gallbladder carcinoma
Conditions
Interventions
Cohort A:Iparomlimab and Tuvonralimab: 5.0 mg/kg, intravenous drip, once every 21 days until disease progression or intolerable toxicity
Gemcitabine (1000mg/m2. Body surface area, intravenous infusion), cisplatin (25mg/m2. Body surface area, intravenous infusion
Take the medicine once a week with a 7-day interval. Each course of treatment lasts for 3 weeks, and the maximum treatment cycle is eight courses.
During the maintenance phase, single-agent maintenanc
Cohort B:For patients with advanced gallbladder cancer who have failed treatment with GC or GS regimens, Iparomlimab and Tuvonralimab: 5.0 mg/kg, intravenous drip, once every 21 days, until disease pr
On the first day, continuous intravenous infusion of 5-FU was initiated, with a total dose of 2400mg/m2. The body surface area was covered and the infusion was completed within the second day. The int
Sponsors
The First Affiliated Hospital of Nanchang University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Sign a written informed consent before any trial-related procedures are implemented; 2. Male or female, aged 18 or above, and no more than 75 years old; 3. The ECOG PS score is 0-2 points; 4. Unresectable locally advanced or metastatic (stage IV) gallbladder adenocarcinoma (including gallbladder duct carcinoma) confirmed by tissue or cellular pathology; 5. Has not received PD-1/CTLA-4 dual-target immune checkpoint inhibitor treatment in the past; 6. Expected survival time >3 months; 7. There must be at least one measurable lesion according to RECIST1.1 standards; 8. All acute toxic reactions resulting from previous anti-tumor treatment were relieved to grade 0-1 (according to NCI CTCAE version 5.0) or to an acceptable level in the inclusion/exclusion criteria; 9. Sufficient organ function: WBC >=3.0*10?/L, PLT >=75*10?/L, Hgb >=80g/L; ALT =7 days can be enrolled). ALB>=28g/L; CCr=80ml/min; 10. For women of childbearing age (WOCBP) with negative pregnancy test results (urine or blood) and who agree to use effective contraceptive methods. A woman of childbearing age refers to a person who is biologically capable of getting pregnant. Reliable contraceptive measures must be continuously used from the beginning of the trial screening.
Exclusion criteria
Exclusion criteria: 1. Pleural effusion, ascites and pericardial effusion with clinical symptoms requiring drainage; 2. There is central nervous system metastasis; 3. Those with severe functional disorders of vital organs (heart, liver, kidneys); 4. Known hypersensitivity or allergic reactions to any of the components under study and treatment; 5. Previous history of organ transplantation or autologous/allogeneic stem cell transplantation; 6. Currently undergoing hormone therapy other than chronic systemic immunotherapy or physiological replacement therapy; 7. Any unstable systemic diseases: Active infection, uncontrolled severe hypertension, unstable angina pectoris, angina pectoris that began to occur within the last 3 months, congested functional failure (New York Heart Association [NYHA] >= grade II), myocardial infarction that occurred within 6 months before enrollment, severe arrhythmia requiring drug treatment, gastrointestinal bleeding or active bleeding tendency within 1 month; 8. Combined with other untreated malignant tumors, except for carcinoma in situ in other parts; 9. Any disease, metabolic disorder, or any physical examination or laboratory suspicion that the patient has contraindications to research drugs or high-risk factors for treatment complications; 10. Have received treatment from other clinical trials or are currently conducting another clinical study within 4 weeks prior to the first administration; 11. Pregnancy or lactation; 12. Subjects who are considered by the researchers to have other adverse health conditions or mental states that may affect protocol compliance and the assessment of trial indicators and are not suitable to participate in the study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS);Progression-Free Survival (PFS);Disease Control Rate (DCR);Duration of Response (DOR);safety evaluation ; | — |
Countries
China
Contacts
Public ContactJunhua Ai
The First Affiliated Hospital of Nanchang University
Outcome results
None listed