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ACTIVE NOT RECRUITING
NCT07306663
PHASE3

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

Sponsor: Jiangsu Cancer Institute & Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

242

Start Date

2021-06-01

Completion Date

2028-06-01

Last Updated

2025-12-29

Healthy Volunteers

No

Interventions

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.

Locations (1)

Jiangsu Cancer Hospital

Nanjing, Jiangsu, China