Active — Not RecruitingPhase 2

Cardenilimab Combined With Chemotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma

China43 participantsStarted 2023-10-23

Plain-language summary

The goal of this trial is to test the efficacy and safety of cardenilimab combined with chemotherapy in the conversion therapy of locally advanced unresectable esophageal squamous cell carcinoma. type of study: clinical trial

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Absolute neutrophil count (ANC) ≥1.5x109/L without using granulocyte colony-stimulating factor in the past 14 days;
. Without blood transfusion in the past 14 days, platelets ≥100×109/L;
. Hemoglobin \>9g/dL without blood transfusion or erythropoietin use in the past 14 days;
. Total bilirubin ≤1.5×upper limit of normal (ULN);
. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) are within ≤2.5×ULN
. Serum creatinine ≤1.5×ULN and creatinine clearance (calculated using the Cockcroft-Gault formula) ≥60 ml/min;
. Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN;
. Euthyroid, defined as thyroid stimulating hormone (TSH) within the normal range. If baseline TSH is outside the normal range, subjects can also be enrolled if total T3 (or FT3) and FT4 are within the normal range;

Exclusion criteria

. Other malignant diseases diagnosed within 5 years before the first dose (excluding radical basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and/or carcinoma in situ that has been radically resected);

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Objective Response Rate

Timeframe: 2-5 years

Trial details

NCT IDNCT06165380

SponsorLi Zhang

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-08-31

View on ClinicalTrials.gov More Esophageal Squamous Cell Carcinoma trials