Actively Recruiting
Phase Ib/II Trial of Ivonescimab (AK112) Combined With Albumin-Paclitaxel and Cisplatin as Neoadjuvant Therapy for Resectable, Locally Advanced Esophageal Squamous Cell Carcinoma
Led by Tang-Du Hospital · Updated on 2026-02-03
45
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of Ivonescimab (AK112) with albumin-paclitaxel and cisplatin as a neoadjuvant therapy for patients with resectable, locally advanced esophageal squamous cell carcinoma. This prospective, multicenter Phase Ib/II trial aims to study the treatment's safety, dosage, and effectiveness in preparing patients for surgery by reducing tumor size before the operation. Participants receive AK112 intravenously every three weeks, with dosing starting at 10 mg/kg in the first cohort and increasing to 20 mg/kg in the second. Another group receives AK112 combined with albumin-paclitaxel and carboplatin chemotherapy administered intravenously in cycles of three every three weeks. The study includes a dose escalation phase followed by a treatment phase to assess the best dose and combination. Throughout the study, participants will undergo various assessments including monitoring for dose-limiting toxicities, adverse events, and major pathologic response for up to two years. Other evaluations include tumor response, event-free survival, and overall survival. Safety monitoring continues for 90 days after the last dose, with participants expected to comply with scheduled visits, treatments, laboratory tests, and study procedures over the study duration.
CONDITIONS
Brief 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
- Participants aged between 18 and 75 years, male or female
- Histologically confirmed resectable, locally advanced esophageal squamous cell carcinoma with specified tumor and lymph node stages
- No suspicious lymph nodes in the neck region except upper thoracic esophageal area; no systemic metastasis on imaging
- Expected to achieve R0 resection
- At least one measurable tumor lesion present
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Expected survival of at least 3 months
- Normal thyroid function or acceptable thyroid hormone levels
- Adequate hematology, liver, renal, coagulation, and cardiac function as defined by specific laboratory values
- Negative pregnancy test for women of reproductive age and use of reliable contraception for participants of reproductive capacity
- 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 in situ cancers
- Prior treatment with PD-1/PD-L1 inhibitors, T-cell receptor-targeting drugs, or anti-angiogenic agents
- Systemic non-specific immune-modulating therapy or certain herbal treatments within 2 weeks before study drug
- Active autoimmune disease requiring systemic treatment
- Brainstem, meningeal, or spinal metastasis or compression
- Significant pleural, pericardial, or peritoneal effusions requiring treatment
- Recent significant gastrointestinal obstruction or complications within 6 months
- Active inflammatory gastrointestinal diseases
- Tumor encircling major vessels or severe necrosis/hemorrhage posing bleeding risk
- Interstitial lung disease grade 2 or higher
- Severe cardiovascular disease including uncontrolled hypertension, recent heart events, or low heart function
- Severe arrhythmias or recent cerebrovascular events
- Severe infection or recent systemic antimicrobial therapy
- 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 9 weeks
Participants receive intravenous AK112 every 3 weeks combined with Albumin-paclitaxel and carboplatin chemotherapy for a total of 3 cycles as neoadjuvant therapy before surgery.
3 treatment cycles with infusions on days 1 and 8 for Albumin-paclitaxel, and day 1 for carboplatin and AK112, every 3 weeks
Trial Site Locations
Total: 1 location
1
Tangdu Hospitial
Xi'an, Shannxi, China
Actively Recruiting
Research Team
X
Xiaolong Yan
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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