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

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

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.

Sponsors & Collaborators

• Beijing Bethune Charitable Foundation

  collaborator UNKNOWN

• Jiangsu Cancer Institute & Hospital

  lead OTHER

Principal Investigators

• Jinjun Ye · Jiangsu Cancer Institute & Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-06-01

Primary Completion

2028-06-01

Completion

2028-06-01

Countries

• China

Study Locations