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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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ClinicalTrials.gov Identifier: NCT06020885
Recruitment Status : Recruiting
First Posted : September 1, 2023
Last Update Posted : September 1, 2023
Sponsor:
Information provided by (Responsible Party):
Hui Liu, Sun Yat-sen University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Esophageal Squamous Cell Carcinoma Radiation: Split-course hypo-CCRT Drug: Induction chemo-immunotherapy Drug: Concurrent chemotherapy Phase 1

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Actual Study Start Date : August 1, 2023
Estimated Primary Completion Date : January 31, 2024
Estimated Study Completion Date : July 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Experiment group

This is a prospective, single-arm, phase 1 trial. A total of 18 unresectable LA-ESCC patients are required to be enrolled.

  1. Induction chemo-immunotherapy All patients receive 2-3 cycles of Abraxane 260mg/m2 d1+cisplatin 60mg/m2 d1+Toripalimab 240mg d1.
  2. 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.
 Radiation: Split-course hypo-CCRT

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.

Drug: Induction chemo-immunotherapy
All patients receive 2-3 cycles of Abraxane 260mg/m2 d1+cisplatin 60mg/m2 d1+Toripalimab 240mg d1.

Drug: Concurrent chemotherapy
Concurrent capecitabine was administered orally at 1000mg/m2 twice daily within half an hour after meals concurrently with radiotherapy.


Outcome Measures
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Primary Outcome Measures :
  1. Tolerated fraction dose [ Time Frame: 6 months ]
    Define the maximum tolerated fraction dose (MTD) for split-course hypo-CCRT following induction chemo-immunotherapy.


Secondary Outcome Measures :
  1. 2-year overall survival rate [ Time Frame: 2-year ]
  2. 2-year progression-free survival rate [ Time Frame: 2-year ]
  3. Clinical response rate [ Time Frame: 2 months after radiotherapy ]
    The percentage of patients who had partial remission or complete remission after therapy

  4. The rate of grade 3 or 4 toxicities according to CTCAE5.0 [ Time Frame: 1 year after therapy ]
    the percentage of patients who develop grade 3 or 4 toxicities


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06020885


Contacts
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Contact: Bo Qiu, Professor +86-020-87343031 qiubo@sysucc.org.cn

Locations
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China, Guangdong
Sun yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Bo Qiu, Professor    +862087343031    qiubo@sysucc.org.cn   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Hui Liu, Professor Sun yat-sen universtiy cancer center
More Information
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Responsible Party: Hui Liu, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT06020885    
Other Study ID Numbers: GASTO-10102
First Posted: September 1, 2023    Key Record Dates
Last Update Posted: September 1, 2023
Last Verified: August 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hui Liu, Sun Yat-sen University:
Split-course hypofractionated concurrent chemoradiotherapy
Fraction dose escalation
Induction chemo-immunotherapy
Unresectable locally advanced esophageal squamous carcinoma
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Esophageal Neoplasms
Gastrointestinal Neoplasms
 Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Immunomodulating Agents
Immunologic Factors
Physiological Effects of Drugs