A Single-arm, Single-center, Exploratory Clinical Study of Bemosubaiabimab Combined With Anlotinib and Radiotherapy and Chemotherapy for the Treatment of Oligometastatic Esophageal Cancer
Overview
- Phase
- Phase 2
- Status
- Recruiting
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Objective Response Rate（ORR）
Overview
Brief 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.
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
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
The treatment group using pembrolizumab combined with anlotinib and radiotherapy and chemotherapy
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
Intervention: The treatment group using pembrolizumab combined with anlotinib and radiotherapy and chemotherapy (Drug)
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- Progression Free Survival（PFS）(one year)
- Disease Control Rate(DCR)(one year)
- Duration of Response(DoR)(one year)
- Overall Survival(one year)
- Safety(one year)