Sintilimab and Chemotherapy Sequential Radiotherapy in Advanced Esophageal Cancer

NCT ID: NCT06138028

Last Updated: 2024-07-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-20
• Study Completion Date: 2026-10-31

Brief 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.

Conditions

Metastatic Esophageal Squamous Cell Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Combined chemo-immuno-irradiation

TP regimen plus PD-1 inhibitor for 4 cycles then irradiation and PD-1 inhibitor maintenance therapy for 13 cycles.

Group Type: EXPERIMENTAL

TP regimen (cis-platinum ; Tocetaxel ) combined with PD-1 inhibitors（Sintilimab）

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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。

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qingdao Central Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Qingdao Central Hospital, Qingdao Cancer Hospital

Qingdao, Shandong, China

Site Status: RECRUITING

Qingdao Central Hospital

Qingdao, Shandong, China

Site Status: RECRUITING

Countries

China

Facility Contacts

youxin ji, M.D.

Role: primary

mdji001@gmail.com

8653268665078

KEKE NIE, MD

Role: primary

NIEKEKEQD@163.COM

68665078

Other Identifiers

KY202306702

Identifier Type: -

Identifier Source: org_study_id