Esophageal Squamous Cell Carcinoma (ESCC)Phase 2NCT06603402
Low-Dose Involved-Field Radiotherapy Plus Immunochemotherapy for ESCC
A Phase 2 study testing low-dose involved-field radiotherapy combined with immunochemotherapy in people with Esophageal Squamous Cell Carcinoma (ESCC) and Immunotherapy, run by Sichuan University at 1 site in China.
Trial summary
The aim of this clinical trial is to evaluate whether low-dose involved-field radiotherapy combined with immunochemotherapy can reduce treatment-related adverse effects, enhance progression-free survival (PFS), and improve overall survival (OS) in patients with locally advanced, unresectable esophageal squamous cell… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma (ESCC), Immunotherapy
- What is being tested?
- low-dose involved-field radiotherapy combined with immunochemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteChina
- Study dates
- 24 Aug 2023to 1 Sep 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Age 18-80 years
- Patients with locally advanced, unresectable ESCC who have received radical treatment (radical chemoradiotherapy or radical radiochemotherapy), including:
- Cervical esophagus involvement, T4 stage, supraclavicular lymph node metastasis, or inability to tolerate or refusal of surgery due to personal reasons; Failure of neoadjuvant or conversion therapy;Unresectable local recurrence after surgery (with measurable target lesions)
- No evidence of tumor recurrence or metastasis on follow-up examination 2-3 weeks after radical treatment
- Ability to provide fresh tumor tissue specimens (baseline)
- Normal function of major organs
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- Performance Status (PS) score ≤ 1
- Patients of childbearing potential must agree to use contraception.
- Voluntary participation with signed informed consent
Who cannot join
- History of fistula formation due to primary tumor invasion
- High risk of gastrointestinal bleeding, esophageal fistula, or esophageal perforation.
- Poor nutritional status
- Previous immune-related adverse events during prior radical treatment, including grade ≥3 immune-related pneumonitis, myocarditis, etc
- Presence of symptoms or signs of interstitial disease
- Patients with any severe and/or uncontrolled medical condition
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- Presence of concurrent malignancies
- Presence of other autoimmune diseases or long-term use of immunosuppressants or corticosteroids.
- Patients who are difficult to communicate with or are unlikely to comply with long-term follow-up.
- Any other conditions that the investigator deems unsuitable for participation.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
zhenyu ding, MD, 18980601957, dingzhenyu@scu.edu.cn
About this study
Official title: Low-Dose Involved-Field Radiotherapy Combined with Immunochemotherapy for Locally Advanced, Unresectable Esophageal Squamous Cell Carcinoma: a Prospective, Single-Arm, Phase II Study.
The aim of this clinical trial is to evaluate whether low-dose involved-field radiotherapy combined with immunochemotherapy can reduce treatment-related adverse effects, enhance progression-free survival (PFS), and improve overall survival (OS) in patients with locally advanced, unresectable esophageal squamous cell carcinoma.
The key questions this study seeks to address are:
Read more
- Can low-dose involved-field radiotherapy combined with immunochemotherapy reduce treatment-related adverse effects?
- Does this combined approach improve PFS and OS in these patients?
Participants in the study will:
- Undergo an endoscopy at West China Hospital to confirm their diagnosis.
- Receive a treatment regimen that includes low-dose radiotherapy at 45.0 Gy in 1.8 Gy per fraction over 25 fractions, alongside immunochemotherapy, with three cycles of chemotherapy administered every 3 weeks.
- After completing the full treatment regimen, participants will undergo regular follow-up visits and monitoring by healthcare professionals.
Read the detailed description
This is a single-arm, single-center, prospective clinical study aimed at evaluating the efficacy and safety of low-dose involved-field radiotherapy combined with immunochemotherapy in patients with locally advanced, unresectable esophageal squamous cell carcinoma (ESCC). The study will enroll subjects with pathologically confirmed ESCC (via histology or cytology), clinically staged as cT1-4aN+M0, who are deemed unsuitable for surgical intervention by the investigators or have declined surgical treatment.
Initially, patients will receive one cycle of induction immunochemotherapy consisting of paclitaxel or nab-paclitaxel plus carboplatin, in combination with camrelizumab administered at 200 mg intravenously every three weeks. On the first day of the second chemotherapy cycle, low-dose involved-field radiotherapy will commence. The radiotherapy protocol involves a total dose of 45.0 Gy delivered in 25 fractions of 1.8 Gy each (45.0 Gy/1.8 Gy per fraction over 25 fractions). The clinical target volume (CTV) is defined by extending the gross tumor volume (GTV) 3 cm superiorly and inferiorly, and 0.5 cm anteriorly, posteriorly, and laterally; for involved lymph nodes (GTVn), a 0.5 cm margin is added in all directions.
