Actively Recruiting
A Prospective, Multicenter, Phase Ib/II Trial of Ivonescimab (AK112) Combined With Albumin-Paclitaxel and Cisplatin as Neoadjuvant Therapy for ESCC
Led by Tang-Du Hospital · Updated on 2026-02-03
45
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Prospective, Multicenter, Phase Ib/II Trial of Ivonescimab (AK112) Combined with Albumin-Paclitaxel and Cisplatin as Neoadjuvant Therapy for Resectable, Locally Advanced Esophageal Squamous Cell Carcinoma
CONDITIONS
Official Title
A Prospective, Multicenter, Phase Ib/II Trial of Ivonescimab (AK112) Combined With Albumin-Paclitaxel and Cisplatin as Neoadjuvant Therapy for ESCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent must be obtained before any study procedures.
- Age between 18 and 75 years inclusive, male or female.
- Histologically confirmed resectable, locally advanced esophageal squamous cell carcinoma with specific tumor and lymph node stages.
- No suspicious lymph nodes in the neck region except upper thoracic esophageal area; no evidence of systemic metastasis.
- Expected to achieve R0 surgical resection.
- At least one measurable tumor lesion present.
- ECOG performance status of 0 or 1.
- Expected survival of at least 3 months.
- Normal thyroid function or specific normal thyroid hormone levels if TSH is abnormal.
- Adequate organ function based on hematology, liver, renal, coagulation, and cardiac criteria.
- Negative serum pregnancy test for eligible females; willing to use reliable contraception during the study and 90 days after.
- Willing and able to comply with study schedule and requirements.
You will not qualify if you...
- History of other malignancies within 5 years except certain localized or curable conditions.
- Prior treatment with PD-1/PD-L1 inhibitors, T-cell receptor targeting drugs, or anti-angiogenic agents.
- Received systemic non-specific immune-modulating therapy or anti-tumor traditional Chinese medicine within 2 weeks before study drug.
- Active autoimmune disease requiring systemic treatment (excluding hormone replacement therapies).
- Brainstem, meningeal, or spinal metastasis or compression.
- Significant pleural, pericardial, or peritoneal effusions requiring treatment.
- History of significant gastrointestinal obstruction, perforation, abscess, or fistula within 6 months.
- Active inflammatory gastrointestinal diseases.
- Tumor involving major vessels or with severe necrosis/hemorrhage posing bleeding risk.
- Interstitial lung disease grade 2 or higher.
- Severe cardiovascular diseases including uncontrolled hypertension, recent heart events, chronic heart failure class 2 or above, or severe arrhythmias.
- Cerebrovascular accident or transient ischemic attack within 4 weeks.
- Severe infection within 4 weeks or recent systemic antimicrobial therapy for active infection.
- Active tuberculosis or syphilis.
- Positive HIV antibody or active hepatitis B or C infection.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tangdu Hospitial
Xi'an, Shannxi, China
Actively Recruiting
Research Team
X
Xiaolong Yan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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