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

NCT05515315 | Recruiting Phase 2

• 1 other identifier: TPT-ESCC
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Immunotherapy Esophagus Cancer

Outcome Measures

Primary Outcomes (1)

• progression free survival

  Time from enrollment to the onset of disease progression or death

  up to 24 months

Secondary Outcomes (2)

• Objective Response Rate (ORR)

  every 6 weeks （up to 24 months）

• Overall survival (OS)

  every 3 months (up to 24 months)

Study Arms (1)

Tislelizumab combined with chemothapy

EXPERIMENTAL

Drug: Tislelizumab; Drug: Albumin paclitaxel; Drug: Nedaplatin; Radiation: radiotherapy

Interventions

Tislelizumab DRUG

Participants will receive Tislelizumab, 200mg, intravenously over 30 - 60 minutes, day 1 of every 3 weeks

Tislelizumab combined with chemothapy

Albumin paclitaxel DRUG

Participants will receive Albumin paclitaxel 260 mg/m2 , day 1 of every 3 weeks

Tislelizumab combined with chemothapy

Nedaplatin DRUG

Participants will receive Nedaplatin 80 mg/m2 , day 1 of every 3 weeks

Tislelizumab combined with chemothapy

radiotherapy RADIATION

50-60Gy/25-30f

Tislelizumab combined with chemothapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fuzhou General Hospital: lead

Study Sites (1)

Ye zai sheng

Fuzhou, Fujian, 350500, China

RECRUITING

MeSH Terms

Interventions

tislelizumab; nedaplatin; Radiotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Fu zhi chao, Doctor of Medicine

CONTACT

13774562945; fauster1112@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2022
• First Posted: August 25, 2022
• Study Start: May 31, 2022
• Primary Completion: May 31, 2025
• Study Completion (Estimated): May 31, 2027
• Last Updated: February 7, 2024

Record last verified: 2024-02

Locations

CN (1)