Sintilimab and Chemotherapy Sequential Radiotherapy in Advanced Esophageal Cancer

• Sponsor: Qingdao Central Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06138028
• Collaborator: (none)
• Enrollment: 90
• Locations: 2
• Arm: 1
• Anticipated Duration (Months): 37.4
• Patients Per Site: 45
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Esophageal Squamous Cell Carcinoma	Drug: TP regimen (cis-platinum ; Tocetaxel ) combined with PD-1 inhibitors（Sintilimab）	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 90 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Prospective Study of Sintilimab Combination With Chemotherapy Sequential Radiotherapy for Advanced Esophageal Squamous Cell Carcinoma
• Actual Study Start Date: Sep 20, 2023
• Anticipated Primary Completion Date: Oct 31, 2025
• Anticipated Study Completion Date: Oct 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Combined chemo-immuno-irradiation 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）; 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.

Outcome Measures

Primary Outcome Measures

1. OS [up to 24 months]

   overall survival

2. PFS [up to 12 months]

   progression-free survival

Secondary Outcome Measures

1. overall response rate [up to 12 weeks]

   ORR

2. toxicities [up to 12 weeks]

   toxicities

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

1. 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%;
2. 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。

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Qingdao Central Hospital, Qingdao Cancer Hospital	Qingdao	Shandong	China	266042
2	Qingdao Central Hospital	Qingdao	Shandong	China	266042

Sponsors and Collaborators

• Qingdao Central Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Qingdao Central Hospital
• ClinicalTrials.gov Identifier: NCT06138028
• Other Study ID Numbers: KY202306702
• First Posted: Nov 18, 2023
• Last Update Posted: Nov 18, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma; Cisplatin; Immune Checkpoint Inhibitors

Study Results

No Results Posted as of Nov 18, 2023