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

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

Study Overview

• Status: Recruiting
• Conditions: Immunotherapy Esophagus Cancer
• Intervention / Treatment: Drug: Tislelizumab; Drug: Albumin paclitaxel; Drug: Nedaplatin; Radiation: radiotherapy

• Study Type: Interventional
• Enrollment (Estimated): 93
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Fu zhi chao, Doctor of Medicine; Phone Number: 86 13774562945; Email: fauster1112@126.com

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350500
      • Recruiting
      • Ye zai sheng
      • Contact: Fu zhi chao, doctor; Phone Number: 86 13774562945; Email: fauster1112@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tislelizumab combined with chemothapy	Drug: Tislelizumab; Participants will receive Tislelizumab, 200mg, intravenously over 30 - 60 minutes, day 1 of every 3 weeks; Drug: Albumin paclitaxel; Participants will receive Albumin paclitaxel 260 mg/m2 , day 1 of every 3 weeks; Drug: Nedaplatin; Participants will receive Nedaplatin 80 mg/m2 , day 1 of every 3 weeks; Radiation: radiotherapy; 50-60Gy/25-30f

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
progression free survival	Time from enrollment to the onset of disease progression or death	up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR)	Objective Response Rate Determine the tumor shrinkage rate, tumor boundary and the adhesion of tumor	every 6 weeks （up to 24 months）
Overall survival (OS)	Defined from date of Signing ICF to date of first documentation of death from any cause or censored at the date of the last follow-up.	every 3 months (up to 24 months)

Collaborators and Investigators

• Sponsor: Fuzhou General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2022
• Primary Completion (Estimated): May 31, 2025
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: August 19, 2022
• First Submitted That Met QC Criteria: August 24, 2022
• First Posted (Actual): August 25, 2022

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 4, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Neoplasms, Squamous Cell; Carcinoma, Squamous Cell; Esophageal Neoplasms; Esophageal Squamous Cell Carcinoma; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Antineoplastic Agents, Immunological; Paclitaxel; Nedaplatin; Tislelizumab
• Other Study ID Numbers: TPT-ESCC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No