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Active, Not Recruiting

NCT Number: NCT06020885

Fraction Dose Escalation of Split-course Hypofractionated Concurrent Chemoradiotherapy Following Induction Chemo-immunotherapy in Unresectable Locally Advanced Esophageal Squamous Carcinoma: a Phase I Study.

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Esophageal Squamous Cell Carcinoma Carcinoma Carcinoma, Squamous Cell Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Sun yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Split-course hypo-CCRT

Radiation

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.

Induction Chemo-Immunotherapy

Drug

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

Concurrent chemotherapy

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 1, 2023
Registry last updated
Jul 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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