RecruitingPhase 3NCT06194734

A Study of KC1036 Versus Investigator's Choice of Chemotherapy in Patients With Advanced Esophageal Cancer

A Randomized, Controlled, Open-label, Multicenter Phase III Study to Evaluate the Efficacy and Safety of KC1036 Versus Investigator's Choice of Chemotherapy as Third-line Therapy in Patients With Advanced Esophageal Squamous Cell Carcinoma


Sponsor

Beijing Konruns Pharmaceutical Co., Ltd.

Enrollment

490 participants

Start Date

Feb 5, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing KC1036 (an experimental treatment) against standard chemotherapy chosen by the doctor for people with advanced esophageal cancer that has already been treated with immunotherapy and at least one other line of chemotherapy. **You may be eligible if...** - You are between 18 and 75 years old - You have advanced esophageal or esophagogastric junction squamous cell carcinoma, confirmed by biopsy - Your cancer previously received a PD-1 or PD-L1 inhibitor and at least one other line of chemotherapy - You have at least one measurable tumor - Your general health (ECOG 0–1), weight (≥40 kg), and organ function meet study requirements **You may NOT be eligible if...** - You have untreated brain metastases - You have another cancer diagnosis in the last 5 years - You previously received irinotecan, docetaxel, or tegafur gimeracil oteracil (S-1) - You have significant cardiovascular disease - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGKC1036

KC1036 60mg QD orally, before a meal, continuous administration, 21 days as a cycle

DRUGIrinotecan

Irinotecan intravenously administered at 130-150 mg/m2 once every 2 weeks

DRUGDocetaxel

Docetaxel intravenously administered at 60-75 mg/m2 once every 3 weeks;

DRUGS-1

S-1 orally administered 40-60mg Bid on Day 1 to Day 14 of every 3 weeks, 21 days as a cycle


Locations(1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06194734


Related Trials