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Sintilimab Plus Chemotherapy Followed by dCRT in Locally Advanced ESCC

Sponsor
Fudan University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03985046
Collaborator
(none)
75
Enrollment
1
Location
1
Arm
38.7
Anticipated Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to observe and evaluate the efficacy and safety of A sintilimab plus chemotherapy followed by definitive concurrent chemoradiotherapy in locally advanced esophageal squamous cell carcinoma.

Condition or Disease Intervention/Treatment Phase
  • Drug: Sintilimab plus Chemotherapy
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
75 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Pilot Study of Sintilimab Plus Chemotherapy Followed by Definitive Concurrent Chemoradiotherapy in Locally Advanced Esophageal Squamous Cell Carcinoma
Actual Study Start Date :
Oct 10, 2019
Actual Primary Completion Date :
May 31, 2021
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sintilimab plus chemotherapy

Drug: Sintilimab plus Chemotherapy
Sintilimab will be administered intravenously, a fixed dose of 200 mg. Paclitaxel 135mg/m2, carboplatin AUC=6. Once every 3 weeks.

Outcome Measures

Primary Outcome Measures

  1. Local Control Rate [up to 42 months]

Secondary Outcome Measures

  1. Adverse Events [up to 42 months]

  2. Progression-free Survival [up to 42 months]

  3. Overall Survival [up to 42 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Written informed consent

  2. Aged 18-75 years

  3. Histologically confirmed esophageal squamous cell carcinoma

  4. Clinical stages T3-4N0M0 or TxN1M0 or TxNxM1a or TxNxM1b (Only for cervical lymph nodes or celiac lymph nodes metastasis) based on the 6th UICC-TNM classification

  5. Eastern Cooperative Oncology Group(ECOG) performance status: 0-1 8. Life expectancy ≥3 months 9. Adequate organ functions Absolute neutrophil counts (ANC) ≥1.5×109⁄L; Hemoglobin (Hb) ≥9g⁄dl; Platelet (Plt) ≥100×109⁄L; Total bilirubin ≤1.5 upper limit of normal (ULN); Aspartate transaminase (AST) ≤2.5 ULN; Alanine aminotransferase (ALT) ≤2.5 ULN; Creatinine ≤1.5 ULN

Exclusion Criteria:

  1. Esophageal perforation or hematemesis

  2. Any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism and hypothyroidism (effective hormone replacement therapy excepted)) and immunosuppressive agents or systemic hormonal therapy indicated within 28 days (for adverse events of chemoradiotherapy excepted).

  3. Previously received or receiving other PD-1 antibody therapy or other immunotherapy against PD-1/PD-L1.

  4. Allergic to macromolecular protein preparations, or to any of the ingredients in sintilimab for injection.

  5. Uncontrolled heart diseases or clinical symptoms, such as: (1) New York Heart Association(NYHA) class II or higher heart failure; (2) unstable angina; (3) myocardial infarction within 1 year; (4)clinically significant arrhythmia requiring clinical intervention.

  6. Congenital or acquired immunodeficiency (such as HIV infection); active hepatitis B (HBV-DNA≥104 copy number/ml) or hepatitis C (positive hepatitis C antibody, and HCV-RNA is higher than the detection limit of the analytical method); active tuberculosis.

  7. Active infection or unexplained fever >38.5 °C within 2 weeks before randomization (fever due to tumor excepted, according to investigator).

  8. Patients with fertility reluctant to take contraceptive measures during the trial, or female patients pregnant or breastfeeding.

  9. According to the investigator, other factors that may cause termination of the study. ie, other serious diseases (including mental illness) require combined treatment, family or social factors, which may affect the safety or the collection of trial data.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fudan Universtiy Shanghai Cancer Center Shanghai Shanghai China 200032

Sponsors and Collaborators

  • Fudan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kuai Le Zhao, MD, Professor, Fudan University
ClinicalTrials.gov Identifier:
NCT03985046
Other Study ID Numbers:
  • ESO-Shanghai14
First Posted:
Jun 13, 2019
Last Update Posted:
Jun 8, 2021
Last Verified:
Jun 1, 2021
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

Study Results

No Results Posted as of Jun 8, 2021