carcinoma mixed type) confirmed by histopathology; 3. Patients who have not received systemic treatment in the past, or who have relapsed more than 6 months after receiving (neoadjuvant) therapy/radical treatment regimens (including radical surgical resection and radical chemoradiotherapy regimens) in the past; Note: This includes patients with advanced or recurrent non-target lesions who have progressed again after radiotherapy alone. The time from the end of palliative treatment for local lesions (non-target lesions) to the time of enrollment Two weeks; 4. According to the Response Evaluation Criteria for Solid Tumors (RECIST Version 1.1), there is at least one measurable lesion, and it can be accurately measured by magnetic resonance imaging (MRI) or computed tomography (CT) in at least one direction (the maximum diameter needs to be recorded), among which the longest diameter in the baseline period is >=10 mm (if it is a lymph node, The short diameter is required to be >=15 mm. Measurable lesions should not have received local treatments such as radiotherapy. (Lesions located within the previous radiotherapy area, if confirmed to have progressed and meet the RECIST1.1 criteria, can also be selected as target lesions.) 5. Male or female patients aged between 18 and 75; 6. Eastern Cooperative Oncology Group (ECOG) Physical Condition (PS) score: 0-1 point; 7. The expected survival period exceeds 3 months; 8. Have adequate organ and bone marrow functions, that is, meet the following criteria: a) The standards for blood routine examination need to be met (no blood transfusion or blood products within 14 days, and no correction using G-CSF and other hematopoietic stimulating factors) : • Hemoglobin content (HB) >=100g/L; • White blood cell count (WBC) >=3.0×10^9/L; • Neutrophil count (ANC) >=1.5×10^9/L; • Platelet count (PLT) >=75×10^9/L. b) Biochemical tests need to meet the following standards: • Serum total bilirubin (TBIL) =60ml/min; (Cockcroft-Gault formula) c) Adequate coagulation function, defined as the International normalized ratio (INR) or prothrombin time (PT) = the lower limit of the normal value (50%); e) Myocardial enzyme spectrum: Within the normal range. 9. Women of childbearing age must take appropriate contraceptive measures from screening to 3 months after stopping the study treatment, and they must be non-lactating patients. Before initiating the administration of the drug, a negative pregnancy test is conducted, or one of the following criteria is met to prove there is no risk of pregnancy: a) Postmenopause is defined as amenorrhea for at least 12 months after the age of more than 50 and the cessation of all exogenous hormone replacement therapies; b) Women under the age of 50 who have experienced amenorrhea for 12 months or more after discontinuing all exogenous hormone treatments and whose luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels are within the laboratory reference range
Exclusion criteria
Exclusion criteria: 1. Patients who have previously received anlotinib hydrochloride treatment or any treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies; 2. ESCC that is known to have complete obstruction under endoscopy and requires interventional treatment to relieve the obstruction; 3. Patients with ulcerative ESCC Note: Here, it mainly refers to patients whose ulcers are adjacent to blood vessels, increasing the risk of bleeding. 4. Patients who have undergone endoesophageal or tracheal stent implantation; 5. Patients with a higher risk of bleeding or perforation due to significant tumor invasion of adjacent organs (large arteries or trachea) of esophageal lesions, or those who have already formed fistulas; 6. Received major surgical treatment, incision biopsy or obvious traumatic injury within 28 days before enrollment; 7. There are multiple factors that affect the use of therapeutic drugs, such as: inability to swallow or chronic diarrhea or intestinal obstruction, significantly affecting drug administration and absorption, or a known history of severe allergy to any of the drug components in this study. 8. Patients who have received anti-tumor treatment with traditional Chinese medicine within the past 2 weeks (the traditional Chinese medicine contains the following herbs such as Brucea javanica, Coix Seed, Lentinula edodes, Cantharidin, toad skin, Astragalus membranaceus, Sophora flavessus, Aconitum vulgaris, and Chebulic myrochev, etc.) are allowed to be enrolled if the time since the last use of traditional Chinese medicine for anti-tumor treatment is more than 2 weeks. 9. The burden of liver metastases accounts for more than 50% of the entire liver volume. 10. Patients with any severe and/uncontrolled diseases, including: a) Patients whose blood pressure is not well controlled by antihypertensive drugs (systolic blood pressure >=150 mmHg or diastolic blood pressure >=100 mmHg); Or patients who use two or more antihypertensive drugs to control blood pressure; Patients who have had hypertensive crisis or hypertensive encephalopathy in the past; b) Suffering from grade I or above myocardial ischemia or myocardial infarction, arrhythmia (including the QTc interval in men) Patients with 450ms (more than 470ms in females), grade >=2 congestive heart failure (New York Heart Association (NYHA) classification), severe/unstable angina pectoris, and those who have undergone coronary/peripheral artery bypass grafting; c) Active or uncontrolled severe infection (>=CTCAE grade 2 infection), with known active pulmonary tuberculosis; d) Renal failure requires hemodialysis or peritoneal dialysis e) Liver diseases such as liver cirrhosis, decompensated liver disease, and chronic active hepatitis; f) Poor control of diabetes (fasting blood glucose (FBG) 10mmol/L g) Routine urine test indicates urine protein >=++, and confirms 24-hour urine protein quantification >1.0g; 11. Long-term unhealed wounds or fractures; 12. Screen patients who had symptoms of hematemesis or hematochezia within 3 months before the screening and had a daily blood volume of >=2.5mL, or any bleeding events >=CTCAE grade 3, or patients with any signs of bleeding or medical history regardless of severity as judged by the researchers as unsuitable for inclusion; Or abnormal coagulation function (INR>1.5 or prothrombin time (PT) ULN+4 seconds or APTT >Patients with a tendency to bleed or undergoing thrombolytic or anticoagulant therapy (1.5 ULN);Note: On the premise that the In
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety; | — |
Countries
China
Contacts
Public ContactCheng Meiying
Zhenjiang First People's Hospital (Affiliated People’s Hospital of Jiangsu University)
Outcome results
None listed