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Tests treatment safety and results for ESCC
Official title Efficacy and Safety of Anlotinib Combined With Bemocizumab for Neoadjuvant Therapy of Esophageal Squamous Cell Carcinoma(ESCC)
ClinicalTrials.gov ID: NCT07627347
What this study is testing
What is anlotinib+bevacizumab?
anlotinib+bevacizumab is an investigational medicine, given as an once-daily, being studied as a potential treatment for escc.
Also referred to as Neoadjuvant Therapy.
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 explore the efficacy and safety of anlotinib combined with bemocizumab as neoadjuvant therapy for resectable esophageal squamous cell carcinoma, with the goal of improving the pathological complete response (pCR) rate and margin-negative resection(R0) resection rate in patients undergoing esophageal cancer surgery, as well as enhancing disease-free survival (DFS) in postoperative patients. This will provide guidance and new options for the treatment of patients with locally advanced esophageal cancer.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Aged 18-70, both male and female
- After gastroscopy/ultrasonic gastroscopy biopsy, the pathology suggests squamous cell carcinoma of the esophagus, and the clinical diagnosis is...
- Patients with non-cervical esophageal cance
- The patient has not previously received systemic or local treatment for esophageal cancer, and according to the RECIST 1.1 criteria, there is at...
- ECOG PS: 0-1
You likely can't join if
- Within the past 5 years, there has been or is currently a co-occurrence of other malignant tumors, except for cured cervical carcinoma in situ...
- Patients with ulcerative esophageal squamous cell carcinoma
- Patients with esophageal fistula or tracheal fistula;
- Those who are allergic to anlotinib and bemusuban
- Those with a history of immune deficiency, including HIV-positive or suffering from other acquired or congenital immune deficiency diseases, or those...
- Patients with any severe and/or uncontrolled diseases
See the full eligibility criteria
- Aged 18-70, both male and female
- After gastroscopy/ultrasonic gastroscopy biopsy, the pathology suggests squamous cell carcinoma of the esophagus, and the clinical diagnosis is cT2N1-2M0 or cT3N0-2M0, with TNM staging of II-III B
- Patients with non-cervical esophageal cance
- The patient has not previously received systemic or local treatment for esophageal cancer, and according to the RECIST 1.1 criteria, there is at least one measurable lesion for imaging evaluation of neoadjuvant therapy
- ECOG PS: 0-1
- Expected survival duration ≥ 12 months
- The people had no functional disorders of major organs, and the researchers assessed that thyroid, lung, liver, kidney, and heart functions were basically normal;
- Women of childbearing age must have already taken reliable contraceptive measures or undergone a pregnancy test (serum or urine) within 7 days prior to enrollment, with a negative result, and be willing to use...
- The people voluntarily joined this study, signed the informed consent form, exhibited good compliance, actively cooperated with the planned schedule by returning to the hospital for regular clinical follow-ups and...
- Within the past 5 years, there has been or is currently a co-occurrence of other malignant tumors, except for cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive...
- Patients with ulcerative esophageal squamous cell carcinoma
- Patients with esophageal fistula or tracheal fistula;
- Those who are allergic to anlotinib and bemusuban
- Those with a history of immune deficiency, including HIV-positive or suffering from other acquired or congenital immune deficiency diseases, or those who have undergone organ transplantation
- Patients with any severe and/or uncontrolled diseases
- Unresolved toxic reactions above CTC AE Grade 1 caused by any previous treatment, excluding alopecia;
- Individuals with multiple factors affecting oral medication administration, such as inability to swallow, chronic diarrhea, and intestinal obstruction
- Urine routine test indicates proteinuria ≥++ and confirmed 24-hour urine protein quantitation \> 1.0 g
- people who underwent major surgical procedures, incisional biopsies, or significant traumatic injuries within 28 days prior to grouping
- Abnormal coagulation function: INR \> 1.5 or prothrombin time (PT) \> ULN + 4 seconds or APTT \> 1.5ULN), with a tendency to bleed or undergoing thrombolytic or anticoagulant therapy; patients who have experienced any...
- Those who have experienced arterial or venous thromboembolic events within 6 months, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, and pulmonary embolism
- Pregnant or lactating women
- Patients with distant metastasis
- Patients with significant bone marrow suppression
- Suffering from mental illness or having a history of abuse of psychotropic drugs;
- Patients who have participated in other drug clinical trials within 4 weeks;
- Patients with concomitant diseases that, according to the researcher's judgment, pose serious risks to patient safety or affect patients' ability to complete the study
- Individuals with hereditary bleeding tendency, coagulation dysfunction, potential invasion of large blood vessels, and other bleeding risks, who have experienced clinically significant bleeding symptoms or have a clear...
- Researchers consider those who are not suitable for inclusion
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, 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.