KC1036 plus a PD-1 antibody and platinum chemotherapy for first-line 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 is a multicenter Phase II study combining oral KC1036 with the PD-1 antibody toripalimab and standard platinum-based chemotherapy (paclitaxel and cisplatin) for first-line treatment of advanced esophageal squamous cell carcinoma. The trial includes a Phase IIa dose-escalation and expansion component testing KC1036 at 20, 30, or 40 mg once daily to characterize safety, followed by a randomized Phase IIb evaluation with 2–3 cohorts (up to ~50 subjects per arm) to help identify a recommended dose for further study. Treatments are given every three weeks with KC1036 taken daily and continued until confirmed disease progression by RECIST v1.1, unacceptable toxicity, death, or start of another anti-tumor therapy. Safety, tumor response, and tolerability are the main outcomes guiding dose selection and further development.

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;
* Patients who have not received prior systemic anti-tumor therapy for the current recurrent or metastatic disease;
* 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 kg/m2;
* Adequate bone marrow, renal, and hepatic function;
* Female patients of childbearing potential with a negative blood pregnancy test completed within 7 days before the first dose;
* Patients should participate in the study voluntarily and sign informed consent.

Exclusion Criteria:

* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastasis;
* Other malignancies within the past 5 years;
* Known hypersensitivity to any monoclonal antibodies or chemotherapy components;
* Gastrointestinal abnormalities;
* High risk of bleeding or fistula due to tumor invasion of adjacent organs, or existing esophageal/tracheal fistula;
* Cardiovascular and cerebrovascular diseases;
* Prior therapy with anti-angiogenic drugs or immunotherapy; Systemic therapy, investigational drugs, or live vaccines within 4 weeks prior to the first dose; Palliative radiotherapy within 2 weeks or major surgery within 28 days prior to enrollment;
* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage;
* Presence of unresolved toxicities from prior anti-tumor therapy, defined as having not resolved to NCI CTCAE 5.0 Grade 0 or 1;
* Active autoimmune disease or a history of autoimmune disease requiring systemic treatment;
* Active infections, including severe infection (CTCAE \> Grade 2) within 4 weeks, active tuberculosis, or positive status for HIV, HBV, or HCV;
* 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 conditions assessed by the investigator that would increase safety risks or interfere with the study results.

Where it's running

• Cancer Hospital, Chinese Academy of Medical Sciences
  Beijing, China Recruiting

Study contacts

• Study coordinator: Jing Huang, Ph.D
• Email: huangjingwg@163.com
• Phone: +86-010-87788293

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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.