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Trial Title: Induction Tislelizumab Combined With Chemotherapy Followed by Definitive Chemoradiotherapy in the Treatment of Locally Unresectable Esophageal Squamous Cell Carcinoma

NCT ID: NCT05515315

Condition: Immunotherapy Esophagus Cancer

Conditions: Official terms:
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Esophageal Neoplasms
Paclitaxel
Tislelizumab
Nedaplatin

Study type: Interventional

Study phase: Phase 2

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: Tislelizumab
Description: Participants will receive Tislelizumab, 200mg, intravenously over 30 - 60 minutes, day 1 of every 3 weeks
Arm group label: Tislelizumab combined with chemothapy

Intervention type: Drug
Intervention name: Albumin paclitaxel
Description: Participants will receive Albumin paclitaxel 260 mg/m2 , day 1 of every 3 weeks
Arm group label: Tislelizumab combined with chemothapy

Intervention type: Drug
Intervention name: Nedaplatin
Description: Participants will receive Nedaplatin 80 mg/m2 , day 1 of every 3 weeks
Arm group label: Tislelizumab combined with chemothapy

Intervention type: Radiation
Intervention name: radiotherapy
Description: 50-60Gy/25-30f
Arm group label: Tislelizumab combined with chemothapy

Summary: To explore the efficacy of Tislelizumab combined with chemotherapy in the treatment of locally unresectable esophageal squamous cell carcinoma (ESCC)

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Histologically confirmed localized ESCC that is suitable for cCRT, including: stage II-IVA (AJCC version 8) inoperable ESCC (medically unfit for surgery or refusing surgical intervention);; - Aged 18-70, both sexes; - ECOG score 0-1 - The presence of measurable and/or nonmeasurable lesions that met the definition of RECIST1.1; - Adequate organ and bone marrow function, meeting the following definitions: 1. Blood routine (no blood transfusion, no granulocyte colony-stimulating factor [G-CSF], and no other drugs were used within 14 days before treatment);Absolute neutrophil count (ANC) ≥1.5×109/L;Hemoglobin (HB) ≥9.0 g/dL;Platelet count (PLT) ≥100×109/L; 2. Blood biochemistry Creatinine clearance rate ≥60 mL/min;Total bilirubin (TBIL) ≤ 1.5×ULN;Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≤2.5×ULN; - Expected survival time > 6 months; - Fertile female subjects and male subjects with partners of reproductive age are required to use a medically approved contraceptive method during the study treatment period and for at least 3 months after the last treatment; - Patients who volunteered to participate in this study and signed the informed consent form. Exclusion Criteria: - A history of fistula caused by primary tumor invasion; - Presence of clinically uncontrolled pleural effusion, pericardial effusion, or ascites that required repeated drainage or medical intervention (within 2 weeks before randomization); - Known intolerance or resistance to chemotherapy specified in the trial protocol; - have received any other ESCC antitumor therapy (e.g., therapy targeting PD-1, PD-L1, PD-L2 or other tumor immunotherapy, radiotherapy, targeted therapy, ablation or other systemic or local antitumor therapy); - Patients with active autoimmune disease or a history of autoimmune disease that may relapse, or a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; - History of interstitial lung disease, non-infectious pneumonia or uncontrolled systemic diseases, including pulmonary fibrosis and acute lung disease; - Severe chronic or active infection (including tuberculosis infection) requiring systemic antimicrobial therapy, antifungal therapy or antiviral therapy before enrollment; - Known history of HIV infection; - Other malignancies (except cured basal cell carcinoma of the skin, carcinoma in situ of the breast and carcinoma in situ of the cervix) in the past 5 years; - Received live vaccine within 28 days before enrollment; - while participating in another therapeutic clinical trial.

Gender: All

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Locations:

Facility:
Name: Ye zai sheng

Address:
City: Fuzhou
Zip: 350500
Country: China

Status: Recruiting

Contact:
Last name: Fu zhi chao, doctor

Phone: 13774562945

Phone ext: 86
Email: fauster1112@126.com

Start date: May 31, 2022

Completion date: May 31, 2027

Lead sponsor:
Agency: Fuzhou General Hospital
Agency class: Other

Source: Fuzhou General Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05515315

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