Actively Recruiting
AK112 Combined With Chemotherapy as the First-line Treatment in Advanced Esophageal Squamous Cell Carcinoma Patients
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2025-01-22
30
Participants Needed
1
Research Sites
145 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single arm，phase 2 study evaluating the safety and efficacy of Ivonescimab(AK112) combined with chemotherapy in the treatment of advanced esophageal squamous cell carcinoma (ESCC). In this study, patients with advanced esophageal squamous cell carcinoma who had not received any systematic treatment in the past will be enrolled. The research will be conducted in two stages. In the first part, 6 patients were enrolled in the group. After the last subject in the group completed at least 21 days of observation after the first medication, the researchers will conduct a preliminary safety and effectiveness assessment. If the safety and tolerability are good, it will enter the second expansion part till the study enrolled 30 patients. Patients who met the inclusion criteria were treated with AK112 (20mg/kg, intravenous infusion, d1, Q3W) in combination with albumin paclitaxel (220mg/m2, intravenous infusion, d1, Q3W) and cisplatin (75mg/m2, intravenous infusion, d1, Q3W), of which the maximum treatment time of chemotherapy was up to six cycles, and the maximum treatment time of AK112 was 24 months. Patients received regular and periodic reviews, with imaging evaluations every 6 weeks.
CONDITIONS
Official Title
AK112 Combined With Chemotherapy as the First-line Treatment in Advanced Esophageal Squamous Cell Carcinoma Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed the informed consent
- Male or female patients aged 18 to 75 years
- ECOG physical status score of 0 or 1
- Diagnosed with non-resectable or metastatic advanced esophageal squamous cell carcinoma confirmed by pathology
- No previous systemic treatment for ESCC
- Expected survival time of at least 3 months
- At least one measurable metastatic lesion by RECIST version 1.1
- Normal organ function including hematology, kidney, liver, and coagulation parameters
- Women of childbearing age must have a negative pregnancy test within 14 days before enrollment and agree to use contraception during and for 8 weeks after treatment
- Men must agree to use contraception during and for 8 weeks after treatment
- Willingness to comply with study visits, treatment plans, and tests
You will not qualify if you...
- Local advanced esophageal squamous cell carcinoma that can be cured by surgery or radiation
- Other malignant tumors within 5 years except some skin and early-stage cancers
- Active bleeding lesions seen by endoscopy
- Participation in other clinical trials or research treatments within 4 weeks prior
- Prior immunotherapy including immune checkpoint inhibitors or immune cell therapy
- Systemic non-specific immunomodulatory therapy within 2 weeks prior
- Active autoimmune diseases requiring systemic treatment within 2 years
- Ongoing systemic glucocorticoid or immunosuppressive therapy within 7 days prior (physiological doses allowed)
- Significant gastrointestinal issues or active uncontrolled inflammatory gastrointestinal diseases
- History of serious heart conditions or recent vascular events
- Severe infections or active hepatitis B or C requiring treatment
- History of organ or stem cell transplantation
- Unresolved toxicities from previous treatments
- Allergy or severe hypersensitivity to study drugs or monoclonal antibodies
- Live vaccine use within 30 days prior or planned during study
- History of mental illness, drug or alcohol abuse
- Pregnant or breastfeeding women
- Recent major surgery or severe trauma within 30 days prior or planned within 30 days after treatment
- Tumors with high risk of bleeding or invasion into critical vessels or organs
- History of bleeding disorders or requiring long-term anticoagulation
- Other risks deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Actively Recruiting
Research Team
T
Ting Deng, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here