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Clinical trial Recruiting at 1 site Phase 3 Interventional Ages 18 to 75

Comparing KC1036 to standard chemotherapy for advanced esophageal cancer

Official title: 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

Run by Beijing Konruns Pharmaceutical Co., Ltd. · NCT06194734 · Data updated 2026-11-12

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

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years to 75 Years
SexAll
Enrollment490 (estimated)
SponsorBeijing Konruns Pharmaceutical Co., Ltd.
Industry-sponsored
Drugs / interventionschemotherapy, immunotherapy
Locations1 site (Beijing)
StatusRecruiting
StartedFebruary 5, 2024
Main results expectedDecember 30, 2026
Study endsDecember 30, 2027
Registry record updatedMarch 7, 2024
Trial IDNCT06194734 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably not a fit

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

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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

Who can join: the full rules

Show full inclusion / exclusion 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 it's running

  • 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
  • Email: huangjingwg@163.com
  • Phone: 010-87788293

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Esophageal Squamous Cell Carcinoma 83Beijing Konruns Pharmaceutical Co., Ltd. 3
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.