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

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• Esophageal Squamous Cell Carcinoma 645

Esophageal Squamous Cell Carcinoma

645 studies on the registry are indexed under Esophageal Squamous Cell Carcinoma; 275 are open to participants now.

This study's planned enrollment of 45 is below the median of 65 across 539 interventional studies indexed under Esophageal Squamous Cell Carcinoma.

Lead sponsor

This is the only study on the registry with Ming-Yu Lien as lead sponsor.

Study arms

• Experimental
  Arm 1

  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

• DrugTislelizumab

  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.)

• DrugPaclitaxel

  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.)

• DrugCisplatin

  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. )

• RadiationRadiation Therapy

  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.

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.

5. Event-free survival (EFS)

   Event-free survival (EFS) is defined as the time from enrollment to an event which may include radiographic progression, clinical progression, 2nd aerodigestive tract squamous cell carcinoma, and death.

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

6. Distant metastasis-free survival (DMFS)

   Distant metastasis-free survival (DMFS) is defined as the time from enrollment until evidence of distant metastasis recurrence or death.

   Time frame: From date of enrollment to first documented distant metastasis or death, assessed up to 2 years

7. Overall survival (OS)

   Overall survival (OS) is defined as the time from enrollment to death

   Time frame: From date of enrollment to death, assessed up to 2 years

8. Recurrence-free survival (RFS)

   Recurrence-free survival (RFS) is Measure the length of time that patients remain free of disease recurrence or progression following initial treatment.

   Time frame: From date of initial treatment to first documented recurrence or death, assessed up to 2 years

9. Adverse events

   Adverse events related to protocol immunotherapy, chemotherapy, radiotherapy and conversion surgery .

   Time frame: From the date of informed consent until the completion of study treatment and follow-up period, up to 2 years.