Esophageal CancerPhase 2NCT07455019
A Study of Bemosubaiabimab Combined With Anlotinib and Radiotherapy and Chemotherapy for the Treatment of Oligometastatic Esophageal Cancer
A Phase 2 study testing The treatment group using pembrolizumab combined with anlotinib and radiotherapy and chemotherapy in people with Esophageal Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
This study aims to evaluate the efficacy and safety of bemosubabimab combined with anlotinib and radiotherapy and chemotherapy in the treatment of patients with oligometastatic esophageal cancer. The study adopted a single-center, single-arm trial design. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- The treatment group using pembrolizumab combined with anlotinib and radiotherapy and chemotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2025to 30 Apr 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily participated in this study and signed the informed consent form, with good compliance and cooperation during the follow-up;
- Male or female aged 18 years or above;
- Patients diagnosed with oligometastatic esophageal squamous cell carcinoma through imaging. Oligometastatic esophageal cancer is defined as having no more than 5 metastatic lesions other than the primary tumor at the initial diagnosis or during treatment, and the metastatic lesions involve no more than 2 distant organs, and the disease duration is more than 3 months;
- At least one measurable lesion according to the RECIST 1.1 standard;
- Expected lifespan of at least 3 months;
- ECOG (Eastern Cooperative Oncology Group) score: 0-1 point;
- Adequate organ and bone marrow functions;
- For fertile women, appropriate contraceptive measures must be taken from the screening to 3 months after stopping the study treatment, and must be non-lactating subjects. Before starting the medication, the pregnancy test should be negative. For men, they must agree to use appropriate methods of contraception during the trial and for 8 weeks after the last administration of the trial drug or have undergone surgical sterilization.
Who cannot join
- Have received PD-1/PD-L1/CTLA-4 antibody or anti-angiogenic drugs (such as sunitinib, sorafenib, regorafenib, bevacizumab, imatinib, apatinib, etc.) in the past;
- Have participated in other drug clinical trials within the past 4 weeks or received systematic anti-tumor chemotherapy, radiotherapy or other anti-tumor treatments;
- Patients with a high bleeding tendency;
- Have received organ transplantation in the past;
- Have other inoperable conditions;
- Subjects with any severe and/or uncontrolled diseases, including:
Show all 17Show fewer
- Patients with hypertension who cannot achieve good control with a single antihypertensive drug (systolic blood pressure ≥ 150 mmHg, diastolic blood pressure ≥ 100 mmHg); or using two or more antihypertensive drugs to control blood pressure; n) Patients with grade II or above myocardial ischemia or myocardial infarction, arrhythmia (including QTc, male ≥ 450 ms; female ≥ 470 ms) and ≥ 2 grade congestive heart failure (New York Heart Association (NYHA) classification); o) Active or uncontrolled severe infection (NCI-CTC AE grade ≥ 2 infection); p) Liver cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis (hepatitis virus load > 1000 IU/ml) requiring antiviral treatment; q) Renal failure requiring hemodialysis or peritoneal dialysis; r) Have a history of immunodeficiency disease, including HIV positive or having other acquired or congenital immune deficiency diseases, or having a history of organ transplantation; s) Have a history of non-infectious pneumonia requiring systemic glucocorticoid treatment or current non-infectious pneumonia/interstitial lung disease; t) Diabetic subjects with poor blood sugar control (fasting blood glucose (FBG) > 10 mmol/L); u) Urine protein ≥ ++ and confirmed 24-hour urine protein quantification > 1.0 g; v) Abnormal coagulation function (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds or APTT > 1.5 ULN), with bleeding tendency or undergoing thrombolysis or anticoagulation treatment; Note: As long as the international normalized ratio (INR) of the drug activity is ≤ 1.5 within 14 days before starting the study treatment, it is allowed to use a small dose of heparin (i.e., enoxaparin 40 mg/day) or a small dose of aspirin (daily dosage ≤ 100 mg) for preventive purposes; w) Have any unrelieved toxic reaction higher than NCI-CTC AE grade 1 caused by previous treatment, or have not fully recovered from previous surgery; x) Have subjects with epileptic seizures and need for treatment;
- Subjects who need to use corticosteroids (> 10 mg/day prednisone equivalent dose) or other immunosuppressive drugs for systemic treatment within 7 days before the administration of the study drug. Excluded:
- If there is no active autoimmune disease, inhalation or local use of corticosteroids and doses exceeding the efficacy dose of prednisone > 10 mg/day are allowed.
