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A Study of IO Plus Radiotherapy in Patients With Advanced ESCC.

Primary Purpose

Metastatic Esophageal Squamous Cell Carcinoma

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Radiotherapy
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Esophageal Squamous Cell Carcinoma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 18-80, had an Eastern Cooperative Oncology Group performance status score of 0-1; Patients had unresectable or recurrent esophageal squamous cell carcinoma that precluded esophagectomy or definitive chemoradiation, or distant metastatic disease; Patients had received no previous systemic therapy (patients who had progressed ≥6 months after [neo]adjuvant therapy or definitive chemoradiation were eligible); Patients accepted at least one cycle of anti-PD-1 immunotherapy combined chemotherapy as 1st line treatment. All lesions of current diagnosis did not receive local treatment such as radiotherapy, surgery, radiofrequency ablation before enrollment. The measurable lesion was determined by the investigator based on the RECIST 1.1 assessment. A lesion located in a previous radiotherapy area can be considered a target lesion if it is confirmed to progress and is considered to be measurable according to RECIST 1.1. Estimated survival time >12 weeks. The function of vital organs meets the following requirements: Neutrophil absolute count (ANC) ≥ 1.5 × 10^9 / L platelets ≥ 100 × 10^9 / L; Hemoglobin ≥ 9g / dL; serum albumin ≥ 2.8g / dL; Total bilirubin ≤ 1.5 × ULN, ALT, AST and / or AKP ≤ 2.5 × ULN; if there is liver metastasis, ALT and / or AST ≤ 5 × ULN; if there is liver metastasis or bone metastasis AKP ≤ 5 × ULN; serum creatinine ≤ 1.5 × ULN or creatinine clearance > 60 mL / min; For patients with pulmonary lesions or previous lung irradiation who are known or suspected to have impaired lung function, the forced expiratory volume (FEV1) for 1 second of lung function must be above 1L. Female subjects of childbearing age must have a negative urine or serum pregnancy test within 72 hours prior to randomization. Subjects agreed to adequate contraception during the trial. The patient is voluntarily enrolled and obtained the informed consent form signed by the patient or his legal representative. Exclusion Criteria: Patients who are prior exposure to immune-mediated therapy. Patients participated in any investigational drug study within 4 weeks preceding the start of treatment. The toxicity of previous anti-tumor treatment has not recovered to ≤ National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0 level 1 (except for hair loss) or the level specified by the inclusion/exclusion criteria. Patients with uncontrolled brain metastases, or vertebral body metastasis with spinal cord compression symptoms. Patients with uncontrolled pleural, pericardial or pelvic effusion that requires repeated drainage. Patients with history of immunodeficiency, or severe medical diseases that are not well controlled, which may have effect on the treatment of this study. Any other malignant tumor was diagnosed within 5 years prior to or after the diagnosis of ESCC, except for malignant tumors with a low risk of metastasis and death (5-year survival rate >90%), such as well-treated basal cells or squamous cell skin cancer or cervical cancer in situ.

Sites / Locations

  • Fudan University Shanghai cancer centerRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental group

Arm Description

Patients will be treated with anti-PD-1 Immune Checkpoint Inhibitors combined with chemotherapy used as 1st line treatment for metastatic ESCC.Radiotherapy will be conducted after four cycles of IO plus chemotherapy or started simultaneously.

Outcomes

Primary Outcome Measures

OS from start of 1st line treatment in metastatic ESCC
Median OS and OS rate at 12 months and 24 months will be analysed based on Kaplan-Meier method and presented along with its 95% confidence interval.

Secondary Outcome Measures

PFS from start of 1st line treatment in metastatic ESCC
Median PFS and PFS rate at 6 months, 12months and 18 months will be analysed based on Kaplan-Meier method and presented along with its 95% confidence interval.
Disease control rate
the ratio of patients with the best therapeutic evaluation is CR, PR and SD

