esophageal cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years male or female; 2. Esophageal squamous cell carcinoma confirmed by pathology or histology is accompanied by distant metastasis at the first diagnosis or metastasis after surgery/radical chemoradiotherapy; 3. ECOG-PS score is 0-1, and the expected survival time is 3 months or more; 4. Accept PD-1 inhibitor combined with chemoradiotherapy; 5. At least one measurable lesion should be evaluated according to the RECISTv1.1 criteria; 6. Voluntary informed consent.
Exclusion criteria
Exclusion criteria: 1. Other malignant tumors have been diagnosed in the past 5 years, except for basal cell carcinoma, squamous cell carcinoma of the skin or cervical carcinoma in situ and breast cancer which have been effectively removed; 2. Previous treatment with CD137 agonist or immune checkpoint blocking therapy, including anti-CTLA-4, anti-PD-1 or anti-PD-L1 antibodies; 3. Major surgical operation or unhealed wound, ulcer or fracture; 4. Patients who have received any previous radiotherapy treatment; 5. Allergy to drugs or any component in excipients; 6. History or evidence of interstitial lung disease or non-infectious pneumonia treated with corticosteroids (such as congenital pulmonary fibrosis, protracted pneumonia, drug-induced pneumonia, congenital pneumonia), or any active pneumonia detected on chest CT scan; 7. Patients with congenital or acquired immune deficiency (such as HIV-infected persons), active hepatitis B (HBV-DNA=104 copy number/mL) or hepatitis C (antibody positive for Hepatitis C and HCV-RNA higher than the lower limit for analysis), positive for tuberculosis, and inactive hepatitis B patients should take oral antiviral drugs simultaneously.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;DOR;DCR;ORR;QoL; | — |
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival; | — |
Countries
China
Contacts
Renmin Hospital of Wuhan University