Study of Tislelizumab Combined With Chemoradiotherapy and Surgery for Unresectable Esophageal Squamous Cell Carcinoma

NCT07039162 | Recruiting Phase 2

• 1 other identifier: CMUH-BGB-A317-CS01
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 8

Brief Summary

This is a Phase II, open-label, single-arm, multicenter study evaluating the safety and efficacy of combining Tislelizumab with induction chemoradiotherapy (CRT), followed by conversion surgery, in patients with locally advanced, unresectable esophageal squamous cell carcinoma (ESCC). Patients will receive induction CRT with weekly paclitaxel and cisplatin along with Tislelizumab, followed by two cycles of consolidation Tislelizumab-chemotherapy. If the tumor becomes resectable, patients will undergo surgery. The primary goal is to assess the 2-year overall survival (OS) rate. Secondary outcomes include pathological complete response (pCR), conversion rate, R0 resection rate, disease-free survival (DFS), recurrence-free survival (RFS), and treatment-related adverse events.

Conditions

Esophageal Squamous Cell Carcinoma (ESCC); Locally Advanced Unresectable Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

• 2-year OS rate

  Estimated 2-year OS rate is defined as number of participants alive divided by the number of participants.

  From the date of first treatment (induction chemoradiotherapy) to 2 years after treatment initiation.

Secondary Outcomes (9)

• Pathological complete response (pCR) rate

  At time of surgery (8 to 12 weeks after completion of induction or consolidation treatment)

• Conversion rate

  Assessed within 12 weeks after completion of induction or consolidation treatment.

• R0 resection rate

  Assessed at time of surgery (8 to 12 weeks after completion of induction or consolidation treatment)

• Disease-free survival (DFS)

  From enrollment until disease recurrence or death, whichever occurs first, assessed up to 2 years.

• Event-free survival (EFS)

  From date of enrollment to first documented event or death, assessed up to 2 years.

Study Arms (1)

Arm 1

EXPERIMENTAL

Single-arm study: Participants will receive Tislelizumab in combination with chemoradiotherapy (Paclitaxel + Cisplatin) and conversion surgery if the tumor becomes resectable. The treatment sequence involves induction chemoradiotherapy, followed by consolidation chemotherapy and surgery if applicable.

Drug: Tislelizumab; Drug: Paclitaxel; Drug: Cisplatin; Radiation: Radiation Therapy

Interventions

Tislelizumab DRUG

1. ICRT phase -Tislelizumab and CRT regimen Tislelizumab 200 mg IV, C1D1 and C4D1 2. Consolidation phase: Tislelizumab-Paclitaxel-Cisplatin regimen Tislelizumab 200 mg IV, D1, every 3 weeks (\*The regimen is repeated until unacceptable toxicity or disease progression, up to maximum of 2 cycles. ) 3. Adjuvant phase-Tislelizumab Tislelizumab 200 mg IV, D1, every 3 weeks (\*The regimen is repeated until unacceptable toxicity or disease progression, up to maximum of one year or 17 cycles.)

Arm 1

Paclitaxel DRUG

1. ICRT phase -Tislelizumab and CRT regimen Paclitaxel 50 mg/m2 IV, D1, weekly (\* 4-6 cycles judged by investigators.) 2. Consolidation phase: Tislelizumab-Paclitaxel-Cisplatin regimen Paclitaxel 135 mg/m2 IV, D1, every 3 weeks (\*The regimen is repeated until unacceptable toxicity or disease progression, up to maximum of 2 cycles.)

Arm 1

Cisplatin DRUG

1. ICRT phase -Tislelizumab and CRT regimen Cisplatin 25 mg/m2 IV, D1, weekly ( 4-6 cycles judged by investigators.) 2. Consolidation phase: Tislelizumab-Paclitaxel-Cisplatin regimen Cisplatin 75 mg/m2 IV, D1, every 3 weeks (\*The regimen is repeated until unacceptable toxicity or disease progression, up to maximum of 2 cycles. )

Arm 1

Radiation Therapy RADIATION

1\. ICRT phase -Tislelizumab and CRT regimen Radiotherapy treatment: IMRT 41-50.4Gy, a dose of 1.8 to 2Gy per day, 5 days per week for 5 weeks during the RT phase.

