Esophageal cancer
Conditions
Interventions
Experimental group:Combination therapy of anti-CTLA-4/PD-1 bispecific antibody with chemotherapy
Sponsors
The Second Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Be able to understand and voluntarily sign the written informed consent form, which must be signed before performing the specified study procedures required by the research; 2.Male or female aged >=18 years and =6 months; 5.Patients with unresectable or metastatic advanced esophageal squamous cell carcinoma confirmed by histopathological or cytological examination; 6.Have progressed after receiving at least first-line chemotherapy or discontinued first-line chemotherapy due to intolerance; If disease progression occurs during neoadjuvant/adjuvant chemotherapy or radical chemoradiotherapy or within 6 months after the last treatment, it is considered as having received first-line treatment; 7.At least one measurable lesion according to RECIST v1.1 criteria; 8.Meet the indications and basic requirements for chemotherapy, including essentially normal peripheral blood counts, no significant abnormalities in heart, liver, or kidney function, essentially normal electrocardiogram, and no unhealed wounds on the body; Laboratory indicators must meet the following requirements: Peripheral white blood cells (WBC) >=3.5×10^9/L, platelets (PLT) >=80×10^9/L, hemoglobin (Hb) >=80 g/L; Renal function: Serum creatinine (Cr) <=2.0×upper normal limit (UNL), blood urea nitrogen (BUN) <=2.5×UNL. Liver function: serum bilirubin (BIL) <=2.5×UNL, serum transaminase (ALT/AST) <=2.5×UNL; 9.For subjects who have previously used other chemotherapeutic drugs or radiotherapy, a washout period of at least 4 weeks is required before entering this trial; 10.Voluntary participation with good compliance, ability to cooperate with trial observation, and signed written informed consent form.
Exclusion criteria
Exclusion criteria: 1.patients with severe heart disease or history (including angina requiring medication, refractory hypertension, congestive heart failure, myocardial infarction, uncontrolled high-risk arrhythmia, or valvular heart disease); 2.patients with severe dysfunction of vital organs such as lungs, liver, or kidneys; 3.patients with intestinal obstruction, inflammation, unhealed wounds, ulcers, fistulas, or bleeding disorders; 4.subjects with other malignancies within the past 5 years or concurrent malignancies (excluding cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and breast cancer with no recurrence for >3 years after radical surgery); 5.active or uncontrolled severe infections (>=CTCAE grade 2 infection); 6.patients with current or prior central nervous system (CNS) metastasis; 7.patients requiring antiviral therapy for HIV, HBV, or HCV infection; 8.patients who have received CYP3A inhibitor treatment within the past 2 weeks; 9.patients with uncontrolled neurological or psychiatric disorders, poor compliance, or inability to cooperate and describe treatment responses; 10.patients participating in other clinical trials; 11. any other conditions deemed by the investigator to make the patient unsuitable for this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to Relief (TTR);Duration of Response, DOR;Progression-Free Survival, PFS;Disease Control Rate, DCR;Overall Survival, OS;Safety; | — |
Countries
China
Contacts
Public ContactMingjun Zhang
The Second Affiliated Hospital of Anhui Medical University.
Outcome results
None listed