Following disease stabilization, patients will continue with maintenance therapy using camrelizumab monotherapy for up to one year or until disease progression, as assessed by RECIST 1.1 criteria, or the emergence of intolerable adverse effects. Upon completion of treatment, subjects will undergo routine follow-up according to standard care protocols to document survival status and long-term adverse reactions.
The study utilizes a historical control one-year progression-free survival (PFS) rate of 34% from definitive chemoradiotherapy in locally advanced ESCC. It is hypothesized that the combination of camrelizumab with dual-agent chemotherapy (paclitaxel or nab-paclitaxel plus carboplatin) and sequential low-dose involved-field radiotherapy will improve the 12-month PFS rate to 52%. Based on a two-sided significance level (α) of 0.05 and a power (1-β) of 80%, the required sample size is calculated to be 37 patients. Accounting for a 10% dropout rate, a total of 41 patients will be enrolled in the study.
- Being tested
- low-dose involved-field radiotherapy combined with immunochemotherapy
- Keywords
- Esophageal Squamous Cell Carcinoma, Radiotherapy, immunotherapy
- 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.
low-dose involved-field radiotherapy combined with immunochemotherapyRadiation
low-dose involved-field radiotherapy combined with immunochemotherapy
| Study group | Role | What they receive |
|---|---|---|
| low-dose involved-field radiotherapy combined with immunochemotherapy | Experimental | low-dose involved-field radiotherapy combined with immunochemotherapy Receives: Radiation: low-dose involved-field radiotherapy combined with immunochemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety of low-dose involved-field radiotherapy combined with immunochemotherapy
This study will collected any adverse medical events that occurred during the study drug treatment, and the treatment-related adverse events as assessed by\" CTCAE v5.0\".
Measured: 12months
Secondary outcomes (3)
The efficacy of low-dose involved-field radiotherapy combined with immunochemotherapy
The 1-year Progression-free survival (PFS) rate will be evaluated as the primary endpoint using RECIST 1.1 criteria.
Measured: 12months
The efficacy of low-dose involved-field radiotherapy combined with immunochemotherapy
Evaluate objective response rate (ORR) using the RECIST 1.1 criteria
Measured: 12months
The efficacy of low-dose involved-field radiotherapy combined with immunochemotherapy
Using the RECIST1.1 tumor evaluation criteria for efficacy evaluation, evaluate overall survival (OS)
Measured: 24months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start24 Aug 2023
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell Carcinoma (ESCC)Studies of the same condition, open and under way.
- More trials run by Sichuan 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhen-Yu Ding, Sichuan University
- Investigators
- zhenyu ding, MD, Principal investigator, West China Hospital, Sichuan University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06603402
- Sponsor's protocol ID
- HX-LION Study
- Status last verified
- Sep 2024
- First submitted
- 13 Sep 2024
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-Dose Involved-Field Radiotherapy Combined with Immunochemotherapy for Locally Advanced, Unresectable Esophageal Squamous Cell Carcinoma: a Prospective, Single-Arm, Phase II Study.
- ClinicalTrials.gov ID
- NCT06603402
- Acronym / sponsor ID
- HX-LION Study
- Keywords
- Esophageal Squamous Cell Carcinoma, Radiotherapy, immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- Sichuan UniversityUniversity, hospital or other
- Study start
- 24 Aug 2023 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 19 Sep 2024 (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.
The aim of this clinical trial is to evaluate whether low-dose involved-field radiotherapy combined with immunochemotherapy can reduce treatment-related adverse effects, enhance progression-free survival (PFS), and improve overall survival (OS) in patients with locally advanced, unresectable esophageal squamous cell carcinoma.
The key questions this study seeks to address are:
- Can low-dose involved-field radiotherapy combined with immunochemotherapy reduce treatment-related adverse effects?
- Does this combined approach improve PFS and OS in these patients?
Participants in the study will:
- Undergo an endoscopy at West China Hospital to confirm their diagnosis.
- Receive a treatment regimen that includes low-dose radiotherapy at 45.0 Gy in 1.8 Gy per fraction over 25 fractions, alongside immunochemotherapy, with three cycles of chemotherapy administered every 3 weeks.
- After completing the full treatment regimen, participants will undergo regular follow-up visits and monitoring by healthcare professionals.
