Phase II Study of Different Doses of Radiotherapy Combined With Sintilimab in the Treatment of Locally Advanced Esophageal Squamous Cell Carcinoma

Fujian Provincial Cancer Hospital

Status and phase: Not yet enrolling; Phase 2

Conditions: Esophageal Squamous Cell Carcinoma

Treatments: Drug: chemoradiotherapy （CRT）+sintilimab 1; Drug: CRT+sintilimab 2

Study type: Interventional

Funder types: Other

Identifiers

NCT06468644

ConES-ljc

Details and patient eligibility

About

This study is aimed to evaluate the efficacy and safety of different doses of radiotherapy combined with sintilimab in locally advanced esophageal squamous cell carcinoma.

Full description

This study was designed as a two cohorts, phase II trial. Subjects will receive different doses of radiotherapy combined with sintilimab. The primary endpoint is progression-free survival.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≥18 years old
• Histopathological examination of the primary biopsy confirmed the diagnosis of locally advanced esophageal squamous cell carcinoma
• At least one measurable lesion
• Eastern cooperative oncology group (ECOG) performance status of 0 to 1
• With adequate organs function

Exclusion criteria

• Patients with active malignancy within 5 years other than the tumor studied in this study or a localized tumor that has been cured such as resected basal or squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, or breast cancer
• Patients who have a higher risk of bleeding or perforation due to the tumor's obvious invasion of the adjacent organs (aorta or trachea) of the esophageal lesion, or patients who have formed a fistula
• Patients who have received any anti-tumor therapy for the research disease in the past, including radiotherapy, chemotherapy, immunotherapy (including but not limited to interleukin, interferon, thymus hormone) and traditional Chinese medicine therapy

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Group A

Experimental group

Description:

dose 1 of radiotherapy+sintilimab

Treatment:

Drug: chemoradiotherapy （CRT）+sintilimab 1

Group B

Experimental group

Description:

dose 2 of radiotherapy+sintilimab

Treatment:

Drug: CRT+sintilimab 2