- Physiological doses of systemic corticosteroids do not exceed 10 mg/day prednisone or other corticosteroids with equivalent doses.
- Corticosteroids as preventive medication for hypersensitivity reactions (such as before CT examination);
- Subjects who received live vaccines or attenuated vaccines within 30 days before the first administration of the study drug, or plan to receive live vaccines or attenuated vaccines during the study;
- Have multiple factors affecting oral drugs (such as inability to swallow, chronic diarrhea, etc.);
- Have a history of substance abuse of psychotropic drugs and cannot quit or have mental disorders;
- Have a history of severe hypersensitivity reaction to other monoclonal antibodies;
- Had experienced severe allergic reactions to anlotinib hydrochloride, bemosubaymab and/or the excipients in the investigational drugs;
- According to the investigator's judgment, had accompanying diseases that seriously endangered the safety of the subjects or affected their ability to complete 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
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu
Ge Xiao Lin, 62306360
About this study
Official title: A Single-arm, Single-center, Exploratory Clinical Study of Bemosubaiabimab Combined With Anlotinib and Radiotherapy and Chemotherapy for the Treatment of Oligometastatic Esophageal Cancer
This study aims to evaluate the efficacy and safety of bemosubabimab combined with anlotinib and radiotherapy and chemotherapy in the treatment of patients with oligometastatic esophageal cancer. The study adopted a single-center, single-arm trial design.
Eligible patients with oligometastatic esophageal squamous cell carcinoma were treated with bemosubaiabant, anlotinib, and combined radiotherapy and chemotherapy for 4 to 6 cycles, followed by maintenance treatment with bemosubaiabant and anlotinib.
Read more
During the study period, the subjects were not allowed to receive any other anti-tumor treatments.
If the dose of anlotinib hydrochloride was adjusted due to safety events for the subjects, the anlotinib hydrochloride would be dispensed according to the investigator's prescription.
Read the detailed description
This study aims to evaluate the efficacy and safety of bemosubabimab combined with anlotinib and radiotherapy and chemotherapy in the treatment of patients with oligometastatic esophageal cancer. The study adopted a single-center, single-arm trial design.
Eligible patients with oligometastatic esophageal squamous cell carcinoma were treated with bemosubaiabant, anlotinib, and combined radiotherapy and chemotherapy for 4 to 6 cycles, followed by maintenance treatment with bemosubaiabant and anlotinib.
During the study period, the subjects were not allowed to receive any other anti-tumor treatments.
If the dose of anlotinib hydrochloride was adjusted due to safety events for the subjects, the anlotinib hydrochloride would be dispensed according to the investigator's prescription.
- Conditions
- Esophageal Cancer
- Being tested
- The treatment group using pembrolizumab combined with anlotinib and radiotherapy and chemotherapy
- Keywords
- Bemosubantiab, Anlotinib, Oligometastasis of esophageal cancer
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The treatment group using pembrolizumab combined with anlotinib and radiotherapy and chemotherapyDrug
For eligible patients with metastatic esophageal squamous cell carcinoma, they will receive a combination of bemosubaiabumab, anlotinib, radiotherapy and chemotherapy for 4 to 6 cycles, followed by maintenance treatment with bemosubaiabumab and anlotinib.
- BeMosubaiabumab: 1200mg each time, intravenous injection, once every 3 weeks, with 3 weeks as one treatment cycle.
- Anlotinib Hydrochloride: 10mg, taken orally before breakfast (the time of taking the medicine each day should be as similar as possible), once a day. Take for 2 weeks, then stop for 1 week. 3 weeks constitute one treatment cycle for 2 treatment cycles; if there is a missed dose during the treatment period, and the time from the missed dose to the next dose is less than 12 hours, no additional dose will be given. The dose can be adjusted to 8mg according to the patient's condition.
