Esophageal Squamous Cell CarcinomaPhase 2NCT07188103
Ivonescimab Plus Short-Course Hypofractionated Radiotherapy as Second-Line Therapy for Esophageal Squamous Cell Carcinoma
A Phase 2 study testing Ivonescimab+Radiotherapy in people with Esophageal Squamous Cell Carcinoma, run by Anhui Provincial Hospital at 1 site in China.
Trial summary
In the era of immunotherapy, the standard second-line treatment regimen for locally advanced/metastatic esophageal squamous cell carcinoma (ESCC) remains controversial. This prospective, single-center, single-arm phase II clinical study aims to evaluate the efficacy and safety of Ivonescimab combined with short-course… 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?
- Ivonescimab+Radiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to 30 Jun 2027
- Phase
- Phase 2
- 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
- a. Patients with histologically confirmed esophageal squamous cell carcinoma (ESCC) , aged 18-80 years;
- b. Unresectable locally advanced, postoperative recurrent, or metastatic ESCC that has progressed on or is intolerant to first-line systemic therapy. For patients who received definitive concurrent chemoradiotherapy (CCRT) , disease progression during or within 6 months post-treatment is considered first-line treatment failure;
- c. At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) . All positive regional lymph nodes are counted as a single lesion, while non-regional metastatic lymph nodes are counted per station;
- d. Adequate major organ function, defined as:
- Hematology:
- Hemoglobin (Hb) ≥ 90 g/L
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- White blood cell (WBC) count ≥ 1.5 × 10⁹/L
- Platelet count ≥ 60 × 10⁹/L
- Serum biochemistry:
- Albumin ≥ 25 g/L
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal (ULN)
- Total bilirubin ≤ 1.5 × ULN
- Serum creatinine ≤ 1.5 × ULN or creatinine clearance (CrCl) ≥ 60 mL/min
- Echocardiography:
- Left ventricular ejection fraction (LVEF) ≥ 50% (lower limit of normal)
- e. Eastern Cooperative Oncology Group (ECOG) performance status: 0-2;
- f. Expected survival ≥ 3 months;
- g. Voluntarily enrolled, with signed informed consent, and willing to comply with study protocols and follow-up.
Who cannot join
- a. Patients with severe organ dysfunction, uncontrolled acute infection, or significant comorbidities;
- b. Patients with vertebral metastases accompanied by spinal cord compression symptoms;
- c. Patients with esophagotracheal or esophagomediastinal fistulas;
- d. Patients with uncontrolled pleural, pericardial, or pelvic effusions requiring repeated drainage;
- e. Patients with esophageal primary/metastatic lesions invading the heart or great vessels, as assessed by the responsible physician, with a risk of life-threatening hemorrhage;
- f. Patients with esophageal primary/metastatic lesions invading the trachea or bronchi, as assessed by the responsible physician, with a risk of esophagotracheal fistula;
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- g. Patients not suitable for short-course hypofractionated radiotherapy, as evaluated by the responsible physician;
- h. Pregnant or lactating women;
- i. Patients with mental disorders, or those with a history of psychotropic drug abuse and unable to quit;
- j. Patients who have participated in other drug clinical trials within the past 4 weeks;
- k. Patients or their families who refuse to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Anhui Provincal Hospital
Hefei, Anhui, 230000
About this study
Official title: Efficacy and Safety of Ivonescimab Combined With Short-Course Hypofractionated Radiotherapy as Second-Line Therapy for Locally Advanced/Metastatic Esophageal Squamous Cell Carcinoma: A Prospective, Single-Center, Single-Arm Phase II Clinical Study
In the era of immunotherapy, the standard second-line treatment regimen for locally advanced/metastatic esophageal squamous cell carcinoma (ESCC) remains controversial. This prospective, single-center, single-arm phase II clinical study aims to evaluate the efficacy and safety of Ivonescimab combined with short-course hypofractionated radiotherapy as a second-line therapy for patients with locally advanced/metastatic ESCC. The study plans to enroll 37 patients who have failed first-line treatment, without grouping, all of whom will receive Ivonescimab combined with short-course hypofractionated radiotherapy. The primary endpoints are progression-free survival (PFS) and safety, while the secondary endpoints include overall survival (OS), duration of response (DOR), and objective response rate (ORR). The study duration is 2 years.
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- Ivonescimab+Radiotherapy
- Keywords
- Esophageal cancer, Hypofractionated Radiotherapy, Ivonescimab
- Medical subject headings
- Esophageal Squamous Cell Carcinoma, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ivonescimab+RadiotherapyDrug
Short-course hypofractionated radiotherapy was administered to progressive lesions after first-line treatment, with a prescribed dose of 20 Gy in 5 fractions (95% PTV). The monoclonal antibody was initiated within 1 week after completing the radiotherapy regimen, at a dose of 20 mg/kg. Ivonescimab was administered every three weeks until disease progression, intolerable toxicity, or patient refusal.
| Study group | Role | What they receive |
|---|---|---|
| Ivonescimab+Radiotherapy | Experimental | Short-course hypofractionated radiotherapy was administered to progressive lesions after first-line treatment, with a prescribed dose of 20 Gy in 5 fractions (95% PTV). The monoclonal antibody was initiated within 1 week after completing the radiotherapy regimen, at a dose of 20 mg/kg. Ivonescimab was administered every three weeks until disease progression, intolerable toxicity, or patient refusal. Receives: Drug: Ivonescimab+Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
progression free survival
Measured: From date of enrollment until the date of first documented progression (radiologic or clinical), assessed every 8 weeks up to 36 months
Advese Events
Advese Events
Measured: Assessed every 8 weeks up to 36 months from the date of enrollment
Secondary outcomes (4)
OS
overall survival
Measured: From date of enrollment until the date of death from any cause, assessed up to 36 months
ORR
Objective Response Rate
Measured: From enrollment to the time of the second radiological evaluation
DOR
Duration of Response
Measured: the period from the first assessment of Complete Response (CR) or Partial Response (PR) to the first occurrence of Progressive Disease (PD) or death.
