Recurrent or advanced esophageal squamous cell carcinoma
Conditions
Interventions
Test group:Low-dose radiotherapy combined with chemotherapy and immunotherapy
Sponsors
The First Hospital of Jiaxing
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years, ECOG score 0-2. 2. Pathologically diagnosed as recurrent/metastatic esophageal squamous cell carcinoma. 3. No history of PD-1 inhibitor treatment, or those who discontinued PD-1 inhibitor treatment for more than three months after treatment (not due to PD-1 resistance). 4. The functions of important organs meet the following requirements: a. Absolute neutrophil count (ANC) >= 1.5 × 10^9/L b. Platelets >= 100 × 10^9/L; c. Hemoglobin >= 9 g/dL; d. Serum albumin >= 2.8 g/dL; e. Total bilirubin 60 mL/min; g. For those with lung lesions and known or suspected impaired lung function, forced expiratory volume in one second (FEV1) must be above 1 L. 5. For pregnant women of reproductive age, the urine or serum pregnancy test result within 72 hours before randomization must be negative. The subjects agree to adequate contraception during the trial. 6. The subjects voluntarily participate in the study and obtain the informed consent signed by the subject or their legal representative.
Exclusion criteria
Exclusion criteria: 1. Patients resistant to PD-1 inhibitors. 2. Subjects with or highly suspected presence of esophageal fistula. 3. At the time of this diagnosis, the toxicity of previous anti-tumor treatment has not returned to 2 grade), such as severe pneumonia, sepsis, infection complications, etc. .have active tuberculosis; have symptoms and signs of infection within 2 weeks before enrollment or need oral or intravenous antibiotic treatment, except for preventive use of antibiotics. 10. Known to have acute or chronic active hepatitis B (HBsAg positive and HBV DNA viral load >= 10^3 copies/mL or > 200 IU/ml) or acute or chronic active hepatitis C (HCV antibody positive and HCV RNA positive). 11. Within 4 weeks before PD-1 treatment or within 5 drug elimination half-lives (whichever is longer) received systemic immunostimulant treatment (including but not limited to interferons and interleukin-2), received chemotherapy, immunotherapy (such as interleukin, interferon, thymosin) or any experimental treatment within 14 days before starting the study or within 5 drug elimination half-lives (whichever is longer) after the start of the study treatment. 12. According to the investigator's judgment, the subject cannot cooperate with the treatment, or the subject has other factors that may force them to prematurely terminate the study, such as having other serious diseases (including mental diseases) that require combined treatment, abnormal laboratory test values, family or social factors, which may affect the safety of the subject or the collection of trial data. 13. The pathological diagnosis of metastatic lesions is clearly different from the primary lesion or diagnosed as a second primary tumor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-month progression-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;objective remission rate;progression free survival;quality of life;security;overall survival; | — |
Countries
China
Contacts
Public ContactMaoyi Xu
The First Hospital of Jiaxing
Outcome results
None listed