- Radiotherapy: 50.4 Gy in 28 fractions. ④ Chemotherapy: The researcher will select the chemotherapy regimen based on the specific conditio
| Study group | Role | What they receive |
|---|---|---|
| The treatment group using pembrolizumab combined with anlotinib and radiotherapy and chemotherapy | Experimental | For eligible patients with metastatic esophageal squamous cell carcinoma, they will receive a combination of bemosubaiabumab, anlotinib, radiotherapy and chemotherapy for 4 to 6 cycles, followed by maintenance treatment with bemosubaiabumab and anlotinib.
* BeMosubaiabumab: 1200mg each time, intravenous injection, once every 3 weeks, with 3 weeks as one treatment cycle.
* Anlotinib Hydrochloride: 10mg, taken orally before breakfast (the time of taking the medicine each day should be as similar as possible), once a day. Take for 2 weeks, then stop for 1 week. 3 weeks constitute one treatment cycle for 2 treatment cycles; if there is a missed dose during the treatment period, and the time from the missed dose to the next dose is less than 12 hours, no additional dose will be given. The dose can be adjusted to 8mg according to the patient's condition.
* Radiotherapy: 50.4 Gy in 28 fractions. ④ Chemotherapy: The researcher will select the chemotherapy regimen based on the specific conditi Receives: Drug: The treatment group using pembrolizumab combined with anlotinib and radiotherapy and chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate（ORR）
The proportion of patients whose tumors have shrunk to a certain extent and maintained that state for a certain period of time, including cases of complete response (CR) and partial response (PR).
Measured: one year
Secondary outcomes (5)
Progression Free Survival（PFS）
It refers to the period from the date of the first medication administration to the date of the first occurrence of disease progression or any cause of death, whichever comes first.
Measured: one year
Disease Control Rate(DCR)
The percentage of cases with complete remission, partial remission and stable disease that have been confirmed among the evaluable efficacy patients
Measured: one year
Duration of Response(DoR)
The time period from the first assessment of the tumor as being in complete response (CR) or partial response (PR) to the first assessment of the tumor as being in progressive disease (PD) or death due to any cause.
Measured: one year
Overall Survival
The period from the date of the first medication administration to (due to any cause) death
Measured: one year
Safety
Safety monitoring (reporting of adverse events or serious adverse events) should be conducted from the time the subjects are enrolled until the end of the study.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start1 May 2025
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical 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
- 28 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07455019
- Sponsor's protocol ID
- 2025-SR-813
- Status last verified
- Mar 2026
- First submitted
- 3 Mar 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Single-center, Exploratory Clinical Study of Bemosubaiabimab Combined With Anlotinib and Radiotherapy and Chemotherapy for the Treatment of Oligometastatic Esophageal Cancer
- ClinicalTrials.gov ID
- NCT07455019
- Acronym / sponsor ID
- 2025-SR-813
- Conditions
- Esophageal Cancer
- Keywords
- Bemosubantiab, Anlotinib, Oligometastasis of esophageal cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 6 Mar 2026 (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 study aims to evaluate the efficacy and safety of bemosubabimab combined with anlotinib and radiotherapy and chemotherapy in the treatment of patients with oligometastatic esophageal cancer. The study adopted a single-center, single-arm trial design.
Eligible patients with oligometastatic esophageal squamous cell carcinoma were treated with bemosubaiabant, anlotinib, and combined radiotherapy and chemotherapy for 4 to 6 cycles, followed by maintenance treatment with bemosubaiabant and anlotinib.
During the study period, the subjects were not allowed to receive any other anti-tumor treatments.
If the dose of anlotinib hydrochloride was adjusted due to safety events for the subjects, the anlotinib hydrochloride would be dispensed according to the investigator's prescription.
Detailed description
This study aims to evaluate the efficacy and safety of bemosubabimab combined with anlotinib and radiotherapy and chemotherapy in the treatment of patients with oligometastatic esophageal cancer. The study adopted a single-center, single-arm trial design.
Eligible patients with oligometastatic esophageal squamous cell carcinoma were treated with bemosubaiabant, anlotinib, and combined radiotherapy and chemotherapy for 4 to 6 cycles, followed by maintenance treatment with bemosubaiabant and anlotinib.
During the study period, the subjects were not allowed to receive any other anti-tumor treatments.
