NCT04974047

Study of Tislelizumab in Participants With Resectable Esophageal Squamous Cell Carcinoma

A Phase 2, Multicenter, Open-label, 2-Cohort Study to Investigate the Efficacy and Safety of PET Guided Neoadjuvant Treatment With Tislelizumab (BGB-A317) Plus Chemotherapy/Chemoradiotherapy in Patients With Resectable Esophageal Squamous Cell Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: BeiGene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the pathological complete response (pCR) in participants receiving tislelizumab plus chemotherapy/chemoradiotherapy as neoadjuvant treatment.

Detailed description

This study enrolled participants with esophageal squamous cell carcinoma who were eligible to have their tumor removed by surgery (also called surgical resection). The treatment phase of the study included the following: * Induction therapy, in which participants received 1 cycle of chemotherapy; * Neoadjuvant therapy (neoadjuvant refers to treatment that occurs before surgery, which can make the tumor easier to remove). In this study participants received neoadjuvant therapy based on their response to induction therapy. Response to induction therapy was assessed using the maximum standardized uptake value (SUVmax) measured using a Positron Emission Tomography (PET) scan. The SUV number refers to the level of brightness on the PET scan which reflects metabolic activity; increased metabolic activity can indicate cancerous growth. * Participants with a decrease in SUVmax of 35% or more after induction therapy received neoadjuvant treatment with tislelizumab plus chemotherapy. * Participants with a decrease in SUVmax less than 35% after induction therapy received neoadjuvant treatment with tislelizumab plus chemotherapy and radiotherapy. * Surgery to remove the remaining tumor (resection) was to occur 4-6 weeks after completion of neoadjuvant treatment. After surgery participants were followed until death, lost to follow-up, withdrawal of consent, or until the study was completed

Conditions

• Resectable Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Tislelizumab	Administered intravenously on Day 1 of each 21-Day Cycle.
DRUG	Paclitaxel	135 mg/m\^2 administered intravenously on Day 1 of each 21-Day Cycle.
DRUG	Cisplatin	80 mg/m\^2 administered intravenously on Day 1 of each 21-Day Cycle.
DRUG	5-fluorouracil	1000 mg/m\^2 administered intravenously over Day 1 through 4 of each 21-Day Cycle.
RADIATION	Radiotherapy	40 grays/20 fractions
PROCEDURE	Surgical resection	Performed as indicated in the treatment arm.

Timeline

• Start date: 2021-08-17
• Primary completion: 2023-04-17
• Completion: 2024-10-25
• First posted: 2021-07-23
• Last updated: 2025-12-01
• Results posted: 2025-12-01

Locations

8 sites across 1 country: China