Sintilimab and Chemotherapy Sequential Radiotherapy in Advanced Esophageal Cancer

November 13, 2023 updated by: Qingdao Central Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Qingdao, Shandong, China, 266042
        • Recruiting
        • Qingdao Central Hospital, Qingdao Cancer Hospital
        • Principal Investigator:
          • ketao lan, M.D.
        • Sub-Investigator:
          • youxin ji, M.D.
        • Contact:
        • Sub-Investigator:
          • chunling zhang, M.D.
      • Qingdao, Shandong, China, 266042
        • Recruiting
        • Qingdao Central Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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。

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OS
Time Frame: up to 24 months
overall survival
up to 24 months
PFS
Time Frame: up to 12 months
progression-free survival
up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall response rate
Time Frame: up to 12 weeks
ORR
up to 12 weeks
toxicities
Time Frame: up to 12 weeks
toxicities
up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qingdao Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2023

Primary Completion (Estimated)

October 31, 2025

Study Completion (Estimated)

October 31, 2026

Study Registration Dates

First Submitted

November 8, 2023

First Submitted That Met QC Criteria

November 13, 2023

First Posted (Estimated)

November 17, 2023

Study Record Updates

Last Update Posted (Estimated)

November 17, 2023

Last Update Submitted That Met QC Criteria

November 13, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY202306702

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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