Advanced rare gastrointestinal tumors (anal squamous cell carcinoma, peritoneal mesothelioma, and peritoneal metastatic cancer) that have failed first-line or above treatment
Conditions
Interventions
Anal squamous cell carcinoma group:Iparomlimab/tuvonralimab,regorafenib
Peritoneal mesothelioma group:Iparomlimab/tuvonralimab,regorafenib
Peritoneal metastases group:Iparomlimab/tuvonralimab,regorafenib
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Sign the informed consent form; 2.18-75 years old, gender not limited; 3.Pathological confirmed anal squamous cell carcinoma, peritoneal mesothelioma, and peritoneal metastatic cancer; 4.Recurrent or metastatic disease, with at least one measurable lesion (RECIST 1.1 criteria) in the subject and an estimated survival time of at least 12 weeks; 5.ECOG score ranges from 0 to 2 points; 6.Failure of first-line or above drug systemic therapy; 7.Having sufficient bone marrow, liver and kidney function: Absolute neutrophil count >= 1500/mm3, platelet count >= 90 × 10^3/mm3, hemoglobin >= 9g/dL; Total bilirubin = 40 ml/min; 8.Women of childbearing age and their spouses are willing to use effective contraceptive methods during the treatment period and within 7 months of the last treatment.
Exclusion criteria
Exclusion criteria: 1.Known to be allergic to the treatment medication received; 2.Baseline LVEF180 mmHg or diastolic blood pressure>100 mmHg), clinically symptomatic heart valve disease, unstable angina, myocardial infarction, or high-risk arrhythmia; 11.Previous or current autoimmune diseases, including but not limited to Crohn's disease, ulcerative colitis, systemic lupus erythematosus, sarcoidosis, Wegener's syndrome (granulomatous disease of multivessel vasculitis), Graves' disease, rheumatoid arthritis, pituitary inflammation, uveitis, autoimmune hepatitis, systemic sclerosis (scleroderma, etc.), Hashimoto's thyroiditis, autoimmune vasculitis, autoimmune neuropathy (Guillain Barre syndrome), etc. Except for the following cases: type I diabetes, hypothyroidism with stable hormone replacement therapy (including hypothyroidism caused by autoimmune thyroid disease), psoriasis or vitiligo without systemic treatment; 12.Patients receiving long-term or high-dose corticosteroid treatment (inhaled steroids or short-term oral steroids are allowed to resist vomiting or promote appetite); 13.Individuals without legal capacity, those whose medical or ethical reasons affect the continuation of research; 14.Pregnant and lactating female patients, or those who wish to conceive during treatment; 15.There is a persistent infection with>level 2 (CTC-AE) present; Unhealed wounds, ulcers, or fractures, or patients with a history of organ transplantation; 16.Having jaundice, ascites, and/or alkaline phosphatase >= 3 times ULN; Persistent proteinuria, urinary protein/creatinine ratio>3.5g/24 hours, or renal failure requiring blood or peritoneal dialysis, and/or >= grade 3 (CTC-AE); 17.Evidence or medical history of coagulation mechanism disorders such as bleeding events of >= grade 3 (CTC-AE); Known human immunodeficiency virus (HIV) infection or hepatitis B and C infection; 18.There are unresolved toxicities (CTC-AE) of grade>1 caused by any previous treatment/procedure, excluding hair loss, anemia, and hypothyroidism; 19.After comprehensive assessment of the patient's condition by the researchers, it is deemed inappropriate for them to participate in this study.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Progression free survival;Overall survival;Safety; | — |
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Countries
China
Contacts
Public ContactXicheng Wang
Peking Union Medical College Hospital
Outcome results
None listed