Chemotherapy, Concurrent Chemoradiotherapy, Esophageal Squamous Cell Carcinomas, Immunotherapy
Conditions
Keywords
esophageal cancer, chemoradiotherapy, immunotherapy, chemotherapy
Brief summary
This is an investigator-initiated, single-arm, exploratory clinical study.The study population consisted of non-operative Locally Advanced Esophageal Cancer . The purpose of this study was to evaluate the efficacy and safety of Concurrent Chemoradiotherapy Following Immunotherapy Plus Chemotherapy for Patients With Locally-advanced Esophageal Squamous Cell Cancer.
Interventions
DRUGchemotherapy combined with PD-1 inhibitors
Induction chemotherapy combined with PD-1 inhibitors followed with standard concurrent chemoradiotherapy
Sponsors
Shanghai Chest Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aged ≥ 18 years at the time of screening. 2. Histologically confirmed squamous cell carcinoma; 3. Locally-advanced ,medical inoperability, technical irresectability, or patient refusal to surgery; 4. Eastern Cooperative Oncology Group (ECOG) performance status:0-2; 5. Able to eat a semi-liquid diet; 6. Less than 20% weight loss within 6 months; 7. Adequate hepatic function, renal function, hematologic function and coagulation function; 8. Documented informed consent.
Exclusion criteria
1. Distant metastasis; 2. Known malignancy diagnosed or require active treatment in the last 5 years, except for cancers that can be cured by surgery including cervical cancer in situ, basal or squamous cell skin cancer, breast ductal carcinoma in situ, localized prostate cancer; 3. Prior thoracic irradiation, chemotherapy, or lobectomy 4. Known diseases or conditions that are contraindicated for radiotherapy or surgery; 5. Allergy to the research medications; 6. Pregnant women or women preparing for pregnancy; 7. Diagnosis of autoimmune disease or history of chronic autoimmune disease 8. Absence of informed consent because of psychological, family, social and other factors; 9. Patients with comorbidities (chronic pulmonary disease, poorly controlled hypertension, unstable angina, myocardial infarction within 6 months, unstable mental disorders requiring therapy).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival Rate | 2 years after last patient enrolled | Overall survival rate is defined as the percentage of participants who are alive up to 2 years from enrollment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| progression-free Survival (PFS) | 2 years after last patient enrolled | Progression-free survival is defined as the time between date of enrollment and first date of recurrence or death, whichever occurs first.Recurrence is defined as the appearance of one or more new lesions, which can be local, regional, or distant in location from the primary tumor site ( assessed by imaging or pathology). All deaths without prior recurrence are considered as PFS events. |
| Treatment related complications | During the procedure | complications after treatment |
Countries
China
Outcome results
None listed