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

Phase 2

Not yet recruiting

• Conditions: Esophageal Squamous Cell Carcinoma
• Interventions: Drug: chemoradiotherapy （CRT）+sintilimab 1; Drug: CRT+sintilimab 2

• Registration Number: NCT06468644
• Lead Sponsor: Fujian Cancer Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2024-06
• Study Start: 2024-06-17
• Study First Submitted: 2024-06-17
• Study First Submitted QC: 2024-06-17
• Last Update Submitted: 2024-06-17
• Study First Posted: 2024-06-21
• Last Update Posted: 2024-06-21
• Primary Completion: 2026-06
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	chemoradiotherapy （CRT）+sintilimab 1	dose 1 of radiotherapy+sintilimab
Group B	CRT+sintilimab 2	dose 2 of radiotherapy+sintilimab

Primary Outcome Measures

Name	Time	Method
progression free survival	1 years	the time from random assignment in a clinical trial to disease progression or death from any cause
Incidence rate of adverse events	3 years	The ratio of the number of cases with adverse events to the total number of cases available for evaluation.

Secondary Outcome Measures

Name	Time	Method
overall survival	3 years	the time from randomization to death
Objective Response Rate	3 months after therapy	the proportion of patients with a complete response or partial response to treatment according to Response Evaluation Criteria in Solid Tumors 1.1