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New treatment option for Esophageal Cancer
Official title A Study of Bemosubaiabimab Combined With Anlotinib and Radiotherapy and Chemotherapy for the Treatment of Oligometastatic Esophageal Cancer
ClinicalTrials.gov ID: NCT07455019
What this study is testing
What is The treatment group using pembrolizumab combined with anlotinib and radiotherapy and chemotherapy?
The treatment group using pembrolizumab combined with anlotinib and radiotherapy and chemotherapy is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for esophageal cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- At least one measurable lesion according to the RECIST 1.1 standard;
- Expected lifespan of at least 3 months;
You likely can't join if
- Have received PD-1/PD-L1/CTLA-4 antibody or anti-angiogenic drugs (such as sunitinib, sorafenib, regorafenib, bevacizumab, imatinib, apatinib, etc.)...
- Have participated in other drug clinical trials within the past 4 weeks or received systematic anti-tumor chemotherapy, radiotherapy or other...
- Patients with a high bleeding tendency;
- Have received organ transplantation in the past;
- Have other inoperable conditions;
- people with any severe and/or uncontrolled diseases, including: m) Patients with hypertension who cannot achieve good control with a single...
See the full eligibility 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...
- 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 people. Before starting the medication, the pregnancy test...
- 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;
- people 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...
- people 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...
- people 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 people or affected their ability to complete the study.
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.