Back to resultsFraction Dose Escalation of Split-course Hypofractionated Concurrent Chemoradiotherapy Following Induction Chemo-immunotherapy in Unresectable Locally Advanced Esophageal Squamous Carcinoma: a Phase I Study.
Primary Purpose
Esophageal Squamous Cell Carcinoma
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Split-course hypo-CCRT
Induction chemo-immunotherapy
Concurrent chemotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma focused on measuring Split-course hypofractionated concurrent chemoradiotherapy, Fraction dose escalation, Induction chemo-immunotherapy, Unresectable locally advanced esophageal squamous carcinoma
Eligibility Criteria
Inclusion Criteria: histologically confirmed ESCC II-IVB stages (IVB stage only with metastatic celiac or supraclavicular lymph nodes) based on the TNM staging system proposed by the International Union Against Cancer (UICC 2002) Eastern Cooperative Oncology Group (ECOG) performance status score 0-1 Charlson Comorbidity Index score≤4 oral medication can be administered despite esophageal obstruction adequate hematological, renal and hepatic functions Exclusion Criteria: contraindication for radiotherapy or chemotherapy prior malignancies, except for curable non-melanoma skin cancer or cervical carcinoma in situ distant metastasis, except for celiac or supraclavicular lymph nodes metastases
Sites / Locations
- Sun yat-sen University Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experiment group
Arm Description
This is a prospective, single-arm, phase 1 trial. A total of 18 unresectable LA-ESCC patients are required to be enrolled. Induction chemo-immunotherapy All patients receive 2-3 cycles of Abraxane 260mg/m2 d1+cisplatin 60mg/m2 d1+Toripalimab 240mg d1. Hypo-CCRT Evaluation will be performed three weeks after the induction chemo-immunotherapy, LA-ESCC patients without disease progression will continue the split-course hypo-CCRT treatment. Split-course hypo-CCRT is administered at the following three dose levels: Level 1: DT 3000cGy/10 daily fractions/300cGy in the first course, DT 2000cGy/10 daily fractions/200cGy in the second course; Level 2: DT 2800cGy/7 daily fractions/400cGy in the first course, DT 2200cGy/10 daily fractions/220cGy in the second course; Level 3: DT 2500cGy/5 daily fractions/500cGy in the first course, DT 2500cGy10 daily fractions/250cGy in the second course.
Outcomes
Primary Outcome Measures
Tolerated fraction dose
Define the maximum tolerated fraction dose (MTD) for split-course hypo-CCRT following induction chemo-immunotherapy.
Secondary Outcome Measures
2-year overall survival rate
2-year progression-free survival rate
Clinical response rate
The percentage of patients who had partial remission or complete remission after therapy
The rate of grade 3 or 4 toxicities according to CTCAE5.0
the percentage of patients who develop grade 3 or 4 toxicities
Full Information
NCT ID
NCT06020885
First Posted
August 26, 2023
Last Updated
August 26, 2023
Sponsor
Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT06020885
Brief Title
Fraction Dose Escalation of Split-course Hypofractionated Concurrent Chemoradiotherapy Following Induction Chemo-immunotherapy in Unresectable Locally Advanced Esophageal Squamous Carcinoma: a Phase I Study.
Official Title
Fraction Dose Escalation of Split-course Hypofractionated Concurrent Chemoradiotherapy Following Induction Chemo-immunotherapy in Unresectable Locally Advanced Esophageal Squamous Carcinoma: a Phase I Study.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen 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 Phase I study is to determine the maximum tolerated fraction dose (MTD) for split-course hypo-CCRT following induction chemo-immunotherapy in LA-ESCC patients, to clarify the dosimetric advantage of split-course hypo-CCRT, and to investigate the treatment-related toxicities and quality of life of the new regimen.
Detailed Description
This Phase I study is to determine the maximum tolerated fraction dose (MTD) for split-course hypo-CCRT following induction chemo-immunotherapy in LA-ESCC patients, to clarify the dosimetric advantage of split-course hypo-CCRT, and to investigate the treatment-related toxicities and quality of life of the new regimen.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Squamous Cell Carcinoma
Keywords
Split-course hypofractionated concurrent chemoradiotherapy, Fraction dose escalation, Induction chemo-immunotherapy, Unresectable locally advanced esophageal squamous carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experiment group
Arm Type
Experimental
Arm Description
This is a prospective, single-arm, phase 1 trial. A total of 18 unresectable LA-ESCC patients are required to be enrolled.
