Sintilimab and Chemotherapy Sequential Radiotherapy in Advanced Esophageal Cancer

Metastatic Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:

The Prospective Study of Sintilimab Combination With Chemotherapy Sequential Radiotherapy for Advanced Esophageal Squamous Cell Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06138028
• Other study ID #: KY202306702
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: September 20, 2023
• Est. completion date: October 31, 2026

Study information

• Verified date: November 2023
• Source: Qingdao Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an investigator-initiated, single-arm, exploratory clinical study.The study population consisted of treatment naive advanced esophageal squamous cell carcinoma patients. The purpose of this study was to evaluate the efficacy and safety of immunotherapy combined with chemotherapy and residual lesions irradiation of esophageal squamous cell carcinoma.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: October 31, 2026
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Diagnosed with Stage IV esophagus squamous cell carcinoma.

2. Expected survival time =3 months

3. Enrolled patients must have at least one measurable lesion conforming to the RECIST V1.1 definition.

4. Physical fitness ECOG score of 0 or 1

5. Organ function levels must meet the following requirements and meet the following standards:

A) Bone marrow function: absolute neutrophil count (ANC) =1.5×10^9/L, platelet count =90×10^9/L, hemoglobin =90 g/L; B) Liver function: Total bilirubin TBIL=1.5×ULN (total bilirubin =3×ULN in Subjects with Gilbert's syndrome, liver cancer or liver metastasis), AST and ALT =2.5×ULN in patients without liver metastasis, AST and ALT =5.0×ULN in patients with liver metastasis; C) Renal function: Creatinine (Cr) =1.5×ULN, or creatinine clearance (Ccr) =50 mL/min (according to Cockcroft and Gault formula); D) Urine routine / 24-hour protein quantification: qualitative urine protein =1+ (if qualitative urine protein =2+, 24 hours < 1g can be included); E) Cardiac function: left ventricular ejection fraction =50%; F) Coagulation function: International standardized ratio (INR) =1.5×ULN, and activated partial thrombin time (APTT) =1.5×ULN;

Exclusion Criteria:

1. Known or suspected history of active autoimmune diseases, autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, pituitaritis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes)

2. Have a history of immunodeficiency, including HIV positive, or other acquired, congenital immunodeficiency disease, or history of organ transplantation and bone marrow transplantation;Interstitial lung disease, drug-induced pneumonia,requiring steroid therapy or active pneumonia with clinical symptoms or severe pulmonary dysfunction;

3. There are clinical symptoms or diseases of the heart that are not well controlled, such as: (1) heart failure of NYHA class 2 or higher (2) unstable angina (3) myocardial infarction within 24 weeks (4) clinical need for treatment or Interventional supraventricular or ventricular arrhythmia;

4. Have a tendency to hereditary bleeding or coagulopathy. Clinically significant bleeding symptoms or clear bleeding tendency within 3 months prior to enrollment, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood++ and above;

5. Allergic reactions to test drugs for this application;

6. Pregnant or lactating women; Those whom the investigator considered unsuitable for inclusion?

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Squamous Cell Carcinoma
• Metastatic Esophageal Squamous Cell Carcinoma

Intervention

Drug:
• TP regimen (cis-platinum ; Tocetaxel ) combined with PD-1 inhibitors(Sintilimab)
TP regimen (cis-platinum ; Tocetaxel ) combined with PD-1 inhibitors(Sintilimab)for 4 cycles, then irradiation of the residual lesions for 50Gy/2Gy/25f. After complete irradiation, sintilimab is administered every 21 days a cycle for additional 13 cycles.

Locations

Country	Name	City	State
China	Qingdao Central Hospital	Qingdao	Shandong
China	Qingdao Central Hospital, Qingdao Cancer Hospital	Qingdao	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qingdao Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OS	overall survival	up to 24 months
Primary	PFS	progression-free survival	up to 12 months
Secondary	overall response rate	ORR	up to 12 weeks
Secondary	toxicities	toxicities	up to 12 weeks