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

NCT05547828 | Unknown Phase 2

• 1 other identifier: TD-CR-ESCC
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

ESCC

Keywords

PD-1; RCT; Ⅳb ESCC; 1 line

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Disease Control Rate (DCR)

  Up to 24 months

• Progression Free Survival (PFS)

  Up to 24 months

• Overall survival (OS)

  Up to 24 months

• Drug-Related Safety Indicators

  Up to 24 months

Study Arms (1)

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)

Drug: Tislelizumab combined with chemoradiotherapy

Interventions

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)

Tislelizumab combined with chemoradiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• \. 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.

You may not qualify if:

• Previous antitumor therapy or radiation therapy for any malignant tumor;
• patients receiving standard treatment;
• concurrently receiving anti-tumor therapy in other clinical trials, including endocrine therapy, bisphosphonate therapy, or immunotherapy;
• 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;
• Serious heart disease or discomfort, including but not limited to the following:
• Inability to swallow, bowel obstruction, or other factors that interfere with drug taking and absorption;
• 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;
• 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;
• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Xinxiang Medical College: lead
• BeiGene: collaborator

MeSH Terms

Interventions

Chemoradiotherapy

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Central Study Contacts

Qingqin Zhang

CONTACT

+8615936504409; zhangqingqin814@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: This study is a single-arm, prospective, open-label clinical study
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2022
• First Posted: September 21, 2022
• Study Start: December 20, 2022
• Primary Completion: December 20, 2024
• Study Completion: December 20, 2024
• Last Updated: September 21, 2022

Record last verified: 2022-09