NCT06194734

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 490 (estimated)
• Sponsor: Beijing Konruns Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Detailed description

This is a randomized, controlled, open-label, multicenter phase III trial. Patients with advanced recurrent or metastatic esophageal squamous cell carcinoma that has received PD-1 or PD-L1 inhibitors and at least second-line systemic therapy will be randomized at a 1: 1 ratio to receive KC1036 or the investigator's choice of chemotherapy (Irinotecan/Docetaxel/S-1) until confirmed disease progression assessed by the RECIST V1.1 standard, death, intolerable toxicity, initiation of a new anti-tumor therapy, other reasons leading to treatment discontinuation as specified by protocol.

Conditions

• Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	KC1036	KC1036 60mg QD orally, before a meal, continuous administration, 21 days as a cycle
DRUG	Irinotecan	Irinotecan intravenously administered at 130-150 mg/m2 once every 2 weeks
DRUG	Docetaxel	Docetaxel intravenously administered at 60-75 mg/m2 once every 3 weeks；
DRUG	S-1	S-1 orally administered 40-60mg Bid on Day 1 to Day 14 of every 3 weeks, 21 days as a cycle

Timeline

• Start date: 2024-02-05
• Primary completion: 2026-12-30
• Completion: 2027-12-30
• First posted: 2024-01-08
• Last updated: 2024-03-07

Locations

1 site across 1 country: China