Neoplasms

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Digestive System Diseases

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Carcinoma

Carcinoma, Squamous Cell

Esophageal Squamous Cell Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Esophageal Neoplasms

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Esophageal Diseases

Esophageal Cancer

Antineoplastic Agents

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Paclitaxel

Albumin-Bound Paclitaxel

Tislelizumab

Antineoplastic Agents, Immunological

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)

Tislelizumab combined with chemoradiotherapy

Qingqin Zhang

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.

This study is a single-arm, prospective, open-label clinical study

Efficacy and Safety of Tislelizumab and Nab-paclitaxel Combined With Low-dose Radiotherapy in Patients With Stage IVb Esophageal Squamous Cell Carcinoma

Safety and Efficacy of Tislelizumab Combined With Chemoradiotherapy in First-line Treatment of Stage IVb Esophageal Squamous Cell Carcinoma

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（%）.

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（%）.

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.

Defined as the time from randomization to death from any cause（Unit: month）.

Exposure to the investigational drug and incidence, nature, and severity of adverse events, including serious adverse events（n，%）。

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Efficacy and Safety of Tislelizumab and Nab-paclitaxel Combined With Low-dose Radiotherapy in Patients With Stage IVb Esophageal Squamous Cell Carcinoma	NCT05547828	ESCC	Tislelizumab co...	18 Years - 75 Years	The First Affiliated Hospital of Xinxiang Medical College
Efficacy and Safety of Tislelizumab and Nab-paclitaxel Combined With Low-dose Radiotherapy in Patients With Stage IVb Esophageal Squamous Cell Carcinoma	NCT05547828	ESCC	Tislelizumab co...	18 Years - 75 Years	The First Affiliated Hospital of Xinxiang Medical College

Spots Global Cancer Trial Database for tislelizumab combined with chemoradiotherapy