NCT07306663

Sintilimab Combined With Chemotherapy Induction Therapy Followed by CCRT vs. CCRT for Esophageal Cancer: A Randomized Controlled Phase Ⅲ Clinical Study

Sintilimab Combined With Chemotherapy Induction Therapy Followed by Concurrent Chemoradiotherapy vs. Concurrent Chemoradiotherapy for Esophageal Cancer: A Randomized Controlled Phase Ⅲ Clinical Study

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 242 (estimated)
• Sponsor: Jiangsu Cancer Institute & Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The objective of this clinical trial is to determine whether the addition of immunotherapy combined with chemotherapy before chemoradiotherapy can increase the survival rate of patients with esophageal cancer. It will also assess the safety of this regimen. The primary questions it aims to answer include: * Can the addition of immunotherapy combined with chemotherapy before chemoradiotherapy reduce the rate of disease recurrence among participants? * What adverse reactions will participants experience during the treatment process? * Compared with traditional chemoradiotherapy, will this regimen extend the survival period of participants? Participants will: * Undergo two cycles of immunotherapy combined with chemotherapy, administered every three weeks, followed by concurrent chemoradiotherapy, which includes 28 sessions of radiotherapy and five sessions of chemotherapy during the concurrent period; or proceed directly to concurrent chemoradiotherapy, and then receive two cycles of chemotherapy after the completion of radiotherapy, administered once a month. * Undergo regular tests and examinations to evaluate efficacy and safety. * Record symptoms that occur during the treatment period.

Conditions

• Esophageal Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Sintilimab	200mg, once every three weeks, administered before concurrent chemoradiotherapy.
DRUG	3-Weekly Paclitaxel plus Carboplatin (TC) Chemotherapy	Three-weekly induction chemotherapy regimen: Paclitaxel (135 mg/m², d1) + Carboplatin (AUC=5, d1), administered every 21 days.
DRUG	Weekly TC Chemotherapy	Paclitaxel (50 mg/m², intravenous infusion on Day 1 of each week) combined with Carboplatin (AUC 2, intravenous infusion on Day 1 of each week), administered for 5 consecutive weeks as part of concurrent chemoradiotherapy.
DRUG	Four-Weekly TC Consolidation Chemotherapy	Four-weekly consolidation chemotherapy regimen: Paclitaxel (175 mg/m², intravenous infusion on Day 1) combined with Carboplatin (AUC 5, intravenous infusion on Day 1), administered every 28 days for 2 cycles following concurrent chemoradiotherapy.
RADIATION	Definitive Radiotherapy	Definitive radiotherapy administered at a total dose of 50.4 Gy in 28 daily fractions (1.8 Gy per fraction) over approximately 5.5 weeks, delivered concurrently with weekly chemotherapy.

Timeline

• Start date: 2021-06-01
• Primary completion: 2028-06-01
• Completion: 2028-06-01
• First posted: 2025-12-29
• Last updated: 2025-12-29

Locations

1 site across 1 country: China