Esophageal Squamous Cell CarcinomaPhase 1NCT06020885
Fraction Dose Escalation of Split-course Hypofractionated Concurrent Chemoradiotherapy Following Induction Chemo-immunotherapy in Unresectable Locally Advanced Esophageal Squamous Carcinoma: a Phase I Study.
A Phase 1 study testing Split-course hypo-CCRT, Induction chemo-immunotherapy and Concurrent chemotherapy in people with Esophageal Squamous Cell Carcinoma, run by Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- What is being tested?
- Split-course hypo-CCRT, Induction chemo-immunotherapy and Concurrent chemotherapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 31 Aug 2023to 30 Oct 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
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.
Read the 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.
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- Split-course hypo-CCRT, Induction chemo-immunotherapy, Concurrent chemotherapy
- Keywords
- Split-course hypofractionated concurrent chemoradiotherapy, Fraction dose escalation, Induction chemo-immunotherapy, Unresectable locally advanced esophageal squamous carcinoma
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Split-course hypo-CCRTRadiation
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-immunotherapyDrug
All patients receive 2-3 cycles of Abraxane 260mg/m2 d1+cisplatin 60mg/m2 d1+Toripalimab 240mg d1.
Concurrent chemotherapyDrug
Concurrent capecitabine was administered orally at 1000mg/m2 twice daily within half an hour after meals concurrently with radiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: Split-course hypo-CCRT; Drug: Induction chemo-immunotherapy; Drug: Concurrent chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerated fraction dose
Define the maximum tolerated fraction dose (MTD) for split-course hypo-CCRT following induction chemo-immunotherapy.
Measured: 6 months
Secondary outcomes (4)
2-year overall survival rate
Measured: 2-year
2-year progression-free survival rate
Measured: 2-year
Clinical response rate
The percentage of patients who had partial remission or complete remission after therapy
Measured: 2 months after radiotherapy
The rate of grade 3 or 4 toxicities according to CTCAE5.0
the percentage of patients who develop grade 3 or 4 toxicities
Measured: 1 year after therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2023
- Study start31 Aug 2023
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui Liu, Sun Yat-sen University
- Investigators
- Hui Liu, Professor, Principal investigator, Sun yat-sen universtiy cancer center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06020885
- Sponsor's protocol ID
- GASTO-10102
- Status last verified
- Jul 2025
- First submitted
- 26 Aug 2023
- Last updated
- 21 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liu 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.
PubMed 42028290
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06020885
- Acronym / sponsor ID
- GASTO-10102
- Conditions
- Esophageal Squamous Cell Carcinoma
- Keywords
- Split-course hypofractionated concurrent chemoradiotherapy, Fraction dose escalation, Induction chemo-immunotherapy, Unresectable locally advanced esophageal squamous carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 31 Aug 2023 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 1 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experiment group | Experimental | Radiation: Split-course hypo-CCRT, Drug: Induction chemo-immunotherapy, Drug: Concurrent chemotherapyThis 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Split-course hypo-CCRTSplit-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 | Experiment group |
| Induction chemo-immunotherapyAll patients receive 2-3 cycles of Abraxane 260mg/m2 d1+cisplatin 60mg/m2 d1+Toripalimab 240mg d1. | Drug | Experiment group |
| Concurrent chemotherapyConcurrent capecitabine was administered orally at 1000mg/m2 twice daily within half an hour after meals concurrently with radiotherapy. | Drug | Experiment group |
Primary outcome
Tolerated fraction dose
Time frame: 6 months
Define the maximum tolerated fraction dose (MTD) for split-course hypo-CCRT following induction chemo-immunotherapy.
4 secondary outcomes
2-year overall survival rate
Time frame: 2-year
2-year progression-free survival rate
Time frame: 2-year
Clinical response rate
Time frame: 2 months after radiotherapy
The rate of grade 3 or 4 toxicities according to CTCAE5.0
Time frame: 1 year after therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2025.
- Derived from this study: PubMed 42028290Liu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hui Liu, Professor principal investigator
Sun yat-sen universtiy cancer center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Split-course hypo-CCRT, Induction chemo-immunotherapy and Concurrent chemotherapy in people with Esophageal Squamous Cell Carcinoma, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerated fraction dose (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06020885, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2025.