New drug combo shows promise against tough esophageal cancer
NCT ID NCT06143748
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new drug called cadonilimab, combined with chemotherapy and radiation, for people with advanced esophageal cancer that cannot be removed by surgery. The goal is to see if this combination can better control the cancer and prevent it from coming back. About 46 participants will receive the treatment and be followed for three years.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 46 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2024
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Histologically confirmed squamous cell carcinoma of the esophagus; 2. Locally advanced, and absence of distant metastasis disease, confirmed by endoscopic ultrasound (EUS) and PET-CT scan, stage II-IVA (according to UICC TNM version 8); 3. Not suitable for surgery (either for medical reasons or patient's choice); 4. Age at diagnosis 18 to 75 years; 5. No prior cancer therapy; 6. Estimated life expectancy \>6 months; 7. Eastern Cooperative Oncology Group performance status ≤ 2 8. No history of concomitant or previous malignancy; 9. The function of important organs meets the following requirements: a. white blood cell count (WBC) ≥4.0×109/L, absolute neutrophil count (ANC) ≥1.5×109/L; b. platelets ≥100×109/L; c. hemoglobin ≥9g/dL; d. serum albumin ≥2.8g/dL; e. total bilirubin ≤1.5×ULN, ALT, AST and/or AKP ≤2.5×ULN; f. serum creatinine ≤1.5×ULN or creatinine clearance rate \>60 mL/min; 10. Ability to understand the study and sign informed consent. Exclusion Criteria: 1. Patients who have been treated previously with anti-tumor therapy (including chemotherapy, radiotherapy, surgery, immunotherapy, etc.); 2. Patients with distant metastasis disease or esophageal fistula at diagnosis; 3. Known or suspected allergy or hypersensitivity to monoclonal antibodies, any ingredients of cadonilimab, and the chemotherapeutic drugs paclitaxel or cisplatin; 4. Patients who have a preexisting or coexisting bleeding disorder; 5. Female patients who are pregnant or lactating; 6. Inability to provide informed consent due to psychological, familial, social and other factors; 7. Presence of CTC grade ≥2 peripheral neuropathy; 8. A history of malignancies other than esophageal cancer before enrollment, excluding non-melanoma skin cancer, in situ cervical cancer, or cured early prostate cancer 9. A history of diabetes for more than 10 years and poorly controlled blood glucose levels; 10. Patients who cannot tolerate chemoradiotherapy due to severe cardiac, lung, liver or kidney dysfunction, or hematopoietic disease or cachexia. 11. Active autoimmune diseases, a history of autoimmune diseases (including but not limited to these diseases or syndromes, such as colitis, hepatitis, hyperthyroidism), a history of immunodeficiency (including a positive HIV test result), or other acquired or congenital immunodeficiency diseases, a history of organ transplantation or allogeneic bone marrow transplantation; 12. A history of interstitial lung disease or non-infectious pneumonia; 13. A history of active pulmonary tuberculosis infection within 1 year or a history of active pulmonary tuberculosis infection more than 1 year ago but without formal anti-tuberculosis treatment; 14. Presence of active hepatitis B (HBV DNA ≥ 2000 IU/mL or 104 copies/mL), hepatitis C (positive for hepatitis C antibody, and HCV-RNA levels higher than the lower limit of the assay).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Sun Yat-sen University
Guangzhou, Guangdong, 510060, China
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Other studies related to the condition(s) this trial covers.
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