Combining Cadonilimab with Chemoradiotherapy for Esophageal Cancer

Cadonilimab Combined With Induction Chemotherapy and Definitive Radiotherapy for Patients With Locally Advanced Esophageal Squamous Cell Carcinoma: a Phase II, Single-arm Trial (EC-CRT-006)

This study is testing if adding a new drug called cadonilimab to chemotherapy and radiation can help people with advanced esophageal cancer feel better and have fewer chances of the cancer coming back.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 46 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sun Yat-sen University (other)
• Drugs / interventions: cadonilimab, chemotherapy, immunotherapy, radiation
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06143748 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of cadonilimab, a bispecific PD-1/CTLA-4 antibody, in combination with induction chemotherapy and definitive radiotherapy for patients with unresectable locally advanced esophageal squamous cell carcinoma. A total of 46 patients will receive two cycles of chemotherapy followed by standard radiation therapy, with additional maintenance therapy using cadonilimab. The goal is to improve clinical outcomes and reduce the risk of locoregional recurrence after treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with histologically confirmed locally advanced esophageal squamous cell carcinoma who are not suitable for surgery.

Not a fit: Patients with distant metastasis or those who have received prior cancer therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly enhance treatment outcomes for patients with advanced esophageal cancer.

How similar studies have performed: Other studies have shown promising results with similar combinations of immunotherapy and chemoradiotherapy in advanced esophageal cancer, indicating potential for success.

Eligibility criteria

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).

Where this trial is running

Guangzhou, Guangdong

• Sun Yat-sen University — Guangzhou, Guangdong, China (RECRUITING)

Study contacts

• Principal investigator: Mian Xi, MD — Sun Yat-sen University
• Study coordinator: Mian Xi, MD

Conditions: Esophagus Cancer, Esophageal squamous cell carcinoma, Radiotherapy, Cadonilimab, Induction chemotherapy