Esophageal cancer
Conditions
Interventions
The Group of Camrelumab:Camrelizumab + Paclitaxel (albumin-bound type)
Sponsors
Anyang Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years, both male and female; 2. Esophageal squamous cell carcinoma diagnosed by histology or cytology, with locally advanced unresectable, local recurrence (local lymphatic metastasis), or distant metastasis; 3. Patients who have progressed or intolerated first-line chemotherapy (which may include platinum or fluorouracil-based) (the progress of maintenance treatment after first-line chemotherapy can also be included). Concurrent chemoradiation and chemotherapy for postoperative recurrence or metastasis are considered first-line treatment; for radical concurrent chemoradiation, neoadjuvant/adjuvant therapy (chemotherapy or radiochemotherapy), if the disease progresses during treatment or within 6 months after stopping treatment, it should be count it as a failure of first-line treatment; 4. According to the evaluation criteria for the efficacy of solid tumors (RECIST 1.1), there is at least one measurable lesion, and the measurable lesion should not have received local treatment such as radiotherapy (the lesion located in the area of previous radiotherapy, if it is confirmed that it has progressed, and meets RECIST1.1 Standard, target lesions can also be selected); 5. Tissue samples must be provided for biomarker analysis, and newly obtained tissues are preferred. Patients who cannot provide newly obtained tissues can provide 5-8 5um-thick paraffin sections for archive preservation; 6. ECOG: 0-1; 7. Expected survival period >= 12 weeks; 8. The function of main organs is normal, that is, it meets the following standards: (1) Routine blood examination: 1) HB >= 90g/L; 2) ANC >= 1.5 x 10^9/L; 3) PLT >= 80 x 10^9/L; (2) Biochemical examination: 1) ALB >= 30g/L; 2) ALT and AST = 60ml/min; 9. Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) >= the lower limit of normal (50%). 10. Females of childbearing age should agree to use contraceptive measures (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study; serum or urine pregnancy tests are negative within 7 days before study entry , and must be a non-lactating patient; men should agree to use contraceptive measures during the study period and within 6 months after the end of the study period; 11. Subjects voluntarily joined the study, signed an informed consent form, had good compliance, and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: 1. The patient has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, Hyperthyroidism; patients suffering from vitiligo; asthma has been completely relieved in childhood, and can be included in adults without any intervention; patients with asthma that require bronchodilators for medical intervention cannot be included); 2. The patient is using immunosuppressive agents or systemic hormone therapy to achieve the purpose of immunosuppression (dose >10mg/day prednisone or other curative hormones), and continues to use it within 2 weeks before enrollment; 3. The primary lesion is an esophageal squamous cell carcinoma patient with active bleeding; 4. Patients with esophageal squamous cell carcinoma who have not undergone surgical resection of the primary lesion, but the esophageal lesions have not shrunk after radiotherapy; 5. Those who have received VEGFR inhibitors, such as sorafenib, sunitinib, or apatinib; 6. Those who have a variety of factors that affect oral medications (such as inability to swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.); 7. Patients with brain metastases who have symptoms or who have been under symptom control for less than 3 months; 8. Patients with any severe and/uncontrolled diseases, including: patients with unsatisfactory blood pressure control (systolic blood pressure >= 150 mmHg or diastolic blood pressure >= 100 mmHg); patients with grade I or higher myocardial ischemia or myocardial infarction, arrhythmia (Including QT interval >= 480ms) and grade I cardiac insufficiency; active or uncontrolled severe infection; liver diseases such as decompensated liver disease, active hepatitis B (HBV-DNA >= 104 copies/ml or 2000IU/ ml) or hepatitis C (hepatitis C antibody is positive, and HCV-RNA is higher than the detection limit of the analysis method); urine routine indicates that urine protein is >= ++, and it is confirmed that the 24-hour urine protein quantification is greater than 1.0g; 9. Long-term unhealed wounds or fractures; 10. Pulmonary hemorrhage with NCI CTC AE grade> Grade 1 occurred within 4 weeks before enrollment; bleeding in other parts with NCI CTC AE grade > Grade 2 occurred within 4 weeks before enrollment; hemorrhage tendency (such as active peptic ulcer) or patients who are receiving thrombolytic or anticoagulant therapy such as warfarin, heparin or their analogues; 11. Those who have had arterial/venous thrombotic events within 6 months, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis and pulmonary embolism; 12. Imaging shows that the tumor has invaded important blood vessels or the investigator judges that the tumor is very likely to invade important blood vessels and cause fatal hemorrhage during the follow-up study; 13. Pregnant or lactating women; 14. Patients suffering from other malignant tumors within 5 years (except for cured skin basal cell carcinoma and cervical carcinoma in situ); 15. Persons with a history of psychotropic drug abuse and unable to quit or patients with mental disorders; 16. Patients who have participated in other drug clinical trials within four weeks; 17. According to the judgment of the investigator, patients with concomitant diseases that seriously endanger the safety of the patient or affect t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate, DCR;Progression-free survival, PFS;Overall survival, OS;Safety; | — |
Countries
China
Contacts
Public ContactWang Junsheng
Anyang Cancer Hospital
Outcome results
None listed