Subjects with advanced esophageal squamous cell carcinoma who have progressed previously through immune checkpoint inhibitors (PD-1/PD-L1 inhibitors) combined with platinum-based chemotherapy
Conditions
Interventions
Treatment group:Eligible patients received the eto combination antibody (5 mg/kg) every 3 weeks (Q3W), continuing treatment until disease progression, intolerable toxicity, or loss of clinical benefit
Sponsors
Sichuan Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Sign the informed consent form and voluntarily join this study; 2. Confirmed by histology or cytology as ESCC, locally advanced and unresectable, accompanied by local recurrence (local lymph node metastasis) or distant metastasis; 3. Age >=18 years old and = 3 months (concurrent chemoradiotherapy for postoperative recurrence or metastasis is considered as first-line treatment). For radical concurrent chemoradiotherapy, neoadjuvant/adjuvant therapy (chemotherapy or chemoradiotherapy), if disease progression occurs during the treatment period or within 6 months after treatment cessation, it should be regarded as a failure of first-line treatment. 5.ECOG score: 0-2 points; 6. According to RECIST 1.1, there is at least one measurable lesion; 7. The expected survival period is >=3 months; 8. The functions of important organs meet the following requirements (no blood components or cell growth factors are allowed to be used two weeks before the start of the study treatment) : The blood routine examination must comply with: The absolute neutrophil count (ANC) was >=1.5×10^9/L,Hemoglobin (HB) >=9g/dL,Platelet count (PLT) >=80×10^9/L,Serum albumin (ALB) >=2.8g/dL. Biochemical tests must comply with: Total bilirubin (TBIL) =50ml/min (Cockcroft-Gault formula). 9. The researchers determined that the patient could receive treatment with Iparomlimab and Tuvonralimab.
Exclusion criteria
Exclusion criteria: 1.Pregnant or gestational women; 2. Those who have been confirmed to be allergic to Iparomlimab and Tuvonralimab and/or its excipients; 3. Has experienced severe allergic reactions to other monoclonal antibodies; 4. Have received treatment with CTLA-4 inhibitors previously; 5. Suffering from any active autoimmune disease or having a history of autoimmune diseases, such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (can be included after hormone replacement therapy returns to normal); 6. Suffering from hypertension and unable to achieve good control after antihypertensive drug treatment; 7. Suffering from congenital or acquired immune dysfunction (such as HIV-infected individuals), active hepatitis B (HBV-DNA>=10^4 copies /mL or 2000 IU/mL), or hepatitis C (positive hepatitis C antibody and HCV-RNA higher than the detection limit of the analytical method); 8. Subjects who were required to receive systemic treatment with corticosteroids (> 10mg/ day, prednisone therapeutic dose) or other immunosuppressants within 14 days before the first use of the study drug; 1.In the absence of active autoimmune diseases, inhaled or topical use of steroids and adrenal cortical hormones at a dose > 10mg/ day, the therapeutic dose of prednisone, is permitted as a substitute. 9. The patient has an active infection, a fever of unknown cause >=38.5? within 7 days before medication, or a white blood cell count >15×10^9/L during the baseline period; 10. Patients with active bleeding,Patients with peptic ulcers, perforations or intestinal obstructions; 11. Patients who are participating in clinical trials of other drugs; 12. Patients who have received treatment with other immune checkpoint inhibitors simultaneously; 13. Discontinuation of the first-line immunotherapy due to grade 3-4 immune-related adverse events; 14. For those with active pulmonary tuberculosis infection detected through medical history or CT examination, or those with a history of active pulmonary tuberculosis infection within one year before enrollment, or those with a history of active pulmonary tuberculosis infection more than one year ago but without formal treatment, latent tuberculosis infection is determined based on chest X-ray /CT examination, sputum examination and clinical physical examination. 15. According to the researcher's judgment, there are concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate;OS rate of 6 month, 9 month, 12month;Progress free survival;Safety (incidence and severity of adverse events, clinically significant abnormal laboratory findings);Overall survival; | — |
Countries
China
Contacts
Public ContactLan Haitao
Sichuan Provincial People's Hospital
Outcome results
None listed