Clinical trial · Interventional
Fraction Dose Escalation of Split-course Hypofractionated Concurrent Chemoradiotherapy Following Induction Chemo-immunotherapy in Unresectable Locally Advanced Esophageal Squamous Carcinoma: a Phase I Study.
NCT06020885CI-TRIAL-00092408active not recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Squamous Cell Carcinoma | Esophageal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Concurrent chemotherapy | Drug | — | UNRESOLVED |
| Induction chemo-immunotherapy | Drug | — | UNRESOLVED |
| Split-course hypo-CCRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experiment group
- description
- 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.
- interventionNames
- Radiation: Split-course hypo-CCRT
- Drug: Induction chemo-immunotherapy
- Drug: Concurrent chemotherapy
Primary outcomes (1)
- measure
- Tolerated fraction dose
- timeFrame
- 6 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDLiu F, Wang D, Luo G, Zhang H, Liu Y, Zhang P, Xia B, SiTu Y, Wang M, Zhang D, Hu Y, Wang J, Qiu B, Liu H. Fraction dose escalation of split-course concurrent chemoradiotherapy following induction chemo-immunotherapy in unresectable locally advanced oesophageal squamous carcinoma in China (GASTO-10102): a single-centre phase 1 study. EClinicalMedicine. 2026 Apr 17;95:103893. doi: 10.1016/j.eclinm.2026.103893. eCollection 2026 May. PMID 42028290