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Trial Title:
Efficacy and Safety of Tislelizumab and Nab-paclitaxel Combined With Low-dose Radiotherapy in Patients With Stage IVb Esophageal Squamous Cell Carcinoma
NCT ID:
NCT05547828
Condition:
ESCC
Conditions: Official terms:
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Tislelizumab
Conditions: Keywords:
PD-1
RCT
Ⅳb ESCC
1 line
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Masking description:
This study is a single-arm, prospective, open-label clinical study
Intervention:
Intervention type:
Drug
Intervention name:
Tislelizumab combined with chemoradiotherapy
Description:
Tislelizumab: According to the instructions of tislelizumab, 200 mg intravenously on the
first day of each cycle, 21 days as a cycle.
Nab-paclitaxel: white purple: 100mg/m2 intravenous infusion on d1.8.15 (during
chemotherapy) 100mg/m2 intravenous infusion q3w ╳ 3 cycles (during consolidation therapy)
Radiotherapy: 40Gy/20f, 5 times/w, (esophageal primary tumor and metastatic lymph nodes)
Arm group label:
Tislelizumab combined with chemoradiotherapy
Summary:
This study is a single-arm, prospective, open-label clinical study to evaluate the safety
and efficacy of tislelizumab combined with chemoradiotherapy in first-line treatment of
patients with stage IVb esophageal squamous cell carcinoma.
Detailed description:
This study is a single-center, prospective, single-arm, open-label study. It will explore
the efficacy and safety of tislelizumab combined with nab-paclitaxel in the first-line
treatment of stage IVb esophageal squamous cell carcinoma on the basis of low-dose
radiotherapy（40Gy/20f，5次/w）. To explore new treatment modalities and prolong patient
survival.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Meet the diagnostic criteria of Esophageal squamous cell carcinoma
-diagnosed with stage IVb Esophageal squamous cell carcinoma (UICC/AJCC 8th edition
TNM staging system) by CT/MRI/PET-CT/ECT, laboratory examination and pathological
examination results; specific: any T, any N, M1;
2. No previous anti-tumor treatment; expected survival period of more than half a year;
3.18-75 years old, PS score 0-1;
4. According to RECIST1.1 criteria, there is at least one measurable target lesion, and
tumor imaging evaluation is performed within 28 days before the first dose; 5. Major
organ function is normal, that is, the following criteria are met: 6. No active
autoimmune disease; 7. No active hepatitis; 8. General conditions or medical
complications can tolerate radiotherapy, chemotherapy and immunotherapy; 9. No
history of malignant tumor, no previous anti-tumor therapy; 10. For premenopausal or
surgically sterilized female patients: Consent to abstinence or use of effective
contraception during treatment and for at least 7 months after the last dose of
study treatment; 11. Understand and sign the informed consent form for this study.
Exclusion Criteria:
1. Previous antitumor therapy or radiation therapy for any malignant tumor;
2. patients receiving standard treatment;
3. concurrently receiving anti-tumor therapy in other clinical trials, including
endocrine therapy, bisphosphonate therapy, or immunotherapy;
4. Has undergone major surgical procedures unrelated to colorectal cancer within 4
weeks prior to enrollment, or the patient has not fully recovered from such surgical
procedures;
5. Serious heart disease or discomfort, including but not limited to the following:
6. Inability to swallow, bowel obstruction, or other factors that interfere with drug
taking and absorption;
7. Known history of allergy to the drug components of this regimen; history of
immunodeficiency, including positive HIV test, positive HBV/HCV test, or other
acquired or congenital immunodeficiency diseases, or a history of organ
transplantation;
8. Pregnant or lactating female patients, female patients of childbearing potential
with a positive baseline pregnancy test, or patients of childbearing age who are
unwilling to take effective contraceptive measures throughout the trial period and
within 7 months after the last study drug;
9. Have serious comorbidities or other comorbidities that would interfere with planned
treatment, or any other condition that the investigator considers the patient
unsuitable for participation in this study.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
December 20, 2022
Completion date:
December 20, 2024
Lead sponsor:
Agency:
The First Affiliated Hospital of Xinxiang Medical College
Agency class:
Other
Collaborator:
Agency:
BeiGene
Agency class:
Industry
Source:
The First Affiliated Hospital of Xinxiang Medical College
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05547828
