Promising cocktail for tough cancer? early trial combines immunotherapy, targeted pill, and radiation
NCT ID NCT07455019
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial is testing whether a combination of the immunotherapy drug bemosubaiabimab, the targeted pill anlotinib, plus radiation and chemotherapy can help people with oligometastatic esophageal cancer—cancer that has spread to a few spots. About 28 participants will receive up to 6 cycles of the combo, then continue on the two drugs alone. The main goal is to see how many patients' tumors shrink significantly.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- bemosubaiabimab (a drug given by IV) plus anlotinib hydrochloride (a pill taken by mouth), along with radiation and chemotherapy
- What this could lead to
- If it works, this could point toward a new combination treatment that shrinks tumors and delays progression in people with limited-spread esophageal cancer.
- What could go wrong
- This is a small, early-phase trial with only 28 people and no comparison group, so results may not apply broadly. The combination also carries risks from chemotherapy, radiation, and immune-related side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 28 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
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Apr 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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: m) 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: d) 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. e) Physiological doses of systemic corticosteroids do not exceed 10 mg/day prednisone or other corticosteroids with equivalent doses. f) 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Jiangsu Provincial People's Hospital
RECRUITINGNanjing, Jiangsu, China
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Other studies related to the condition(s) this trial covers.
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- Can a direct hit to tumors make immunotherapy work better?
- New antibody aims to preserve immune checkpoint while fighting cancer
- Can a guided missile for chemo hit tumors harder and spare healthy tissue?
- Can a new drug shrink tumors that resist standard care?