Actively Recruiting
Ivonescimab Combined With Chemotherapy as First-line Treatment for Advanced Esophageal Squamous Cell Carcinoma A Phase 2 Single-Arm Study
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
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 received prior systemic treatment. This phase 2, single-arm study aims to determine how well this combination works and how safe it is for these patients. The study is conducted in two parts: an initial safety evaluation followed by an expansion phase to further assess treatment outcomes. In the first part, 6 patients receive AK112 (20 mg/kg intravenous infusion every 3 weeks) combined with albumin paclitaxel (220 mg/m2 intravenous infusion every 3 weeks) and cisplatin (75 mg/m2 intravenous infusion every 3 weeks). After at least 21 days of observation, a safety and efficacy review is done. If results are favorable, the study proceeds to enroll up to 30 patients in the expansion phase with the same treatment regimen. Chemotherapy is given for a maximum of six cycles, while AK112 treatment can continue for up to 24 months. Participants undergo regular visits during the study with imaging evaluations every 6 weeks to monitor tumor response. Researchers measure the objective response rate at 6 months to evaluate treatment effectiveness. Safety is carefully monitored throughout the study. The total duration of participation depends on treatment length and follow-up assessments. This study offers detailed observation of treatment effects and tolerability in patients with advanced ESCC.
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
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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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