Sintilimab and Chemotherapy Sequential Radiotherapy in Advanced Esophageal Cancer

NCT06138028 | Recruiting Phase 2 DMC

• 1 other identifier: KY202306702
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (2)

• Overall survival (OS)

  time from enrollment to patients death

  up to 24 months

• Progression-free survival (PFS)

  time from disease progression or patient death

  up to 12 months

Secondary Outcomes (2)

• overall response rate (ORR)

  up to 12 weeks

• toxicities

  up to 12 weeks

Study Arms (1)

Combined chemo-immuno-irradiation

EXPERIMENTAL

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

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

Interventions

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

Combined chemo-immuno-irradiation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with Stage IV esophagus squamous cell carcinoma.
• Expected survival time ≥3 months
• Enrolled patients must have at least one measurable lesion conforming to the RECIST V1.1 definition.
• Physical fitness ECOG score of 0 or 1
• 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;

You may not qualify if:

• 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)
• 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；
• 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；
• 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；
• Allergic reactions to test drugs for this application；

Sponsors & Collaborators

• Qingdao Central Hospital: lead

Study Sites (2)

Qingdao Central Hospital, Qingdao Cancer Hospital

Qingdao, Shandong, 266042, China

RECRUITING

Qingdao Central Hospital

Qingdao, Shandong, 266042, China

RECRUITING

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

TP protocol; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: November 18, 2023
• Study Start: September 20, 2023
• Primary Completion: October 31, 2025
• Study Completion (Estimated): October 31, 2026
• Last Updated: July 24, 2024

Record last verified: 2024-07

Locations

CN (2)