Esophageal cancer
Conditions
Interventions
trial group:Drug sensitivity screening
Sponsors
The First Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged 18-75 years, regardless of gender or region; 2. Patients with esophageal squamous cell carcinoma confirmed by histology and / or cytology (including cervical esophageal squamous cell carcinoma); all other histological types were excluded. 3. Be able to obtain patient lesion specimens for primary cell culture in vitro (acquisition methods include puncture, endoscopic biopsy, surgery, etc.); 4. Patients with at least one non esophageal lesion measurable according to recist1.1 (according to RECIST 1.1); local mass confined to esophagus was classified as "unmeasurable"; 5. Cohort 1: advanced esophageal cancer patients treated with first-line treatment, including newly diagnosed patients with unresectable stage IV esophageal cancer, patients with recurrence after surgery or radiotherapy and chemotherapy alone, and patients receiving neoadjuvant therapy. Cohort 2: Patients with advanced esophageal squamous cell carcinoma (including cervical esophageal squamous cell carcinoma) of the second line and above. Patients with second-line and above advanced esophageal squamous cell carcinoma were defined as failure to receive at least the first-line regimen. Treatment failure refers to disease progression during treatment, or disease progression within 4 months after the last Administration (including single drug maintenance treatment of first-line treatment). If neoadjuvant or adjuvant therapy is allowed, recurrence or metastasis occurs during or within 6 months after completion of adjuvant therapy, the failure of first-line systemic treatment for advanced disease is considered. The first-line treatment includes chemotherapy, concurrent chemoradiotherapy, targeted therapy, antiangiogenic therapy, immunotherapy and the combination of the above therapies. Patients who have received second-line and third-line treatment can also be enrolled. 6. Patients who did not receive systemic chemotherapy within 4 weeks before the first dose of study drug (the elution period of oral fluorouracil drugs is 2 weeks) or systemic anti-tumor therapy such as radiotherapy, immunotherapy, biological or hormone therapy, etc; 7. Body weight over 40 kg (including 40 kg), or BMI > 18.5; 8. ECoG score was 0-1; 9. Patients who expected to survive more than 12 weeks; 10. Patients who signed the enrollment consent before treatment.
Exclusion criteria
Exclusion criteria: 1. Patients with complex squamous cell carcinoma, including squamous adenocarcinoma, squamous cell carcinoma, small cell carcinoma, carcinosarcoma, sarcomatoid carcinoma, etc; 2. The patient's lesions could not obtain specimens for primary cell culture in vitro; 3. The toxicity of previous anticancer therapy has not recovered (CTCAE grade 1), or has not recovered from the previous hand The results of drug sensitivity test could not be obtained because of culture failure; 4. Patients with brain metastases at baseline; 5. Patients with malignant tumor in the past 5 years (skin squamous or basal cell carcinoma, cervical carcinoma in situ, radical treatment); The patients with second primary cancer were pregnant and lactating women, and those who were ready to get pregnant in the near future; 6. Patients with the following active infectious diseases, including active tuberculosis, hepatitis, known human immunodeficiency virus (HIV) infection. Those who have neurological or mental disorders and are unable to cooperate or are unwilling to cooperate; 7. Patients with a history of severe complications: severe chronic obstructive pulmonary disease with hypoxemia; uncontrolled hypertension, cerebrovascular accident / stroke, myocardial infarction, unstable angina pectoris, thromboembolism, chronic congestive heart failure, or severe arrhythmias requiring drug treatment; severe hepatitis, liver disease history; nephrotic syndrome, renal insufficiency; activity History of ulcer, abdominal wall fistula, gastrointestinal perforation, or abdominal abscess; uncontrolled diabetes; uncontrolled epilepsy requiring long-term anticonvulsant therapy. 8. Patients with dysphagia who can not be given orally, or who have persistent vomiting or have known drug absorption disorders; 9. Patients with appropriate organ function were excluded from the group if they had the following conditions: (1) The absolute neutrophil count (ANC) = 1.0g/24h; (6) Partial prothrombin time (APTT) and prothrombin time (PT) exceed 1.5 * ULN (subject to the normal value of clinical trial research center); 10. Skin wound, surgical site, wound site, mucosal ulcer or fracture were not completely healed; 11. Over surgical operation within 60 days before randomization; 12. Pregnant or lactating women or women with pregnancy possibility were detected positive for pregnancy before the first medication; 13. Those who have fertility but are not willing to accept contraceptive measures or their sexual partners are not willing to accept contraceptive measures; 14. The researchers considered that the subjects were not suitable to participate in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival;Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease-free survival;Objective response rate; | — |
Countries
China
Contacts
Public ContactZhang Renquan
The First Affiliated Hospital of Anhui Medical University
Outcome results
None listed