Full Information

First Posted
February 27, 2023
Last Updated
July 23, 2023
Sponsor
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT05760391
Brief Title
A Study of IO Plus Radiotherapy in Patients With Advanced ESCC.
Official Title
A Trial of Combination and Timing of Immunotherapy With Radiotherapy in Patients With Advanced Esophageal Squamous Cell Carcinoma.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 28, 2023 (Actual)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
August 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study is a single-arm, prospective, phase II trial for patients with metastatic esophageal squamous cell carcinoma (ESCC) who received immunotherapy plus chemotherapy as the first-line treatment. The aim of the study is to determine if intervening with combined local therapy and immunotherapy and chemotherapy in patients with ESCC led to significant improvements in survival and disease control compared with historical data.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Esophageal Squamous Cell Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Patients will be treated with anti-PD-1 Immune Checkpoint Inhibitors combined with chemotherapy used as 1st line treatment for metastatic ESCC.Radiotherapy will be conducted after four cycles of IO plus chemotherapy or started simultaneously.
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Description
IMRT or SABR for patients with ESCC.
Primary Outcome Measure Information:
Title
OS from start of 1st line treatment in metastatic ESCC
Description
Median OS and OS rate at 12 months and 24 months will be analysed based on Kaplan-Meier method and presented along with its 95% confidence interval.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
PFS from start of 1st line treatment in metastatic ESCC
Description
Median PFS and PFS rate at 6 months, 12months and 18 months will be analysed based on Kaplan-Meier method and presented along with its 95% confidence interval.
Time Frame
18 months
Title
Disease control rate
Description
the ratio of patients with the best therapeutic evaluation is CR, PR and SD
Time Frame
Evaluation at the end of radiotherapy and after every 2 months of systemic therapy.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-80, had an Eastern Cooperative Oncology Group performance status score of 0-1; Patients had unresectable or recurrent esophageal squamous cell carcinoma that precluded esophagectomy or definitive chemoradiation, or distant metastatic disease; Patients had received no previous systemic therapy (patients who had progressed ≥6 months after [neo]adjuvant therapy or definitive chemoradiation were eligible); Patients accepted at least one cycle of anti-PD-1 immunotherapy combined chemotherapy as 1st line treatment. All lesions of current diagnosis did not receive local treatment such as radiotherapy, surgery, radiofrequency ablation before enrollment. The measurable lesion was determined by the investigator based on the RECIST 1.1 assessment. A lesion located in a previous radiotherapy area can be considered a target lesion if it is confirmed to progress and is considered to be measurable according to RECIST 1.1. Estimated survival time >12 weeks. The function of vital organs meets the following requirements: Neutrophil absolute count (ANC) ≥ 1.5 × 10^9 / L platelets ≥ 100 × 10^9 / L; Hemoglobin ≥ 9g / dL; serum albumin ≥ 2.8g / dL; Total bilirubin ≤ 1.5 × ULN, ALT, AST and / or AKP ≤ 2.5 × ULN; if there is liver metastasis, ALT and / or AST ≤ 5 × ULN; if there is liver metastasis or bone metastasis AKP ≤ 5 × ULN; serum creatinine ≤ 1.5 × ULN or creatinine clearance > 60 mL / min; For patients with pulmonary lesions or previous lung irradiation who are known or suspected to have impaired lung function, the forced expiratory volume (FEV1) for 1 second of lung function must be above 1L. Female subjects of childbearing age must have a negative urine or serum pregnancy test within 72 hours prior to randomization. Subjects agreed to adequate contraception during the trial. The patient is voluntarily enrolled and obtained the informed consent form signed by the patient or his legal representative. Exclusion Criteria: Patients who are prior exposure to immune-mediated therapy. Patients participated in any investigational drug study within 4 weeks preceding the start of treatment. The toxicity of previous anti-tumor treatment has not recovered to ≤ National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0 level 1 (except for hair loss) or the level specified by the inclusion/exclusion criteria. Patients with uncontrolled brain metastases, or vertebral body metastasis with spinal cord compression symptoms. Patients with uncontrolled pleural, pericardial or pelvic effusion that requires repeated drainage. Patients with history of immunodeficiency, or severe medical diseases that are not well controlled, which may have effect on the treatment of this study. Any other malignant tumor was diagnosed within 5 years prior to or after the diagnosis of ESCC, except for malignant tumors with a low risk of metastasis and death (5-year survival rate >90%), such as well-treated basal cells or squamous cell skin cancer or cervical cancer in situ.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qi Liu, M.D.
Phone
86-18017317882
Email
18017317882@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kuaile Zhao, M.D.
Facility Information:
Facility Name
Fudan University Shanghai cancer center
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kuaile Zhao
Phone
86-18017312534
Email
kuaile_z@sina.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study of IO Plus Radiotherapy in Patients With Advanced ESCC.

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