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Compares treatment options for Esophageal Squamous Cell Carcinoma
Official title A Study of KC1036 Versus Investigator's Choice of Chemotherapy in Patients With Advanced Esophageal Cancer
ClinicalTrials.gov ID: NCT06194734
What this study is testing
What is KC1036?
KC1036 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for esophageal squamous cell carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Males or females aged 18 to 75 years;
- Histologically or cytologically confirmed esophageal or esophageal-gastric junction squamous cell carcinoma;
- Patient with advanced recurrent or metastatic esophageal squamous cell carcinoma previously treated with a PD-1 or PD-L1 inhibitor and at least...
- At least one measurable tumor lesion according to RECIST 1.1;
- Eastern Cooperative Oncology Group performance status score of 0 or 1;
You likely can't join if
- Any patient who is known to have untreated central nervous system (CNS) metastasis;
- Other kinds of malignancies within 5 years;
- Gastrointestinal abnormalities;
- Cardiovascular and cerebrovascular diseases;
- Prior therapies with vascular targeting inhibitor；
- Previously treated with Irinotecan, Docetaxel and Tegafur Gimeracil Oteracil Potassium；
See the full eligibility criteria
- Males or females aged 18 to 75 years;
- Histologically or cytologically confirmed esophageal or esophageal-gastric junction squamous cell carcinoma;
- Patient with advanced recurrent or metastatic esophageal squamous cell carcinoma previously treated with a 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 \> 12 weeks;
- BMI≥16.0 and weight≥40 kg ;
- Adequate bone marrow, renal, and hepatic function;
- Female patients of childbearing potential with a negative blood pregnancy test completed within 7 days before randomization；
- Patients should participate in the study voluntarily and sign informed consent.
- Any patient who is known to have untreated central nervous system (CNS) metastasis;
- Other kinds of malignancies within 5 years;
- Gastrointestinal abnormalities;
- Cardiovascular and cerebrovascular diseases;
- Prior therapies with vascular targeting inhibitor；
- Previously treated with Irinotecan, Docetaxel and Tegafur Gimeracil Oteracil Potassium；
- Involved in other clinical trials within 4 weeks before enrollment；Prior anti-tumor therapies with radiotherapy, immunotherapy, operation within 4 weeks before enrollment;Prior anti-tumor therapies with small molecule...
- Presence of unresolved toxicities from prior anti-tumor therapy, defined as having not resolved to NCI CTCAE 5.0 Grade 0 or 1;
- Uncontrolled massive ascites, pleural or pericardial effusion;
- Severe infection within 4 weeks prior to randomization (CTCAE \> Grade 2);
- Known history of human immunodeficiency virus (HIV) infection or current active hepatitis B or C infection;
- Pregnant or lactating women;
- Female people of child-bearing potential and male people of reproductive capacity who do not agree to use contraceptive measures during the study and for 6 months after the end of the study.
- Other patients are not eligible for enrollment assessed by investigators.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.