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

ConditionsEsophageal Squamous Cell Carcinoma (ESCC)Locally Advanced Unresectable Esophageal Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age20+
SponsorMing-Yu Lien

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.)

  • 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.)

  • 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. )

  • 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.

Treatment groups

45 Participants
are divided into 1 treatment group
Group A: Arm 1Experimental treatment 4 interventions

Trial outcomes

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.

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

Secondary outcomes

1

Pathological complete response (pCR) rate

Pathological complete response (pCR) rate is defined as number of participants with no evidence of residual tumor cells in the primary site and resected lymph nodes of the operative specimens divided by the number of participants received esophagectomy.

Time frame
At time of surgery (8 to 12 weeks after completion of induction or consolidation treatment)
2

Conversion rate

Conversion rate is defined asnumber of participants received esophagectomy divided by the number of participants.

Time frame
Assessed within 12 weeks after completion of induction or consolidation treatment.
3

R0 resection rate

R0 resection rate is defined as the proportion of participants with negative resection margins (greater than 1 mm) among those who underwent esophagectomy following induction chemoradiotherapy and/or consolidation treatment with tislelizumab.

Time frame
Assessed at time of surgery (8 to 12 weeks after completion of induction or consolidation treatment)
4

Disease-free survival (DFS)

Disease-free survival (DFS) is defined as the time from enrollment until evidence of disease recurrence or death.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ming-Yu Lien

Lead sponsor

China Medical University Hospital

Sponsor institution

BeiGene

Collaborator

Source ClinicalTrials.gov
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