CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 114 target
Drug / intervention
Paclitaxel, Cisplatin +2 moredrug
Likely dose
Paclitaxel, Cisplatin 175mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05520619
NCT05520619Phase 2ActiveUpdate OverdueUpdated 19mo ago · Completion was 7mo ago
Enrollment Stalled

Tislelizumab Plus Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Patients With Locally Advanced Esophageal Squamous Cell Carcinoma: a Phase II, Randomized Trial (EC-CRT-002)

Sun Yat-sen University·interventional·Posted Aug 30, 2022·Updated Nov 18, 2024

In Brief

A Phase 2 clinical trial evaluating Paclitaxel, Cisplatin, tislelizumab, and 1 other intervention for Esophageal Squamous Cell Carcinoma and Locally Advanced Esophageal Squamous Cell Carcinoma. Active but no longer recruiting, targeting 114 participants across 1 site.

Signals

Enrollment appears stalled

Detailed Summary

Definitive chemoradiotherapy (CRT) is the standard treatment option for unresectable locally advanced esophageal cancer (EC). However, as high as more than 40% of EC patients experienced locoregional recurrence after concurrent CRT. Immunotherapy targeting the PD-1/PD-L1 checkpoints has demonstrated promising activity in advanced EC. Recently, the combination of immunotherapy with CRT has emerged as a promising strategy to improve clinical outcomes in EC. The aim of this study was to evaluate whether the efficacy of tislelizumab (an anti-PD-1 antibody) plus induction chemotherapy followed by concurrent chemoradiotherapy would achieve a ≥71% 1-year progression-free survival rate, surpassing the historical 56% rate (NCT02403531) in patients with locally advanced esophageal squamous cell carcinoma (ESCC).

Study Details

Timeline

Phase 2Active
2023202420252026
First PostedAug 30, 2022
Enrollment StartSep 15, 2022
Primary CompletionNov 10, 2025
Study CompletionJul 31, 2026
TodayJul 1, 2026
Enrollment to primary: 3.2 yearsPosted 3.8 years ago

Interventions

Paclitaxel, Cisplatindrug

Patients received 2 cycles of induction chemotherapy with paclitaxel/cisplatin (paclitaxel 135-175mg/m2 and cisplatin 75 mg/m2) prior to radiotherapy. Then patients will receive paclitaxel 45mg/m2 and cisplatin 25 mg/m2 once weekly for 5 weeks during radiotherapy.

tislelizumabdrug

Patients received tislelizumab 200 mg every 3 weeks for 16 cycles in Arm A and 4 cycles in Arm B.

Radiotherapyradiation

All patients received external-beam radiation using intensity-modulated radiotherapy. The prescribed dose is 50.4 Gy in 28 fractions over 5-6 weeks.