CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 136 target
Drug / intervention
Arm A +4 moredrug
Likely dose
Not stated in record
Key inclusion· 9
  • ✓Age ≥70 years
  • ✓Histologically confirmed locally advanced ESCC (cT1N2-3M0, cT2-4bN0-3M0, or cT1-4bN0-3M1 supraclavicular)
  • ✓Clinically staged as II-IVb, inoperable/non-resectable, contraindications to surgery, or refusal of surgery
  • ✓ECOG performance status 0 or 1
Key exclusion· 19
  • ✕Prior surgery for esophageal cancer
  • ✕Esophageal fistulae due to primary tumor infiltration
  • ✕Risk of gastrointestinal bleeding, esophageal fistula, or perforation
  • ✕Poor nutritional status with weight loss ≥10% in prior 2 months without improvement after intervention

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

In the news

1 article

Matched to this trial by ClinicalIndexfrom reputable biotech & medical press.

Search/NCT06061146
NCT06061146Phase 2RecruitingUpdate OverdueUpdated 30mo ago · Completion was 20mo ago
Enrollment Stalled
Update Overdue
CompareCT.gov

Tislelizumab Combined With Concurrent Chemoradiation Versus Concurrent Chemoradiation for Older Patients With Inoperable Locally Advanced Esophageal Squamous Cell Carcinoma: a Randomized, Parallel-controlled, Multicenter Phase II Clinical Study

Tianjin Medical University Cancer Institute and Hospital·interventional·Posted Sep 29, 2023·Updated Dec 26, 2023

In Brief

A Phase 2 clinical trial evaluating Arm A and Arm B for Esophageal Cancer. Currently recruiting, targeting 136 participants across 1 site.

Signals

Enrollment appears stalled

Detailed Summary

This study was conducted in elderly (≥70 years old) patients with locally advanced esophageal squamous cell carcinoma. Aim to find the difference in efficacy and safety between tirilizumab combined with concurrent chemoradiation and standard concurrent chemoradiation. Concurrent chemoradiation is the standard treatment for elderly esophageal cancer. Tirelizumab is the first-line and second-line standard treatment for advanced esophageal squamous carcinoma. However, the effect of tirilizumab combined with concurrent chemoradiation for elder with locally advanced esophageal squamous cell carcinoma is unkown. In the study, the investigators plan to enroll 136 elderly subjects with locally advanced esophageal cancer from five hospitals in China. The enrolled patients will be randomly divided into two groups: tirilizumab combined with concurrent chemoradiation group (Tislelizumab + radiotherapy + tigio) and concurrent chemoradiation group (radiotherapy + tigio). The treatment efficiency and safety will be evaluated.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEsophageal Cancer
CountriesChina
CollaboratorsSichuan Cancer Hospital and Research Institute, Shanxi Province Cancer Hospital, Henan Cancer Hospital, Hunan Cancer Hospital, The First Affiliated Hospital with Nanjing Medical University

Timeline

Phase 2Recruiting
202420252026
First PostedSep 29, 2023
Enrollment StartOct 5, 2023
Primary CompletionOct 1, 2024
Study CompletionOct 1, 2026
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 2.8 years ago

Interventions

Arm Adrug

anti-PD-1 immunotherapy

Arm Adrug

chemotherapy

Arm Aradiation

Radiation Concurrent Radiation, 1.8Gy/f, 28f

Arm Bdrug

chemotherapy

Arm Bradiation

Radiation Concurrent Radiation, 1.8Gy/f, 28f