Sintilimab and Chemotherapy Sequential Radiotherapy in Advanced Esophageal Cancer

Last updated: July 23, 2024
Sponsor: Qingdao Central Hospital
Overall Status: Active - Recruiting

Phase

2/3

Condition

Carcinoma

Lung Cancer

Esophageal Disorders

Treatment

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

Clinical Study ID

NCT06138028
KY202306702
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 RECISTV1.1 definition.

  4. Physical fitness ECOG score of 0 or 1

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

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

Exclusion Criteria:

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

  2. Have a history of immunodeficiency, including HIV positive, or other acquired,congenital immunodeficiency disease, or history of organ transplantation and bonemarrow transplantation;Interstitial lung disease, drug-induced pneumonia,requiringsteroid therapy or active pneumonia with clinical symptoms or severe pulmonarydysfunction;

  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 orInterventional supraventricular or ventricular arrhythmia;

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

  5. Allergic reactions to test drugs for this application;

  6. Pregnant or lactating women; Those whom the investigator considered unsuitable forinclusion。

Study Design

Total Participants: 90
Treatment Group(s): 1
Primary Treatment: TP regimen (cis-platinum ; Tocetaxel ) combined with PD-1 inhibitors(Sintilimab)
Phase: 2/3
Study Start date:
September 20, 2023
Estimated Completion Date:
October 31, 2026

Connect with a study center

  • Qingdao Central Hospital

    Qingdao, Shandong 266042
    China

    Active - Recruiting

  • Qingdao Central Hospital, Qingdao Cancer Hospital

    Qingdao, Shandong 266042
    China

    Active - Recruiting

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