Esophageal squamous cell carcinoma
Conditions
Interventions
experimental group:Antutinib combine Tiggio
Sponsors
The 900th Hospital of The Joint Logistic Support Force of PLA
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 18-75 years old; ECoG PS score: 0-1; expected survival time: more than 3 months; 2; 2. Patients with metastatic esophageal squamous cell carcinoma confirmed by histology or cytology (primary lesions at the gastroesophageal junction: more than 50% of the lesions should be located in the esophagus); 3. Patients who have received first-line chemotherapy combined with immunotherapy in the past have evidence of imaging or clinical disease progression. Only second-line subjects were enrolled in this study. Second line subjects were defined as those who developed during or after chemotherapy combined with immunotherapy in the first-line treatment. (1) The progression of the disease should be confirmed by CT scan. In certain cases, clinical evidence of disease progression, such as any new malignant effusion or aggravation of malignant effusion (as shown by ultrasound records), and confirmed by pathological criteria (histology and / or cytology), is also acceptable. (2) For radical treatment, including neoadjuvant / adjuvant chemotherapy or chemoradiotherapy or radical chemoradiotherapy, if disease progression occurs during treatment or within 6 months after the end of treatment, it will be regarded as the first-line treatment. In case of changing one or more first-line drugs and / or reducing dose due to toxicity / intolerance, it will not be regarded as a new first-line treatment if the researchers consider it clinically appropriate; 4. The time from the disease progression to the end of the last standard treatment was more than 4 weeks; 5. At least one measurable lesion: measurable lesion: at least one measurable diameter (maximum diameter) >= 10 mm in CT and MRI; 6. The laboratory test values of patients before medication should meet the following standards: 1) Blood routine: WBC >= 3.0 x 10^9 / L; ANC >= 1.5 x 10^9 / L; PLT >= 90 x 10^9 / L; Hgb >= 9.0 g / dl 2) Liver function: TBIL = 50 ml / min; 4) Coagulation function: INR <= 1.5, APTT <= 1.5 x ULN; 7. Women of childbearing age must have a serum pregnancy study within 2 weeks before the first medication, and the result is negative. Female subjects of childbearing age and male subjects with a partner of childbearing age were required to use contraception during the study period and within 180 days after the last administration of the study drug; 8. The subjects voluntarily joined the study, signed informed consent, good compliance, and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients who had surgery within 4 weeks; 2. Patients who had received esophageal or mediastinal radiotherapy in the past one month; 3. Patients who have used VEGF monoclonal antibody or VEGFR kinase inhibitor in the past;; 4. Within 5 years, the patient had or had other malignant tumors (except the cured basal cell carcinoma of skin, carcinoma in situ of prostate and carcinoma in situ of cervix); 5. Patients with any active autoimmune disease or history of autoimmune disease (such as but not limited to: autoimmune hepatitis, interstitial pneumonia, enteritis, vasculitis, nephritis; asthma requiring bronchodilator for medical intervention cannot be included); but the following patients are allowed to be included: vitiligo, psoriasis, asthma without systemic treatment Hair loss, well controlled type I diabetes, hypothyroidism with normal thyroid function after replacement therapy; 6. Patients with uncontrolled hypertension treated with standard treatment (blood pressure not stabilized below 150 / 90 mmHg) 7. Patients with any signs of bleeding constitution or history, regardless of severity; any bleeding or bleeding event >= CTCAE 3 within 4 weeks before the first administration Patients with grade A, or gastrointestinal diseases such as unhealed wound, fracture, active ulcer of stomach and duodenum, ulcerative colitis, or active bleeding of unresected tumor, or other conditions that may cause gastrointestinal bleeding and perforation determined by researchers; 8. Patients with definite or suspected brain metastasis. Patients with a history of brain metastasis must have completed treatment and no longer need corticosteroid treatment; 9. Patients with cardiac clinical symptoms or diseases that can not be well controlled, such as: (1) heart failure of NYHA grade 2 or above; (2) unstable angina pectoris; (3) myocardial infarction within 24 weeks; (4) clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention; 10. Patients with clinically uncontrollable effusion in the third space (such as pleural effusion / pericardial effusion, patients who do not need drainage or whose effusion does not increase significantly after 3 days of drainage can be included in the group); 11. Patients with high risk of bleeding or fistula due to obvious invasion of adjacent organs (large artery or trachea) of esophageal lesions; subjects after endotracheal stent implantation. 12. Patients with a history of immunodeficiency, including HIV positive, other acquired or congenital immunodeficiency diseases, or history of organ transplantation or allogeneic bone marrow transplantation; 13. Patients with active hepatitis B (defined as positive results of hepatitis B virus surface antigen (HBsAg) and detection of HBV-DNA higher than the upper limit of normal value in the laboratory of the research center) or patients with hepatitis C (defined as positive results of hepatitis C virus surface antibody (hcsab) and positive results of HCV-RNA); 14. Patients with obvious factors affecting oral drug absorption, such as inability to swallow, chronic diarrhea and intestinal obstruction, etc; 15. For patients whose baseline cellulose test results are >= 2 + proteinuria, 24-hour urine should be collected, and then it must be confirmed that the urine protein content within 24 hours is less than 1g; 16. Patients with allergic reaction to the test drug used in this study; 17. In the judgment of the researcher, there
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival;one-year survival rate;two-year survival rate;objective remission rate;Disease control rate;safety; | — |
Countries
China
Contacts
Public ContactZhichao Fu
The 900th Hospital of the Joint Logistic Support Force of PLA
Outcome results
None listed