Actively Recruiting
A Study of KC1036 Versus Investigator's Choice of Chemotherapy in Patients With Advanced Esophageal Cancer
Led by Beijing Konruns Pharmaceutical Co., Ltd. · Updated on 2024-03-07
490
Participants Needed
1
Research Sites
203 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 versus investigator's choice of chemotherapy in patients with advanced recurrent or metastatic esophageal squamous cell carcinoma
CONDITIONS
Official Title
A Study of KC1036 Versus Investigator's Choice of Chemotherapy in Patients With 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
- Advanced recurrent or metastatic esophageal squamous cell carcinoma previously treated with PD-1 or PD-L1 inhibitor and at least second-line systemic therapy
- 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 16.0 or higher and weight of 40 kg or more
- Adequate bone marrow, kidney, and liver function
- Female patients of childbearing potential with a negative blood pregnancy test within 7 days before randomization
- Voluntary participation with signed informed consent
You will not qualify if you...
- Known untreated central nervous system (CNS) metastasis
- Other cancers within the past 5 years
- Gastrointestinal abnormalities
- Cardiovascular and cerebrovascular diseases
- Prior treatment with vascular targeting inhibitors
- Previous treatment with Irinotecan, Docetaxel, or Tegafur Gimeracil Oteracil Potassium
- Participation in other clinical trials within 4 weeks before enrollment
- Recent anti-tumor therapies including radiotherapy, immunotherapy, surgery within 4 weeks before enrollment
- Recent small molecule targeted therapy within 2 weeks or 5 half-lives before enrollment
- Recent chemotherapy within 3 weeks or 5 half-lives before enrollment
- Unresolved toxicities from prior anti-tumor therapy above grade 1
- Uncontrolled large fluid accumulation such as ascites, pleural or pericardial effusion
- Severe infection within 4 weeks prior to randomization (above grade 2)
- Known HIV infection or active hepatitis B or C
- Pregnant or breastfeeding women
- Female and male subjects not agreeing to contraceptive measures during the study and for 6 months after
- Other conditions making the patient ineligible as assessed by investigators
AI-Screening
AI-Powered Screening
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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
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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