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| Name | Class |
|---|---|
| BeiGene | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tislelizumab combined with chemoradiotherapy | Other | 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tislelizumab combined with chemoradiotherapy | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | It is defined as the number of subjects with the best response effect as complete remission (CR) or partial remission (PR) during the period from the start of the subjects receiving the treatment regimen of this study to the progression of the subjects' disease in the total number of subjects in the analysis data set. percentage of the population(%). | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control Rate (DCR) | Defined as the number of subjects whose tumors shrank or remained stable for a certain period of time from receiving the treatment regimen of this study to the progression of the subject's disease, including complete remission (CR) and partial remission (PR) in the analysis data set percentage of the total population(%). | Up to 24 months |
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Inclusion Criteria:
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;
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qingqin Zhang | Contact | +8615936504409 | zhangqingqin814@163.com |
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This study is a single-arm, prospective, open-label clinical study
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| Progression Free Survival (PFS) | Defined as the time from randomization to tumor progression in any aspect or death from any cause(Unit: month). Assessed according to RECIST 1.1 criteria, analysis of this indicator included tumor evaluation results during study treatment and follow-up. If the patient has several indicators that can be judged as PD, the first indicator will be used for PFS analysis; recurrence, new lesions or death are considered to have reached the end of the study, and the patient is treated with other systemic or target-targeted anti-PD. Tumor treatment is also considered tumor progression. | Up to 24 months |
| Overall survival (OS) | Defined as the time from randomization to death from any cause(Unit: month). | Up to 24 months |
| Drug-Related Safety Indicators | Exposure to the investigational drug and incidence, nature, and severity of adverse events, including serious adverse events(n,%)。 | Up to 24 months |
| ID | Term |
|---|---|
| D059248 | Chemoradiotherapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D011878 | Radiotherapy |
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