Comparing KC1036 to standard chemotherapy for advanced esophageal cancer

Is this trial a fit for you?

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

Who can join: the full rules

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.

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• Sacituzumab Govitecan plus Tislelizumab for advanced esophageal cancer

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• Neoadjuvant therapy with adebrelimab, famitinib, and chemotherapy for resectable ESCC

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  Recruiting Phase 2 First Affiliated Hospital Xi'an Jiaotong University · Xi'an, Shannxi · NCT07796113

• SKB500 combinations for esophageal squamous cell carcinoma

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• Neoadjuvant Cardonilizumab With Chemotherapy Before Surgery for Locally Advanced Esophageal Squamous Cell Carcinoma

  This study tests whether adding cardonilizumab to preoperative chemotherapy (versus chemoradiotherapy) helps patients with locally advanced ESCC have a better chance at complete tumor removal and longer survival.

  Recruiting Phase 2 Tongji Hospital · Wuhan, Hubei · NCT07699185

• Surgery or chemoradiotherapy after neoadjuvant immunochemotherapy for esophageal squamous cell carcinoma

  In people with locally advanced ESCC who respond to neoadjuvant immunochemotherapy, this study tests whether organ preservation with treatment other than surgery can be as effective as radical esophagectomy.

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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.