Esophageal cancer
Conditions
Interventions
Research Group:Chidamide combined with tislelizumab and anlotinib
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old, gender not limited; 2. Locally advanced/metastatic ESCC confirmed by histology or cytology; 3.a. Patients in the advanced stage who had not received treatment were enrolled in cohort A; Patients who failed first-line immunotherapy in the late stage were enrolled in cohort b 4. At least one measurable primary lesion was present before enrollment (in accordance with RECIST v1.1 criteria); 5. ECOG score: 0-2 points; 6. If there is brain metastasis, local treatment must have been received and the clinical stability must be at least 3 months before participating in this study. 7. All acute toxic reactions caused by previous anti-tumor treatments were alleviated to grade 0-1 before the screening period (as judged by NCI CTCAE 5.0; except for toxicities such as alopecia that the researchers considered not to pose a safety risk to the patients); 8. Expected survival time >= 3 months; 9. Bone marrow function: Absolute neutrophil count >= 1.5×10^9/L, platelet count >= 100×10^9/L, hemoglobin >= 90g/L; 10. Liver and kidney function: TBIL= 50ml/min; 11. Thyroid function: Thyroid stimulating hormone (TSH), free thyroxine (FT4), or free triiodothyronine (FT3) are all within ±10% of the normal range. 12. Female patients with reproductive capacity who have a negative blood pregnancy test result within 14 days before treatment. Female subjects of childbearing age and male subjects whose partners are women of childbearing age must agree to use highly effective contraceptive methods for contraception (such as oral contraceptives, intrauterine devices, sexual control or barrier contraception combined with spermicides, etc.) from the signing of the informed consent form to one year after the last administration of the study drug. 13. Voluntarily participate in this clinical trial and sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. There are obvious factors that affect the absorption of oral drugs, such as inability to swallow, chronic diarrhea and intestinal obstruction; 2. Previously received anti-tumor treatment with HDACi; 3. Those who have a history of allergy to the drug components of this plan; 4. Having suffered from other malignant tumors within the past five years, excluding cured papillary thyroid carcinoma, cervical carcinoma in situ, basal cell carcinoma of the skin or squamous cell carcinoma of the skin; 5. Have participated in other drug clinical trials within 4 weeks before enrollment; 6. Have a history of immune deficiency, including a positive HIV test, or suffer from other acquired or congenital immune deficiency diseases, or have a history of organ transplantation; 7. Uncontrollable and significant cardiovascular diseases; A history of clinically significant QT interval prolongation, or a QTc interval during the screening period >450 ms; 8. Positive baseline pregnancy test results in pregnant, lactating female patients or women with fertility; Or subjects of childbearing age who were unwilling to take effective contraceptive measures during the study period and at least 8 weeks after the last administration; 9. According to the researcher's judgment, there are serious concomitant diseases that endanger patient safety or affect the patient's completion of the study (such as severe hypertension, diabetes, thyroid diseases, active infections, etc.); 10. There is a clear history of neurological or mental disorders, including epilepsy or dementia, etc. 11. The researcher determined that the participant was not suitable for this researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival, PFS;Overall survival, OS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR; | — |
Countries
China
Contacts
Public ContactWang feng
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed