| Eligibility |
Inclusion Criteria:
- histopathology confirmed unresectable, locally recurrent or metastatic advanced
esophageal squamous cell carcinoma (excluding mixed type adenosquamous carcinoma );
- Those who have not received systemic treatment before, or who relapsed after (new)
adjuvant therapy/radical surgery more than 6 months ; Note: Including advanced or
recurrent Patients who ever received only radiotherapy on non-target lesions. The
duration from the end of palliative treatment for local lesions (non-target lesions)
to enrollment should > 2 weeks;
- According to RECIST 1.1, at least one measurable lesion; the measurable lesions should
not have received local treatment such as radiotherapy (for the lesions in the area
where received local radiotherapy, it can also be regarded as a target lesion if
confirmed to progress according to the recist1.1);
- Age from 18-75 years old;
- ECOG PS score: 0-1; expected survival time more than 3 months;
- Main organs function is normal;
- Women of childbearing potential should agree to use and utilize an adequate method of
contraception (such as intrauterine device,contraceptive and condom) throughout
treatment and for at least 3 months after study is stopped;the result of serum or
urine pregnancy test should be negative before enrollment;Man participants should
agree to use and utilize an adequate method of contraception throughout treatment and
for at least 2 months after study is stopped.
- Patients should participate in the study voluntarily and sign informed consent
Exclusion Criteria:
- Patients tends to have complete obstruction or patients requiring interventional
treatment for obstruction;
- ulcerated esophageal squamous cell carcinoma patients;
- after esophageal or endotracheal stent implantation;
- Patients with a high risk of bleeding or perforation due to the apparent invasion of
adjacent organs (aorta or trachea) of the esophageal lesion, or patients who have
formed fistulas;
- patients with ESCC who have not undergone surgical resection but have not reduced
esophageal lesions after radiotherapy;
- allergic to paclitaxel and cisplatin preparations or excipients;
- Adjuvant chemotherapy patients who have used paclitaxel or cisplatin, and relapse or
metastasize within one year;
- A variety of factors affecting oral medications (such as inability to swallow, chronic
diarrhea, and intestinal obstruction);
- The of liver metastases accounts for more than 50% of the total liver volume;
- patients with any severe and / or uncontrolled disease, including:Unsatisfactory blood
pressure control using antihypertensive drugs (systolic blood pressure =150 mmhg or
diastolic blood pressure =100) Mmhg) patients; patients with grade = myocardial
ischemia or myocardial infarction, arrhythmia (including qt interval = 480ms);
according to nyha criteria, iii-iv cardiac dysfunction, or cardiac ultrasonography
prompted left ventricular ejection fraction (lvef) <50% of patients;live Severe
infection that is sexual or uncontrolled;Liver diseases such as cirrhosis,
decompensated liver disease, chronic active hepatitis;poor diabetes control (fasting
blood glucose (fbg)>10mmol/l);Urine routine indicates that urine protein = ++, and
confirmed 24-hour urine protein quantitation > 1.0 g;
- long-term unhealed wounds or fractures;
- Patients with active hemorrhage within 2 months of primary lesions; pulmonary
hemorrhage with NCI CTC AE grade >1, 4 weeks before of enrollment; other sites of
bleeding NCI CTC AE grade >2, 4 weeks before of enrollment; patients with bleeding
tendency (such as active gastrointestinal ulcers) or patients undergoing thrombolytic
or anticoagulant therapy such as warfarin, heparin or its analogues;
- Have undergone major surgery (craniotomy, thoracotomy or open surgery) within 4 weeks
prior to the first dose study or Major surgery is required during the study period.
- A history of gastrointestinal perforation and/or fistula occurred within 6 months
prior to treatment; or an overactive/venous thrombosis event such as a cerebrovascular
accident (including transient ischemic attack), deep vein thrombosis, and lung
Embolism.
- Symptomatic central nervous system metastasis and/or cancerous meningitis are known to
exist;
- Clinically significant ascites, including any ascites that can be found on a physical
examination, ascites that has been treated or currently in need of treatment, and only
those with a small amount of ascites but no symptoms can be selected;
- A moderate amount of fluid in both sides of the chest, or a large amount of fluid in
one side of the chest, or has caused respiratory dysfunction Patient to be drained;
- known to have active tuberculosis;
- suffering from interstitial lung disease requiring steroid therapy;
- Uncontrolled metabolic disorders or other non-malignant tumors or systemic diseases or
cancer secondary reactions that can lead to higher medical risks and/or survival
Evaluation of uncertainty;
- Significantly malnourished patients;
- those who have a history of psychotropic substance abuse and are unable to quit or
have a mental disorder;
- A history of immunodeficiency, including a positive HIV test or other acquired,
congenital immunodeficiency disease, or a history of organ transplantation;
- History of other primary malignancies, but the following : 1) complete remission of
malignant tumors for at least 2 years prior to enrollment and no additional treatment
during the study; 2) non-melanoma skin cancer or malignant freckle-like sputum with
adequate treatment and no evidence of disease recurrence; 3) adequately treated and In
situ carcinoma without evidence of disease recurrence;
- Female patients who are pregnant or breastfeeding
- According to the investigator's judgment, there are serious concomitant diseases that
endanger the safety of the patient or affect the patient's completion of the study.
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