Arm 1

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients had histologically confirmed, squamous-cell carcinoma of the esophagus
• Clinical T4 cancer, at least one unresectable metastatic regional lymph node due to invasion into an adjacent organ, or computed tomographic (CT) evidence of M1Lym, such as fixed supraclavicular nodes. Regional lymph nodes are defined on the basis of criteria specified by the eighth edition of the Union for International Cancer Control TNM staging system (Sobin and Wittekind, 2016).
• An age of at least 20 years
• An Eastern Cooperative Oncology Group performance-status score 0 or 1
• Adequate major organ functions
• WBC ≥3,500/mm3
• Hemoglobin ≥ 9.0 g/dL
• Platelet ≥ 80,000/mm3
• Total bilirubin ≤ 2-fold the upper limit of normal (ULN)
• ALT and AST ≤ 5-fold the ULN AND ≤200 U/L
• PT, aPTT and INR ≤1.5-fold the ULN
• Albumin ≥2.5 g/dL
• Creatinine clearance ≥50 ml/min (based upon 24 hours urine collection or calculated by Cockroft-Gault formula)
• Male: ((140 - age) × weight \[kg\])/(72 × serum creatinine \[mg/dL\])
• Female: 0.85 x estimate for male

You may not qualify if:

• Patient has received systemic therapy for advanced ESCC.
• Patients had distant metastasis, including liver, lung, bone and brain metastases.
• Patients had esophageal perforation or esophageal fistula
• Patients had tumor bleeding
• Patients had active infection(e.g. tuberculosis).
• History or known human immunodeficiency virus.
• Subjects with active, known, or suspected autoimmune disease. Subjects with Type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted to enroll.
• Systemic immunosuppression therapy or chronic systemic steroid therapy (more than 10mg daily of prednisolone)
• Known hepatitis B (HBsAg reactive) or C virus infection (positive anti HCV)
• Inactive hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B (HBV DNA \< 500 IU/mL or \< 2500 copies/mL) can be enrolled. Patients with detectable HBsAg or detectable HBV DNA should be managed per treatment guidelines. Patients receiving antivirals at screening should have been treated for \> 2 weeks before randomization/enrollment.
• Patients with a positive HCV antibody test followed by a negative HCV RNA test at screening are eligible.
• Previous therapy targeting T-cell costimulating or immune-checkpoint pathways
• Prior or concurrent malignancies within the last 3 years, with the exception of carcinoma in situ of the cervix, or basal type skin cancer
• Any major surgery within 4 weeks before study enrollment.
• Pregnant women or nursing mothers, or positive pregnancy tests

Sponsors & Collaborators

• Ming-Yu Lien: lead
• BeiGene: collaborator

Study Sites (8)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

NOT YET RECRUITING

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

NOT YET RECRUITING

China Medical University Hospital

Taichung, 404, Taiwan

RECRUITING

Taichung Veterans General Hospital

Taichung, 407219, Taiwan

NOT YET RECRUITING

National Cheng Kung University Hospital

Tainan, Taiwan

NOT YET RECRUITING

National Taiwan University Hospital

Taipei, 100225, Taiwan

NOT YET RECRUITING

Taipei Veterans General Hospital

Taipei, Taiwan

NOT YET RECRUITING

Linkou Chang Gung Memorial Hospital

Taoyuan District, 33305, Taiwan

NOT YET RECRUITING

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

tislelizumab; Paclitaxel; Cisplatin; Radiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Therapeutics

Central Study Contacts

Ming-Yu Lein, MD

CONTACT

0975680832; leinmirain@hotmail.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 INVESTIGATOR
• PI Title: Department of Hematology and Oncology, China Medical University Hospital

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: June 26, 2025
• Study Start: September 26, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 27, 2026

Record last verified: 2025-06

Locations

TW (8)