Comparing KC1036 to standard chemotherapy for 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

This study is testing if a new treatment called KC1036 can work better than standard chemotherapy for people with advanced esophageal cancer.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 490 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Beijing Konruns Pharmaceutical Co., Ltd. (industry)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Beijing)
• Trial ID: NCT06194734 on ClinicalTrials.gov

What this trial studies

This phase III trial evaluates the efficacy and safety of KC1036 compared to the investigator's choice of chemotherapy in patients with advanced recurrent or metastatic esophageal squamous cell carcinoma. Participants will be randomized to receive either KC1036 or one of the standard chemotherapy options (Irinotecan, Docetaxel, or S-1) until disease progression or other specified reasons for discontinuation occur. The study aims to determine if KC1036 offers a better treatment outcome than existing chemotherapy options for this patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with advanced recurrent or metastatic esophageal squamous cell carcinoma who have previously received PD-1 or PD-L1 inhibitors and at least second-line systemic therapy.

Not a fit: Patients with untreated central nervous system metastasis or other malignancies within the past 5 years may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a more effective option for patients with advanced esophageal cancer, potentially improving survival rates and quality of life.

How similar studies have performed: Other studies have shown promise with similar approaches, but the specific efficacy of KC1036 is being evaluated for the first time in this context.

Eligibility criteria

Inclusion 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.

Exclusion Criteria:

* 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 targeting drugs within 2weeks or 5 half-lives (whichever is longer) before enrollment; Prior anti-tumor therapies with chemotherapy within 3 weeks or 5 half-lives (whichever is longer) before enrollment;
* 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 subjects of child-bearing potential and male subjects 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.

Where this trial is running

Beijing

• Cancer Hospital, Chinese Academy of Medical Sciences — Beijing, China (RECRUITING)

Study contacts

• Principal investigator: Jing Huang, Ph.D — Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Study coordinator: Jing Huang, Ph.D

Conditions: Esophageal Squamous Cell Carcinoma