If the dose of anlotinib hydrochloride was adjusted due to safety events for the subjects, the anlotinib hydrochloride would be dispensed according to the investigator's prescription.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The treatment group using pembrolizumab combined with anlotinib and radiotherapy and chemotherapy | Experimental | Drug: The treatment group using pembrolizumab combined with anlotinib and radiotherapy and chemotherapyFor eligible patients with metastatic esophageal squamous cell carcinoma, they will receive a combination of bemosubaiabumab, anlotinib, radiotherapy and chemotherapy for 4 to 6 cycles, followed by maintenance treatment with bemosubaiabumab and anlotinib. * BeMosubaiabumab: 1200mg each time, intravenous injection, once every 3 weeks, with 3 weeks as one treatment cycle. * Anlotinib Hydrochloride: 10mg, taken orally before breakfast (the time of taking the medicine each day should be as similar as possible), once a day. Take for 2 weeks, then stop for 1 week. 3 weeks constitute one treatment cycle for 2 treatment cycles; if there is a missed dose during the treatment period, and the time from the missed dose to the next dose is less than 12 hours, no additional dose will be given. The dose can be adjusted to 8mg according to the patient's condition. * Radiotherapy: 50.4 Gy in 28 fractions. ④ Chemotherapy: The researcher will select the chemotherapy regimen based on the specific conditi |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Voluntarily participated in this study and signed the informed consent form, with good compliance and cooperation during the follow-up;
- Male or female aged 18 years or above;
- Patients diagnosed with oligometastatic esophageal squamous cell carcinoma through imaging. Oligometastatic esophageal cancer is defined as having no more than 5 metastatic lesions other than the primary tumor at the initial diagnosis or during treatment, and the metastatic lesions involve no more than 2 distant organs, and the disease duration is more than 3 months;
- At least one measurable lesion according to the RECIST 1.1 standard;
- Expected lifespan of at least 3 months;
Key exclusion criteria (17 listed)
- Have received PD-1/PD-L1/CTLA-4 antibody or anti-angiogenic drugs (such as sunitinib, sorafenib, regorafenib, bevacizumab, imatinib, apatinib, etc.) in the past;
- Have participated in other drug clinical trials within the past 4 weeks or received systematic anti-tumor chemotherapy, radiotherapy or other anti-tumor treatments;
- Patients with a high bleeding tendency;
- Have received organ transplantation in the past;
- Have other inoperable conditions;
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 |
|---|---|---|
| The treatment group using pembrolizumab combined with anlotinib and radiotherapy and chemotherapyFor eligible patients with metastatic esophageal squamous cell carcinoma, they will receive a combination of bemosubaiabumab, anlotinib, radiotherapy and chemotherapy for 4 to 6 cycles, followed by maintenance treatment with bemosubaiabumab and anlotinib. * BeMosubaiabumab: 1200mg each time, intravenous injection, once every 3 weeks, with 3 weeks as one treatment cycle. * Anlotinib Hydrochloride: 10mg, taken orally before breakfast (the time of taking the medicine each day should be as similar as possible), once a day. Take for 2 weeks, then stop for 1 week. 3 weeks constitute one treatment cycle for 2 treatment cycles; if there is a missed dose during the treatment period, and the time from the missed dose to the next dose is less than 12 hours, no additional dose will be given. The dose can be adjusted to 8mg according to the patient's condition. * Radiotherapy: 50.4 Gy in 28 fractions. ④ Chemotherapy: The researcher will select the chemotherapy regimen based on the specific conditio | Drug | The treatment group using pembrolizumab combined with anlotinib and radiotherapy and chemotherapy |
Primary outcome
Objective Response Rate（ORR）
Time frame: one year
The proportion of patients whose tumors have shrunk to a certain extent and maintained that state for a certain period of time, including cases of complete response (CR) and partial response (PR).
5 secondary outcomes
Progression Free Survival（PFS）
Time frame: one year
Disease Control Rate(DCR)
Time frame: one year
Duration of Response(DoR)
Time frame: one year
Overall Survival
Time frame: one year
Safety
Time frame: one year
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 6 Mar 2026.
- 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.
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 The treatment group using pembrolizumab combined with anlotinib and radiotherapy and chemotherapy in people with Esophageal Cancer, run by The First Affiliated Hospital with Nanjing Medical 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 8 inclusion and 17 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 6 Mar 2026. 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 Ge Xiao Lin (68306360, jsphkj@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate（ORR） (time frame: one year). 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 6 Mar 2026.