DCR
Disease Control Rate
Measured: From enrollment to the time of second radiological evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start1 Jul 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (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 CarcinomaStudies of the same condition, open and under way.
- More trials run by Anhui Provincial HospitalThe 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
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07188103
- Sponsor's protocol ID
- 2025KY-296
- Status last verified
- Sep 2025
- First submitted
- 23 Jul 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Ivonescimab Combined With Short-Course Hypofractionated Radiotherapy as Second-Line Therapy for Locally Advanced/Metastatic Esophageal Squamous Cell Carcinoma: A Prospective, Single-Center, Single-Arm Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT07188103
- Acronym / sponsor ID
- 2025KY-296
- Conditions
- Esophageal Squamous Cell Carcinoma
- Keywords
- Esophageal cancer, Hypofractionated Radiotherapy, Ivonescimab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 23 Sep 2025 (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.
In the era of immunotherapy, the standard second-line treatment regimen for locally advanced/metastatic esophageal squamous cell carcinoma (ESCC) remains controversial. This prospective, single-center, single-arm phase II clinical study aims to evaluate the efficacy and safety of Ivonescimab combined with short-course hypofractionated radiotherapy as a second-line therapy for patients with locally advanced/metastatic ESCC. The study plans to enroll 37 patients who have failed first-line treatment, without grouping, all of whom will receive Ivonescimab combined with short-course hypofractionated radiotherapy. The primary endpoints are progression-free survival (PFS) and safety, while the secondary endpoints include overall survival (OS), duration of response (DOR), and objective response rate (ORR). The study duration is 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ivonescimab+Radiotherapy | Experimental | Drug: Ivonescimab+RadiotherapyShort-course hypofractionated radiotherapy was administered to progressive lesions after first-line treatment, with a prescribed dose of 20 Gy in 5 fractions (95% PTV). The monoclonal antibody was initiated within 1 week after completing the radiotherapy regimen, at a dose of 20 mg/kg. Ivonescimab was administered every three weeks until disease progression, intolerable toxicity, or patient refusal. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- a. Patients with histologically confirmed esophageal squamous cell carcinoma (ESCC) , aged 18-80 years;
- b. Unresectable locally advanced, postoperative recurrent, or metastatic ESCC that has progressed on or is intolerant to first-line systemic therapy. For patients who received definitive concurrent chemoradiotherapy (CCRT) , disease progression during or within 6 months post-treatment is considered first-line treatment failure;
- c. At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) . All positive regional lymph nodes are counted as a single lesion, while non-regional metastatic lymph nodes are counted per station;
- d. Adequate major organ function, defined as:
- Left ventricular ejection fraction (LVEF) ≥ 50% (lower limit of normal)
Key exclusion criteria (11 listed)
- a. Patients with severe organ dysfunction, uncontrolled acute infection, or significant comorbidities;
- b. Patients with vertebral metastases accompanied by spinal cord compression symptoms;
- c. Patients with esophagotracheal or esophagomediastinal fistulas;
- d. Patients with uncontrolled pleural, pericardial, or pelvic effusions requiring repeated drainage;
- e. Patients with esophageal primary/metastatic lesions invading the heart or great vessels, as assessed by the responsible physician, with a risk of life-threatening hemorrhage;
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 |
|---|---|---|
| Ivonescimab+RadiotherapyShort-course hypofractionated radiotherapy was administered to progressive lesions after first-line treatment, with a prescribed dose of 20 Gy in 5 fractions (95% PTV). The monoclonal antibody was initiated within 1 week after completing the radiotherapy regimen, at a dose of 20 mg/kg. Ivonescimab was administered every three weeks until disease progression, intolerable toxicity, or patient refusal. | Drug | Ivonescimab+Radiotherapy |
Primary outcome
PFS
Time frame: From date of enrollment until the date of first documented progression (radiologic or clinical), assessed every 8 weeks up to 36 months
progression free survival
Advese Events
Time frame: Assessed every 8 weeks up to 36 months from the date of enrollment
Advese Events
4 secondary outcomes
OS
Time frame: From date of enrollment until the date of death from any cause, assessed up to 36 months
ORR
Time frame: From enrollment to the time of the second radiological evaluation
DOR
Time frame: the period from the first assessment of Complete Response (CR) or Partial Response (PR) to the first occurrence of Progressive Disease (PD) or death.
DCR
Time frame: From enrollment to the time of second radiological evaluation
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 23 Sep 2025.
- Individual participant dataSharing planned: Undecided. undecided
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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.
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 Ivonescimab+Radiotherapy in people with Esophageal Squamous Cell Carcinoma, run by Anhui Provincial Hospital 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 18 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 23 Sep 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 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?
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?
Contact Huiquan Liu (+86 15005518171, 759821691@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: From date of enrollment until the date of first documented progression (radiologic or clinical), assessed every 8 weeks up to 36 months). The study lists 2 primary outcomes in all. 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 23 Sep 2025; AzTrials last refreshed its copy on 2 Nov 2026.