Detailed description
This is a single-arm, single-center, prospective clinical study aimed at evaluating the efficacy and safety of low-dose involved-field radiotherapy combined with immunochemotherapy in patients with locally advanced, unresectable esophageal squamous cell carcinoma (ESCC). The study will enroll subjects with pathologically confirmed ESCC (via histology or cytology), clinically staged as cT1-4aN+M0, who are deemed unsuitable for surgical intervention by the investigators or have declined surgical treatment.
Initially, patients will receive one cycle of induction immunochemotherapy consisting of paclitaxel or nab-paclitaxel plus carboplatin, in combination with camrelizumab administered at 200 mg intravenously every three weeks. On the first day of the second chemotherapy cycle, low-dose involved-field radiotherapy will commence. The radiotherapy protocol involves a total dose of 45.0 Gy delivered in 25 fractions of 1.8 Gy each (45.0 Gy/1.8 Gy per fraction over 25 fractions). The clinical target volume (CTV) is defined by extending the gross tumor volume (GTV) 3 cm superiorly and inferiorly, and 0.5 cm anteriorly, posteriorly, and laterally; for involved lymph nodes (GTVn), a 0.5 cm margin is added in all directions.
Following disease stabilization, patients will continue with maintenance therapy using camrelizumab monotherapy for up to one year or until disease progression, as assessed by RECIST 1.1 criteria, or the emergence of intolerable adverse effects. Upon completion of treatment, subjects will undergo routine follow-up according to standard care protocols to document survival status and long-term adverse reactions.
The study utilizes a historical control one-year progression-free survival (PFS) rate of 34% from definitive chemoradiotherapy in locally advanced ESCC. It is hypothesized that the combination of camrelizumab with dual-agent chemotherapy (paclitaxel or nab-paclitaxel plus carboplatin) and sequential low-dose involved-field radiotherapy will improve the 12-month PFS rate to 52%. Based on a two-sided significance level (α) of 0.05 and a power (1-β) of 80%, the required sample size is calculated to be 37 patients. Accounting for a 10% dropout rate, a total of 41 patients will be enrolled in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| low-dose involved-field radiotherapy combined with immunochemotherapy | Experimental | Radiation: low-dose involved-field radiotherapy combined with immunochemotherapylow-dose involved-field radiotherapy combined with immunochemotherapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18-80 years
- Patients with locally advanced, unresectable ESCC who have received radical treatment (radical chemoradiotherapy or radical radiochemotherapy), including:
- Cervical esophagus involvement, T4 stage, supraclavicular lymph node metastasis, or inability to tolerate or refusal of surgery due to personal reasons; Failure of neoadjuvant or conversion therapy;Unresectable local recurrence after surgery (with measurable target lesions)
- No evidence of tumor recurrence or metastasis on follow-up examination 2-3 weeks after radical treatment
- Ability to provide fresh tumor tissue specimens (baseline)
Key exclusion criteria (10 listed)
- History of fistula formation due to primary tumor invasion
- High risk of gastrointestinal bleeding, esophageal fistula, or esophageal perforation.
- Poor nutritional status
- Previous immune-related adverse events during prior radical treatment, including grade ≥3 immune-related pneumonitis, myocarditis, etc
- Presence of symptoms or signs of interstitial disease
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 |
|---|---|---|
| low-dose involved-field radiotherapy combined with immunochemotherapylow-dose involved-field radiotherapy combined with immunochemotherapy | Radiation | low-dose involved-field radiotherapy combined with immunochemotherapy |
Primary outcome
The safety of low-dose involved-field radiotherapy combined with immunochemotherapy
Time frame: 12months
This study will collected any adverse medical events that occurred during the study drug treatment, and the treatment-related adverse events as assessed by\" CTCAE v5.0\".
3 secondary outcomes
The efficacy of low-dose involved-field radiotherapy combined with immunochemotherapy
Time frame: 12months
The efficacy of low-dose involved-field radiotherapy combined with immunochemotherapy
Time frame: 12months
The efficacy of low-dose involved-field radiotherapy combined with immunochemotherapy
Time frame: 24months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- Individual participant dataSharing planned: No
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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.
zhenyu ding, MD principal investigator
West China Hospital, Sichuan University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing low-dose involved-field radiotherapy combined with immunochemotherapy in people with Esophageal Squamous Cell Carcinoma (ESCC) and Immunotherapy, run by Sichuan 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 9 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 3 Dec 2024. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact zhenyu ding, MD (+86 028-854-22562, dingzhenyu@scu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The safety of low-dose involved-field radiotherapy combined with immunochemotherapy (time frame: 12months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Dec 2024.