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

NCT06020885 | Active Not Recruiting Phase 1

• 1 other identifier: GASTO-10102
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Squamous Cell Carcinoma

Keywords

Split-course hypofractionated concurrent chemoradiotherapy; Fraction dose escalation; Induction chemo-immunotherapy; Unresectable locally advanced esophageal squamous carcinoma

Outcome Measures

Primary Outcomes (1)

• Tolerated fraction dose

  Define the maximum tolerated fraction dose (MTD) for split-course hypo-CCRT following induction chemo-immunotherapy.

  6 months

Secondary Outcomes (4)

• 2-year overall survival rate

  2-year

• 2-year progression-free survival rate

  2-year

• Clinical response rate

  2 months after radiotherapy

• The rate of grade 3 or 4 toxicities according to CTCAE5.0

  1 year after therapy

Study Arms (1)

Experiment group

EXPERIMENTAL

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; Drug: Induction chemo-immunotherapy; Drug: Concurrent chemotherapy

Interventions

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.

Experiment group

Induction chemo-immunotherapy DRUG

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

Experiment group

Concurrent chemotherapy DRUG

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

Experiment group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, 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

Study Officials

• Hui Liu, Professor

  Sun yat-sen universtiy cancer center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 26, 2023
• First Posted: September 1, 2023
• Study Start: August 31, 2023
• Primary Completion: October 30, 2025
• Study Completion: October 30, 2025
• Last Updated: July 21, 2025

Record last verified: 2025-07

Locations

CN (1)