To hear about similar clinical trials, please enter your email below
Trial Title:
Sintilimab and Chemotherapy Sequential Radiotherapy in Advanced Esophageal Cancer
NCT ID:
NCT06138028
Condition:
Metastatic Esophageal Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Cisplatin
Immune Checkpoint Inhibitors
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
TP regimen (cis-platinum ; Tocetaxel ) combined with PD-1 inhibitors（Sintilimab）
Description:
TP regimen (cis-platinum ; Tocetaxel ) combined with PD-1 inhibitors（Sintilimab）for 4
cycles, then irradiation of the residual lesions for 50Gy/2Gy/25f. After complete
irradiation, sintilimab is administered every 21 days a cycle for additional 13 cycles.
Arm group label:
Combined chemo-immuno-irradiation
Summary:
This is an investigator-initiated, single-arm, exploratory clinical study.The study
population consisted of treatment naive advanced esophageal squamous cell carcinoma
patients. The purpose of this study was to evaluate the efficacy and safety of
immunotherapy combined with chemotherapy and residual lesions irradiation of esophageal
squamous cell carcinoma.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Diagnosed with Stage IV esophagus squamous cell carcinoma.
2. Expected survival time ≥3 months
3. Enrolled patients must have at least one measurable lesion conforming to the RECIST
V1.1 definition.
4. Physical fitness ECOG score of 0 or 1
5. Organ function levels must meet the following requirements and meet the following
standards:
A) Bone marrow function: absolute neutrophil count (ANC) ≥1.5×10^9/L, platelet count
≥90×10^9/L, hemoglobin ≥90 g/L; B) Liver function: Total bilirubin TBIL≤1.5×ULN (total
bilirubin ≤3×ULN in Subjects with Gilbert's syndrome, liver cancer or liver metastasis),
AST and ALT ≤2.5×ULN in patients without liver metastasis, AST and ALT ≤5.0×ULN in
patients with liver metastasis; C) Renal function: Creatinine (Cr) ≤1.5×ULN, or
creatinine clearance (Ccr) ≥50 mL/min (according to Cockcroft and Gault formula); D)
Urine routine / 24-hour protein quantification: qualitative urine protein ≤1+ (if
qualitative urine protein ≥2+, 24 hours < 1g can be included); E) Cardiac function: left
ventricular ejection fraction ≥50%; F) Coagulation function: International standardized
ratio (INR) ≤1.5×ULN, and activated partial thrombin time (APTT) ≤1.5×ULN;
Exclusion Criteria:
1. Known or suspected history of active autoimmune diseases, autoimmune diseases (such
as interstitial pneumonia, colitis, hepatitis, pituitaritis, vasculitis, nephritis,
hyperthyroidism, hypothyroidism, including but not limited to these diseases or
syndromes)
2. Have a history of immunodeficiency, including HIV positive, or other acquired,
congenital immunodeficiency disease, or history of organ transplantation and bone
marrow transplantation；Interstitial lung disease, drug-induced pneumonia,requiring
steroid therapy or active pneumonia with clinical symptoms or severe pulmonary
dysfunction；
3. There are clinical symptoms or diseases of the heart that are not well controlled,
such as: (1) heart failure of NYHA class 2 or higher (2) unstable angina (3)
myocardial infarction within 24 weeks (4) clinical need for treatment or
Interventional supraventricular or ventricular arrhythmia；
4. Have a tendency to hereditary bleeding or coagulopathy. Clinically significant
bleeding symptoms or clear bleeding tendency within 3 months prior to enrollment,
such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult
blood++ and above；
5. Allergic reactions to test drugs for this application；
6. Pregnant or lactating women； Those whom the investigator considered unsuitable for
inclusion。
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Qingdao Central Hospital, Qingdao Cancer Hospital
Address:
City:
Qingdao
Zip:
266042
Country:
China
Status:
Recruiting
Contact:
Last name:
youxin ji, M.D.
Phone:
8653268665078
Email:
mdji001@gmail.com
Investigator:
Last name:
ketao lan, M.D.
Email:
Principal Investigator
Investigator:
Last name:
chunling zhang, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
youxin ji, M.D.
Email:
Sub-Investigator
Facility:
Name:
Qingdao Central Hospital
Address:
City:
Qingdao
Zip:
266042
Country:
China
Status:
Recruiting
Contact:
Last name:
KEKE NIE, MD
Phone:
68665078
Email:
NIEKEKEQD@163.COM
Start date:
September 20, 2023
Completion date:
October 31, 2026
Lead sponsor:
Agency:
Qingdao Central Hospital
Agency class:
Other
Source:
Qingdao Central Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06138028
