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

Phase 2

Recruiting

• Conditions: Immunotherapy Esophagus Cancer
• Interventions: Drug: Tislelizumab; Drug: Albumin paclitaxel; Drug: Nedaplatin; Radiation: radiotherapy

• Registration Number: NCT05515315
• Lead Sponsor: Fuzhou General Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-31
• Study First Submitted: 2022-08-19
• Study First Submitted QC: 2022-08-24
• Study First Posted: 2022-08-25
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-04
• Last Update Posted: 2024-02-07
• Primary Completion: 2025-05-31
• Study Completion: 2027-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 93

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tislelizumab combined with chemothapy	Nedaplatin	-
Tislelizumab combined with chemothapy	Albumin paclitaxel	-
Tislelizumab combined with chemothapy	radiotherapy	-
Tislelizumab combined with chemothapy	Tislelizumab	-

Primary Outcome Measures

Name	Time	Method
progression free survival	up to 24 months	Time from enrollment to the onset of disease progression or death

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	every 6 weeks （up to 24 months）	Objective Response Rate Determine the tumor shrinkage rate, tumor boundary and the adhesion of tumor
Overall survival (OS)	every 3 months (up to 24 months)	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.

Trial Locations

Locations (1)

Ye zai sheng; 🇨🇳 Fuzhou, Fujian, China