Actively Recruiting
Ivonescimab (AK112) Combined With Chemotherapy as First-line Treatment for 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
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of Ivonescimab (AK112) combined with chemotherapy as a first-line treatment for patients with advanced esophageal squamous cell carcinoma (ESCC) who have not previously received systemic treatment. This phase 2, single-arm study aims to observe treatment responses and tolerability in this patient group, with the study conducted in two stages to monitor initial safety and expand enrollment based on results. In the initial safety phase, 6 patients receive AK112 (20 mg/kg) intravenously every three weeks along with albumin paclitaxel (220 mg/m2) and cisplatin (75 mg/m2) on the same schedule. Chemotherapy is limited to six cycles, while AK112 treatment may continue for up to 24 months. After safety evaluation, up to 30 additional patients will be enrolled in an expansion phase to further assess efficacy and safety, with potential dose adjustments based on early findings. Participants will undergo regular assessments including imaging every 6 weeks to evaluate tumor response. The primary measure is the objective response rate at 6 months, while secondary outcomes include overall survival at 24 months, progression-free survival at 12 months, disease control rate, and duration of response at 6 months. Safety observations and laboratory tests are conducted throughout treatment, with adherence to scheduled visits and study procedures required. The total duration of participation varies depending on treatment continuation and follow-up.
CONDITIONS
Brief 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 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 ESCC confirmed by pathology
- No previous systemic treatment for ESCC
- Expected survival time of at least 3 months
- At least one measurable metastatic lesion per RECIST 1.1 criteria
- Normal organ function including adequate blood counts, kidney, liver, and coagulation parameters
- Women of childbearing age must have a negative pregnancy test and agree to contraception; men must agree to contraception
- Willingness to comply with study visits, treatments, and tests
You will not qualify if you...
- Local advanced ESCC potentially curable by surgery or radiation
- Other malignant tumors within 5 years except certain cured cancers
- Active bleeding lesions seen on endoscopy
- Participation in other clinical trials or use of investigational drugs within 4 weeks
- Previous immunotherapy or immune cell treatments
- Recent systemic immunomodulatory or immunosuppressive therapy
- Active autoimmune diseases requiring systemic treatment within 2 years
- Current systemic glucocorticoid or immunosuppressive therapy (excluding low-dose glucocorticoids)
- Significant gastrointestinal complications or inflammatory diseases
- Recent serious heart conditions or vascular disease
- Recent thromboembolism or uncontrolled hypertension
- Recent severe infections or active hepatitis B or C infection
- History of organ or stem cell transplantation
- Unresolved toxicity from prior cancer treatments
- Allergies to study drug components or monoclonal antibodies
- Recent live vaccination
- History of mental illness or substance abuse
- Pregnant or breastfeeding women
- Recent major surgery or trauma
- Tumor conditions posing bleeding risks or invasion of critical structures
- History of severe bleeding or coagulation disorders
- Other risks deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 24 months
Participants receive Ivonescimab combined with albumin paclitaxel and cisplatin. The chemotherapy is administered in up to six 3-week cycles, while Ivonescimab treatment can continue for up to 24 months.
Infusions every 3 weeks on Day 1 of each cycle
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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