Induction chemo-immunotherapy All patients receive 2-3 cycles of Abraxane 260mg/m2 d1+cisplatin 60mg/m2 d1+Toripalimab 240mg d1.
Hypo-CCRT Evaluation will be performed three weeks after the induction chemo-immunotherapy, LA-ESCC patients without disease progression will continue the split-course hypo-CCRT treatment.
Split-course hypo-CCRT is administered at the following three dose levels:
Level 1: DT 3000cGy/10 daily fractions/300cGy in the first course, DT 2000cGy/10 daily fractions/200cGy in the second course;
Level 2: DT 2800cGy/7 daily fractions/400cGy in the first course, DT 2200cGy/10 daily fractions/220cGy in the second course;
Level 3: DT 2500cGy/5 daily fractions/500cGy in the first course, DT 2500cGy10 daily fractions/250cGy in the second course.
Intervention Type
Radiation
Intervention Name(s)
Split-course hypo-CCRT
Intervention Description
Split-course hypo-CCRT is administered at the following three dose levels:
Level 1: DT 3000cGy/10 daily fractions/300cGy in the first course, DT 2000cGy/10 daily fractions/200cGy in the second course;
Level 2: DT 2800cGy/7 daily fractions/400cGy in the first course, DT 2200cGy/10 daily fractions/220cGy in the second course;
Level 3: DT 2500cGy/5 daily fractions/500cGy in the first course, DT 2500cGy10 daily fractions/250cGy in the second course.
Intervention Type
Drug
Intervention Name(s)
Induction chemo-immunotherapy
Intervention Description
All patients receive 2-3 cycles of Abraxane 260mg/m2 d1+cisplatin 60mg/m2 d1+Toripalimab 240mg d1.
Intervention Type
Drug
Intervention Name(s)
Concurrent chemotherapy
Intervention Description
Concurrent capecitabine was administered orally at 1000mg/m2 twice daily within half an hour after meals concurrently with radiotherapy.
Primary Outcome Measure Information:
Title
Tolerated fraction dose
Description
Define the maximum tolerated fraction dose (MTD) for split-course hypo-CCRT following induction chemo-immunotherapy.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
2-year overall survival rate
Time Frame
2-year
Title
2-year progression-free survival rate
Time Frame
2-year
Title
Clinical response rate
Description
The percentage of patients who had partial remission or complete remission after therapy
Time Frame
2 months after radiotherapy
Title
The rate of grade 3 or 4 toxicities according to CTCAE5.0
Description
the percentage of patients who develop grade 3 or 4 toxicities
Time Frame
1 year after 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:
histologically confirmed ESCC
II-IVB stages (IVB stage only with metastatic celiac or supraclavicular lymph nodes) based on the TNM staging system proposed by the International Union Against Cancer (UICC 2002)
Eastern Cooperative Oncology Group (ECOG) performance status score 0-1
Charlson Comorbidity Index score≤4
oral medication can be administered despite esophageal obstruction
adequate hematological, renal and hepatic functions
Exclusion Criteria:
contraindication for radiotherapy or chemotherapy
prior malignancies, except for curable non-melanoma skin cancer or cervical carcinoma in situ
distant metastasis, except for celiac or supraclavicular lymph nodes metastases
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bo Qiu, Professor
Phone
+86-020-87343031
Email
qiubo@sysucc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui Liu, Professor
Organizational Affiliation
Sun yat-sen universtiy cancer center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bo Qiu, Professor
Phone
+862087343031
Email
qiubo@sysucc.org.cn
12. IPD Sharing Statement
Learn more about this trial
Fraction Dose Escalation of Split-course Hypofractionated Concurrent Chemoradiotherapy Following Induction Chemo-immunotherapy in Unresectable Locally Advanced Esophageal Squamous Carcinoma: a Phase I Study.
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