Clinical trial NCT04212598: The Value of Sintilimab Consolidation Therapy After Definitive Concurrent Chemoradiotherapy for Locally Advanced Thoracic Esophageal Cancer
Official title: The Value of Sintilimab Consolidation Therapy After Definitive Concurrent Chemoradiotherapy for Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma, an Open, Prospective, Single-arm Phase II Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Esophageal Squamous Cell Carcinoma
Keywords: Chemoradiotherapy
Esophageal Squamous Cell Carcinoma
Immunotherapy
Lead sponsor: Wuhan University
Sponsor class: OTHER
First posted: 2019-12-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a single arm phase II study.
Primary purpose: TREATMENT

Brief summary: Esophageal cancer is a kind of disease with high incidence and mortality. Definitive concurrent chemoradiotherapy is an important treatment for locally advanced esophageal squamous cell carcinoma. To Investigate the value of immunotherapy consolidation in locally advanced esophageal squamous cell carcinoma after completing radical concurrent chemoradiotherapy.

Detailed description: In East countries, especially China, more than 75 percent of esophageal cancers are primary squamous cell cancers located in the middle and upper thoracic segments, whereas adenocarcinoma accounted for less than 20 percent.Unlike other malignancies, more than half of esophageal cancer were diagnosed as locally advanced at the time of diagnosis. Definitive concurrent chemoradiotherapy is an important treatment for locally advanced esophageal squamous cell carcinoma.

Immune checkpoint inhibitors are a new class of antitumor drugs. They are different from traditional cytotoxic chemotherapy drugs and can target the regulatory molecules that play an inhibitory role in the tumor immune system.

Recent clinical studies had shown that for locally advanced non-small cell lung cancer, maintenance therapy with the immune checkpoint inhibitor could significantly improve the overall survival for locally advanced non-small cell lung cancer after definitive concurrent chemoradiotherapy. Moreover, the immune checkpoint inhibitor PD-1 has also been shown to be a promising anticancer agent in esophageal cancers. Therefore, the present study intended to give a standard dose (50.4Gy/28F) to locally advanced esophageal squamous cell carcinoma for radical chemoradiotherapy, and than to give the Sintilimab as consolidation therapy for 1 year after completion of radiotherapy. At the time point of 6 weeks after radiotherapy, all participates need a full evaluation of the treatment response. In patients with residual disease, we would give them an additional radiotherapy boost to 61.2 Gy/34F under the guidance of PET-CT or ultrasound endoscopy.

Eligibility criteria: Inclusion Criteria:

* ECOG 0-1; Life expectancy \>6 months;
* Stage II/III esophageal cancer;
* Pathology confirmed squamous cell carcinoma;
* Hemoglobin ≥10g/dl, WBC ≥3.0 x 109/L, platelet ≥100 x 109/L; CR≤ 1.0x normal upper limit, total bilirubin ≤ 1.5x normal upper limit, AST and ALT≤ 1.5x normal upper limit, AKP≤ 2.5x normal upper limit;
* Have a full understanding of this study, participate voluntarily, have follow-up conditions and sign the informed consent;

Exclusion Criteria:

* Stage IV esophageal cancer;
* Esophageal adenocarcinoma;
* Gastric esophageal junction adenocarcinoma;
* ECOG \> 2;
* Progression after first-course radiotherapy;
* Existing active infection, such as active tuberculosis, hepatitis, etc.;

Primary outcomes:
measure: Percentage of patients with disease progression within 2 years after treatment
timeFrame: 2-years
Secondary outcomes:
measure: Percentage of patients who died within 2 years after treatment
timeFrame: 2-years
Other outcomes:
measure: The number of patients with treatment-related toxicity between the treatment period and half a year after treatment
timeFrame: 0.5-year
Locations:
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
Study officials:
affiliation: Zhongnan Hospital
name: Conghua Xie, MD
role: STUDY_DIRECTOR
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