Esophagus cancer
Conditions
Interventions
Trial group:Cadonilimab combined with radiotherapy: 1. Radiotherapy: Involved field (IFI) IMRT metastatic lymph nodes 50-60Gy/25-30f or oligometastatic GTV-M 4-8Gy/ F, 3-5 F
2. Immunotherapy: Cadonilimab 6mg/kg, Q2W*2-4cycles combined with radiotherapy, followed by consolidation and maintenance treatment for 17 cycles (6mg/kg, Q2W), up to a maximum of 1 year. In the first
Sponsors
Sichuan Cancer Hospital & Institute
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntary participation in this clinical study, understanding of the study procedures, and ability to provide written informed consent; 2. Age 18-75 years (inclusive) at the time of signing informed consent, both males and females eligible. 3. ECOG performance status 0 or 1. 4. Histologically or cytologically confirmed advanced unresectable or metastatic ESCC. 5. Radiographic progression (per RECIST v1.1) during or after prior anti-PD-(L)1 therapy, with lesions deemed suitable for radiotherapy by a radiation oncologist. 6. Ability to provide tumor tissue specimens, either archived within 6 months prior to first dose of study drug or freshly obtained. Specific requirements detailed in the laboratory manual. Pulmonary function within 3 months must meet FEV1>1.0L, FEV1%>40%. 7. Per RECIST v1.1 criteria, subjects must have measurable target lesions assessable by CT or MRI. Tumor imaging assessment must be performed within 28 days prior to first dose. 8. Adequate hematologic and major organ function as defined by the following laboratory results, which must be completed within 14 days prior to first study treatment: (1) Complete blood count (no hematopoietic growth factors or blood transfusions within 14 days prior to first study treatment): absolute neutrophil count (ANC) >=1.5×10^9/L, absolute lymphocyte count (LC) >=0.5×10^9/L; platelet count (PLT) >=100×10^9/L, hemoglobin (Hb) >=90g/L. (2) Liver function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =3 g/dL; (3) Renal function: creatinine clearance rate (CrCl) >=45mL/minute (calculated by Cockcroft-Gault formula); (4) Coagulation function: international normalized ratio (INR) =50% 9. Non-surgically sterile subjects of childbearing potential (male or female) must agree to abstain from heterosexual intercourse or use at least one medically accepted contraceptive method (e.g., bilateral tubal ligation, male sterilization, ovulation-suppressing hormonal contraceptives, hormone-releasing or copper intrauterine devices) during the study treatment period and for 180 days after the end of study treatment; non-surgically sterile female subjects of childbearing potential must have a negative serum HCG test within 14 days prior to first dose.
Exclusion criteria
Exclusion criteria: 1. Positive COVID-19 antigen or PCR test reported by a certified laboratory during screening. 2. Imaging shows tumor adjacent to critical vascular structures, or investigator confirms that the patient's tumor may invade critical vessels and may cause fatal bleeding (i.e., imaging evidence indicates tumor invasion or adjacency to major blood vessels). 3. Investigator assesses that the patient's tumor invades adjacent organs of the esophageal lesion (e.g., aorta or respiratory tract) and the risk of fistula is increased during study treatment; gastrointestinal perforation and/or fistula or aorto-esophageal fistula occurred within 6 months prior to randomization. 4. Active leptomeningeal disease or poorly controlled, untreated brain metastases: Note: Patients with a history of central nervous system (CNS) metastasis treatment who are stable at screening may be enrolled only if all of the following criteria are met: (1) No evidence of immediate progression on brain imaging at screening and no evidence of new brain metastases. (2) Clinically stable for at least 2 weeks. (3) Measurable and/or evaluable disease outside the CNS. (4) Not currently requiring corticosteroid therapy for CNS disease; corticosteroids discontinued >=3 days prior to randomization; stable doses of anticonvulsants are permitted. (5) No stereotactic radiosurgery or whole-brain radiotherapy within 14 days prior to randomization. 5. Active autoimmune disease or history of autoimmune disease (Appendix 6) with potential for recurrence. Note: Patients with the following conditions are not excluded and may proceed with further screening: (1) Well-controlled type I diabetes mellitus. (2) Hypothyroidism (provided it is controlled with hormone replacement therapy alone). (3) Celiac disease controlled by diet alone. (4) Skin conditions not requiring systemic treatment (e.g., vitiligo, psoriasis, alopecia). (5) Any other condition not expected to recur in the absence of external triggers. 6. Any malignancy within 10 mg/d prednisone or equivalent) or other immunosuppressive therapy within Grade 1, or >=Grade 3 hypoalbuminemia despite standard medical therapy, within <=14 days prior to randomization. 9. Poorly controlled pleural effusion, pericardial effusion, or ascites requiring frequent drainage (recurrence within <=14 days after intervention). 10. History of interstitial lung disease, non-infectious pneumonitis, or poorly controlled pulmonary disease (including pulmonary fibrosis or acute pu
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Downstaging Rate (T and/or N downstaging);Major Pathological Response (MPR);Disease-Free Survival (DFS);Overall Survival (OS);Disease Control Rate (DCR) (RECIST v1.1 and/or PERCIST v1.0); | — |
Countries
China
Contacts
Public ContactLi Tao
Sichuan Cancer Hospital & Institute
Outcome results
None listed