Status:
RECRUITING
Consolidation of Toripalimab After Chemoradiotherapy in Elderly Esophageal Cancer (EC-CRT-007)
Lead Sponsor:
Sun Yat-sen University
Collaborating Sponsors:
Nanfang Hospital, Southern Medical University
Zhujiang Hospital
Conditions:
Locally Advanced Esophageal Squamous Cell Carcinoma
Eligibility:
All Genders
70-85 years
Phase:
PHASE2
Brief Summary
Although definitive chemoradiotherapy (CRT) is the standard treatment option for unresectable locally advanced esophageal cancer, elderly patients tolerate intravenous concurrent CRT less well with ag...
Detailed Description
A total of 140 patients with elderly, unresectable, locally advanced ESCC will be stratified according to age (70-80 vs. ≥80) and TNM stage (I/II vs. III/IV) and randomly assigned (1:1) to receive tor...
Eligibility Criteria
Inclusion
- Histologically confirmed squamous cell carcinoma of the esophagus;
- Locally advanced, and absence of hematogenous metastasis disease according to UICC TNM version 8;
- Not suitable for surgery (either for medical reasons or patient's choice);
- Age at diagnosis 70 to 85 years;
- No prior cancer therapy;
- Estimated life expectancy \>6 months;
- Eastern Cooperative Oncology Group performance status ≤ 2
- No history of concomitant or previous malignancy;
- 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;
- Ability to understand the study and sign informed consent.
Exclusion
- Patients who have been treated previously with anti-tumor therapy (including chemotherapy, radiotherapy, surgery, immunotherapy, etc.);
- Patients with hematogenous metastasis disease or esophageal fistula at diagnosis;
- Known or suspected allergy or hypersensitivity to monoclonal antibodies, any ingredients of cadonilimab, and the chemotherapeutic drugs paclitaxel or cisplatin;
- Patients who have a preexisting or coexisting bleeding disorder;
- Inability to provide informed consent due to psychological, familial, social and other factors;
- Presence of CTC grade ≥2 peripheral neuropathy;
- A history of malignancies other than esophageal cancer before enrollment, excluding non-melanoma skin cancer, in situ cervical cancer, or cured early prostate cancer
- A history of diabetes for more than 10 years and poorly controlled blood glucose levels;
- Patients who cannot tolerate chemoradiotherapy due to severe cardiac, lung, liver or kidney dysfunction, or hematopoietic disease or cachexia.
- 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;
- A history of interstitial lung disease or non-infectious pneumonia;
- 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;
- 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).
Key Trial Info
Start Date :
March 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT06187597
Start Date
March 1 2024
End Date
December 31 2028
Last Update
March 12 2024
Active Locations (1)
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1
Mian Xi
Guangzhou, Guangdong, China, 510060