Actively Recruiting
KC1036 in Combination With PD-1 Antibody and Platinum-based Chemotherapy for First-line Advanced Esophageal Cancer
Led by Beijing Konruns Pharmaceutical Co., Ltd. · Updated on 2026-03-20
60
Participants Needed
1
Research Sites
155 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the efficacy and safety of KC1036 in combination with PD-1 antibody and platinum-based chemotherapy as a first-line treatment for patients with unresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC).
CONDITIONS
Official Title
KC1036 in Combination With PD-1 Antibody and Platinum-based Chemotherapy for First-line Advanced Esophageal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females aged 18 to 75 years
- Histologically or cytologically confirmed esophageal or esophageal-gastric junction squamous cell carcinoma
- No prior systemic anti-tumor therapy for current recurrent or metastatic disease
- At least one measurable tumor lesion according to RECIST 1.1
- Eastern Cooperative Oncology Group performance status score of 0 or 1
- Life expectancy greater than 12 weeks
- Body Mass Index (BMI) of at least 16.0 kg/m2
- Adequate bone marrow, kidney, and liver function
- Female patients of childbearing potential must have a negative pregnancy test within 7 days before the first dose
- Voluntary participation with signed informed consent
You will not qualify if you...
- Symptomatic, untreated, or actively progressing central nervous system (CNS) metastasis
- Other malignancies within the past 5 years
- Known allergies to monoclonal antibodies or chemotherapy components
- Gastrointestinal abnormalities
- High risk of bleeding or fistula due to tumor invasion or existing esophageal/tracheal fistula
- Cardiovascular or cerebrovascular diseases
- Prior treatment with anti-angiogenic drugs or immunotherapy
- Systemic therapy, investigational drugs, or live vaccines within 4 weeks before first dose
- Palliative radiotherapy within 2 weeks or major surgery within 28 days before enrollment
- Uncontrolled pleural effusion, pericardial effusion, or ascites needing repeated drainage
- Unresolved toxicities from prior anti-tumor therapy above Grade 1
- Active autoimmune disease or history requiring systemic treatment
- Active infections including severe infections in past 4 weeks, active tuberculosis, or positive HIV, HBV, or HCV status
- Pregnant or lactating women
- Lack of agreement to use contraception during study and for 6 months after
- Other conditions that increase safety risks or interfere with study results as assessed by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, China, 100021
Actively Recruiting
Research Team
J
Jing Huang, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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